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PIPE-791

Phase 1

Chronic Osteoarthritis Pain | Small molecule | Pain |Contineum Therapeutics, Inc.|Last Updated: Mar 18, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment43

FDA Designations

No designations recorded

Clinical trial landscape

PIPE-791 · 3 trials · 11 indications

Phase 1 3
NCT06810245Study of PIPE-791 for Subjects With Chronic Osteoarthritis Pain or Chronic Low Back PainChronic Osteoarthritis Pain
COMPLETED43 Analytics
NCT06683612PET Study of PIPE-791 in Healthy Volunteers and Volunteers With PrMS and IPFIdiopathic Pulmonary Fibrosis (IPF)
COMPLETED16 Analytics
NCT05983939Study Evaluating Safety and Tolerability of Escalating Single and Multiple Doses of PIPE-791 and Food Effect in Healthy VolunteersMultiple Sclerosis
COMPLETED56 Analytics
PHASE1COMPLETED
Study of PIPE-791 for Subjects With Chronic Osteoarthritis Pain or Chronic Low Back Pain
Chronic Osteoarthritis PainUnlock trial analytics
PHASE1COMPLETED
PET Study of PIPE-791 in Healthy Volunteers and Volunteers With PrMS and IPF
Idiopathic Pulmonary Fibrosis (IPF)Unlock trial analytics
PHASE1COMPLETED
Study Evaluating Safety and Tolerability of Escalating Single and Multiple Doses of PIPE-791 and Food Effect in Healthy Volunteers
Multiple SclerosisUnlock trial analytics

Study Endpoints

Primary Endpoints

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

The relationship between PIPE-791 plasma concentration and brain and lung LPA1 occupancy.
Baseline to up to 28 days post-dose
The PIPE-791 EC50 (i.e., the plasma concentration of PIPE-791 associated with 50% occupancy of LPA1) in the brain and lungs.
Baseline to up to 28 days post-dose
Pharmacokinetics (PK): blood concentration levels of PIPE-791
Baseline to up to 28 days post-dose
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
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 -
PlaceboPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
PIPE-791DRUGPIPE-791 tablet, taken once daily for 4 weeks
PlaceboDRUGPlacebo tablet, taken once daily for 4 weeks
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Eligibility Criteria

Age Range18 Years to 70 Years
SexALL
Healthy VolunteersNo
Study Sites5

Key Inclusion Criteria * Male or female 18 to 70 years of age, inclusive, at the first Screening visit. * Only one of the following chronic pain diagnoses at least 6 months prior to Screening: * Osteoarthritis of the knee OR low back pain (with or without painful lumbosacral radiculopathy) * Plain ...

Countries:United StatesUnited Kingdom
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Frequently asked questions about PIPE-791

What is PIPE-791 used for?

PIPE-791 is an investigational small molecule being developed for Idiopathic Pulmonary Fibrosis (IPF), Multiple Sclerosis, and Chronic Osteoarthritis Pain. It is currently in Phase 1 clinical development and is not yet approved by the FDA.

What does PIPE-791 target?

PIPE-791 is a small molecule being developed by Contineum Therapeutics. Its specific molecular target has not been disclosed in available clinical trial information. The drug is being studied for its potential effects in IPF, Multiple Sclerosis, and chronic pain conditions.

Who makes PIPE-791?

PIPE-791 is being developed by Contineum Therapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol CTNM. The company is conducting Phase 1 clinical trials to evaluate the drug's safety and tolerability.

What phase is PIPE-791 in?

PIPE-791 is in Phase 1 clinical development. It is an investigational drug and has not received FDA approval. Clinical trials have been completed to evaluate safety, tolerability, and other early-stage parameters in healthy volunteers and patient populations.

What clinical trials is PIPE-791 in?

PIPE-791 has been studied in three completed Phase 1 trials: NCT05983939 evaluated safety and tolerability in healthy volunteers, NCT06683612 was a PET study in healthy volunteers and those with progressive MS and IPF, and NCT06810245 studied the drug in chronic osteoarthritis pain and chronic low back pain.

Is PIPE-791 the same as other drugs?

PIPE-791 is the primary name used in clinical trials and by its developer, Contineum Therapeutics. No alternative names have been reported in the available clinical trial information, so it is not known to be the same as any other marketed or investigational drug.