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balinatunfib

Phase 2

Colitis Ulcerative | Small molecule | Immunology |Sanofi|Last Updated: May 22, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
Double-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment325
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07222189A Study to Investigate the Long-term Safety, Tolerability and Efficacy of Balinatunfib in Participants With Crohn's Disease or Ulcerative Colitis (SPECIFI-IBD-LTS)PHASE2 ENROLLING BY_INVITATION 325 — — May 19, 2026May 10, 2030May 22, 20262 Bulgaria, Chile
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Study Endpoints
Primary Endpoints
Number of participants with Crohn's Disease with treatment emergent adverse events (TEAEs), serious adverse events (SAEs) and adverse events of special interest (AESIs)
Up to End of Study (approximately 106 weeks)
Number of participants with ulcerative colitis with treatment emergent adverse events (TEAEs), serious adverse events (SAEs) and adverse events of special interest (AESIs)
Up to End of Study (approximately 106 weeks)
Secondary Endpoints
Proportion of participants with Crohn's Disease in endoscopic remission based on simple endoscopic score for Crohn's disease (SES-CD)
Week 52
Proportion of participants with Crohn's Disease in clinical remission based on Crohn's disease activity index (CDAI)
Week 52
Proportion of participants with ulcerative colitis in clinical remission based on modified Mayo Score (mMS)
Week 52
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
CD cohort: balinatunfib dose regimen 1EXPERIMENTALParticipants will receive balinatunfib dose regimen 1
CD cohort: balinatunfib dose regimen 2EXPERIMENTALParticipants will receive balinatunfib dose regimen 2
CD cohort: balinatunfib dose regimen 3EXPERIMENTALParticipants will receive balinatunfib dose regimen 3
CD cohort: PlaceboPLACEBO_COMPARATORParticipants will receive balinatunfib-matching placebo
UC cohort: balinatunfib dose regimen 1EXPERIMENTALParticipants will receive balinatunfib dose regimen 1
UC cohort: balinatunfib dose regimen 2EXPERIMENTALParticipants will receive balinatunfib dose regimen 2
UC cohort: balinatunfib dose regimen 3EXPERIMENTALParticipants will receive balinatunfib dose regimen 3
UC cohort: PlaceboPLACEBO_COMPARATORParticipants will receive balinatunfib-matching placebo
Interventions
NameTypeDescription
balinatunfibDRUGPharmaceutical form:Tablet -Route of administration:Oral
balinatunfib-matching placeboDRUGPharmaceutical form:Tablet -Route of administration:Oral
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Eligibility Criteria
Age Range19 Years — 77 Years
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: Participants are eligible to be included in the study only if all of the following criteria apply: * Participants with Crohn's Disease (CD) or ulcerative colitis (UC) who completed treatment at Week 52 of the SPECIFI-CD (DRI18212) or SPECIFI-UC (DRI17822) studies, respectively:...

Countries:BulgariaChile
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT07222189Status: NOT_YET_RECRUITING → ENROLLING_BY_INVITATION
LOWMay 24, 2026NCT07222189studyFirstPostDate: changed