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 + degradation000
PK (methods · studies · scaling/HED · PK-PD)000
Safety + immunogenicity000
GLP / CMC outsourcing4002026-09-08
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-20260703-004 KAN-165Same-plate Gq and beta-arrestin bias gate for v40.9 and v41 challengersdraftiris2026-07-03
STU-26-NPS-20260703-003 KAN-164Same-plate truncation check for v40.22-v40.25 versus v40.9draftiris2026-07-03
STU-26-NPS-20260703-002 KAN-158Rapid LC-MS stability add-on for v41 challengers versus v40.9draftiris2026-07-03
STU-26-NPS-20260703-001 KAN-157Same-plate 107I/107N IP1 triage of v41 challengers against v40.9draftiris2026-07-03
STU-260701-NPSv417-PKADMENPSv41.7 — SQ/IN PK/ADME, acute + day-14 terminal plasma/braindraftmelissa2026-07-02

Overdue across all stages (0)

KeyStatusDueAssigneeVendorCRO progressSummary
none

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
2026-07-013.390.31129fitfit_source_file=HEK_NPSR1_107I/Assay_07012026_IP1_Combined_Expt2_Expt3_4Plates/output/fit_parameters.csv
2026-07-010.111.2389fitfit_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)
2026-07-010.200.95110fitfit_source_file=HEK_NPSR1_107I/Assay_07012026_IP1_Combined_Expt2_Expt3_4Plates/output/fit_parameters.csv
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
2026-06-300.051.1295fitfit_source_file=HEK_NPSR1_107I/Assay_06302026_IP1_Expt1_4Plates_Repeat/output/fit_parameters.csv
2026-06-300.122.8198fitfit_source_file=HEK_NPSR1_107I/Assay_06302026_IP1_Expt1_4Plates_Repeat/output/fit_parameters.csv
2026-06-300.200.7994tracker
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
2026-07-020.251.2986tracker
2026-07-020.251.2986fitfit_source_file=CHO_NPS_107N/Assay_07022026_IP1_CHO_NPS_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
2026-07-0112.791.08101fitfit_source_file=CHO_NPS_107N/Assay_07012026_cAMP_Expt1_4Plates/output/fit_parameters.csv
2026-06-303.831.19124fitfit_source_file=CHO_NPS_107N/Assay_06302026_cAMP_2Plates/output/fit_parameters.csv
2026-06-304.770.95115fitfit_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
2026-06-240.281.1181fitfit_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
2026-06-240.281.11trackerExpt 3 & 4 - Auto-injected
2026-06-230.151.5090fitfit_source_file=CHO_NPS_107N/Assay_06232026_NPS_Expt2_1Plate/output/fit_parameters.csv
2026-06-230.151.50trackerPlate: plate1
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
2026-06-192.470.78107fitfit_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
2026-06-300.050.44102fitfit_source_file=HEK_NPSR1_107I/Assay_06302026_IP1_Expt1_4Plates_Repeat/output/fit_parameters.csv
2026-06-300.091.0897tracker
2026-06-300.091.0897fitfit_source_file=HEK_NPSR1_107I/Assay_06302026_IP1_Expt1_4Plates_Repeat/output/fit_parameters.csv
2026-06-260.071.09100fitfit_source_file=HEK_NPSR1_107I/Assay_06262026_IP1_Expt1_4Plates/output/fit_parameters.csv
2026-06-261.110.37trackerExpt1 - Auto-injected
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
2026-07-014.810.72100fitfit_source_file=CHO_NPS_107N/Assay_07012026_cAMP_Expt1_4Plates/output/fit_parameters.csv
2026-07-011.090.36113fitfit_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
2026-06-300.061.1693fitfit_source_file=HEK_NPSR1_107I/Assay_06302026_IP1_Expt1_4Plates_Repeat/output/fit_parameters.csv
2026-06-300.140.62111tracker
2026-06-300.140.62111fitfit_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
2026-06-230.470.67trackerPlate: plate4
2026-06-230.470.6798fitfit_source_file=CHO_NPS_107N/Assay_06232026_NPS_Expt1_4Plates/output/fit_parameters.csv
2026-06-230.251.56100fitfit_source_file=CHO_NPS_107N/Assay_06232026_NPS_Expt1_4Plates/output/fit_parameters.csv
2026-06-190.881.09tracker
2026-06-190.881.09101fitfit_source_file=CHO_NPS_107N/Assay_06192026_NPS_6Plates/output/fit_parameters.csv
2026-06-160.070.9174fitfit_source_file=CHO_NPS_107N/Assay_06162026_NPS_4Plates_Rescue/output/fit_parameters.csv
2026-06-160.280.9174trackerDicey - Plate 4. 67 pM. Partial masking used.
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
2026-06-300.131.06105fitfit_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
2026-06-300.121.57104fitfit_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
