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TR987 0.1%+ Standard of Care

Phase 3

Venous Leg Ulcer | Small molecule | Cardiovascular |cbdMD, Inc.|Last Updated: Feb 12, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment312

FDA Designations

No designations recorded

Clinical trial landscape

TR987 0.1%+ Standard of Care · 1 trial · 8 indications

Phase 3 1
NCT06707090Tissue Repair Gel in Venous Leg Ulcers (US)Venous Leg Ulcer
RECRUITING312 Analytics
PHASE3RECRUITING
Tissue Repair Gel in Venous Leg Ulcers (US)
Venous Leg UlcerUnlock trial analytics

Study Endpoints

Primary Endpoints

Proportion of participants with Complete Closure of the target ulcer at or before the Week-16 end of treatment (EOT) visit.
16 weeks

Patient count

Secondary Endpoints

Proportion of participants with Complete Closure of the target ulcer at or before the Week 16 visit AND for whom the ulcer remains closed at the 3-Month Follow-Up visit after such closure (a composite endpoint)
16 weeks
Change from baseline in participant's perception of pain level at 12 weeks.
12 weeks
Percent change from baseline in the target ulcer area at 12 and 16 weeks. In the event of Complete Closure before these time points, the target ulcer area will be deemed to be zero at those time points for purposes of calculation of this endpoint.
12 and 16 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
TR987 0.1% gel + Standard of CareEXPERIMENTALParticipants will receive up to 16 weeks of TR987 0.1% gel topically + Standard of Care (wound cleansing/dressings and compression bandaging). Treatment will be twice weekly for the first four weeks then weekly for the remaining 12 weeks.
Standard of CareOTHER -

Interventions

NameTypeDescription
TR987 0.1% gel + Standard of CareDRUG6mg topical gel for application plus Standard of Care (wound cleansing/dressings and compression bandaging)
Standard of careOTHERStandard of Care (wound cleansing/dressings and compression bandaging)
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites33

Inclusion Criteria: * Adults 18 years and older * Venous insufficiency has been clinically diagnosed clinically and medically confirmed. * Females who are neither pregnant nor breastfeeding and if of child-bearing potential are on an acceptable method of birth control. * The Venous Ulcer should be ...

Countries:United States
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Frequently asked questions about TR987 0.1%+ Standard of Care

What is TR987 0.1%+ Standard of Care used for?

TR987 0.1%+ Standard of Care is an investigational small molecule gel being studied for the treatment of venous leg ulcers, including venous stasis ulcers and non-healing wounds. It is administered as a 0.1% gel in combination with standard of care. The drug is currently in Phase 3 clinical development.

Who makes TR987 0.1%+ Standard of Care?

TR987 0.1%+ Standard of Care is being developed by cbdMD, Inc., a company traded on the NYSE American under the ticker symbol YCBD. The company is conducting a Phase 3 clinical trial to evaluate the drug for venous leg ulcers.

What phase is TR987 0.1%+ Standard of Care in?

TR987 0.1%+ Standard of Care is in Phase 3 clinical development. It is an investigational drug and has not been approved by the FDA. The ongoing Phase 3 trial is recruiting participants in the United States.

What clinical trials is TR987 0.1%+ Standard of Care in?

TR987 0.1%+ Standard of Care is being evaluated in a Phase 3 clinical trial with the identifier NCT06707090. This randomized, double-blind, controlled study is enrolling 312 participants aged 18 years and older with venous leg ulcers in the United States.

Is TR987 0.1%+ Standard of Care the same as TR987 0.1% gel + Standard of Care?

Yes, TR987 0.1%+ Standard of Care is also known as TR987 0.1% gel + Standard of Care. Both names refer to the same investigational drug product being developed by cbdMD, Inc. for the treatment of venous leg ulcers.