Modality
ASO
MOA
VEGFi
Target
B7-H3
Pathway
Apoptosis
PNHRBCML
Development Pipeline
Preclinical
~Jul 2009
→ ~Oct 2010
Phase 1
~Jan 2011
→ ~Apr 2012
Phase 2
~Jul 2012
→ ~Oct 2013
Phase 3
~Jan 2014
→ ~Apr 2015
NDA/BLA
~Jul 2015
→ ~Oct 2016
Approved
Jan 2017
→ Jan 2027
ApprovedCurrent
NCT06711573
2,383 pts·CML
2025-10→2026-04·Terminated
NCT07052625
316 pts·PNH
2017-01→2027-01·Terminated
2,699 total pts2 indications
CompletedCurrentUpcoming
Catalysts (2)
2026-04-055d awayPh3 Readout· CML
2027-01-129mo awayPh3 Readout· PNH
Trial Timeline
2017Q2Q3Q42018Q2Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027
Approved
Termina…
Approved
Termina…
Catalysts
Ph3 Readout
2026-04-05 · 5d away
CML
Ph3 Readout
2027-01-12 · 9mo away
PNH
Terminated|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT06711573 | Approved | CML | Terminated | 2383 | CR |
| NCT07052625 | Approved | PNH | Terminated | 316 | ACR20 |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| LLY-4358 | Eli Lilly | Phase 3 | B7-H3 | |
| Ceviglumide | Roche | NDA/BLA | B7-H3 | |
| MRK-5413 | Merck & Co | Phase 1 | GLP-1R | |
| Doxasotorasib | AbbVie | Phase 2 | CD38 | |
| 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 | |
| Ceviderotide | Novo Nordisk | Preclinical | IL-13 | |
| NVO-7872 | Novo Nordisk | NDA/BLA | B7-H3 |