Modality
Peptide
MOA
KIF18Ai
Target
CDK2
Pathway
Fibrosis
Huntington's
Development Pipeline
Preclinical
~Jul 2014
→ ~Oct 2015
Phase 1
~Jan 2016
→ ~Apr 2017
Phase 2
~Jul 2017
→ ~Oct 2018
Phase 3
~Jan 2019
→ ~Apr 2020
NDA/BLA
Jul 2020
→ May 2029
NDA/BLACurrent
NCT04481918
318 pts·Huntington's
2020-11→2029-05·Terminated
NCT05465970
427 pts·Huntington's
2020-07→2026-08·Recruiting
745 total pts1 indication
Approved
CompletedCurrentUpcoming
Catalysts (2)
2026-08-235mo awayPh3 Readout· Huntington's
2029-05-053.1y awayPh3 Readout· Huntington's
Trial Timeline
Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3
NDA/BLA
Recruit…
NDA/BLA
Termina…
Catalysts
Ph3 Readout
2026-08-23 · 5mo away
Huntington's
Ph3 Readout
2029-05-05 · 3.1y away
Huntington's
RecruitingTerminated|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT04481918 | NDA/BLA | Huntington's | Terminated | 318 | CR |
| NCT05465970 | NDA/BLA | Huntington's | Recruiting | 427 | FEV1 |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| PFE-3703 | Pfizer | Phase 1/2 | CDK2 | |
| PFE-7550 | Pfizer | Phase 3 | Aβ | |
| Ribosacituzumab | Roche | Approved | Cl18.2 | |
| RHH-8482 | Roche | Phase 1 | BTK | |
| NVS-3297 | Novartis | Preclinical | CDK2 | |
| Pexatenlimab | Novartis | Phase 1/2 | GPRC5D | |
| TAK-1836 | Takeda | Preclinical | EGFR | |
| Fixainavolisib | Takeda | Preclinical | CDK2 | |
| AMG-1919 | Amgen | Phase 2/3 | CDK2 | |
| AMG-415 | Amgen | Phase 1 | CDK2 |