Modality
Small Molecule
MOA
KRASG12Ci
Target
BCMA
Pathway
mTOR
SCLCHNSCCPBC
Development Pipeline
Preclinical
~Mar 2013
→ ~Jun 2014
Phase 1
~Sep 2014
→ ~Dec 2015
Phase 2
~Mar 2016
→ ~Jun 2017
Phase 3
Sep 2017
→ Mar 2026
Phase 3Current
NCT06412937
578 pts·SCLC
2017-09→TBD·Completed
NCT07452425
1,463 pts·PBC
2025-09→2026-03·Recruiting
NCT06868435
923 pts·SCLC
2018-09→2025-08·Completed
2,964 total pts2 indications
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (2)
2025-08-118mo agoPh3 Readout· SCLC
2026-03-202w agoPh3 Readout· PBC
Trial Timeline
Q3Q42018Q2Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2
P3
Complet…
P3
Complet…
P3
Recruit…
Catalysts
Ph3 Readout
2025-08-11 · 8mo ago
SCLC
Ph3 Readout
2026-03-20 · 2w ago
PBC
RecruitingCompleted|StartCompletionToday
Trials (3)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT06412937 | Phase 3 | SCLC | Completed | 578 | ORR |
| NCT07452425 | Phase 3 | PBC | Recruiting | 1463 | eGFR |
| NCT06868435 | Phase 3 | SCLC | Completed | 923 | ACR20 |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| LLY-1956 | Eli Lilly | Phase 1/2 | BCMA | |
| Lisolucimab | Novartis | Approved | CD20 | |
| Gozelemzoparlimab | Merck & Co | Phase 2 | FXIa | |
| ABB-8696 | AbbVie | Phase 3 | BCMA | |
| AZN-4015 | AstraZeneca | Preclinical | BCMA | |
| AZN-8478 | AstraZeneca | NDA/BLA | SHP2 | |
| Pexazasiran | Sanofi | Preclinical | FXIa | |
| Terasacituzumab | Novo Nordisk | NDA/BLA | IL-23 | |
| REG-2328 | Regeneron | Phase 1 | BCMA | |
| Adagratapinarof | Vertex Pharma | Preclinical | BCMA |