Modality
Small Molecule
MOA
KRASG12Di
Target
PCSK9
Pathway
Notch
AMLRett
Development Pipeline
Preclinical
~Feb 2014
→ ~May 2015
Phase 1
~Aug 2015
→ ~Nov 2016
Phase 2
~Feb 2017
→ ~May 2018
Phase 3
~Aug 2018
→ ~Nov 2019
NDA/BLA
~Feb 2020
→ ~May 2021
Approved
Aug 2021
ApprovedCurrent
NCT03883596
366 pts·AML
2021-08→TBD·Recruiting
366 total pts1 indication
CompletedCurrentUpcoming
Trial Timeline
Approved
Recruit…
Recruiting|StartCompletionToday
Trials (1)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT03883596 | Approved | AML | Recruiting | 366 | DAS28 |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| Doxarasimod | Merck & Co | NDA/BLA | FGFR | |
| Pexarelsin | AstraZeneca | Phase 1 | DLL3 | |
| Ivotuximab | GSK | NDA/BLA | GIP-R | |
| GIL-4361 | Gilead Sciences | Preclinical | PCSK9 | |
| REG-2172 | Regeneron | Phase 1/2 | PCSK9 | |
| BMR-8377 | BioMarin | Phase 1/2 | PCSK9 | |
| Capifutibatinib | Incyte | Phase 3 | PCSK9 | |
| INC-5849 | Incyte | Phase 2 | PCSK9 | |
| Talatapinarof | Samsung Biologics | Phase 1/2 | PCSK9 | |
| Terarasimod | Krystal Biotech | Phase 1/2 | PI3Kα |