2026-06-260.600.4097fitfit_source_file=HEK_NPSR1_107I/Assay_06262026_IP1_Expt1_4Plates/output/fit_parameters.csv
2026-06-260.270.34118fitfit_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
2026-07-017.532.4699fitfit_source_file=CHO_NPS_107N/Assay_07012026_cAMP_Expt1_4Plates/output/fit_parameters.csv
2026-07-010.280.2097fitfit_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
2026-06-230.710.8693fitfit_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
2026-06-230.710.86trackerPlate: plate2
2026-06-190.160.76tracker
2026-06-190.160.76102fitfit_source_file=CHO_NPS_107N/Assay_06192026_NPS_6Plates/output_3_4/fit_parameters.csv
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
2026-07-010.221.70106fitfit_source_file=HEK_NPSR1_107I/Assay_07012026_IP1_Combined_Expt2_Expt3_4Plates/output/fit_parameters.csv
2026-07-010.161.0499fitfit_source_file=HEK_NPSR1_107I/Assay_07012026_IP1_Combined_Expt2_Expt3_4Plates/output/fit_parameters.csv
2026-07-010.221.70106tracker
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
2026-06-230.231.22trackerPlate: plate1
2026-06-230.231.2295fitfit_source_file=CHO_NPS_107N/Assay_06232026_NPS_Expt2_1Plate/output/fit_parameters.csv
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
2026-07-010.180.48115trackerFlag: Massive pipetting error / shallow slope (Plate 2/3 artifact)
2026-07-010.180.48115fitfit_source_file=HEK_NPSR1_107I/Assay_07012026_IP1_Combined_Expt2_Expt3_4Plates/output/fit_parameters.csv
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
2026-05-060.09fitfit_source_file=HEK_NPSR1_107I/Assay_05062026_NPS_IP1/output/fit_parameters_v2.csv
2026-05-060.0994tracker★ SUB-nM HIT: 12x NPS. R²=0.79. Confirm.
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
2026-06-230.300.9498fitfit_source_file=CHO_NPS_107N/Assay_06232026_NPS_Expt2_1Plate/output/fit_parameters.csv
2026-06-230.300.94trackerPlate: plate1
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
2026-05-0617.290.23154trackerINACTIVE: EC50=17 nM, R²=0.55, curve essentially flat.
2026-05-0617.29fitfit_source_file=HEK_NPSR1_107I/Assay_05062026_NPS_IP1/output/fit_parameters_v2.csv
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
2026-07-010.170.53115fitfit_source_file=HEK_NPSR1_107I/Assay_07012026_IP1_Combined_Expt2_Expt3_4Plates/output/fit_parameters.csv
2026-07-012.440.32126fitfit_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)
2026-06-300.040.7291tracker
2026-06-300.040.7291fitfit_source_file=HEK_NPSR1_107I/Assay_06302026_IP1_Expt3_2Plates/output/fit_parameters.csv
0.17 nM · n=5
IP1 · hNPSR1 Asn107
dateec50 (nM)hillemax (%)srcnote
2026-06-240.451.14trackerExpt 3 & 4 - Auto-injected
2026-06-240.451.1484fitfit_source_file=CHO_NPS_107N/Assay_06242026_NPS_Expt3_and_4_4Plates/output/fit_parameters.csv
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
2026-06-260.262.39trackerExpt1 - Auto-injected
2026-06-260.262.39111fitfit_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
2026-06-260.231.05101fitfit_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
2026-06-230.961.19trackerPlate: plate4
2026-06-230.550.9295fitfit_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
2026-06-230.952.1687fitfit_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
2026-06-190.141.17tracker
2026-06-190.141.1798fitfit_source_file=CHO_NPS_107N/Assay_06192026_NPS_6Plates/output_3_4/fit_parameters.csv
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
2026-06-240.192.1092fitfit_source_file=CHO_NPS_107N/Assay_06242026_NPS_Expt3_and_4_4Plates/output/fit_parameters.csv
2026-06-240.181.26102fitfit_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
2026-06-100.122.9296fitfit_source_file=CHO_NPS_107N/Assay_06102026_NPS_4Plates/analysis/fit_parameters.csv
2026-06-100.122.9296tracker23.5x NPS. R²=0.772.
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
2026-07-020.111.7972tracker
2026-07-020.111.7972fitfit_source_file=CHO_NPS_107N/Assay_07022026_IP1_CHO_NPS_4Plates/output/fit_parameters.csv
2026-06-300.821.03115fitfit_source_file=CHO_NPS_107N/Assay_06302026_cAMP_2Plates/output/fit_parameters.csv
2026-06-301.171.18179fitfit_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
no tickets

