Modality
Cell Therapy
MOA
PRMT5i
Target
CD47
Pathway
Ferroptosis
GA
Development Pipeline
Preclinical
~Jan 2010
→ ~Apr 2011
Phase 1
~Jul 2011
→ ~Oct 2012
Phase 2
~Jan 2013
→ ~Apr 2014
Phase 3
~Jul 2014
→ ~Oct 2015
NDA/BLA
~Jan 2016
→ ~Apr 2017
Approved
Jul 2017
→ Sep 2031
ApprovedCurrent
NCT07296124
1,619 pts·GA
2023-07→2026-06·Terminated
NCT04115225
2,921 pts·GA
2017-07→2031-09·Completed
4,540 total pts1 indication
CompletedCurrentUpcoming
Catalysts (2)
2026-06-183mo awayPh3 Readout· GA
2031-09-065.4y awayPh3 Readout· GA
Trial Timeline
Q2Q3Q42018Q2Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q42031Q2Q3Q4
Approved
Complet…
Approved
Termina…
Catalysts
Ph3 Readout
2026-06-18 · 3mo away
GA
Ph3 Readout
2031-09-06 · 5.4y away
GA
CompletedTerminated|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT07296124 | Approved | GA | Terminated | 1619 | CR |
| NCT04115225 | Approved | GA | Completed | 2921 | SeizFreq |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| LLY-6079 | Eli Lilly | Phase 2 | MDM2 | |
| LLY-8903 | Eli Lilly | Preclinical | CD47 | |
| RHH-8550 | Roche | Approved | BCL-2 | |
| RHH-682 | Roche | Phase 2 | FXIa | |
| Talainavolisib | Novo Nordisk | Preclinical | KRASG12D | |
| GSK-4334 | GSK | Preclinical | CD47 | |
| Motainavolisib | Amgen | NDA/BLA | CD47 | |
| AMG-4531 | Amgen | Phase 2/3 | KRASG12C | |
| GIL-9142 | Gilead Sciences | Phase 1 | FXIa | |
| Semainavolisib | Gilead Sciences | Phase 2 | PARP |