NPS — IND process tracker

4 open chemical decisions

Lys position
Lys11HomoLysHomoHomoLysOrnithineLys12
v40.22 (Lys11) vs v40.9 (HomoLys11) head-to-head; v40.24 / v40.25 extra reach reads
Chain length
C16C18 satC18:1C20
C16 over-covered. v40.4 reads C18:1. C20 + saturated C18 are KAN gap-fills.
Truncation
1-201-131-12
Covered on both Nle11 (v40.2 / v40.3) and HomoLys11 (v40.10 / v40.11) scaffolds.
no linked tickets
C-terminus
-NH2-OH (free acid)
Only -NH2 in current queue. -OH gap-fill filed.

IND stages at a glance

StageOpenOverdueDoneNext due
Lead optimization 12002026-07-06
Stability + degradation1002026-08-14
PK (methods · studies · scaling/HED · PK-PD)16302026-06-26
Safety + immunogenicity3002026-07-21
GLP / CMC outsourcing7002026-09-08
Regulatory (AU CTN)2002026-09-15

Active studies (preclin.study)

StudyTitleStatusOwnerUpdated
STU-olden-dl-dmuo-st0067NPSv40.9 1000ug vs. NPSv40.9 500ug vs. NPSv40.9 200ug vs. NPSv40.9 100ug vs. Placebo, subq, 100ul, 0.9% saline, n = 15executing2026-07-01
STU-olden-dl-lr5i-st0076NPSv41.8 500ug vs. NPSv41.20 500ug vs. Placebo, 0.9% saline, SQ, n = 15executing2026-07-01
STU-olden-dl-bnkz-st0003NPSv40.2 100ug vs. NPSv40.17 100ug vs. NPSv40.3 100ug vs. NPSv40.5 100ug vs. Placebo, IN, 100ug, 0.25% TMC, 5% HP-beta-cyclodextrin, n = 20executing2026-07-01
STU-olden-dl-qmlo-st0075NPSv40.9 1000ug vs. NPSv40.9 500ug vs. NPSv41.7 1000ug vs. NPSv41.7 500ug vs. Placebo, subq, n = 15executing2026-07-01
STU-olden-dl-nbtc-st0044NPSv40.9 25ug vs. NPSv40.9 50ug vs. NPSv40.9 100ug vs. NPSv40.9 200ug vs. Placebo, IN, 0.25% TMC, 10uL, n = 15executing2026-07-01
STU-olden-dl-hga4-st0078NPSv41.18 500ug vs. NPSv41.13 500ug vs. NPSv40.9 500ug vs. Placebo, SQ, 0.9% saline, n = 15executing2026-07-01
STU-olden-dl-fswz-st0077NPSv41.21 500ug vs. NPSv41.12 500ug vs. NPSv41.8 500ug vs. Placebo, 0.9% saline, subQ, n = 15executing2026-07-01
STU-26-NPS-20260629-001 KAN-87Lead-lock same-plate IP1 for NPSR1 107I and 107N coveragelockediris2026-06-30
STU-26-NPS-20260629-003 KAN-89Accelerated LC-MS stability triage for NPS lead-lock pairlockediris2026-06-30
STU-26-NPS-20260629-002 KAN-88Human albumin functional-shift screen for lipidated NPS leaderslockediris2026-06-30
STU-26-NPS-20260703-003 KAN-123Same-plate IP1 and cAMP bridge for the v40 terminal-state comparator pairdraftiris2026-07-03
STU-26-NPS-20260703-002 KAN-122Fast LC-MS degradation spot-check for NPSv41 hits versus v40 lead-lock comparatorsdraftiris2026-07-03
STU-26-NPS-20260703-001 KAN-121Same-plate IP1 and beta-arrestin triage for NPSv41 low-Emax potency hitsdraftiris2026-07-03
STU-26-NPS-20260702-002 KAN-115Same-plate 107I/107N IP1 bridge for full-Emax NPS backupsdraftiris2026-07-03
STU-26-NPS-20260702-001 KAN-114Same-plate 107I/107N IP1 bridge for NPSv41 potency versus Emax ceilingdraftiris2026-07-03
STU-260701-NPSv417-PKADMENPSv41.7 — SQ/IN PK/ADME, acute + day-14 terminal plasma/braindraftmelissa2026-07-02
STU-26-NPS-20260630-002 KAN-109Same-plate IP1 and beta-arrestin separation screen for v40 leadersdraftiris2026-06-30
STU-26-NPS-20260630-001 KAN-108Same-plate 107I/107N IP1 bridge for NPSv40.24 lead inclusiondraftiris2026-06-30

Overdue across all stages (6)

KeyStatusDueAssigneeVendorCRO progressSummary
KAN-20Idea2026-06-22Moaraj Hasanno vendorpick vendor (-11d to due)SPPS synthesis - NPS 40.9
KAN-24Idea2026-06-26Moaraj Hasanno vendorpick vendor (-7d to due)PK study design + AEC (Animal Ethics Committee) protocol (mouse single-dose IV/SC)
KAN-21Idea2026-06-26Moaraj Hasanno vendorpick vendor (-7d to due)RP-HPLC purification + lyophilization (NXN + NPS)
KAN-16Idea2026-06-26Moaraj Hasanno vendorpick vendor (-7d to due)Peptide Synthesis & Purification
KAN-29Idea2026-06-30Moaraj Hasanno vendorpick vendor (-3d to due)Reference standards, IS qualification + stock/working solutions
KAN-25Idea2026-06-30Moaraj Hasanno vendorpick vendor (-3d to due)Dose formulation, dose verification, and vehicle bridging

