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LY4065967

Phase 2

Chronic Pain | Small molecule | Pain |Eli Lilly and Company|Trials Updated: Sep 4, 2026

LY4065967 development status

Highest phase Phase 2
Registered trials 5 across 1 sponsor since Sep 2024

LY4065967 target and mechanism

ModalitySmall molecule

Also known as LY4065967 Tablet

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials3
Total Enrollment450

FDA Designations

No designations recorded

LY4065967 clinical trials

LY4065967 · 3 trials · 4 indications

Phase 2 3
NCT07641504A Chronic Pain Master Protocol (CPMP): A Study of LY4065967 in Participants With Chronic Low Back PainChronic Pain
RECRUITING150 Analytics
NCT07641517A Chronic Pain Master Protocol (CPMP): A Study of LY4065967 in Participants With Osteoarthritis PainOsteoarthritis, Knee
RECRUITING150 Analytics
NCT07285018A Chronic Pain Master Protocol (CPMP): A Study of LY4065967 in Participants With Diabetic Peripheral Neuropathic PainDiabetic Peripheral Neuropathic Pain
RECRUITING150 Analytics
PHASE2RECRUITING
A Chronic Pain Master Protocol (CPMP): A Study of LY4065967 in Participants With Chronic Low Back Pain
Chronic PainUnlock trial analytics
PHASE2RECRUITING
A Chronic Pain Master Protocol (CPMP): A Study of LY4065967 in Participants With Osteoarthritis Pain
Osteoarthritis, KneeUnlock trial analytics
PHASE2RECRUITING
A Chronic Pain Master Protocol (CPMP): A Study of LY4065967 in Participants With Diabetic Peripheral Neuropathic Pain
Diabetic Peripheral Neuropathic PainUnlock trial analytics

Study Endpoints

Primary Endpoints

Change from Baseline in Average Pain Intensity as Measured by the Numeric Rating Scale (NRS)
Baseline, Week 8

Secondary Endpoints

Change from Baseline in Mean Overall Improvement as Measured by Patient Global Impression of Change (PGI-C)
Baseline, Week 8
Change from Baseline in Worst Pain Intensity as Measured by NRS
Baseline, Week 8
Change from Baseline in Sleep Scale from the Medical Outcomes Study (MOS Sleep Scale)
Baseline, Week 8
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
LY4065967EXPERIMENTALLY4065967 administered orally.
PlaceboPLACEBO_COMPARATORPlacebo administered orally.

Interventions

NameTypeDescription
LY4065967DRUGAdministered orally.
PlaceboDRUGAdministered orally
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites37

Inclusion Criteria: * Have a history of low back pain for at least 3 months located between the 12th thoracic vertebra and the lower gluteal folds, with or without radiation * Have a body mass index at screening of ≤40 kilograms per meter squared (kg/m²). * Have stable glycemic control as indicated...

Countries:United StatesPuerto Rico
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Competitive Landscape -Chronic Pain 78 trials

Recent Changes (Last 90 Days)

LOWSep 4, 2026NCT07641504lastUpdatePostDate: changed
LOWSep 4, 2026NCT07641517lastUpdatePostDate: changed
LOWSep 4, 2026NCT07641504lastUpdatePostDate: changed
LOWSep 4, 2026NCT07641517lastUpdatePostDate: changed
LOWAug 21, 2026NCT07641504lastUpdatePostDate: changed
LOWAug 21, 2026NCT07641517lastUpdatePostDate: changed
LOWAug 21, 2026NCT07641504lastUpdatePostDate: changed
LOWAug 21, 2026NCT07641517lastUpdatePostDate: changed
LOWAug 20, 2026NCT07641504Status: NOT_YET_RECRUITING → RECRUITING
LOWAug 20, 2026NCT07641517Status: NOT_YET_RECRUITING → RECRUITING
LOWAug 20, 2026NCT07641504Status: NOT_YET_RECRUITING → RECRUITING
LOWAug 20, 2026NCT07641517Status: NOT_YET_RECRUITING → RECRUITING
LOWAug 20, 2026NCT07641504Status: NOT_YET_RECRUITING → RECRUITING
LOWAug 20, 2026NCT07641517Status: NOT_YET_RECRUITING → RECRUITING
LOWAug 20, 2026NCT07641504Status: NOT_YET_RECRUITING → RECRUITING
LOWAug 20, 2026NCT07641517Status: NOT_YET_RECRUITING → RECRUITING
LOWJul 22, 2026NCT07641504lastUpdatePostDate: changed
LOWJul 22, 2026NCT07641504lastUpdatePostDate: changed

Frequently asked questions about LY4065967

What is LY4065967?

LY4065967 is an investigational small molecule developed by Eli Lilly and Company for the treatment of chronic pain. It is being studied in Phase 2 clinical trials across several pain conditions, including chronic low back pain, diabetic peripheral neuropathic pain, and knee osteoarthritis pain. It is not yet approved for any indication.

What is LY4065967 used for?

LY4065967 is being evaluated for chronic pain conditions, specifically chronic low back pain, diabetic peripheral neuropathic pain, and osteoarthritis of the knee. These are the indications under study in its ongoing Phase 2 clinical program. No approved use has been established for LY4065967.

Who makes LY4065967?

LY4065967 is developed by Eli Lilly and Company, which trades on the New York Stock Exchange under the ticker LLY. Lilly is the sponsor of the ongoing Phase 2 clinical trials evaluating the drug in chronic pain indications.

What phase is LY4065967 in?

LY4065967 is in Phase 2 clinical development. All of its ongoing trials are Phase 2 studies, and the drug remains investigational. It has not been approved by the FDA or any other regulatory authority for any indication.

What clinical trials is LY4065967 in?

LY4065967 is being studied in three recruiting Phase 2 trials: NCT07641517 in knee osteoarthritis pain, NCT07641504 in chronic low back pain, and NCT07285018 in diabetic peripheral neuropathic pain. Each trial is randomized, double-blind, and placebo-controlled, enrolling approximately 150 participants in the United States and Puerto Rico.

Is LY4065967 the same as LY4065967 Tablet?

Yes. LY4065967 Tablet is an alternative name for LY4065967, referring to the same investigational small molecule developed by Eli Lilly and Company for chronic pain. Searches for either name refer to the same Phase 2 drug candidate.