Modality
ERT
MOA
BiTE
Target
PSMA
Pathway
RAS/MAPK
NMOSDMyelofibrosisUrothelial Ca
Development Pipeline
Preclinical
~Mar 2020
→ ~Jun 2021
Phase 1
Sep 2021
→ Dec 2031
Phase 1Current
NCT03937118
2,076 pts·NMOSD
2021-09→2031-01·Recruiting
NCT07839655
16 pts·Urothelial Ca
2022-09→2031-12·Terminated
2,092 total pts2 indications
Phase 2
Phase 3
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (2)
2031-01-064.8y awayInterim· NMOSD
2031-12-055.7y awayInterim· Urothelial Ca
Trial Timeline
Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q42031Q2Q3Q4
P1
Recruit…
P1
Termina…
Catalysts
Interim
2031-01-06 · 4.8y away
NMOSD
Interim
2031-12-05 · 5.7y away
Urothelial Ca
RecruitingTerminated|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT03937118 | Phase 1 | NMOSD | Recruiting | 2076 | CR |
| NCT07839655 | Phase 1 | Urothelial Ca | Terminated | 16 | ORR |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| LLY-3251 | Eli Lilly | Phase 2 | MDM2 | |
| AZN-3724 | AstraZeneca | Preclinical | PSMA | |
| Zanutinib | Bristol-Myers Squibb | Phase 2/3 | APOC3 | |
| Doxacagene | Sanofi | Approved | PSMA | |
| GSK-2051 | GSK | Phase 1 | PSMA | |
| Bemarelsin | Daiichi Sankyo | Preclinical | GLP-1R | |
| DSN-7360 | Daiichi Sankyo | Approved | SGLT2 | |
| GIL-2445 | Gilead Sciences | Phase 2/3 | PSMA | |
| BII-8315 | Biogen | NDA/BLA | CDK2 | |
| BII-1564 | Biogen | Phase 2 | PSMA |