Compound × complete-assay coverage

"Complete" assay set: 107I IP1 · 107N IP1 · 107I FLIPR · 107N FLIPR · bArr · cAMP — same-plate, same-producer-batch. Cells show best EC50 in nM and run count. Empty cells (—) are missing reads.
CompoundQtySynthIn-vitro (cell assays)In-vivo + stability
IP1 (107I)IP1 (107N)FLIPR (107I)FLIPR (107N)bArr (107N)cAMP (107N)SC actigraphyEEGPK plasmaPK CSF/brainStability (LC-MS)
NPSv40.9
ANCHOR · Lead candidate — HomoLys11, 1-20, -NH2 — in all three head-to-heads
SF(Nω-methyl-Arg)N(Sar)VGTG(N-Me-Nle)(HomoLys)-K[(γ-E)-(C16 Pal)]-TSFQRAKS-NH2
not trackedthrough HPLC
0.00 nM · n=16
IP1 · hNPSR1 Ile107
dateec50 (nM)hillemax (%)srcnote
2026-07-010.111.2389fitfit_source_file=HEK_NPSR1_107I/Assay_07012026_IP1_Combined_Expt2_Expt3_4Plates/output/fit_parameters.csv
2026-07-010.200.95110fitfit_source_file=HEK_NPSR1_107I/Assay_07012026_IP1_Combined_Expt2_Expt3_4Plates/output/fit_parameters.csv
2026-07-013.390.31129fitfit_source_file=HEK_NPSR1_107I/Assay_07012026_IP1_Combined_Expt2_Expt3_4Plates/output/fit_parameters.csv
2026-07-010.490.27147fitfit_source_file=HEK_NPSR1_107I/Assay_07012026_IP1_Combined_Expt2_Expt3_4Plates/output/fit_parameters.csv
2026-07-013.390.31129trackerFlag: Massive pipetting error / shallow slope (Plate 2/3 artifact)
2026-06-300.200.7994tracker
2026-06-300.021.34102fitfit_source_file=HEK_NPSR1_107I/Assay_06302026_IP1_Expt3_2Plates/output/fit_parameters.csv
2026-06-300.200.7994fitfit_source_file=HEK_NPSR1_107I/Assay_06302026_IP1_Expt3_2Plates/output/fit_parameters.csv
2026-06-300.122.8198fitfit_source_file=HEK_NPSR1_107I/Assay_06302026_IP1_Expt1_4Plates_Repeat/output/fit_parameters.csv
2026-06-300.051.1295fitfit_source_file=HEK_NPSR1_107I/Assay_06302026_IP1_Expt1_4Plates_Repeat/output/fit_parameters.csv
2026-06-260.560.37115fitfit_source_file=HEK_NPSR1_107I/Assay_06262026_IP1_Expt1_4Plates/output/fit_parameters.csv
2026-06-260.560.37trackerExpt1 - Auto-injected
2026-06-260.112.2994fitfit_source_file=HEK_NPSR1_107I/Assay_06262026_IP1_Expt1_4Plates/output/fit_parameters.csv
2026-05-220.048.0061fitfit_source_file=HEK_NPSR1_107I/Assay_05222026_NPS_4Plates/output/fit_parameters.csv
2026-04-170.001.04103wuxiP2; P1: Z'=0.768; P2: Z'=0.833
2026-01-010.0461trackerTested 05/22/2026. R2=0.74.
0.03 nM · n=18
IP1 · hNPSR1 Asn107
dateec50 (nM)hillemax (%)srcnote
2026-07-020.251.2986fitfit_source_file=CHO_NPS_107N/Assay_07022026_IP1_CHO_NPS_4Plates/output/fit_parameters.csv
2026-07-020.251.2986tracker
2026-07-0112.791.08101fitfit_source_file=CHO_NPS_107N/Assay_07012026_cAMP_Expt1_4Plates/output/fit_parameters.csv
2026-07-01395347.570.15-177fitfit_source_file=CHO_NPS_107N/Assay_07012026_cAMP_Expt1_4Plates/output/fit_parameters.csv
2026-06-304.770.95115fitfit_source_file=CHO_NPS_107N/Assay_06302026_cAMP_2Plates/output/fit_parameters.csv
2026-06-303.831.19124fitfit_source_file=CHO_NPS_107N/Assay_06302026_cAMP_2Plates/output/fit_parameters.csv
2026-06-250.220.9299wuxiP1; P1: Z'=0.724; P2: Z'=0.752
2026-06-240.281.11trackerExpt 3 & 4 - Auto-injected
2026-06-240.281.1181fitfit_source_file=CHO_NPS_107N/Assay_06242026_NPS_Expt3_and_4_4Plates/output/fit_parameters.csv
2026-06-240.141.06102fitfit_source_file=CHO_NPS_107N/Assay_06242026_NPS_Expt3_and_4_4Plates/output/fit_parameters.csv
2026-06-230.151.5090fitfit_source_file=CHO_NPS_107N/Assay_06232026_NPS_Expt2_1Plate/output/fit_parameters.csv
2026-06-232.210.5396fitfit_source_file=CHO_NPS_107N/Assay_06232026_NPS_Expt1_4Plates/output/fit_parameters.csv
2026-06-230.311.6299fitfit_source_file=CHO_NPS_107N/Assay_06232026_NPS_Expt1_4Plates/output/fit_parameters.csv
2026-06-230.151.50trackerPlate: plate1
2026-06-192.470.78107fitfit_source_file=CHO_NPS_107N/Assay_06192026_NPS_6Plates/output/fit_parameters.csv
2026-06-192.470.78tracker
2026-06-150.311.4148fitfit_source_file=CHO_NPS_107N/Assay_06152026_NPS_Troubleshooting/output/fit_parameters.csv
2026-04-170.030.84103wuxiP2; P1: Z'=0.747; P2: Z'=0.771
0.62 nM · n=1
Ca2+ · hNPSR1 Ile107
dateec50 (nM)hillemax (%)srcnote
2026-04-170.621.16122wuxiP2; P1: Z'=0.777; P2: Z'=0.581
0.17 nM · n=2
Ca2+ · hNPSR1 Asn107
dateec50 (nM)hillemax (%)srcnote
2026-04-170.170.8287wuxiP2; P1: Z'=0.655; P2: Z'=0.674
2026-04-170.170.8287wuxiP2; P1: Z'=0.655; P2: Z'=0.674
1.47 nM · n=3
bArr · hNPSR1 Asn107
dateec50 (nM)hillemax (%)srcnote
2026-06-034.020.99135wuxiP2; P1: Z'=0.735; P2: Z'=0.756
2026-04-221.470.95108wuxiP2; P1: Z'=0.528; P2: Z'=0.573
2026-04-221.470.95108wuxiP2; P1: Z'=0.528; P2: Z'=0.573
0.12 nM · n=4
cAMP · hNPSR1 Asn107
dateec50 (nM)hillemax (%)srcnote
2026-07-0112.791.08101tracker
2026-06-304.770.95115tracker
2026-04-210.121.00100wuxiP2; P1: Z'=0.733; P2: Z'=0.690
2026-04-210.121.00100wuxiP2; P1: Z'=0.733; P2: Z'=0.690
0-6h: -33% sleep (NPSv41.18 500ug)
0-24h: -28% sleep (NPSv41.18 500ug)
DL-HGA4-st0078 · 12 Olden runs · latest 2026-06-29
post-lockpost-lockpost-lockplanned
NPSv40.22
Lys position · Lys11
SF(Nomega-methyl-Arg)N(Sar)VGTG(N-Me-Nle)K-K[(gamma-E)-(C16 Pal)]-TSFQRAKS-NH2
partial
0.05 nM · n=6
IP1 · hNPSR1 Ile107
dateec50 (nM)hillemax (%)srcnote
2026-06-300.091.0897fitfit_source_file=HEK_NPSR1_107I/Assay_06302026_IP1_Expt1_4Plates_Repeat/output/fit_parameters.csv
2026-06-300.091.0897tracker
2026-06-300.050.44102fitfit_source_file=HEK_NPSR1_107I/Assay_06302026_IP1_Expt1_4Plates_Repeat/output/fit_parameters.csv
2026-06-261.110.37trackerExpt1 - Auto-injected
2026-06-260.071.09100fitfit_source_file=HEK_NPSR1_107I/Assay_06262026_IP1_Expt1_4Plates/output/fit_parameters.csv
2026-06-261.110.37107fitfit_source_file=HEK_NPSR1_107I/Assay_06262026_IP1_Expt1_4Plates/output/fit_parameters.csv
0.10 nM · n=7
IP1 · hNPSR1 Asn107
dateec50 (nM)hillemax (%)srcnote
2026-07-011.090.36113fitfit_source_file=CHO_NPS_107N/Assay_07012026_cAMP_Expt1_4Plates/output/fit_parameters.csv
2026-07-014.810.72100fitfit_source_file=CHO_NPS_107N/Assay_07012026_cAMP_Expt1_4Plates/output/fit_parameters.csv
2026-06-302.791.29145fitfit_source_file=CHO_NPS_107N/Assay_06302026_cAMP_2Plates/output/fit_parameters.csv
2026-06-250.100.78101wuxiP1; P1: Z'=0.724; P2: Z'=0.752
2026-06-230.211.2996fitfit_source_file=CHO_NPS_107N/Assay_06232026_NPS_Expt1_4Plates/output/fit_parameters.csv
2026-06-230.440.82trackerPlate: plate3
2026-06-230.440.8284fitfit_source_file=CHO_NPS_107N/Assay_06232026_NPS_Expt1_4Plates/output/fit_parameters.csv
2.79 nM · n=2
cAMP · hNPSR1 Asn107
dateec50 (nM)hillemax (%)srcnote
2026-07-014.810.72100tracker
2026-06-302.791.29145tracker
plannedpost-lockpost-lockpost-lockplanned
NPSv40.24
Lys position · HomoHomoLys11 (secondary — extra reach)
SF(Nomega-methyl-Arg)N(Sar)VGTG(N-Me-Nle)(HomoHomoLys)-K[(gamma-E)-(C16 Pal)]-TS…
not trackedpartial
0.06 nM · n=6
IP1 · hNPSR1 Ile107
dateec50 (nM)hillemax (%)srcnote
2026-06-300.140.62111fitfit_source_file=HEK_NPSR1_107I/Assay_06302026_IP1_Expt1_4Plates_Repeat/output/fit_parameters.csv
2026-06-300.140.62111tracker
2026-06-300.061.1693fitfit_source_file=HEK_NPSR1_107I/Assay_06302026_IP1_Expt1_4Plates_Repeat/output/fit_parameters.csv
