Modality
Gene Therapy
MOA
SGLT2i
Target
MET
Pathway
Apoptosis
MDSNMOSD
Development Pipeline
Preclinical
~Nov 2011
→ ~Feb 2013
Phase 1
~May 2013
→ ~Aug 2014
Phase 2
~Nov 2014
→ ~Feb 2016
Phase 3
~May 2016
→ ~Aug 2017
NDA/BLA
~Nov 2017
→ ~Feb 2019
Approved
May 2019
→ Apr 2029
ApprovedCurrent
NCT07536198
533 pts·NMOSD
2021-04→2029-04·Recruiting
NCT03003847
2,452 pts·NMOSD
2019-05→2026-08·Not yet recruiting
NCT03804994
1,491 pts·NMOSD
2023-03→2026-04·Terminated
4,476 total pts1 indication
CompletedCurrentUpcoming
Catalysts (3)
2026-04-264w awayPh3 Readout· NMOSD
2026-08-144mo awayPh3 Readout· NMOSD
2029-04-123.0y awayPh3 Readout· NMOSD
Trial Timeline
Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2
Approved
Not yet…
Approved
Recruit…
Approved
Termina…
Catalysts
Ph3 Readout
2026-04-26 · 4w away
NMOSD
Ph3 Readout
2026-08-14 · 4mo away
NMOSD
Ph3 Readout
2029-04-12 · 3.0y away
NMOSD
RecruitingTerminatedNot yet recruiting|StartCompletionToday
Trials (3)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT07536198 | Approved | NMOSD | Recruiting | 533 | Safety |
| NCT03003847 | Approved | NMOSD | Not yet recr... | 2452 | BodyWt |
| NCT03804994 | Approved | NMOSD | Terminated | 1491 | PANSS |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| JNJ-8232 | Johnson & Johnson | NDA/BLA | MALT1 | |
| Bemalucimab | Bristol-Myers Squibb | Phase 1/2 | Aβ | |
| SNY-5783 | Sanofi | Phase 1/2 | MET | |
| BAY-3308 | Bayer | Phase 1 | ALK | |
| Sotosacituzumab | Vertex Pharma | Phase 1 | MET | |
| MRN-8225 | Moderna | Preclinical | TNFα | |
| Motazanubrutinib | Biogen | Preclinical | CD38 | |
| ALN-5628 | Alnylam | Phase 1/2 | APOC3 | |
| RVM-274 | Revolution Medicines | Phase 3 | MET | |
| Talazasiran | Kymera | NDA/BLA | MET |