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PIPE-791 Dose A

Phase 2

Idiopathic Pulmonary Fibrosis | Small molecule | Respiratory |Contineum Therapeutics, Inc.|Last Updated: Jun 8, 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
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment324
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07284459Study to Evaluate the Efficacy, Safety, and Tolerability of PIPE 791 in Subjects With Idiopathic Pulmonary FibrosisPHASE2 RECRUITING 324Jan 8, 2026Jun 1, 2028Jun 8, 202619 Australia, Canada +3
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Study Endpoints
Primary Endpoints
Absolute change in forced vital capacity (FVC) (mL)
From baseline to Week 26
Secondary Endpoints
To investigate the safety and tolerability of PIPE-791 compared to placebo based on percentage of treatment-emergent adverse events (TEAE)
From baseline to Week 30
Relative change in FVC (mL)
From baseline to Week 26
Proportion of subjects with a ≥10% absolute decline in percent predicted FVC (ppFVC)
From baseline to Weeks 12 and Week 26
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
PIPE-791 Dose AEXPERIMENTAL -
PIPE-791 Dose BEXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
PIPE-791 Dose ADRUGSubjects will receive a daily oral dose of PIPE-791 in tablet form
PIPE-791 Dose BDRUGSubjects will receive a daily oral dose of PIPE-791 in tablet form
PlaceboDRUGSubjects will receive a daily oral dose of matching Placebo in tablet form
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Eligibility Criteria
Age Range40 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites19

Key Inclusion Criteria: * Male or female ≥ 40 years of age at the time of Randomization * A diagnosis of IPF within 7 years prior to Screening, based on the 2018 ATS/ERS/JRS/ALAT practice guideline as confirmed by the Investigator, and a centrally read screening HRCT with verification of usual inte...

Countries:AustraliaCanadaIsraelSouth KoreaUnited Kingdom
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Recent Changes (Last 90 Days)
LOWJun 8, 2026NCT07284459lastUpdatePostDate: changed
LOWJun 8, 2026NCT07284459lastUpdatePostDate: changed
LOWJun 8, 2026NCT07284459lastUpdatePostDate: changed
LOWJun 5, 2026NCT07284459lastUpdatePostDate: changed
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LOWJun 4, 2026NCT07284459lastUpdatePostDate: changed
LOWJun 4, 2026NCT07284459lastUpdatePostDate: changed
LOWJun 4, 2026NCT07284459lastUpdatePostDate: changed
LOWJun 4, 2026NCT07284459lastUpdatePostDate: changed
LOWJun 2, 2026NCT07284459lastUpdatePostDate: changed
LOWJun 2, 2026NCT07284459lastUpdatePostDate: changed
LOWJun 2, 2026NCT07284459lastUpdatePostDate: changed
LOWMay 26, 2026NCT07284459primaryCompletionDate: changed
LOWMay 24, 2026NCT07284459studyFirstPostDate: changed