Modality
Fusion Protein
MOA
FXIai
Target
KRASG12D
Pathway
STING
MDDNMOSDSMA
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
→ Mar 2029
ApprovedCurrent
NCT03146920
1,702 pts·NMOSD
2023-03→2025-05·Terminated
NCT07905940
1,270 pts·NMOSD
2022-08→2027-03·Active
NCT06817460
1,274 pts·NMOSD
2022-07→2029-03·Recruiting
4,246 total pts1 indication
CompletedCurrentUpcoming
Catalysts (3)
2025-05-1411mo agoPh3 Readout· NMOSD
2027-03-1011mo awayPh3 Readout· NMOSD
2029-03-233.0y awayPh3 Readout· NMOSD
Trial Timeline
Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2
Approved
Recruit…
Approved
Active
Approved
Termina…
Catalysts
Ph3 Readout
2025-05-14 · 11mo ago
NMOSD
Ph3 Readout
2027-03-10 · 11mo away
NMOSD
Ph3 Readout
2029-03-23 · 3.0y away
NMOSD
RecruitingActiveTerminated|StartCompletionToday
Trials (3)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT03146920 | Approved | NMOSD | Terminated | 1702 | VA |
| NCT07905940 | Approved | NMOSD | Active | 1270 | NT-proBNP |
| NCT06817460 | Approved | NMOSD | Recruiting | 1274 | NT-proBNP |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| NVS-6360 | Novartis | Approved | CD38 | |
| Rilulemzoparlimab | Novartis | Phase 2/3 | KRASG12D | |
| MRK-3745 | Merck & Co | Phase 2 | WRN | |
| AZN-1715 | AstraZeneca | Phase 3 | AHR | |
| BMY-2495 | Bristol-Myers Squibb | Phase 3 | KRASG12D | |
| BMY-9931 | Bristol-Myers Squibb | Phase 1 | GPRC5D | |
| SNY-2934 | Sanofi | Phase 3 | KRASG12D | |
| Talainavolisib | Novo Nordisk | Preclinical | KRASG12D | |
| NVO-7877 | Novo Nordisk | Preclinical | GPRC5D | |
| TAK-8730 | Takeda | Phase 2 | VEGF |