Modality
Fusion Protein
MOA
FcRni
Target
B7-H3
Pathway
PD-1/PD-L1
NASH
Development Pipeline
Preclinical
~Jan 2017
→ ~Apr 2018
Phase 1
~Jul 2018
→ ~Oct 2019
Phase 2
~Jan 2020
→ ~Apr 2021
Phase 3
~Jul 2021
→ ~Oct 2022
NDA/BLA
~Jan 2023
→ ~Apr 2024
Approved
Jul 2024
→ Mar 2030
ApprovedCurrent
NCT06411535
570 pts·NASH
2024-07→2030-03·Not yet recruiting
570 total pts1 indication
CompletedCurrentUpcoming
Catalysts (1)
2030-03-164.0y awayPh3 Readout· NASH
Trial Timeline
Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2
Approved
Not yet…
Catalysts
Ph3 Readout
2030-03-16 · 4.0y away
NASH
Not yet recruiting|StartCompletionToday
Trials (1)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT06411535 | Approved | NASH | Not yet recr... | 570 | UPDRS |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| LLY-4358 | Eli Lilly | Phase 3 | B7-H3 | |
| Ceviglumide | Roche | NDA/BLA | B7-H3 | |
| ABB-2476 | AbbVie | Phase 1/2 | USP1 | |
| 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 | |
| Suracagene | GSK | Phase 3 | PRMT5 | |
| DSN-5254 | Daiichi Sankyo | Phase 1 | B7-H3 |