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balinatunfib

Phase 2

Colitis Ulcerative | Small molecule | Gastrointestinal |Sanofi|Last Updated: Jun 23, 2026

Success Probability

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Trial Design

Double-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment325

FDA Designations

No designations recorded

Clinical trial landscape

balinatunfib · 2 trials · 4 indications

Phase 2 1Phase 1 1
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)Colitis Ulcerative
ENROLLING BY_INVITATION325 Analytics
PHASE2ENROLLING BY_INVITATION
A Study to Investigate the Long-term Safety, Tolerability and Efficacy of Balinatunfib in Participants With Crohn's Disease or Ulcerative Colitis (SPECIFI-IBD-LTS)
Colitis Ulcerative
NCT07222189325
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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)
Change from baseline in the QT interval corrected using the Fridericia formula (QTcF) centrally assessed using a semi-automatic reading
Baseline to day 2

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
Balinatunfib Treatment AEXPERIMENTALParticipants will receive a single oral dose of balinatunfib.
Balinatunfib Treatment BEXPERIMENTALParticipants will receive a single oral dose of balinatunfib.
Moxifloxacin Treatment CACTIVE_COMPARATORParticipants will receive a single oral dose of moxifloxacin.
Placebo Treatment DPLACEBO_COMPARATORParticipants will receive a single oral dose of balinatunfib matching placebo and moxifloxacin matching placebo.

Interventions

NameTypeDescription
balinatunfibDRUGPharmaceutical form:Tablet -Route of administration:Oral
balinatunfib-matching placeboDRUGPharmaceutical form:Tablet -Route of administration:Oral
MoxifloxacinDRUGPharmaceutical form: Tablet Route of administration: Oral
PlaceboDRUGPharmaceutical form: Tablet Route of administration: Oral
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Eligibility Criteria

Age Range19 Years to 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:BulgariaChileUnited States
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Recent Changes (Last 90 Days)

MEDIUMJul 24, 2026NCT07272629TRIAL_REMOVED: changed
MEDIUMJul 24, 2026NCT07272629TRIAL_REMOVED: changed
HIGHJun 23, 2026NCT07272629Status: ACTIVE_NOT_RECRUITING → COMPLETED
HIGHJun 23, 2026NCT07272629Status: ACTIVE_NOT_RECRUITING → COMPLETED

Frequently asked questions about balinatunfib

What is Balinatunfib used for?

Balinatunfib is an investigational small molecule being studied for the treatment of ulcerative colitis and Crohn's disease, which are inflammatory bowel conditions. It is also being evaluated for its effect on cardiac repolarization in healthy volunteers. The drug is in early clinical development and is not yet approved.

Who makes Balinatunfib?

Balinatunfib is being developed by Sanofi, a global biopharmaceutical company traded on the NASDAQ under the ticker symbol SNY. Sanofi is conducting clinical trials to evaluate the safety, tolerability, and efficacy of this investigational drug in patients with inflammatory bowel disease.

What phase is Balinatunfib in?

Balinatunfib is in Phase 1 clinical development. One Phase 1 study has been completed, and a Phase 2 study is enrolling by invitation. The drug is investigational and has not received FDA approval.

What clinical trials is Balinatunfib in?

Balinatunfib has two clinical trials. NCT07222189 is a Phase 2 study of long-term safety and efficacy in ulcerative colitis and Crohn's disease, enrolling 325 participants in Bulgaria and Chile. NCT07272629 is a completed Phase 1 study of its effect on cardiac repolarization in 48 healthy adults in the United States.

Is Balinatunfib the same as any other drug?

No alternative names for Balinatunfib have been disclosed. The drug is identified by its investigational name in clinical trial registries and is being developed by Sanofi for inflammatory bowel disease and cardiac safety evaluation.