Modality
mAb
MOA
CDK2i
Target
CDK2
Pathway
T-cell
TTR AmyloidosisDravetPNH
Development Pipeline
Preclinical
~Dec 2016
→ ~Mar 2018
Phase 1
Jun 2018
→ Jun 2028
Phase 1Current
NCT05454590
2,037 pts·PNH
2018-06→2025-08·Terminated
NCT07045848
2,197 pts·TTR Amyloidosis
2024-10→2028-06·Recruiting
4,234 total pts2 indications
Phase 2
Phase 3
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (2)
2025-08-108mo agoPh2 Data· PNH
2028-06-162.2y awayPh2 Data· TTR Amyloidosis
Trial Timeline
Q2Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3
P1/2
Termina…
P1/2
Recruit…
Catalysts
Ph2 Data
2025-08-10 · 8mo ago
PNH
Ph2 Data
2028-06-16 · 2.2y away
TTR Amyloidosis
RecruitingTerminated|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT05454590 | Phase 1/2 | PNH | Terminated | 2037 | OS |
| NCT07045848 | Phase 1/2 | TTR Amyloidosis | Recruiting | 2197 | CfB |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| Tirafotisoran | Roche | Phase 2 | CD38 | |
| NVS-3297 | Novartis | Preclinical | CDK2 | |
| ABB-3951 | AbbVie | Phase 2/3 | TNFα | |
| AZN-6870 | AstraZeneca | Phase 2/3 | EGFR | |
| Fixainavolisib | Takeda | Preclinical | CDK2 | |
| Tirasotorasib | Takeda | NDA/BLA | IL-17A | |
| Mavuglumide | Bayer | Approved | GLP-1R | |
| DSN-3066 | Daiichi Sankyo | Phase 3 | IL-13 | |
| AMG-1919 | Amgen | Phase 2/3 | CDK2 | |
| AMG-415 | Amgen | Phase 1 | CDK2 |