Modality
Small Molecule
MOA
DLL3 ADC
Target
KRASG12C
Pathway
Hedgehog
ALL
Development Pipeline
Preclinical
~Jan 2015
→ ~Apr 2016
Phase 1
~Jul 2016
→ ~Oct 2017
Phase 2
~Jan 2018
→ ~Apr 2019
Phase 3
~Jul 2019
→ ~Oct 2020
NDA/BLA
~Jan 2021
→ ~Apr 2022
Approved
Jul 2022
ApprovedCurrent
NCT05260658
2,523 pts·ALL
2022-07→TBD·Recruiting
NCT05991387
1,809 pts·ALL
2024-10→TBD·Completed
4,332 total pts1 indication
CompletedCurrentUpcoming
Catalysts (1)
2025-09-176mo agoOrphan Drug· ALL
Trial Timeline
Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q4
Approved
Recruit…
Approved
Complet…
Catalysts
Orphan Drug
2025-09-17 · 6mo ago
ALL
RecruitingCompleted|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT05260658 | Approved | ALL | Recruiting | 2523 | Safety |
| NCT05991387 | Approved | ALL | Completed | 1809 | PANSS |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| JNJ-179 | Johnson & Johnson | Approved | KRASG12C | |
| NVS-4076 | Novartis | Preclinical | TROP-2 | |
| Rimamavacamten | Merck & Co | Phase 1 | PI3Kα | |
| BMY-4586 | Bristol-Myers Squibb | Preclinical | KRASG12C | |
| Doxarapivir | Bristol-Myers Squibb | Phase 3 | KRASG12C | |
| AMG-9654 | Amgen | Phase 2 | GPRC5D | |
| AMG-4531 | Amgen | Phase 2/3 | KRASG12C | |
| REG-8074 | Regeneron | Phase 2/3 | KRASG12C | |
| VRT-1891 | Vertex Pharma | Phase 1 | KRASG12C | |
| Pemitapinarof | BeiGene | Approved | KRASG12C |