Modality
Small Molecule
MOA
PRMT5i
Target
SMN2
Pathway
Sphingolipid
CholangiocarcinomaLNRCC
Development Pipeline
Preclinical
~May 2016
→ ~Aug 2017
Phase 1
~Nov 2017
→ ~Feb 2019
Phase 2
May 2019
→ Jan 2031
Phase 2Current
NCT03775366
1,684 pts·RCC
2019-09→2031-01·Terminated
NCT05109457
582 pts·RCC
2019-05→TBD·Completed
2,266 total pts1 indication
Phase 3
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (1)
2031-01-254.8y awayPh2 Data· RCC
Trial Timeline
Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q42031Q2
P2
Complet…
P2
Termina…
Catalysts
Ph2 Data
2031-01-25 · 4.8y away
RCC
CompletedTerminated|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT03775366 | Phase 2 | RCC | Terminated | 1684 | BodyWt |
| NCT05109457 | Phase 2 | RCC | Completed | 582 | HAM-D |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| LLY-6079 | Eli Lilly | Phase 2 | MDM2 | |
| RHH-8550 | Roche | Approved | BCL-2 | |
| RHH-682 | Roche | Phase 2 | FXIa | |
| Talainavolisib | Novo Nordisk | Preclinical | KRASG12D | |
| NVO-6275 | Novo Nordisk | Phase 1 | SMN2 | |
| TAK-5300 | Takeda | Phase 1 | SMN2 | |
| AMG-4531 | Amgen | Phase 2/3 | KRASG12C | |
| GIL-9142 | Gilead Sciences | Phase 1 | FXIa | |
| Semainavolisib | Gilead Sciences | Phase 2 | PARP | |
| GIL-2259 | Gilead Sciences | Approved | SMN2 |