2026-06-260.102.21106fitfit_source_file=HEK_NPSR1_107I/Assay_06262026_IP1_Expt1_4Plates/output/fit_parameters.csv
2026-06-260.224.95trackerExpt1 - Auto-injected
2026-06-260.224.9597fitfit_source_file=HEK_NPSR1_107I/Assay_06262026_IP1_Expt1_4Plates/output/fit_parameters.csv
0.07 nM · n=10
IP1 · hNPSR1 Asn107
dateec50 (nM)hillemax (%)srcnote
2026-07-0138.050.5089fitfit_source_file=CHO_NPS_107N/Assay_07012026_cAMP_Expt1_4Plates/output/fit_parameters.csv
2026-07-015.420.57107fitfit_source_file=CHO_NPS_107N/Assay_07012026_cAMP_Expt1_4Plates/output/fit_parameters.csv
2026-06-306.820.87122fitfit_source_file=CHO_NPS_107N/Assay_06302026_cAMP_2Plates/output/fit_parameters.csv
2026-06-230.251.56100fitfit_source_file=CHO_NPS_107N/Assay_06232026_NPS_Expt1_4Plates/output/fit_parameters.csv
2026-06-230.470.67trackerPlate: plate4
2026-06-230.470.6798fitfit_source_file=CHO_NPS_107N/Assay_06232026_NPS_Expt1_4Plates/output/fit_parameters.csv
2026-06-190.881.09tracker
2026-06-190.881.09101fitfit_source_file=CHO_NPS_107N/Assay_06192026_NPS_6Plates/output/fit_parameters.csv
2026-06-160.280.9174trackerDicey - Plate 4. 67 pM. Partial masking used.
2026-06-160.070.9174fitfit_source_file=CHO_NPS_107N/Assay_06162026_NPS_4Plates_Rescue/output/fit_parameters.csv
1.85 nM · n=1
bArr · hNPSR1 Asn107
dateec50 (nM)hillemax (%)srcnote
2026-06-031.850.92129wuxiP2; P1: Z'=0.735; P2: Z'=0.756
5.42 nM · n=2
cAMP · hNPSR1 Asn107
dateec50 (nM)hillemax (%)srcnote
2026-07-015.420.57107tracker
2026-06-306.820.87122tracker
plannedpost-lockpost-lockpost-lockplanned
NPSv40.25
Lys position · Ornithine11 (secondary)
SF(Nomega-methyl-Arg)N(Sar)VGTG(N-Me-Nle)(Orn)-K[(gamma-E)-(C16 Pal)]-TSFQRAKS-N…
not trackedthrough HPLC
0.12 nM · n=8
IP1 · hNPSR1 Ile107
dateec50 (nM)hillemax (%)srcnote
2026-06-300.121.57104fitfit_source_file=HEK_NPSR1_107I/Assay_06302026_IP1_Expt1_4Plates_Repeat/output/fit_parameters.csv
2026-06-300.192.1394fitfit_source_file=HEK_NPSR1_107I/Assay_06302026_IP1_Expt1_4Plates_Repeat/output/fit_parameters.csv
2026-06-300.131.06105fitfit_source_file=HEK_NPSR1_107I/Assay_06302026_IP1_Expt1_4Plates_Repeat/output/fit_parameters.csv
2026-06-300.192.1394tracker
2026-06-260.600.40trackerExpt1 - Auto-injected
2026-06-260.270.34118fitfit_source_file=HEK_NPSR1_107I/Assay_06262026_IP1_Expt1_4Plates/output/fit_parameters.csv
2026-06-260.600.4097fitfit_source_file=HEK_NPSR1_107I/Assay_06262026_IP1_Expt1_4Plates/output/fit_parameters.csv
2026-06-260.600.79105fitfit_source_file=HEK_NPSR1_107I/Assay_06262026_IP1_Expt1_4Plates/output/fit_parameters.csv
0.16 nM · n=8
IP1 · hNPSR1 Asn107
dateec50 (nM)hillemax (%)srcnote
2026-07-010.280.2097fitfit_source_file=CHO_NPS_107N/Assay_07012026_cAMP_Expt1_4Plates/output/fit_parameters.csv
2026-07-017.532.4699fitfit_source_file=CHO_NPS_107N/Assay_07012026_cAMP_Expt1_4Plates/output/fit_parameters.csv
2026-06-230.472.0296fitfit_source_file=CHO_NPS_107N/Assay_06232026_NPS_Expt1_4Plates/output/fit_parameters.csv
2026-06-230.371.3786fitfit_source_file=CHO_NPS_107N/Assay_06232026_NPS_Expt1_4Plates/output/fit_parameters.csv
2026-06-230.710.8693fitfit_source_file=CHO_NPS_107N/Assay_06232026_NPS_Expt1_4Plates/output/fit_parameters.csv
2026-06-230.710.86trackerPlate: plate2
2026-06-190.160.76102fitfit_source_file=CHO_NPS_107N/Assay_06192026_NPS_6Plates/output_3_4/fit_parameters.csv
2026-06-190.160.76tracker
2.75 nM · n=1
bArr · hNPSR1 Asn107
dateec50 (nM)hillemax (%)srcnote
2026-06-032.750.85129wuxiP2; P1: Z'=0.735; P2: Z'=0.756
7.53 nM · n=1
cAMP · hNPSR1 Asn107
dateec50 (nM)hillemax (%)srcnote
2026-07-017.532.4699tracker
plannedpost-lockpost-lockpost-lockplanned
NPSv40.10
Truncation · 1-13, HomoLys11 scaffold
SF(Nω-methyl-Arg)N(Sar)VGTG(N-Me-Nle)(HomoLys)-K[(γ-E)-(C16 Pal)]-T-NH2
not trackedSPPS complete; awaiting HPLC/MS
0.11 nM · n=9
IP1 · hNPSR1 Ile107
dateec50 (nM)hillemax (%)srcnote
2026-07-010.221.70106tracker
2026-07-010.161.0499fitfit_source_file=HEK_NPSR1_107I/Assay_07012026_IP1_Combined_Expt2_Expt3_4Plates/output/fit_parameters.csv
2026-07-010.221.70106fitfit_source_file=HEK_NPSR1_107I/Assay_07012026_IP1_Combined_Expt2_Expt3_4Plates/output/fit_parameters.csv
2026-05-220.161.0461fitfit_source_file=HEK_NPSR1_107I/Assay_05222026_NPS_4Plates/output/fit_parameters.csv
2026-05-080.110.7781fitfit_source_file=HEK_NPSR1_107I/Assay_05082026_NPS_NXN_HEK/output/fit_parameters.csv
2026-05-060.4477tracker2.5x NPS. Hill=5.0 railed — fit unreliable. Rerun.
2026-05-060.445.0077fitfit_source_file=HEK_NPSR1_107I/Assay_05062026_NPS_IP1/output/fit_parameters.csv
2026-05-060.44fitfit_source_file=HEK_NPSR1_107I/Assay_05062026_NPS_IP1/output/fit_parameters_v2.csv
2026-01-010.1661trackerTested 05/22/2026. R2=0.86.
0.23 nM · n=3
IP1 · hNPSR1 Asn107
dateec50 (nM)hillemax (%)srcnote
2026-06-250.241.03101wuxiP1; P1: Z'=0.724; P2: Z'=0.752
2026-06-230.231.2295fitfit_source_file=CHO_NPS_107N/Assay_06232026_NPS_Expt2_1Plate/output/fit_parameters.csv
2026-06-230.231.22trackerPlate: plate1
0-6h: +22% sleep (EEG NPSv40.10 100ug)
0-24h: +71% sleep (EEG NPSv40.10 100ug)
DL-arPA-st0046 · 2 Olden runs · latest 2026-06-01
NPSv40.11
Truncation · 1-12, HomoLys11 scaffold (verify material quantity)
SF(Nω-methyl-Arg)N(Sar)VGTG(N-Me-Nle)(HomoLys)-K[(γ-E)-(C16 Pal)]-NH2
not trackedthrough HPLC
0.09 nM · n=9
IP1 · hNPSR1 Ile107
dateec50 (nM)hillemax (%)srcnote
2026-07-010.180.48115fitfit_source_file=HEK_NPSR1_107I/Assay_07012026_IP1_Combined_Expt2_Expt3_4Plates/output/fit_parameters.csv
2026-07-010.180.48115trackerFlag: Massive pipetting error / shallow slope (Plate 2/3 artifact)
2026-07-010.130.58110fitfit_source_file=HEK_NPSR1_107I/Assay_07012026_IP1_Combined_Expt2_Expt3_4Plates/output/fit_parameters.csv
2026-05-220.100.7670fitfit_source_file=HEK_NPSR1_107I/Assay_05222026_NPS_4Plates/output/fit_parameters.csv
2026-05-080.280.8183fitfit_source_file=HEK_NPSR1_107I/Assay_05082026_NPS_NXN_HEK/output/fit_parameters.csv
2026-05-060.0994tracker★ SUB-nM HIT: 12x NPS. R²=0.79. Confirm.
2026-05-060.09fitfit_source_file=HEK_NPSR1_107I/Assay_05062026_NPS_IP1/output/fit_parameters_v2.csv
2026-05-060.090.6094fitfit_source_file=HEK_NPSR1_107I/Assay_05062026_NPS_IP1/output/fit_parameters.csv
2026-01-010.1070trackerTested 05/22/2026. R2=0.95.
0.16 nM · n=3
IP1 · hNPSR1 Asn107
dateec50 (nM)hillemax (%)srcnote
2026-06-250.161.00101wuxiP1; P1: Z'=0.724; P2: Z'=0.752
2026-06-230.300.94trackerPlate: plate1
2026-06-230.300.9498fitfit_source_file=CHO_NPS_107N/Assay_06232026_NPS_Expt2_1Plate/output/fit_parameters.csv
planned
NPSv40.2
Truncation · 1-13, Lys11 scaffold
SF(Nω-methyl-Arg)N(Sar)VGTGM(Nle)-K[(γ-E)-(C16 Pal)]-T-NH2
not trackedSPPS complete; awaiting HPLC/MS
17.29 nM · n=3
IP1 · hNPSR1 Ile107
dateec50 (nM)hillemax (%)srcnote
2026-05-0617.290.23154fitfit_source_file=HEK_NPSR1_107I/Assay_05062026_NPS_IP1/output/fit_parameters.csv
2026-05-0617.29fitfit_source_file=HEK_NPSR1_107I/Assay_05062026_NPS_IP1/output/fit_parameters_v2.csv