Analytical QC workstream (@Mo)

KeyStatusDueAssigneeVendorCRO progressSummary
no tickets

In-vitro potency workstream (@Stephen)

KeyStatusDueAssigneeVendorCRO progressSummary
no tickets

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

KeyStatusDueAssigneeVendorCRO progressSummary
no tickets

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. Default order: furthest along the funnel first; click a column header to re-sort.
VendorWorkstreamStatusOwnerCRO progressLast engagementNotes
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.
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.
CPC Scientificcmc_drug_substance_gmpquote inmelissaQuote in · Detailed quote provided for CAPABLE-001 Phase I AP2026-01-22 📄Detailed 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.
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.
Sinopepcmc_drug_substance_gmpquote inmelissaQuote in · Quote received for CAPABLE-001 Phase I API manufac2026-01-22 📄Quote 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 proposal CD/Tides/01072026/47287/1.0/NC co2026-07-01 📄Syngene proposal CD/Tides/01072026/47287/1.0/NC covers process familiarization, ~5 g lab/PoC synthesis with ~500 mg shipped to Capable, and ~200 g non-GMP 49-mer peptide synthesis for $651,940 with 27-week lead time including ~5 weeks raw material procurement. Project starts upon WO/PO execution. Deliverables include analytical method development and analytical test report; tentative purity NLT 95% to be confirmed. Offer valid 30 days from proposal date. Payment terms are 50% invoiced upon project start and 50% upon completion. Delivery terms are Ex-works, Bangalore; other Incoterms can be supported with freight passed through at actuals. Storage beyond 7 days after completion is out of scope and would require separate pricing.
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 · Quotation DPT-251219 from Viva CDMO/PPO covers pro2026-01-22 📄Quotation DPT-251219 from Viva CDMO/PPO covers production of at least 500 mg CAPABLE-001 peptide API, cGMP or GMP-like, for Phase I clinical use and Australia IND-enabling filing. Deliverables include tox batch and GMP batch product, process optimization report, reference material characterization report and CoAs, toxicity/GMP batch production report, analytical method validation reports, stability study reports, and IND filing documentation. Payment terms are 50% due within 5 business days after contract signing and 50% upon delivery; cold-chain shipping billed at actual cost. Quote notes Capable should verify the listed peptide sequence before proceeding.
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 liste2026-01-22 📄CAPABLE-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.
Viva Biotechcmc_ich_q1a_stabilityquote inmelissaQuote in · Quotation DPT-251219 includes stability study repo📄Quotation DPT-251219 includes stability study reports as part of the IND package documentation deliverables for CAPABLE-001. No executed contract is evidenced; payment obligations begin after contract signing.
WuXi AppTec (HongKong) Limited / XenoBiotic Laboratories, Incgenotox_amesquote inmelissaQuote in · WuXi quotation V3 includes a GLP FDA/OECD bacteria2026-05-08 📄WuXi quotation V3 includes a GLP FDA/OECD bacterial reverse mutation assay (Ames).
WuXi AppTec (HongKong) Limited / XenoBiotic Laboratories, Incgenotox_micronucleusquote inmelissaQuote in · WuXi quotation V3 includes a GLP FDA/OECD in vivo 2026-05-08 📄WuXi quotation V3 includes a GLP FDA/OECD in vivo peripheral blood micronucleus assay in rats using FCM with SEND.
WuXi AppTec (HongKong) Limited / XenoBiotic Laboratories, Incglp_tox_non_rodentquote inmelissaQuote in · WuXi quotation V3 covers a GLP FDA/OECD 14-day rep2026-05-08 📄WuXi quotation V3 covers a GLP FDA/OECD 14-day repeated intranasal dose toxicity and toxicokinetics study in Beagle dogs with a 14-day recovery period.
WuXi AppTec (HongKong) Limited / XenoBiotic Laboratories, Incglp_tox_rodentquote inmelissaQuote in · WuXi quotation V3 covers a GLP FDA/OECD 14-day rep2026-05-08 📄WuXi quotation V3 covers a GLP FDA/OECD 14-day repeated intranasal dose toxicity and toxicokinetics study in rats with a 14-day recovery period.
IIT Research Institutehistologyquote inmelissaQuote in · IITRI GLP tox estimates include histology/patholog2026-01-05 📄IITRI 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/evalu2026-01-22 📄Quotation includes histopathology processing/evaluation options by a DACVP pathologist for rodent and non-rodent tox studies.
Charles River Laboratoriessafety_pharm_ich_s7aquote inmelissaQuote in · Avance Gap Analysis review found standalone hERG r2026-06-30 📧 📄Avance Gap Analysis review found standalone hERG recommended on pages 8 and 13; dog ECG alone may not satisfy the hERG requirement.
