Modality
Small Molecule
MOA
FXIai
Target
USP1
Pathway
Angiogenesis
Prostate Ca
Development Pipeline
Preclinical
~Jul 2016
→ ~Oct 2017
Phase 1
~Jan 2018
→ ~Apr 2019
Phase 2
~Jul 2019
→ ~Oct 2020
Phase 3
~Jan 2021
→ ~Apr 2022
NDA/BLA
~Jul 2022
→ ~Oct 2023
Approved
Jan 2024
→ Feb 2028
ApprovedCurrent
NCT03553295
1,238 pts·Prostate Ca
2024-01→2025-12·Active
NCT08711564
1,366 pts·Prostate Ca
2024-03→2028-02·Completed
2,604 total pts1 indication
CompletedCurrentUpcoming
Catalysts (2)
2025-12-223mo agoPh3 Readout· Prostate Ca
2028-02-171.9y awayPh3 Readout· Prostate Ca
Trial Timeline
2024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028
Approved
Active
Approved
Complet…
Catalysts
Ph3 Readout
2025-12-22 · 3mo ago
Prostate Ca
Ph3 Readout
2028-02-17 · 1.9y away
Prostate Ca
ActiveCompleted|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT03553295 | Approved | Prostate Ca | Active | 1238 | PANSS |
| NCT08711564 | Approved | Prostate Ca | Completed | 1366 | ACR20 |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| NVS-6360 | Novartis | Approved | CD38 | |
| MRK-3745 | Merck & Co | Phase 2 | WRN | |
| ABB-2476 | AbbVie | Phase 1/2 | USP1 | |
| AZN-1715 | AstraZeneca | Phase 3 | AHR | |
| BMY-9931 | Bristol-Myers Squibb | Phase 1 | GPRC5D | |
| NVO-7877 | Novo Nordisk | Preclinical | GPRC5D | |
| TAK-8730 | Takeda | Phase 2 | VEGF | |
| Semazasiran | BeiGene | Phase 1 | PD-1 | |
| Pexanesiran | United Therapeutics | Phase 1 | BCMA | |
| NUV-283 | Nuvalent | Phase 3 | B7-H3 |