Modality
Fusion Protein
MOA
BCL-2i
Target
KRASG12C
Pathway
Cell Cycle
ADPKDEpilepsyHeart Failure
Development Pipeline
Preclinical
~Oct 2011
→ ~Jan 2013
Phase 1
~Apr 2013
→ ~Jul 2014
Phase 2
~Oct 2014
→ ~Jan 2016
Phase 3
~Apr 2016
→ ~Jul 2017
NDA/BLA
Oct 2017
→ Jun 2028
NDA/BLACurrent
NCT05035108
63 pts·Heart Failure
2023-10→2026-09·Terminated
NCT06304849
206 pts·Epilepsy
2017-10→2028-06·Completed
269 total pts2 indications
Approved
CompletedCurrentUpcoming
Catalysts (2)
2026-09-065mo awayPh3 Readout· Heart Failure
2028-06-272.2y awayPh3 Readout· Epilepsy
Trial Timeline
Q42018Q2Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3
NDA/BLA
Complet…
NDA/BLA
Termina…
Catalysts
Ph3 Readout
2026-09-06 · 5mo away
Heart Failure
Ph3 Readout
2028-06-27 · 2.2y away
Epilepsy
CompletedTerminated|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT05035108 | NDA/BLA | Heart Failure | Terminated | 63 | EDSS |
| NCT06304849 | NDA/BLA | Epilepsy | Completed | 206 | 6MWD |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| PFE-5501 | Pfizer | Phase 1 | BTK | |
| JNJ-179 | Johnson & Johnson | Approved | KRASG12C | |
| RHH-3592 | Roche | Phase 1/2 | GIP-R | |
| Geliderotide | Novartis | NDA/BLA | IL-17A | |
| BMY-4586 | Bristol-Myers Squibb | Preclinical | KRASG12C | |
| Doxarapivir | Bristol-Myers Squibb | Phase 3 | KRASG12C | |
| Tezecilimab | Takeda | NDA/BLA | Tau | |
| AMG-4531 | Amgen | Phase 2/3 | KRASG12C | |
| Rimaosocimab | Amgen | Preclinical | FXIa | |
| REG-8074 | Regeneron | Phase 2/3 | KRASG12C |