WuXi AppTec (HongKong) Limited / XenoBiotic Laboratories, Incsafety_pharm_ich_s7aquote inmelissaQuote in · WuXi quotation V3 includes a GLP FDA/OECD hERG ass2026-05-08 📄WuXi quotation V3 includes a GLP FDA/OECD hERG assay in a manual patch-clamp platform.
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.
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.
AmbioPharmcmc_drug_substance_gmpRFQ sentmelissaRFQ open 162d · Discussed for CAPABLE-001 Phase I API manufacturin2026-01-22 📄Discussed for CAPABLE-001 Phase I API manufacturing as a fast GMP peptide option at gram-kg scale; no response to inquiry.
BCN Peptidescmc_drug_substance_gmpRFQ sentmelissaRFQ open 162d · Discussed for CAPABLE-001 Phase I API manufacturin2026-01-22 📄Discussed for CAPABLE-001 Phase I API manufacturing as an EU GMP peptide option; first response took 4 days and status was slow response.
Catalentcmc_drug_substance_gmpRFQ sentmelissaRFQ open 162d · Discussed for CAPABLE-001 Phase I API manufacturin2026-01-22 📄Discussed for CAPABLE-001 Phase I API manufacturing as a large CDMO network option; no response to inquiry.
CordenPharmacmc_drug_substance_gmpRFQ sentmelissaRFQ open 162d · Discussed for CAPABLE-001 Phase I API manufacturin2026-01-22 📄Discussed 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 manufacturin2026-01-22 📄Discussed 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 disc📄Capable NDA shared; awaiting signature before discussing needs.
Cyprotexsafety_pharm_ich_s7aRFQ sentmelissaRFQ sent · NDA shared from Capable for hERG/genotox vendor ev📄NDA shared from Capable for hERG/genotox vendor evaluation.
Pharmalegacysafety_pharm_ich_s7aRFQ sentmelissaRFQ sent · Quote requested for hERG/genotox vendor evaluation📄Quote requested for hERG/genotox vendor evaluation.
CMAXclinical_phase_1_crono contractmelissano_contract📄Listed in the Phase 1 CRO assessment with Adelaide noted as location; no contract or contact details shown.
GLGclinical_phase_1_crono contractmelissano_contract2026-05-15 📄Indication 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_contract2026-05-27 📄Discussed as an option for sourcing additional consultants or expert-network support for Australian clinical trial resourcing; no active contract or direct engagement stated in the excerpt.
Linear Clinical Researchclinical_phase_1_crono contractmelissano_contract📄Listed as a Phase 1 clinical CRO assessment option; no contract or contact details shown.
Novotrialsclinical_phase_1_crono contractmelissano_contract📄Listed 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_contract📄Listed as a Phase 1 clinical CRO assessment option; Brisbane and Melbourne noted as locations. No contract or contact details shown.
Scientia Clinical Researchclinical_phase_1_crono contractmelissano_contract📄Listed as a Phase 1 clinical CRO assessment option; no contract or contact details shown.
SSRclinical_phase_1_crono contractmelissano_contract📄Phase 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; experience with biotech sponsors noted as 80-90%; 2 medical monitors; emergency response via GP/ex-GP; FDA/EMA audit track record noted as good so far with last audit in 2019.
Aurigene Pharmaceutical Servicescmc_drug_substance_gmpno contractmelissano_contract📄Responsive initial contact; Helena and Nico to meet team once specifications are confirmed.
Bioconcmc_drug_substance_gmpno contractmelissano_contract2026-06-02 📄Call completed; judged not suitable due to large scale and fewer drug discovery capabilities. Referred Capable to Syngene.
Chinapeptidescmc_drug_substance_gmpno contractmelissano_contract2026-01-22 📄Declined 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.
Ramshan Lifesciencescmc_drug_substance_gmpno contractmelissano_contract📄No response to calls, emails, and website outreach.
Saicmc_drug_substance_gmpno contractmelissano_contract📄Listed in India CROs manufacturing tracker; no response to outreach by calls, emails, and website.
Charles River Laboratoriesgenotox_amesno contractmelissano_contract2026-04-05 📧 📄Debrief identifies genotoxicity as a hard regulatory gap and action item; Charles River is one of three vendors to contact for AMES plus chromosomal aberration plus micronucleus, estimated around $100K and 8-12 weeks, to run in parallel with in vivo tox.
Covancegenotox_amesno contractmelissano_contract2026-04-05 📄Debrief identifies genotoxicity as a hard regulatory gap and action item; Covance is one of three vendors to contact for AMES plus chromosomal aberration plus micronucleus, estimated around $100K and 8-12 weeks, to run in parallel with in vivo tox.
