Modality
Gene Therapy
MOA
ALKi
Target
BCL-2
Pathway
Cell Cycle
PSPMCLNASH
Development Pipeline
Preclinical
~Nov 2019
→ ~Feb 2021
Phase 1
~May 2021
→ ~Aug 2022
Phase 2
Nov 2022
→ Jun 2031
Phase 2Current
NCT05379602
296 pts·MCL
2023-05→2031-06·Recruiting
NCT06104888
393 pts·PSP
2022-11→2031-05·Terminated
689 total pts2 indications
Phase 3
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (2)
2031-05-115.1y awayPh3 Readout· PSP
2031-06-155.2y awayPh3 Readout· MCL
Trial Timeline
Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q42031Q2Q3
P2/3
Termina…
P2/3
Recruit…
Catalysts
Ph3 Readout
2031-05-11 · 5.1y away
PSP
Ph3 Readout
2031-06-15 · 5.2y away
MCL
RecruitingTerminated|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT05379602 | Phase 2/3 | MCL | Recruiting | 296 | Safety |
| NCT06104888 | Phase 2/3 | PSP | Terminated | 393 | ACR20 |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| Miriosocimab | Pfizer | Phase 1 | PARP | |
| RHH-8550 | Roche | Approved | BCL-2 | |
| MRK-7739 | Merck & Co | Preclinical | IL-23 | |
| BMY-2495 | Bristol-Myers Squibb | Phase 3 | KRASG12D | |
| DSN-5254 | Daiichi Sankyo | Phase 1 | B7-H3 | |
| Sovacapivasertib | Amgen | Phase 3 | WEE1 | |
| Zanuratamab | Gilead Sciences | Phase 1/2 | CDK2 | |
| GIL-2445 | Gilead Sciences | Phase 2/3 | PSMA | |
| Rimaglumide | Biogen | Phase 1/2 | BCL-2 | |
| ALN-3284 | Alnylam | Phase 2/3 | CDK2 |