← Pipeline|Semafutibatinib

Semafutibatinib

Phase 3
BIO-5552
Source: Trial-derived·Trials: 3
Modality
Radioligand
MOA
TYK2i
Target
Nectin-4
Pathway
PD-1/PD-L1
RettCrohn'sCF
Development Pipeline
Preclinical
~Feb 2014
~May 2015
Phase 1
~Aug 2015
~Nov 2016
Phase 2
~Feb 2017
~May 2018
Phase 3
Aug 2018
Aug 2027
Phase 3Current
NCT08780253
683 pts·Crohn's
2018-082025-01·Active
NCT07658278
2,370 pts·Crohn's
2024-112027-08·Active
NCT07188287
2,271 pts·Rett
2025-022026-06·Recruiting
5,324 total pts2 indications
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (3)
2025-01-251.2y agoPh3 Readout· Crohn's
2026-06-263mo awayPh3 Readout· Rett
2027-08-221.4y awayPh3 Readout· Crohn's
Trial Timeline
Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q4
P3
Active
P3
Active
P3
Recruit…
Catalysts
Ph3 Readout
2025-01-25 · 1.2y ago
Crohn's
Ph3 Readout
2026-06-26 · 3mo away
Rett
Ph3 Readout
2027-08-22 · 1.4y away
Crohn's
RecruitingActive|StartCompletionToday
Trials (3)
NCTPhaseIndicationStatusNEP
NCT08780253Phase 3Crohn'sActive683VA
NCT07658278Phase 3Crohn'sActive2370NT-proBNP
NCT07188287Phase 3RettRecruiting2271BodyWt
Competitors (10)
DrugCompanyPhaseTargetMOA
NidasacituzumabEli LillyApprovedCFTRTYK2i
LisonaritideEli LillyPhase 3IL-13TYK2i
MRK-2473Merck & CoPhase 1/2Nectin-4TYK2i
ZorisotorasibAstraZenecaPhase 1WRNTYK2i
SNY-8628SanofiNDA/BLAB7-H3TYK2i
DSN-1421Daiichi SankyoPhase 3Nectin-4STINGag
VoxacageneGilead SciencesPhase 2/3SOS1TYK2i
SotosacituzumabVertex PharmaPhase 1METTYK2i
SotorapivirModernaApprovedFLT3TYK2i
OlpainavolisibModernaPhase 1MeninTYK2i