Modality
Peptide
MOA
Menini
Target
SMN2
Pathway
RNA Splicing
NMOSDMigraine
Development Pipeline
Preclinical
~May 2011
→ ~Aug 2012
Phase 1
~Nov 2012
→ ~Feb 2014
Phase 2
~May 2014
→ ~Aug 2015
Phase 3
~Nov 2015
→ ~Feb 2017
NDA/BLA
~May 2017
→ ~Aug 2018
Approved
Nov 2018
→ Oct 2031
ApprovedCurrent
NCT07515052
495 pts·NMOSD
2018-11→2031-05·Terminated
NCT06053301
1,089 pts·Migraine
2021-04→2031-10·Completed
NCT07306383
331 pts·Migraine
2023-12→2030-10·Recruiting
+1 more trial
3,319 total pts2 indications
CompletedCurrentUpcoming
Catalysts (3)
2030-10-274.6y awayPh3 Readout· Migraine
2031-05-055.1y awayPh3 Readout· NMOSD
2031-10-115.5y awayPh3 Readout· Migraine
Trial Timeline
Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q42031Q2Q3Q4
Approved
Termina…
Approved
Complet…
Approved
Active
Approved
Recruit…
Catalysts
Ph3 Readout
2030-10-27 · 4.6y away
Migraine
Ph3 Readout
2031-05-05 · 5.1y away
NMOSD
Ph3 Readout
2031-10-11 · 5.5y away
Migraine
RecruitingActiveCompletedTerminated|StartCompletionToday
Trials (4)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT07515052 | Approved | NMOSD | Terminated | 495 | ACR20 |
| NCT06053301 | Approved | Migraine | Completed | 1089 | Safety |
| NCT07306383 | Approved | Migraine | Recruiting | 331 | LiverFat |
| NCT08360312 | Approved | NMOSD | Active | 1404 | UPCR |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| Mavutenlimab | Johnson & Johnson | Phase 3 | Cl18.2 | |
| Ivorelsin | Eli Lilly | Approved | JAK1 | |
| NVO-2974 | Novo Nordisk | NDA/BLA | PARP | |
| NVO-6275 | Novo Nordisk | Phase 1 | SMN2 | |
| TAK-5300 | Takeda | Phase 1 | SMN2 | |
| GIL-2259 | Gilead Sciences | Approved | SMN2 | |
| REG-647 | Regeneron | Preclinical | SMN2 | |
| TXG-6755 | 10x Genomics | Approved | CD123 | |
| Zoricapivasertib | CSL Limited | Phase 2 | HER2 | |
| Fixatapinarof | Jiangsu Hengrui | Preclinical | PLK4 |