Modality
Radioligand
MOA
Cl18.2
Target
CDK2
Pathway
JAK/STAT
PNH
Development Pipeline
Preclinical
~Jan 2018
→ ~Apr 2019
Phase 1
~Jul 2019
→ ~Oct 2020
Phase 2
~Jan 2021
→ ~Apr 2022
Phase 3
~Jul 2022
→ ~Oct 2023
NDA/BLA
~Jan 2024
→ ~Apr 2025
Approved
Jul 2025
→ May 2028
ApprovedCurrent
NCT04432139
2,918 pts·PNH
2025-07→2028-05·Recruiting
2,918 total pts1 indication
CompletedCurrentUpcoming
Catalysts (1)
2028-05-212.1y awayPh3 Readout· PNH
Trial Timeline
Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2
Approved
Recruit…
Catalysts
Ph3 Readout
2028-05-21 · 2.1y away
PNH
Recruiting|StartCompletionToday
Trials (1)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT04432139 | Approved | PNH | Recruiting | 2918 | UPCR |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| PFE-3703 | Pfizer | Phase 1/2 | CDK2 | |
| NVS-3297 | Novartis | Preclinical | CDK2 | |
| Zorivorutinib | Bristol-Myers Squibb | Approved | DLL3 | |
| Fixainavolisib | Takeda | Preclinical | CDK2 | |
| AMG-1919 | Amgen | Phase 2/3 | CDK2 | |
| AMG-415 | Amgen | Phase 1 | CDK2 | |
| AMG-9052 | Amgen | Phase 2/3 | CDK2 | |
| Zanuratamab | Gilead Sciences | Phase 1/2 | CDK2 | |
| Elrarapivir | Regeneron | Phase 1 | GIP-R | |
| Nirabrutinib | BioNTech | Phase 2/3 | CDK2 |