Modality
mRNA
MOA
USP1i
Target
PI3Kα
Pathway
Fibrosis
Urothelial Ca
Development Pipeline
Preclinical
~Jun 2012
→ ~Sep 2013
Phase 1
~Dec 2013
→ ~Mar 2015
Phase 2
~Jun 2015
→ ~Sep 2016
Phase 3
~Dec 2016
→ ~Mar 2018
NDA/BLA
Jun 2018
→ Sep 2031
NDA/BLACurrent
NCT05204918
2,361 pts·Urothelial Ca
2018-06→2031-09·Terminated
2,361 total pts1 indication
Approved
CompletedCurrentUpcoming
Catalysts (1)
2031-09-195.5y awayPh3 Readout· Urothelial Ca
Trial Timeline
Q2Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q42031Q2Q3Q4
NDA/BLA
Termina…
Catalysts
Ph3 Readout
2031-09-19 · 5.5y away
Urothelial Ca
Terminated|StartCompletionToday
Trials (1)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT05204918 | NDA/BLA | Urothelial Ca | Terminated | 2361 | EDSS |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| Voxaderotide | Johnson & Johnson | NDA/BLA | PI3Kα | |
| Rimamavacamten | Merck & Co | Phase 1 | PI3Kα | |
| SNY-2934 | Sanofi | Phase 3 | KRASG12D | |
| Fixazanubrutinib | Amgen | Phase 2 | PI3Kα | |
| AMG-9052 | Amgen | Phase 2/3 | CDK2 | |
| Datozumab | Regeneron | Phase 1 | B7-H3 | |
| GMA-1468 | Genmab | NDA/BLA | PI3Kα | |
| GMA-729 | Genmab | Phase 2 | BCL-2 | |
| Pexanaritide | Innovent Bio | Preclinical | SGLT2 | |
| 369-789 | Hansoh Pharma | Phase 3 | PI3Kα |