Modality
Degrader
MOA
PCSK9i
Target
Nectin-4
Pathway
Hedgehog
MCL
Development Pipeline
Preclinical
~Feb 2012
→ ~May 2013
Phase 1
~Aug 2013
→ ~Nov 2014
Phase 2
~Feb 2015
→ ~May 2016
Phase 3
~Aug 2016
→ ~Nov 2017
NDA/BLA
~Feb 2018
→ ~May 2019
Approved
Aug 2019
→ Nov 2029
ApprovedCurrent
NCT08478486
321 pts·MCL
2019-08→2029-11·Terminated
321 total pts1 indication
CompletedCurrentUpcoming
Catalysts (1)
2029-11-253.7y awayPh3 Readout· MCL
Trial Timeline
Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q4
Approved
Termina…
Catalysts
Ph3 Readout
2029-11-25 · 3.7y away
MCL
Terminated|StartCompletionToday
Trials (1)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT08478486 | Approved | MCL | Terminated | 321 | eGFR |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| MRK-8368 | Merck & Co | Phase 3 | ALK | |
| MRK-2473 | Merck & Co | Phase 1/2 | Nectin-4 | |
| Ribofutibatinib | AstraZeneca | Phase 2/3 | SOS1 | |
| AZN-4015 | AstraZeneca | Preclinical | BCMA | |
| DSN-1421 | Daiichi Sankyo | Phase 3 | Nectin-4 | |
| Polazasiran | Amgen | Phase 2 | LAG-3 | |
| Cevitinib | Regeneron | Phase 3 | FGFR | |
| INC-1261 | Incyte | Phase 1/2 | PRMT5 | |
| ION-3857 | Ionis | Preclinical | Nectin-4 | |
| Mavutuximab | Hansoh Pharma | Phase 2/3 | PI3Kα |