Modality
Small Molecule
MOA
BCL-2i
Target
CDK4/6
Pathway
PD-1/PD-L1
DMD
Development Pipeline
Preclinical
~Oct 2017
→ ~Jan 2019
Phase 1
~Apr 2019
→ ~Jul 2020
Phase 2
~Oct 2020
→ ~Jan 2022
Phase 3
~Apr 2022
→ ~Jul 2023
NDA/BLA
~Oct 2023
→ ~Jan 2025
Approved
Apr 2025
→ Mar 2031
ApprovedCurrent
NCT03595066
373 pts·DMD
2025-04→2031-03·Recruiting
373 total pts1 indication
CompletedCurrentUpcoming
Catalysts (1)
2031-03-094.9y awayPh3 Readout· DMD
Trial Timeline
Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q42031Q2
Approved
Recruit…
Catalysts
Ph3 Readout
2031-03-09 · 4.9y away
DMD
Recruiting|StartCompletionToday
Trials (1)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT03595066 | Approved | DMD | Recruiting | 373 | VA |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| PFE-5501 | Pfizer | Phase 1 | BTK | |
| RHH-3592 | Roche | Phase 1/2 | GIP-R | |
| Geliderotide | Novartis | NDA/BLA | IL-17A | |
| Tezecilimab | Takeda | NDA/BLA | Tau | |
| Rimaosocimab | Amgen | Preclinical | FXIa | |
| Motavorutinib | Amgen | Phase 3 | CDK4/6 | |
| Ribozanubrutinib | Regeneron | Phase 1 | CDK4/6 | |
| MRN-5715 | Moderna | NDA/BLA | CDK4/6 | |
| Capifutibatinib | Incyte | Phase 3 | PCSK9 | |
| NBI-408 | Neurocrine | Phase 2/3 | KRASG12D |