Modality
Peptide
MOA
USP1i
Target
CDK2
Pathway
Hedgehog
Parkinson'sMG
Development Pipeline
Preclinical
~Sep 2015
→ ~Dec 2016
Phase 1
~Mar 2017
→ ~Jun 2018
Phase 2
Sep 2018
→ Apr 2030
Phase 2Current
NCT05562448
2,705 pts·MG
2024-05→2025-03·Recruiting
NCT03951363
2,789 pts·MG
2018-09→2030-04·Completed
5,494 total pts1 indication
Phase 3
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (2)
2025-03-051.1y agoPh3 Readout· MG
2030-04-034.0y awayPh3 Readout· MG
Trial Timeline
Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2
P2/3
Complet…
P2/3
Recruit…
Catalysts
Ph3 Readout
2025-03-05 · 1.1y ago
MG
Ph3 Readout
2030-04-03 · 4.0y away
MG
RecruitingCompleted|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT05562448 | Phase 2/3 | MG | Recruiting | 2705 | Mayo |
| NCT03951363 | Phase 2/3 | MG | Completed | 2789 | UPCR |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| PFE-3703 | Pfizer | Phase 1/2 | CDK2 | |
| NVS-3297 | Novartis | Preclinical | CDK2 | |
| SNY-2934 | Sanofi | Phase 3 | KRASG12D | |
| Fixainavolisib | Takeda | Preclinical | CDK2 | |
| AMG-1919 | Amgen | Phase 2/3 | CDK2 | |
| AMG-415 | Amgen | Phase 1 | CDK2 | |
| AMG-9052 | Amgen | Phase 2/3 | CDK2 | |
| Zanuratamab | Gilead Sciences | Phase 1/2 | CDK2 | |
| Datozumab | Regeneron | Phase 1 | B7-H3 | |
| Nirabrutinib | BioNTech | Phase 2/3 | CDK2 |