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TTI-101

Phase 2

Idiopathic Pulmonary Fibrosis | Small molecule | Respiratory |Tvardi Therapeutics, Inc.|Last Updated: Sep 30, 2025

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
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment100
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05671835Study of TTI-101 in Participants With Idiopathic Pulmonary FibrosisPHASE2 COMPLETED 100May 15, 2023Aug 14, 2025Sep 30, 202528 United States
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Study Endpoints
Primary Endpoints
Number of Participants with an Adverse Event (AE)
16 weeks

Incidence of AEs, including serious AEs assessed using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) V.5.0. Clinically significant changes between baseline and postbaseline laboratory assessments, electrocardiograms, vital signs, and physical examinations will be recorded as AEs.

Secondary Endpoints
Maximum Observed Plasma Concentration (Cmax) of TTI-101
Day 1 to Week 12
Time of Maximum Observed Plasma Concentration (tmax) of TTI-101
Day 1 to Week 12
Area Under the Plasma Concentration-time Curve Over a Dosing Interval (AUC[0-τ]) of TTI-101
Day 1 to Week 12
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
TTI-101 400 mg/dayEXPERIMENTALParticipants will receive 400 mg/day of TTI-101 twice daily (BID) for 12 weeks.
TTI-101 800 mg/dayEXPERIMENTALParticipants will receive 800 mg/day of TTI-101 BID for 12 weeks.
PlaceboPLACEBO_COMPARATORParticipants will receive a matching placebo BID for 12 weeks.
Interventions
NameTypeDescription
TTI-101DRUGOrally via a tablet.
PlaceboDRUGOrally via a tablet.
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Eligibility Criteria
Age Range40 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites28

Inclusion Criteria: 1. Diagnosed with IPF based on either the 2018 American Thoracic Society (ATS)/ European Respiratory Society (ERS)/ Japanese Respiratory Society (JRS)/ Latin American Thoracic Association (ALAT) International Diagnostic Guidelines or on the 2022 updated guidelines within 7 years...

Countries:United States
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