2026-05-0617.290.23154trackerINACTIVE: EC50=17 nM, R²=0.55, curve essentially flat.
0-6h: +27% sleep (NPSv40.5 100ug)
0-24h: +25% sleep (NPSv40.5 100ug)
DL-BNkZ-st0003 · 1 Olden runs · latest 2026-05-01
NPSv40.3
Truncation · 1-12, Lys11 scaffold
SF(Nω-methyl-Arg)N(Sar)VGTGM(Nle)-K[(γ-E)-(C16 Pal)]-NH2
not trackedthrough HPLC0-6h: +27% sleep (NPSv40.5 100ug)
0-24h: +25% sleep (NPSv40.5 100ug)
DL-BNkZ-st0003 · 1 Olden runs · latest 2026-05-01
NPSv41.1
C-terminus · -OH variant of v40.9 — critical for in-vivo effect-life decision
SF(Nomega-methyl-Arg)N(Sar)VGTG(N-Me-Nle)(HomoLys)-K[(gamma-E)-(C16 Pal)]-TSFQRA…
not trackedthrough HPLC
0.04 nM · n=5
IP1 · hNPSR1 Ile107
dateec50 (nM)hillemax (%)srcnote
2026-07-012.440.32126fitfit_source_file=HEK_NPSR1_107I/Assay_07012026_IP1_Combined_Expt2_Expt3_4Plates/output/fit_parameters.csv
2026-07-010.170.53115fitfit_source_file=HEK_NPSR1_107I/Assay_07012026_IP1_Combined_Expt2_Expt3_4Plates/output/fit_parameters.csv
2026-07-012.440.32126trackerFlag: Massive pipetting error / shallow slope (Plate 2/3 artifact)
2026-06-300.040.7291fitfit_source_file=HEK_NPSR1_107I/Assay_06302026_IP1_Expt3_2Plates/output/fit_parameters.csv
2026-06-300.040.7291tracker
0.17 nM · n=5
IP1 · hNPSR1 Asn107
dateec50 (nM)hillemax (%)srcnote
2026-06-240.451.1484fitfit_source_file=CHO_NPS_107N/Assay_06242026_NPS_Expt3_and_4_4Plates/output/fit_parameters.csv
2026-06-240.451.14trackerExpt 3 & 4 - Auto-injected
2026-06-240.171.14107fitfit_source_file=CHO_NPS_107N/Assay_06242026_NPS_Expt3_and_4_4Plates/output/fit_parameters.csv
2026-06-100.410.65107fitfit_source_file=CHO_NPS_107N/Assay_06102026_NPS_4Plates/analysis/fit_parameters.csv
2026-06-100.410.65107tracker6.7x NPS. R²=0.904.
0-6h: -33% sleep (NPSv41.18 500ug)
0-24h: -28% sleep (NPSv41.18 500ug)
DL-HGA4-st0078 · 2 Olden runs · latest 2026-06-29
post-lockpost-lockpost-lock
NPSv40.23
Secondary · Nω,Nω-dimethyl-Arg3 — add to cell assays where available (lower priority)
SF(Nomega,Nomega-dimethyl-Arg)N(Sar)VGTG(N-Me-Nle)(HomoLys)-K[(gamma-E)-(C16 Pal…
not trackedpartial
0.05 nM · n=8
IP1 · hNPSR1 Ile107
dateec50 (nM)hillemax (%)srcnote
2026-06-300.121.0393fitfit_source_file=HEK_NPSR1_107I/Assay_06302026_IP1_Expt1_4Plates_Repeat/output/fit_parameters.csv
2026-06-300.140.40106fitfit_source_file=HEK_NPSR1_107I/Assay_06302026_IP1_Expt1_4Plates_Repeat/output/fit_parameters.csv
2026-06-300.058.00103fitfit_source_file=HEK_NPSR1_107I/Assay_06302026_IP1_Expt1_4Plates_Repeat/output/fit_parameters.csv
2026-06-300.140.40106tracker
2026-06-260.231.05101fitfit_source_file=HEK_NPSR1_107I/Assay_06262026_IP1_Expt1_4Plates/output/fit_parameters.csv
2026-06-260.130.72108fitfit_source_file=HEK_NPSR1_107I/Assay_06262026_IP1_Expt1_4Plates/output/fit_parameters.csv
2026-06-260.262.39trackerExpt1 - Auto-injected
2026-06-260.262.39111fitfit_source_file=HEK_NPSR1_107I/Assay_06262026_IP1_Expt1_4Plates/output/fit_parameters.csv
0.55 nM · n=6
IP1 · hNPSR1 Asn107
dateec50 (nM)hillemax (%)srcnote
2026-07-014.760.79106fitfit_source_file=CHO_NPS_107N/Assay_07012026_cAMP_Expt1_4Plates/output/fit_parameters.csv
2026-06-251.710.96102wuxiP1; P1: Z'=0.724; P2: Z'=0.752
2026-06-230.550.9295fitfit_source_file=CHO_NPS_107N/Assay_06232026_NPS_Expt1_4Plates/output/fit_parameters.csv
2026-06-230.961.19trackerPlate: plate4
2026-06-230.952.1687fitfit_source_file=CHO_NPS_107N/Assay_06232026_NPS_Expt1_4Plates/output/fit_parameters.csv
2026-06-230.961.1995fitfit_source_file=CHO_NPS_107N/Assay_06232026_NPS_Expt1_4Plates/output/fit_parameters.csv
4.99 nM · n=1
bArr · hNPSR1 Asn107
dateec50 (nM)hillemax (%)srcnote
2026-06-034.991.03123wuxiP2; P1: Z'=0.735; P2: Z'=0.756
4.76 nM · n=1
cAMP · hNPSR1 Asn107
dateec50 (nM)hillemax (%)srcnote
2026-07-014.760.79106tracker
NPSv40.4
Chain length · C18:1 analog of v40.22 (Lys11, 1-20) — cell assays + in-vivo pending
not trackednot in tracker
NPSv41.12
Chain length · C20 + 1-13 truncation, Lys11, -NH2 — in-vivo data in hand
SF(Nomega-methyl-Arg)N(Sar)VGTGMK-K[(gamma-E)-(C20)]-T-NH2
not trackedpartial
0.14 nM · n=2
IP1 · hNPSR1 Asn107
dateec50 (nM)hillemax (%)srcnote
2026-06-190.141.1798fitfit_source_file=CHO_NPS_107N/Assay_06192026_NPS_6Plates/output_3_4/fit_parameters.csv
2026-06-190.141.17tracker
15.68 nM · n=1
bArr · hNPSR1 Asn107
dateec50 (nM)hillemax (%)srcnote
2026-06-0315.680.95110wuxiP2; P1: Z'=0.735; P2: Z'=0.756
0-6h: -82% sleep (NPSv41.8 500ug)
0-24h: -73% sleep (NPSv41.8 500ug)
DL-fsWz-st0077 · 1 Olden runs · latest 2026-06-27
NPSv41.7
Chain length · C20 analog of v40.9 — HomoLys11, 1-20, -NH2 — in-vivo data in hand
SF(Nomega-methyl-Arg)N(Sar)VGTG(N-Me-Nle)(HomoLys)-K[(gamma-E)-(C20)]-TSFQRAKS-N…
not trackedpartial
0.06 nM · n=4
IP1 · hNPSR1 Ile107
dateec50 (nM)hillemax (%)srcnote
2026-07-010.240.8898tracker
2026-07-010.240.8898fitfit_source_file=HEK_NPSR1_107I/Assay_07012026_IP1_Combined_Expt2_Expt3_4Plates/output/fit_parameters.csv
2026-06-300.061.47103tracker
2026-06-300.061.47103fitfit_source_file=HEK_NPSR1_107I/Assay_06302026_IP1_Expt3_2Plates/output/fit_parameters.csv
0.12 nM · n=7
IP1 · hNPSR1 Asn107
dateec50 (nM)hillemax (%)srcnote
2026-06-240.192.10trackerExpt 3 & 4 - Auto-injected
2026-06-240.181.26102fitfit_source_file=CHO_NPS_107N/Assay_06242026_NPS_Expt3_and_4_4Plates/output/fit_parameters.csv
2026-06-240.192.1092fitfit_source_file=CHO_NPS_107N/Assay_06242026_NPS_Expt3_and_4_4Plates/output/fit_parameters.csv
2026-06-190.141.01tracker
2026-06-190.141.0197fitfit_source_file=CHO_NPS_107N/Assay_06192026_NPS_6Plates/output_3_4/fit_parameters.csv
2026-06-100.122.9296tracker23.5x NPS. R²=0.772.
2026-06-100.122.9296fitfit_source_file=CHO_NPS_107N/Assay_06102026_NPS_4Plates/analysis/fit_parameters.csv
0-6h: -94% sleep (NPSv40.9 500ug)
0-24h: -77% sleep (NPSv41.7 1000ug)
DL-QMLo-st0075 · 2 Olden runs · latest 2026-06-25
NPSv41.8
Chain length · C20 + 1-13 truncation, HomoLys11, -NH2 — in-vivo data in hand
SF(Nomega-methyl-Arg)N(Sar)VGTG(N-Me-Nle)(HomoLys)-K[(gamma-E)-(C20)]-T-NH2
not trackedpartial
0.11 nM · n=2
IP1 · hNPSR1 Ile107
dateec50 (nM)hillemax (%)srcnote
2026-07-010.111.2182fitfit_source_file=HEK_NPSR1_107I/Assay_07012026_IP1_Combined_Expt2_Expt3_4Plates/output/fit_parameters.csv
2026-07-010.111.2182tracker
0.08 nM · n=6
IP1 · hNPSR1 Asn107
dateec50 (nM)hillemax (%)srcnote
2026-07-020.111.7972fitfit_source_file=CHO_NPS_107N/Assay_07022026_IP1_CHO_NPS_4Plates/output/fit_parameters.csv
2026-07-020.111.7972tracker
2026-06-301.171.18179fitfit_source_file=CHO_NPS_107N/Assay_06302026_cAMP_2Plates/output/fit_parameters.csv
2026-06-300.821.03115fitfit_source_file=CHO_NPS_107N/Assay_06302026_cAMP_2Plates/output/fit_parameters.csv
2026-06-190.081.2696fitfit_source_file=CHO_NPS_107N/Assay_06192026_NPS_6Plates/output_3_4/fit_parameters.csv
2026-06-190.081.26tracker
1.17 nM · n=1
cAMP · hNPSR1 Asn107
dateec50 (nM)hillemax (%)srcnote
2026-06-301.171.18179tracker
0-6h: -82% sleep (NPSv41.8 500ug)
0-24h: -73% sleep (NPSv41.8 500ug)
DL-fsWz-st0077 · 2 Olden runs · latest 2026-06-27

