Modality
ERT
MOA
IL-17i
Target
CDK2
Pathway
NF-κB
Ovarian CaNASHHS
Development Pipeline
Preclinical
May 2021
→ Oct 2026
PreclinicalCurrent
NCT03707164
2,035 pts·HS
2021-05→2026-10·Completed
NCT04886249
2,524 pts·HS
2024-03→2026-08·Not yet recruiting
4,559 total pts1 indication
Phase 1
Phase 2
Phase 3
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (2)
2026-08-104mo awayInterim· HS
2026-10-066mo awayInterim· HS
Trial Timeline
Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q4
Preclinical
Complet…
Preclinical
Not yet…
Catalysts
Interim
2026-08-10 · 4mo away
HS
Interim
2026-10-06 · 6mo away
HS
CompletedNot yet recruiting|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT03707164 | Preclinical | HS | Completed | 2035 | MRD |
| NCT04886249 | Preclinical | HS | Not yet recr... | 2524 | SeizFreq |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| PFE-3703 | Pfizer | Phase 1/2 | CDK2 | |
| NVS-3297 | Novartis | Preclinical | CDK2 | |
| SNY-2289 | Sanofi | Phase 2/3 | CD38 | |
| 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 | |
| Elrarapivir | Vertex Pharma | NDA/BLA | PRMT5 | |
| Nirabrutinib | BioNTech | Phase 2/3 | CDK2 | |
| BII-8315 | Biogen | NDA/BLA | CDK2 |