Modality
Small Molecule
MOA
MALT1i
Target
CDK2
Pathway
DDR
MMAMLSCD
Development Pipeline
Preclinical
~Jun 2017
→ ~Sep 2018
Phase 1
~Dec 2018
→ ~Mar 2020
Phase 2
~Jun 2020
→ ~Sep 2021
Phase 3
~Dec 2021
→ ~Mar 2023
NDA/BLA
Jun 2023
→ Apr 2025
NDA/BLACurrent
NCT08718367
894 pts·MM
2023-06→2025-04·Completed
894 total pts1 indication
Approved
CompletedCurrentUpcoming
Catalysts (1)
2025-04-0212mo agoPh3 Readout· MM
Trial Timeline
Q3Q42024Q2Q3Q42025Q2
NDA/BLA
Complet…
Catalysts
Ph3 Readout
2025-04-02 · 12mo ago
MM
Completed|StartCompletionToday
Trials (1)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT08718367 | NDA/BLA | MM | Completed | 894 | SRI-4 |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| PFE-3703 | Pfizer | Phase 1/2 | CDK2 | |
| JNJ-2735 | Johnson & Johnson | Phase 2/3 | Cl18.2 | |
| Riboinavolisib | Johnson & Johnson | Phase 2/3 | GLP-1R | |
| RHH-974 | Roche | Preclinical | JAK1 | |
| NVS-3297 | Novartis | Preclinical | CDK2 | |
| ABB-8985 | AbbVie | Phase 2 | CD20 | |
| Fixainavolisib | Takeda | Preclinical | CDK2 | |
| AMG-1919 | Amgen | Phase 2/3 | CDK2 | |
| AMG-415 | Amgen | Phase 1 | CDK2 | |
| AMG-9052 | Amgen | Phase 2/3 | CDK2 |