Modality
Radioligand
MOA
KRASG12Di
Target
CDK4/6
Pathway
Neuroinflam
AML
Development Pipeline
Preclinical
~Oct 2009
→ ~Jan 2011
Phase 1
~Apr 2011
→ ~Jul 2012
Phase 2
~Oct 2012
→ ~Jan 2014
Phase 3
~Apr 2014
→ ~Jul 2015
NDA/BLA
~Oct 2015
→ ~Jan 2017
Approved
Apr 2017
→ Aug 2030
ApprovedCurrent
NCT04378203
2,767 pts·AML
2018-01→2030-08·Completed
NCT05905201
675 pts·AML
2017-04→2029-08·Active
NCT08557357
2,139 pts·AML
2020-07→2025-04·Terminated
5,581 total pts1 indication
CompletedCurrentUpcoming
Catalysts (4)
2025-04-1611mo agoPh3 Readout· AML
2026-08-285mo awayPh1 Dose Esc· AML
2029-08-223.4y awayPh3 Readout· AML
2030-08-154.4y awayPh3 Readout· AML
Trial Timeline
2017Q2Q3Q42018Q2Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q4
Approved
Active
Approved
Complet…
Approved
Termina…
Catalysts
Ph3 Readout
2025-04-16 · 11mo ago
AML
Ph1 Dose Esc
2026-08-28 · 5mo away
AML
Ph3 Readout
2029-08-22 · 3.4y away
AML
Ph3 Readout
2030-08-15 · 4.4y away
AML
ActiveCompletedTerminated|StartCompletionToday
Trials (3)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT04378203 | Approved | AML | Completed | 2767 | BodyWt |
| NCT05905201 | Approved | AML | Active | 675 | PASI75 |
| NCT08557357 | Approved | AML | Terminated | 2139 | OS |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| Doxarasimod | Merck & Co | NDA/BLA | FGFR | |
| Zanusertib | AbbVie | Approved | PCSK9 | |
| Pexarelsin | AstraZeneca | Phase 1 | DLL3 | |
| Ivotuximab | GSK | NDA/BLA | GIP-R | |
| Motavorutinib | Amgen | Phase 3 | CDK4/6 | |
| Ribozanubrutinib | Regeneron | Phase 1 | CDK4/6 | |
| MRN-5715 | Moderna | NDA/BLA | CDK4/6 | |
| Terarasimod | Krystal Biotech | Phase 1/2 | PI3Kα | |
| Elralucimab | Axsome | Phase 2 | CDK4/6 | |
| DAW-5540 | Day One Bio | Phase 2 | AHR |