Modality
Radioligand
MOA
RAS(ON)i
Target
CDK2
Pathway
Complement
MigraineCKDSMA
Development Pipeline
Preclinical
~Oct 2009
→ ~Jan 2011
Phase 1
~Apr 2011
→ ~Jul 2012
Phase 2
~Oct 2012
→ ~Jan 2014
Phase 3
~Apr 2014
→ ~Jul 2015
NDA/BLA
~Oct 2015
→ ~Jan 2017
Approved
Apr 2017
→ Feb 2027
ApprovedCurrent
NCT04540462
981 pts·Migraine
2017-04→2027-02·Not yet recruiting
NCT07583156
1,822 pts·Migraine
2017-05→TBD·Recruiting
2,803 total pts1 indication
CompletedCurrentUpcoming
Catalysts (1)
2027-02-0810mo awayPh3 Readout· Migraine
Trial Timeline
Q2Q3Q42018Q2Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2
Approved
Not yet…
Approved
Recruit…
Catalysts
Ph3 Readout
2027-02-08 · 10mo away
Migraine
RecruitingNot yet recruiting|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT04540462 | Approved | Migraine | Not yet recr... | 981 | Biomarker |
| NCT07583156 | Approved | Migraine | Recruiting | 1822 | SRI-4 |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| PFE-3703 | Pfizer | Phase 1/2 | CDK2 | |
| NVS-3297 | Novartis | Preclinical | CDK2 | |
| MRK-6781 | Merck & Co | Approved | TIGIT | |
| SNY-9073 | Sanofi | Phase 2 | B7-H3 | |
| Fixainavolisib | Takeda | Preclinical | CDK2 | |
| AMG-1919 | Amgen | Phase 2/3 | CDK2 | |
| AMG-415 | Amgen | Phase 1 | CDK2 | |
| AMG-9052 | Amgen | Phase 2/3 | CDK2 | |
| Zanuratamab | Gilead Sciences | Phase 1/2 | CDK2 | |
| Tixarelsin | Vertex Pharma | Phase 1 | ALK |