Modality
siRNA
MOA
PI3Ki
Target
PRMT5
Pathway
Notch
MigraineNASH
Development Pipeline
Preclinical
~Dec 2009
→ ~Mar 2011
Phase 1
~Jun 2011
→ ~Sep 2012
Phase 2
~Dec 2012
→ ~Mar 2014
Phase 3
~Jun 2014
→ ~Sep 2015
NDA/BLA
~Dec 2015
→ ~Mar 2017
Approved
Jun 2017
→ Sep 2031
ApprovedCurrent
NCT03829309
1,232 pts·Migraine
2017-06→2031-09·Completed
NCT03215766
2,532 pts·Migraine
2020-09→2025-07·Completed
NCT04645038
874 pts·Migraine
2021-11→TBD·Not yet recruiting
4,638 total pts1 indication
CompletedCurrentUpcoming
Catalysts (3)
2025-07-159mo agoPh3 Readout· Migraine
2025-11-164mo agoNDA· Migraine
2031-09-285.5y awayPh3 Readout· Migraine
Trial Timeline
Q2Q3Q42018Q2Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q42031Q2Q3Q4
Approved
Complet…
Approved
Complet…
Approved
Not yet…
Catalysts
Ph3 Readout
2025-07-15 · 9mo ago
Migraine
NDA
2025-11-16 · 4mo ago
Migraine
Ph3 Readout
2031-09-28 · 5.5y away
Migraine
CompletedNot yet recruiting|StartCompletionToday
Trials (3)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT03829309 | Approved | Migraine | Completed | 1232 | ACR20 |
| NCT03215766 | Approved | Migraine | Completed | 2532 | HbA1c |
| NCT04645038 | Approved | Migraine | Not yet recr... | 874 | UPCR |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| Nirarelsin | Johnson & Johnson | Phase 2 | PRMT5 | |
| Tiramavacamten | Roche | Preclinical | SGLT2 | |
| NVS-5126 | Novartis | Phase 3 | SHP2 | |
| MRK-853 | Merck & Co | Phase 1 | PRMT5 | |
| Voxacilimab | AstraZeneca | Phase 1/2 | GLP-1R | |
| Geliderotide | Sanofi | Phase 1/2 | PRMT5 | |
| Rimatenlimab | Novo Nordisk | Phase 2/3 | SGLT2 | |
| NVO-9615 | Novo Nordisk | Phase 2/3 | PRMT5 | |
| Suracagene | GSK | Phase 3 | PRMT5 | |
| REG-3155 | Regeneron | Phase 1/2 | MDM2 |