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PIPE-791

Phase 2

Idiopathic Pulmonary Fibrosis | Small molecule | Neurology |Contineum Therapeutics, Inc.|Trials Updated: Oct 16, 2026

PIPE-791 development status

Highest phase Phase 2
Registered trials 4 across 1 sponsor since Aug 2023

PIPE-791 target and mechanism

Molecular targetLPA1
Target classReceptor
ModalitySmall molecule

Also known as PIPE-791 Dose B

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLEDDMC
Total Trials4
Total Enrollment439

FDA Designations

No designations recorded

PIPE-791 clinical trials

PIPE-791 · 4 trials · 11 indications

Phase 2 1Phase 1 3
NCT07284459Study to Evaluate the Efficacy, Safety, and Tolerability of PIPE 791 in Subjects With Idiopathic Pulmonary FibrosisIdiopathic Pulmonary Fibrosis
RECRUITING324 Analytics
PHASE2RECRUITING
Study to Evaluate the Efficacy, Safety, and Tolerability of PIPE 791 in Subjects With Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary FibrosisUnlock trial analytics

Study Endpoints

Primary Endpoints

Absolute change in forced vital capacity (FVC) (mL)
From baseline to Week 26
Number of subjects with Treatment-emergent adverse events (TEAEs)
For Treatment Period 1, from Baseline (Day 1) to End of Treatment Period 1 (TP1; Day 29), for Treatment Period 2, from Baseline of Treatment Period 2 (TP2; Day 29) to End of TP2 (Day 57).

The number of subjects with TEAEs will be summarized in each treatment arm and compared within each treatment period.

LPA1 occupancy as determined by regional total volume of distribution (VT) at each brain scan.
Baseline to up to 28 days post-dose
LPA1 occupancy as determined by regional total volume of distribution (VT) at each lung scan.
Baseline to up to 28 days post-dose
Safety: Treatment-Emergent Adverse Events (TEAE)
Baseline to 14 days post dosing for SAD cohorts and 14 days post dosing for MAD cohorts

Number of participants with TEAEs

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 participants 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 -
Active followed by PlaceboEXPERIMENTAL -
Placebo followed by ActiveEXPERIMENTAL -
Healthy volunteers, brain PET imagingEXPERIMENTAL -
Healthy volunteers, lung PET imagingEXPERIMENTAL -
Volunteers with PrMSEXPERIMENTAL -
Volunteers with IPFEXPERIMENTAL -
PIPE-791EXPERIMENTAL -

Interventions

NameTypeDescription
PIPE-791 Dose ADRUGParticipants will receive a daily oral dose of PIPE-791 in tablet form
PIPE-791 Dose BDRUGParticipants will receive a daily oral dose of PIPE-791 in tablet form
PlaceboDRUGParticipants will receive a daily oral dose of matching Placebo in tablet form
PIPE-791DRUGPIPE-791 tablet, taken once daily for 4 weeks
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Eligibility Criteria

Age Range40 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites96

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 2022 ATS/ERS/JRS/ALAT practice guideline as confirmed by the Investigator, and a centrally read screening HRCT consistent with usual intersti...

Countries:ArgentinaAustraliaCanadaChileFranceGreeceIsraelNew ZealandPeruPolandPortugalSerbiaSouth KoreaSpainTaiwanUnited KingdomUnited States
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Recent Changes (Last 90 Days)

LOWOct 16, 2026NCT07284459lastUpdatePostDate: changed
LOWOct 16, 2026NCT07284459lastUpdatePostDate: changed
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LOWOct 9, 2026NCT07284459lastUpdatePostDate: changed
LOWOct 9, 2026NCT07284459lastUpdatePostDate: changed
LOWOct 8, 2026NCT07284459lastUpdatePostDate: changed
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LOWOct 2, 2026NCT07284459lastUpdatePostDate: changed
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LOWSep 30, 2026NCT07284459lastUpdatePostDate: changed
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LOWSep 29, 2026NCT07284459lastUpdatePostDate: changed
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LOWSep 28, 2026NCT07284459lastUpdatePostDate: changed
LOWSep 28, 2026NCT07284459lastUpdatePostDate: changed

Frequently asked questions about PIPE-791

What is PIPE-791?

PIPE-791 is an investigational small molecule drug developed by Contineum Therapeutics, Inc. (ticker CTNM). It is being studied for chronic osteoarthritis pain, idiopathic pulmonary fibrosis, and multiple sclerosis. PIPE-791 is not approved and remains in clinical development, with Phase 1 and Phase 2 studies conducted in multiple countries.

What does PIPE-791 target?

PIPE-791 targets LPA1, a receptor. By acting on this receptor, the small molecule is designed to interfere with LPA1-mediated signaling, which is the mechanism under investigation across the company's pain, fibrotic, and neuroinflammatory programs. Contineum Therapeutics is developing PIPE-791 as an oral small molecule therapeutic.

Who makes PIPE-791?

PIPE-791 is developed by Contineum Therapeutics, Inc., which trades under the ticker CTNM. The company is advancing the small molecule across chronic osteoarthritis pain, idiopathic pulmonary fibrosis, and multiple sclerosis indications, with clinical activity spanning Phase 1 and Phase 2 studies in the United States, United Kingdom, and other countries.

What phase is PIPE-791 in?

PIPE-791 is in Phase 1 development overall, with a Phase 2 study now recruiting in idiopathic pulmonary fibrosis. The Phase 1 program includes completed studies in chronic osteoarthritis pain, chronic low back pain, multiple sclerosis, and healthy volunteers. PIPE-791 is investigational and has not been approved by the FDA.

What clinical trials is PIPE-791 in?

PIPE-791 has been studied in four trials. NCT07284459 is a recruiting Phase 2 study in idiopathic pulmonary fibrosis with 324 participants. Completed studies include NCT06810245 in chronic osteoarthritis pain and chronic low back pain, NCT06683612, a PET study in healthy volunteers and patients with multiple sclerosis and IPF, and NCT05983939, a Phase 1 dose-escalation and food-effect study.

Is PIPE-791 the same as PIPE-791 Dose A?

PIPE-791 Dose A is an alternative name used for PIPE-791, the LPA1 receptor small molecule from Contineum Therapeutics. Both names refer to the same investigational asset being studied in chronic osteoarthritis pain, idiopathic pulmonary fibrosis, and multiple sclerosis. Searches for either name lead to the same clinical program.