Modality
Small Molecule
MOA
PLK4i
Target
B7-H3
Pathway
mTOR
RA
Development Pipeline
Preclinical
~Jul 2017
→ ~Oct 2018
Phase 1
Jan 2019
→ Jun 2026
Phase 1Current
NCT08016422
1,102 pts·RA
2019-01→2026-06·Recruiting
1,102 total pts1 indication
Phase 2
Phase 3
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (1)
2026-06-273mo awayPh2 Data· RA
Trial Timeline
2019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3
P1/2
Recruit…
Catalysts
Ph2 Data
2026-06-27 · 3mo away
RA
Recruiting|StartCompletionToday
Trials (1)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT08016422 | Phase 1/2 | RA | Recruiting | 1102 | CR |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| LLY-4358 | Eli Lilly | Phase 3 | B7-H3 | |
| Ceviglumide | Roche | NDA/BLA | B7-H3 | |
| SNY-9600 | Sanofi | NDA/BLA | B7-H3 | |
| SNY-8628 | Sanofi | NDA/BLA | B7-H3 | |
| SNY-9073 | Sanofi | Phase 2 | B7-H3 | |
| NVO-7840 | Novo Nordisk | Phase 2/3 | B7-H3 | |
| NVO-7872 | Novo Nordisk | NDA/BLA | B7-H3 | |
| DSN-5254 | Daiichi Sankyo | Phase 1 | B7-H3 | |
| AMG-2597 | Amgen | Phase 2/3 | CD38 | |
| Datozumab | Regeneron | Phase 1 | B7-H3 |