Eurofinsgenotox_amesno contractmelissano_contract2026-04-05 📄Debrief identifies genotoxicity as a hard regulatory gap and action item; Eurofins is one of three vendors to contact for AMES plus chromosomal aberration plus micronucleus, estimated around $100K and 8-12 weeks, to run in parallel with in vivo tox.
Charles River Laboratoriesgenotox_micronucleusno contractmelissano_contract2026-04-05 📧 📄Debrief identifies genotoxicity as a hard regulatory gap and action item; Charles River is one of three vendors to contact for AMES plus chromosomal aberration plus micronucleus, estimated around $100K and 8-12 weeks, to run in parallel with in vivo tox.
Covancegenotox_micronucleusno contractmelissano_contract2026-04-05 📄Debrief identifies genotoxicity as a hard regulatory gap and action item; Covance is one of three vendors to contact for AMES plus chromosomal aberration plus micronucleus, estimated around $100K and 8-12 weeks, to run in parallel with in vivo tox.
Eurofinsgenotox_micronucleusno contractmelissano_contract2026-04-05 📄Debrief identifies genotoxicity as a hard regulatory gap and action item; Eurofins is one of three vendors to contact for AMES plus chromosomal aberration plus micronucleus, estimated around $100K and 8-12 weeks, to run in parallel with in vivo tox.
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.
PolyPeptide Groupcmc_drug_substance_gmpexpiredmelissaexpired 2026-02-112026-02-11 📄PolyPeptide proposal QT-15449 dated 2026-02-11 covers non-GMP manufacture of 500 mg-1 g Axonic Peptide 1/PPL4166 for Phase I clinical trials in Australia. Scope includes sequence assessment, scalable process development using PeptiSystem Flow, 2 g non-GMP demonstration batch, delivery of 500 mg-1 g non-GMP grade peptide and CoA. Price is $95,000 with ~4-6 week timeline, subject to raw material and suite availability at PO receipt. Analytical method development by RP-HPLC/UPLC is offered for identification, impurity/purity measurement, forced degradation/LC-MS, robustness, impurity MW ID, and peak purity by LC-MS at $45,000 per method with ~12 week timeline. Proposal valid for 90 days; no contractual relationship exists until mutual written Work Order execution, though an MSA can be negotiated.
PolyPeptide Groupcmc_ich_q1a_stabilityexpiredmelissaexpired 2026-02-112026-02-11 📄Optional non-GMP stability study in PolyPeptide proposal QT-15449 dated 2026-02-11 would be performed on each non-GMP batch at -20C +/-5C, 5C +/-3C, and 25C +/-2C/60% RH +/-5% RH through 24 months, testing appearance, water content, and purity at scheduled timepoints. Pricing: $15,000 initiation, $25,000 at 12 months, $10,000 at 24 months. Proposal valid for 90 days; no contractual relationship exists until mutual written Work Order execution.
IIT Research Instituteglp_tox_non_rodentexpiredmelissaexpired 2026-04-052026-04-05 📄Tox CRO debrief says no final CRO decision has been made. IITRI dog non-rodent path is speed-favored but must document the scientific dogs-vs-monkeys rationale because Avance flagged NPSR1 conservation is higher in monkeys; quote expired Mar 5, 2026 and must be reconfirmed before PO.
Pharmaron, Inc.glp_tox_non_rodentexpiredmelissaexpired 2026-04-052026-04-05 📄Pharmaron quoted dogs as the non-rodent species for the cheaper minimum viable tox package; monkey pricing was noted as about $1.05M for 2-week GLP alone and considered a non-starter on speed and price. Quote expired Feb 21, 2026 and pricing is stale.
IIT Research Instituteglp_tox_rodentexpiredmelissaexpired 2026-04-052026-04-05 📄Tox CRO debrief says no final CRO decision has been made. IITRI remains the speed-favored path because it avoids China logistics and saves an estimated 2-4 weeks versus Pharmaron, but quote CA01.05.2026 expired Mar 5, 2026 and pricing/slot availability must be reconfirmed with Todd Bucciarelli before PO. Debrief also flags high method-development cost and need to confirm method development starts immediately at PO; weekly formulation prep assumes 7-day intranasal formulation stability data exists.
Pharmaron, Inc.glp_tox_rodentexpiredmelissaexpired 2026-04-052026-04-05 📄Pharmaron remains a cheaper alternative for the minimum viable rat/dog GLP tox package, estimated around $530K for 14-day studies versus about $1.16M at IITRI, but loses 2-4 weeks to China logistics and its Jan 22, 2026 quote expired Feb 21, 2026. Reconfirmation required before comparison or PO.
IIT Research Institutesafety_pharm_ich_s7aexpiredmelissaexpired 2026-04-052026-04-05 📄Debrief says IITRI dog GLP includes ECG/in vivo CV under ICH S7A, but standalone in vitro hERG patch clamp under ICH S7B may still be required. Capable should confirm with Avance or Novotech whether dog ECG suffices or standalone hERG is needed.
Pharmaron, Inc.safety_pharm_ich_s7aexpiredmelissaexpired 2026-01-222026-01-22 📄Pharmaron 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.