Planned SC mouse studies (@Jigisha)

StudyArmsStatus / note
Lys11 SC studyNPSv40.9 · NPSv40.22 · NPSv40.24 · NPSv40.25@Jigisha — n≥20/group, 1-page plan, verify material first
Truncation SC studyNPSv40.9 · NPSv40.10 · NPSv40.11 · NPSv40.2 · NPSv40.3@Jigisha — n≥20/group, 1-page plan, verify material first
C-terminus SC studyNPSv40.9 · NPSv41.1@Jigisha — critical for finalising -NH2 vs -OH on in-vivo effect-life

Synthesis workstream (@Nico, @Hillary)

Chemistry ask (@Nico): one clean ≥95% pure in-house batch each of v40.9, v40.22, v40.24, v40.25, v41.1.
KeyStatusDueAssigneeVendorCRO progressSummary
KAN-20Idea2026-06-22Moaraj Hasanin-housein-houseSPPS synthesis - NPS 40.9
KAN-21Idea2026-06-26Moaraj Hasanin-housein-houseRP-HPLC purification + lyophilization (NXN + NPS)
KAN-16Idea2026-06-26Moaraj Hasanin-housein-housePeptide Synthesis & Purification

Analytical QC workstream (@Mo)

KeyStatusDueAssigneeVendorCRO progressSummary
KAN-17Idea2026-07-03Moaraj Hasanin-housein-houseAnalytical QC / Mass Spec ID

In-vitro potency workstream (@Stephen)

KeyStatusDueAssigneeVendorCRO progressSummary
KAN-23Idea2026-07-17Moaraj Hasanin-housein-houseNPSR1 IP1 EC50 assay — NPS 40.9
KAN-18Idea2026-07-17Moaraj Hasanin-housein-houseIn-vitro Potency (OX2 IP1 / EC50)

Mechanism + efficacy workstream (in-vitro target engagement, selectivity panel)

KeyStatusDueAssigneeVendorCRO progressSummary
KAN-40Idea2026-07-15Moaraj Hasanin-housein-houseIn-vitro target engagement + selectivity panel
KAN-41Idea2026-08-05Moaraj Hasanin-housein-houseIn-vivo efficacy / target-engagement model (mouse)
KAN-42Idea2026-08-31Moaraj Hasanin-housein-houseMechanism-of-action omics readout + brain exposure

Filed Iris gap-fills (review needed)

