← Pipeline|FDM-9341

FDM-9341

Phase 2/3
Source: Trial-derived·Trials: 2
Modality
Vaccine
MOA
CD3xCD20
Target
JAK1
Pathway
PI3K/AKT
MigraineAMLCRC
Development Pipeline
Preclinical
~Jun 2015
~Sep 2016
Phase 1
~Dec 2016
~Mar 2018
Phase 2
Jun 2018
Feb 2029
Phase 2Current
NCT05667466
2,734 pts·Migraine
2023-092029-02·Recruiting
NCT05778583
1,234 pts·Migraine
2018-062025-04·Completed
3,968 total pts1 indication
Phase 3
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (2)
2025-04-2211mo agoPh3 Readout· Migraine
2029-02-082.9y awayPh3 Readout· Migraine
Trial Timeline
Q2Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2
P2/3
Complet…
P2/3
Recruit…
Catalysts
Ph3 Readout
2025-04-22 · 11mo ago
Migraine
Ph3 Readout
2029-02-08 · 2.9y away
Migraine
RecruitingCompleted|StartCompletionToday
Trials (2)
NCTPhaseIndicationStatusNEP
NCT05667466Phase 2/3MigraineRecruiting2734FEV1
NCT05778583Phase 2/3MigraineCompleted1234LiverFat
Competitors (10)
DrugCompanyPhaseTargetMOA
IvorelsinEli LillyApprovedJAK1Menini
LLY-1184Eli LillyNDA/BLAC5CD3xCD20
RHH-974RochePreclinicalJAK1MALT1i
ZanuderotideNovartisPhase 1/2VEGFCD3xCD20
NVO-1361Novo NordiskPhase 3CD38CD3xCD20
ZorizanubrutinibNovo NordiskPhase 1BTKCD3xCD20
FixatenlimabGSKPhase 1/2JAK1CDK4/6i
PexamavacamtenDaiichi SankyoNDA/BLATIGITCD3xCD20
GIL-8529Gilead SciencesPhase 1/2JAK1EGFRi
ITC-1028Intra-CellularPhase 2BCMACD3xCD20