Open gaps (5) — KAN tickets with no contracted vendor

KANDueAssigneeSummary
KAN-712026-09-08Moaraj HasanGMP clinical batch manufacture (API) + batch record + CoA
KAN-752026-09-15Moaraj HasanClinical protocol + synopsis (FIH SAD)
KAN-742026-09-22Moaraj HasanAuthor Investigator's Brochure (IB)
KAN-722026-09-22Moaraj HasanDrug product CMC: sterile injectable formulation, fill-finish, container-closure
KAN-732026-09-29Moaraj HasanICH Q1A stability program on clinical API + DP lots

Stability + degradation

0 open 0 done
KeyStatusDueAssigneeVendorCRO progressSummary
no tickets

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

0 open 0 done
CRO progress (Drive): 📁 Preclinical development
KeyStatusDueAssigneeVendorCRO progressSummary
no tickets

Safety + immunogenicity

0 open 0 done
CRO progress (Drive): 📁 Tox Studies
KeyStatusDueAssigneeVendorCRO progressSummary
no tickets

GLP / CMC outsourcing

4 open 0 done
KeyStatusDueAssigneeVendorCRO progressSummary
KAN-71Idea2026-09-08Moaraj Hasanno vendorpick vendor (67d to due)GMP clinical batch manufacture (API) + batch record + CoA
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 · Avance Gap Analysis review found standalone hERG rSafety pharmacology core battery (ICH S7A: CV, CNS, respiratory)
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)