Modality
ADC
MOA
PCSK9i
Target
CDK2
Pathway
PI3K/AKT
MDDWilms
Development Pipeline
Preclinical
~Aug 2019
→ ~Nov 2020
Phase 1
~Feb 2021
→ ~May 2022
Phase 2
Aug 2022
→ Jan 2025
Phase 2Current
NCT06147408
2,607 pts·MDD
2023-09→2025-01·Completed
NCT05274214
2,924 pts·MDD
2022-08→TBD·Completed
5,531 total pts1 indication
Phase 3
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (1)
2025-01-161.2y agoPh3 Readout· MDD
Trial Timeline
Q42023Q2Q3Q42024Q2Q3Q42025
P2/3
Complet…
P2/3
Complet…
Catalysts
Ph3 Readout
2025-01-16 · 1.2y ago
MDD
Completed|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT06147408 | Phase 2/3 | MDD | Completed | 2607 | VA |
| NCT05274214 | Phase 2/3 | MDD | Completed | 2924 | EDSS |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| PFE-3703 | Pfizer | Phase 1/2 | CDK2 | |
| NVS-3297 | Novartis | Preclinical | CDK2 | |
| MRK-8368 | Merck & Co | Phase 3 | ALK | |
| Ribofutibatinib | AstraZeneca | Phase 2/3 | SOS1 | |
| AZN-4015 | AstraZeneca | Preclinical | BCMA | |
| Fixainavolisib | Takeda | Preclinical | CDK2 | |
| AMG-1919 | Amgen | Phase 2/3 | CDK2 | |
| Polazasiran | Amgen | Phase 2 | LAG-3 | |
| AMG-415 | Amgen | Phase 1 | CDK2 | |
| AMG-9052 | Amgen | Phase 2/3 | CDK2 |