Modality
Degrader
MOA
CDK4/6i
Target
VEGF
Pathway
Lipid Met
PNH
Development Pipeline
Preclinical
~Mar 2014
→ ~Jun 2015
Phase 1
~Sep 2015
→ ~Dec 2016
Phase 2
~Mar 2017
→ ~Jun 2018
Phase 3
~Sep 2018
→ ~Dec 2019
NDA/BLA
~Mar 2020
→ ~Jun 2021
Approved
Sep 2021
→ Nov 2028
ApprovedCurrent
NCT05210750
2,597 pts·PNH
2025-05→TBD·Not yet recruiting
NCT05594901
332 pts·PNH
2021-09→2028-11·Completed
2,929 total pts1 indication
CompletedCurrentUpcoming
Catalysts (1)
2028-11-182.6y awayPh3 Readout· PNH
Trial Timeline
Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q4
Approved
Complet…
Approved
Not yet…
Catalysts
Ph3 Readout
2028-11-18 · 2.6y away
PNH
CompletedNot yet recruiting|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT05210750 | Approved | PNH | Not yet recr... | 2597 | DOR |
| NCT05594901 | Approved | PNH | Completed | 332 | MRD |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| PFE-5767 | Pfizer | Phase 1/2 | BET | |
| RHH-1969 | Roche | Approved | BET | |
| Zanuderotide | Novartis | Phase 1/2 | VEGF | |
| Ivocapivasertib | Bristol-Myers Squibb | Phase 1 | BET | |
| Zorimavacamten | Bristol-Myers Squibb | Preclinical | Cl18.2 | |
| Fixatenlimab | GSK | Phase 1/2 | JAK1 | |
| TAK-8730 | Takeda | Phase 2 | VEGF | |
| GIL-2011 | Gilead Sciences | Preclinical | VEGF | |
| Bemazumab | Regeneron | Phase 1 | VEGF | |
| VRT-4938 | Vertex Pharma | Preclinical | HER2 |