Some of these are now redundant with the 2026-06-30 state-of-the-union — see notes.
KANAxisStatus / note
KAN-90Chain lengthC20 lipid analog — realized as NPSv41.7 (HomoLys11) and NPSv41.8/v41.12 (truncated); in-vivo data confirmed, compounds promoted to LEAD_OPT_TABLE
KAN-91C-terminusFree-acid (-OH) analog — already in flight as NPSv41.1; close as duplicate
KAN-92Chain lengthSaturated C18 analog — DEFER (future-NPS lever)
KAN-93CMCCMC + accelerated-degradation — re-scope as external-contractor work (Helena owns)

Active engagements (57)

Populated from preclin.cro_capability — writes flow from forwarded CRO emails + Slack @iris cro.
VendorWorkstreamStatusOwnerCRO progressLast engagementNotes
Avanceclinical_phase_1_croRFQ sentmelissaRFQ sent · Being asked whether same batch should support tox Being asked whether same batch should support tox and Phase I for TGA; no contract detail in document.
CMAXclinical_phase_1_crono contractmelissano_contractListed in the Phase 1 CRO assessment with Adelaide noted as location; no contract or contact details shown.
GLGclinical_phase_1_crono contractmelissano_contract2026-05-15Indication debrief calls for arranging 3 Sleep KOL interviews through GLG to confirm unmet need/current clinical practice and discuss Kleine Levin Syndrome before drafting the Phase 1 protocol, then circling back with KOLs after protocol completion.
Guidepointclinical_phase_1_crono contractmelissano_contract2026-05-27Discussed as an option for sourcing additional consultants/expert-network support for Australian clinical trial resourcing; no direct contact or contract detail in document.
Linear Clinical Researchclinical_phase_1_crono contractmelissano_contractListed as a Phase 1 clinical CRO assessment option; no contract or contact details shown.
Novotechclinical_phase_1_croRFQ sentmelissaRFQ sent · Being asked whether same batch should support tox Being asked whether same batch should support tox and Phase I for TGA; no contract detail in document.
Novotrialsclinical_phase_1_crono contractmelissano_contractListed in the Phase 1 CRO assessment; Newcastle location, brand new 30-bed unit, Phase 2/3/4 experience, and best cost noted. No contract or contact details shown.
Nucleus Networkclinical_phase_1_crono contractmelissano_contractListed as a Phase 1 clinical CRO assessment option; Brisbane and Melbourne noted as locations. No contract or contact details shown.
SSRclinical_phase_1_crono contractmelissano_contractPhase 1 CRO assessment notes SSR will review the intranasal device/medicine; CRO-contract-to-dosing timeline estimated at 3 months; recruitment noted as 30 patients in 2-4 months with 20% dropout allowed; usually one site; communication plan needed; 2 medical monitors; emergency response via GP/ex-GP; FDA/EMA audit track record noted as good so far with last audit in 2019.
Scientia Clinical Researchclinical_phase_1_crono contractmelissano_contractListed as a Phase 1 clinical CRO assessment option; no contract or contact details shown.
AmbioPharmcmc_drug_substance_gmpRFQ sentmelissaRFQ open 162d · Discussed for CAPABLE-001 Phase I API manufacturin2026-01-22Discussed for CAPABLE-001 Phase I API manufacturing as a fast GMP peptide option at gram-kg scale; no response to inquiry.
ApiSyn Healthcarecmc_drug_substance_gmpMSAmelissaMSA signed · CDA signed and peptide sequence shared; follow-up CDA signed and peptide sequence shared; follow-up needed for calls.
Aurigene Pharmaceutical Servicescmc_drug_substance_gmpno contractmelissano_contractResponsive initial contact; Helena and Nico to meet team once specifications are confirmed.
BCN Peptidescmc_drug_substance_gmpRFQ sentmelissaRFQ open 162d · Discussed for CAPABLE-001 Phase I API manufacturin2026-01-22Discussed for CAPABLE-001 Phase I API manufacturing as an EU GMP peptide option; first response took 4 days and status was slow response.
Bioconcmc_drug_substance_gmpno contractmelissano_contract2026-06-02Call completed; judged not suitable due to large scale and fewer drug discovery capabilities. Referred Capable to Syngene.
CPC Scientificcmc_drug_substance_gmpquote inmelissaQuote in · Detailed quote provided for CAPABLE-001 Phase I AP2026-01-22Detailed quote provided for CAPABLE-001 Phase I API manufacturing: $286K, non-GMP in March or full GMP in April-May. Put on hold because too expensive and unable to meet the Feb/March target for Phase I-ready material.
Catalentcmc_drug_substance_gmpRFQ sentmelissaRFQ open 162d · Discussed for CAPABLE-001 Phase I API manufacturin2026-01-22Discussed for CAPABLE-001 Phase I API manufacturing as a large CDMO network option; no response to inquiry.
Chinapeptidescmc_drug_substance_gmpno contractmelissano_contract2026-01-22Declined for CAPABLE-001 Phase I API manufacturing because Chinapeptides could not establish GMP-like capability on the required timeline and quoted $700K for facility setup.
CordenPharmacmc_drug_substance_gmpRFQ sentmelissaRFQ open 162d · Discussed for CAPABLE-001 Phase I API manufacturin2026-01-22Discussed for CAPABLE-001 Phase I API manufacturing as a GMP network EU/US option; no response to inquiry.
Eurogenteccmc_drug_substance_gmpRFQ sentmelissaRFQ open 162d · Discussed for CAPABLE-001 Phase I API manufacturin2026-01-22Discussed for CAPABLE-001 Phase I API manufacturing as a GMP peptide manufacturing option; no response to inquiry.
Laurus Labscmc_drug_substance_gmpRFQ sentmelissaRFQ sent · Capable NDA shared; awaiting signature before discCapable NDA shared; awaiting signature before discussing needs.
Piramal Pharma Solutionscmc_drug_substance_gmpquote inmelissaQuote in · Timeline quoted as 18 weeks; awaiting cost, NT to Timeline quoted as 18 weeks; awaiting cost, NT to chase.
PolyPeptide Groupcmc_drug_substance_gmpMSAmelissaMSA signed 2026-01-22 · CAPABLE-001 Phase I API manufacturing option liste2026-01-22CAPABLE-001 Phase I API manufacturing option listed as viable at $95K with 12 week timeline; CDA signed. Strengths noted: scalable process, consistent impurity profile for Phase II, AU experience, and lower cost; risk was longer timeline versus WuXi and possible miss of Q1 target.
Ramshan Lifesciencescmc_drug_substance_gmpno contractmelissano_contractNo response to calls, emails, and website outreach.
Saicmc_drug_substance_gmpno contractmelissano_contractListed in India CROs manufacturing tracker; no response to outreach by calls, emails, and website.
Sinopepcmc_drug_substance_gmpquote inmelissaQuote in · Quote received for CAPABLE-001 Phase I API manufac2026-01-22Quote received for CAPABLE-001 Phase I API manufacturing at $200K. Scope included end-to-end peptide CMC plus cGMP capability and 15 g for analytical development, which was over-scoped for the 500 mg need.
Syngenecmc_drug_substance_gmpquote inmelissaQuote in · Syngene provided proposal CD/Tides/01072026/47287/2026-07-01Syngene provided proposal CD/Tides/01072026/47287/1.0/NC for process familiarization, ~5 g PoC/lab synthesis, and ~200 g non-GMP 49-mer peptide synthesis. Quoted price is $651,940 with 27-week lead time including ~5 weeks raw material procurement; project starts after WO/PO execution. Scope includes analytical method development and analytical test report, with tentative HPLC purity NLT 95% to be confirmed.
VB Shilpacmc_drug_substance_gmpquote inmelissaQuote in · Chased Shriya, VP BD; non-responsive as of 2026-062026-06-02 📧Chased Shriya, VP BD; non-responsive as of 2026-06-02.
Viva Biotechcmc_drug_substance_gmpquote inmelissaQuote in · Quote received for CAPABLE-001: $62K tox-only batc2026-01-22Quote received for CAPABLE-001: $62K tox-only batch in 5 weeks or $676K full IND package in 25 weeks. Tox-only material was fast and cheap but would not meet Phase I requirements; full package was too slow and expensive.
VivaBiotechcmc_drug_substance_gmpquote inmelissaQuote in · VivaBiotech remains a possible secondary/tox-only VivaBiotech remains a possible secondary/tox-only option at $62K for tox batch in 5 weeks or $676K for full package in 25 weeks, but tox-only material is not adequate for Phase I human material and would require bridging analytics to show representativeness of the clinical batch. Preferred approach is one batch unless PolyPeptide slips or MIT/HMS in-house tox is not viable.
WuXi TIDEScmc_drug_substance_gmpquote inmelissaQuote in · CAPABLE-001 Phase I API manufacturing option liste2026-01-22CAPABLE-001 Phase I API manufacturing option listed as viable at $120K with 7-8 week timeline; fastest viable option with AU Phase I experience and ability to ship under quarantine. Status was active with Monday call scheduled; needed clarification whether validated release meant full ICH Q2 or phase-appropriate qualification.
PolyPeptide Groupcmc_ich_q1a_stabilityexpiredmelissaexpired 2026-02-112026-02-11Optional non-GMP stability study proposed for each non-GMP batch at -20C, 5C, and 25C/60% RH through 24 months, measuring appearance, water content, and purity at scheduled timepoints. Pricing is $15,000 initiation, $25,000 at 12 months, and $10,000 at 24 months. Covered under proposal QT-15449, valid for 90 days and not contractual unless a written Work Order is mutually executed.
Viva Biotechcmc_ich_q1a_stabilityquote inmelissaQuote in · Viva quotation DPT-251219 includes stability studyViva quotation DPT-251219 includes stability study reports and analytical method validation reports as documentation deliverables within the IND-enabling package. No executed contract or PO is evidenced; payment terms are contingent on contract signing.
Charles River Laboratoriesgenotox_amesquote inmelissaQuote in · Charles River is listed as one of the parallel gen2026-05-12 📧Charles River is listed as one of the parallel genotoxicity vendor options to source AMES plus chromosomal aberration plus micronucleus, estimated around $100K and 8-12 weeks, with no timeline extension if contracted alongside in vivo tox.
Covancegenotox_amesno contractmelissano_contract2026-04-05Discussed as a parallel genotoxicity vendor option for the required genotox battery; no contact, quote, or contract documented.
Eurofinsgenotox_amesno contractmelissano_contract2026-04-05Discussed as a parallel genotoxicity vendor option for the required genotox battery; no contact, quote, or contract documented.
WuXi AppTec (HongKong) Limited / XenoBiotic Laboratories, Incgenotox_amesquote inmelissaQuote in · Quotation includes a GLP FDA/OECD bacterial revers2026-01-07Quotation includes a GLP FDA/OECD bacterial reverse mutation assay (Ames).
Charles River Laboratoriesgenotox_micronucleusquote inmelissaQuote in · Charles River is listed as one of the parallel gen2026-05-12 📧Charles River is listed as one of the parallel genotoxicity vendor options to source AMES plus chromosomal aberration plus micronucleus, estimated around $100K and 8-12 weeks, with no timeline extension if contracted alongside in vivo tox.
Covancegenotox_micronucleusno contractmelissano_contract2026-04-05Discussed as a parallel genotoxicity vendor option for the required genotox battery, including micronucleus; no contact, quote, or contract documented.
Eurofinsgenotox_micronucleusno contractmelissano_contract2026-04-05Discussed as a parallel genotoxicity vendor option for the required genotox battery, including micronucleus; no contact, quote, or contract documented.
WuXi AppTec (HongKong) Limited / XenoBiotic Laboratories, Incgenotox_micronucleusquote inmelissaQuote in · Quotation includes a GLP FDA/OECD in vivo peripher2026-01-07Quotation includes a GLP FDA/OECD in vivo peripheral blood micronucleus assay in rats using FCM with SEND.
IIT Research Instituteglp_tox_non_rodentexpiredmelissaexpired 2026-01-052026-01-05IITRI recommended for pivotal GLP repeat-dose intranasal tox in rats plus dogs, using dog as non-rodent; dog selection carries an explicitly accepted scientific risk versus monkeys because NPSR1 is more conserved in monkeys. Quote expired Mar 5, 2026 and must be reconfirmed.
Pharmaron, Inc.glp_tox_non_rodentexpiredmelissaexpired 2026-01-222026-01-22Pharmaron quotation PH-AXNC-TSP-2026-01 dated 2026-01-22 covers non-rodent toxicology options including 14-day dog/primate/pig DRF studies and 2-week/4-week GLP repeat-dose toxicity/TK studies in dogs, primates, and pigs with recovery, SEND, dose formulation confirmation, ADA, and related bioanalytical/analytical chemistry support. Quote validity was 30 days from issuance.
WuXi AppTec (HongKong) Limited / XenoBiotic Laboratories, Incglp_tox_non_rodentquote inmelissaQuote in · Quotation covers a 14-day repeated intranasal dose2026-01-07Quotation covers a 14-day repeated intranasal dose toxicity and toxicokinetics study in Beagle dogs with a 14-day recovery period under GLP FDA/OECD.
Charles River Laboratoriesglp_tox_rodentno contractmelissano_contract2026-06-30 📧Toxicology decision debrief recommends Sprague-Dawley rats plus Beagle dogs for GLP repeat-dose intranasal toxicology studies supporting AU TGA CTN Phase I submission of Capable 101, with a recommended 14-day toxicology duration because comparable Phase 1 MAD dosing timelines were 14 days.
IIT Research Instituteglp_tox_rodentexpiredmelissaexpired 2026-01-052026-01-05IITRI recommended for pivotal GLP repeat-dose intranasal tox in rats plus dogs, primarily for speed from US-based logistics; quote CA01.05.2026 expired Mar 5, 2026 and pricing/slot availability must be reconfirmed before PO.
Pharmaron, Inc.glp_tox_rodentexpiredmelissaexpired 2026-01-222026-01-22Pharmaron quotation PH-AXNC-TSP-2026-01 dated 2026-01-22 covers 2-week and 4-week GLP repeat-dose toxicity/TK studies in Sprague Dawley rats via intranasal dosing, with 2-week recovery, dose formulation confirmation, SEND, FOB/respiratory evaluation, ADA, optional cytokine/immunophenotyping, histopathology, and bioanalytical/analytical chemistry support. Quote validity was 30 days from issuance.
WuXi AppTec (HongKong) Limited / XenoBiotic Laboratories, Incglp_tox_rodentquote inmelissaQuote in · Quotation covers a 14-day repeated intranasal dose2026-01-07Quotation covers a 14-day repeated intranasal dose toxicity and toxicokinetics study in rats with a 14-day recovery period under GLP FDA/OECD.
IIT Research Institutehistologyquote inmelissaQuote in · IITRI GLP tox estimates include histology/patholog2026-01-05IITRI GLP tox estimates include histology/pathology processing and microscopic evaluation, including detailed nasal cavity evaluation, with additional-cost target-tissue evaluation where applicable.
Pharmaron, Inc.histologyquote inmelissaQuote in · Quotation includes histopathology processing/evalu2026-01-22Quotation includes histopathology processing/evaluation options by a DACVP pathologist for rodent and non-rodent tox studies.
iHisto Inc.histologyPOmelissaPO live · Safety tissues shipped to iHisto Inc. (Salem, MA) 2026-06-30 📧Safety tissues shipped to iHisto Inc. (Salem, MA) via UPS Next Day Air Early on 2026-06-30, tracking 1Z99F400A003060964. Shipped from Bonneville Labs. Hazardous materials, adult signature required. Moaraj noted significant team effort to get tissues out.
Charles River Laboratoriessafety_pharm_ich_s7aquote inmelissaQuote in · Charles River SOW OPP-423634 includes Manual Patch2026-06-30 📧Charles River SOW OPP-423634 includes Manual Patch Clamp hERG Assay at the Cleveland facility with analytical chemistry, plus HPLC-UV method development and validation for hERG formulations. No MSA is in place; SOW signature and PO are required before work initiation/scheduling confirmation.
Cyprotexsafety_pharm_ich_s7aRFQ sentmelissaRFQ sent · NDA shared from Capable for hERG/genotox vendor evNDA shared from Capable for hERG/genotox vendor evaluation.
IIT Research Institutesafety_pharm_ich_s7aexpiredmelissaexpired 2026-01-052026-01-05IITRI tox package bundles in vivo safety pharmacology endpoints: dog ECG/CV assessment for ICH S7A and rat FOB/respiratory recording. Standalone in vitro hERG may still be needed under ICH S7B; confirm with Avance/Novotech. IITRI quote expired Mar 5, 2026.
Pharmalegacysafety_pharm_ich_s7aRFQ sentmelissaRFQ sent · Quote requested for hERG/genotox vendor evaluationQuote requested for hERG/genotox vendor evaluation.
Pharmaron, Inc.safety_pharm_ich_s7aexpiredmelissaexpired 2026-01-222026-01-22Pharmaron toxicology quotation includes safety-pharmacology-relevant endpoints embedded in GLP toxicology designs: rat FOB and respiratory evaluations, plus dog blood pressure and ECG monitoring around Tmax. Quote validity was 30 days from issuance.
WuXi AppTec (HongKong) Limited / XenoBiotic Laboratories, Incsafety_pharm_ich_s7aquote inmelissaQuote in · Quotation includes a GLP FDA/OECD hERG assay using2026-01-07Quotation includes a GLP FDA/OECD hERG assay using the manual patch-clamp platform.

Open gaps (13) — KAN tickets with no contracted vendor

KANDueAssigneeSummary
KAN-402026-07-15Moaraj HasanIn-vitro target engagement + selectivity panel
KAN-432026-07-21Moaraj HasanIn-vitro safety pharmacology (hERG, cardiovascular liability)
KAN-412026-08-05Moaraj HasanIn-vivo efficacy / target-engagement model (mouse)
KAN-442026-08-10Moaraj HasanImmunogenicity / ADA assay strategy + in-silico risk
KAN-452026-08-31Moaraj HasanGLP tox study design + DART deferral justification
KAN-422026-08-31Moaraj HasanMechanism-of-action omics readout + brain exposure
KAN-712026-09-08Moaraj HasanGMP clinical batch manufacture (API) + batch record + CoA
KAN-752026-09-15Moaraj HasanClinical protocol + synopsis (FIH SAD)
KAN-692026-09-15Moaraj HasanGenotoxicity battery (Ames + in vitro micronucleus)
KAN-742026-09-22Moaraj HasanAuthor Investigator's Brochure (IB)
KAN-722026-09-22Moaraj HasanDrug product CMC: sterile injectable formulation, fill-finish, container-closure
KAN-682026-09-22Moaraj HasanGLP repeat-dose toxicology study (non-rodent) - execution + report
KAN-732026-09-29Moaraj HasanICH Q1A stability program on clinical API + DP lots

Stability + degradation

1 open 0 done
KeyStatusDueAssigneeVendorCRO progressSummary
KAN-15Idea2026-08-14Moaraj Hasanno vendorpick vendor (42d to due)Forced degradation study + impurity criteria

PK (methods · studies · scaling/HED · PK-PD)

16 open 3 overdue 0 done
CRO progress (Drive): 📁 Preclinical development
KeyStatusDueAssigneeVendorCRO progressSummary
KAN-24Idea2026-06-26Moaraj Hasanno vendorpick vendor (-7d to due)PK study design + AEC (Animal Ethics Committee) protocol (mouse single-dose IV/SC)
KAN-29Idea2026-06-30Moaraj Hasanno vendorpick vendor (-3d to due)Reference standards, IS qualification + stock/working solutions
KAN-25Idea2026-06-30Moaraj Hasanno vendorpick vendor (-3d to due)Dose formulation, dose verification, and vehicle bridging
KAN-30Idea2026-07-08Moaraj Hasanno vendorpick vendor (5d to due)Calibration curve + selectivity/specificity (ICH M10)
KAN-26Idea2026-07-10Moaraj Hasanno vendorpick vendor (7d to due)In-life dosing + serial plasma collection (0-24 h timecourse)
KAN-31Idea2026-07-18Moaraj Hasanno vendorpick vendor (15d to due)Accuracy + precision validation runs (within/between-run)
KAN-27Idea2026-07-18Moaraj Hasanno vendorpick vendor (15d to due)Bioanalysis of PK samples on validated 6495D method
KAN-32Idea2026-07-22Moaraj Hasanno vendorpick vendor (19d to due)Matrix effect, recovery, dilution integrity, carryover
KAN-35Idea2026-07-28Moaraj Hasanno vendorpick vendor (25d to due)Cross-species in-vitro scaling inputs (clearance, binding, stability)
KAN-28Idea2026-07-31Moaraj Hasanno vendorpick vendor (28d to due)Non-compartmental PK analysis + IV/SC parameter report
KAN-33Idea2026-08-08Moaraj Hasanno vendorpick vendor (36d to due)Stability validation (stock, bench, freeze-thaw, long-term, autosampler)
KAN-36Idea2026-08-10Moaraj Hasanno vendorpick vendor (38d to due)Allometric scaling model (CL, Vss) + human PK prediction
KAN-38Idea2026-08-10Moaraj Hasanno vendorpick vendor (38d to due)PK/PD biomarker + exposure-response model build
KAN-37Idea2026-08-21Moaraj Hasanno vendorpick vendor (49d to due)Human starting dose: MABEL + NOAEL/BSA HED + safety factor
KAN-34Idea2026-08-28Moaraj Hasanno vendorpick vendor (56d to due)ICH M10 bioanalytical validation report sign-off
KAN-39Idea2026-08-28Moaraj Hasanno vendorpick vendor (56d to due)Clinical dose-escalation scheme + projected exposure margins

Safety + immunogenicity

3 open 0 done
CRO progress (Drive): 📁 Tox Studies
KeyStatusDueAssigneeVendorCRO progressSummary
KAN-43Idea2026-07-21Moaraj Hasanno vendorpick vendor (18d to due)In-vitro safety pharmacology (hERG, cardiovascular liability)
KAN-44Idea2026-08-10Moaraj Hasanno vendorpick vendor (38d to due)Immunogenicity / ADA assay strategy + in-silico risk
KAN-45Idea2026-08-31Moaraj Hasanno vendorpick vendor (59d to due)GLP tox study design + DART deferral justification

GLP / CMC outsourcing

7 open 0 done
KeyStatusDueAssigneeVendorCRO progressSummary
KAN-71Idea2026-09-08Moaraj Hasanno vendorpick vendor (67d to due)GMP clinical batch manufacture (API) + batch record + CoA
KAN-69Idea2026-09-15Moaraj Hasanno vendorpick vendor (74d to due)Genotoxicity battery (Ames + in vitro micronucleus)
KAN-67Idea2026-09-15Moaraj HasanCharles River Laboratories · no contract no_contractGLP repeat-dose toxicology study (rodent) - execution + report
KAN-72Idea2026-09-22Moaraj Hasanno vendorpick vendor (81d to due)Drug product CMC: sterile injectable formulation, fill-finish, container-closure
KAN-70Idea2026-09-22Moaraj HasanCharles River Laboratories · quote in Quote in · Charles River SOW OPP-423634 includes Manual PatchSafety pharmacology core battery (ICH S7A: CV, CNS, respiratory)
KAN-68Idea2026-09-22Moaraj Hasanno vendorpick vendor (81d to due)GLP repeat-dose toxicology study (non-rodent) - execution + report
KAN-73Idea2026-09-29Moaraj Hasanno vendorpick vendor (88d to due)ICH Q1A stability program on clinical API + DP lots

Regulatory (AU CTN)

2 open 0 done
CRO progress (Drive): 📁 Phase 1 trial
KeyStatusDueAssigneeVendorCRO progressSummary
KAN-75Idea2026-09-15Moaraj Hasanno vendorpick vendor (74d to due)Clinical protocol + synopsis (FIH SAD)
KAN-74In Progress2026-09-22Moaraj Hasanno vendorpick vendor (81d to due)Author Investigator's Brochure (IB)