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ENX-102

Phase 2

General Anxiety Disorder | Small molecule | Psychiatry |cbdMD, Inc.|Last Updated: Sep 17, 2025

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment38

FDA Designations

No designations recorded

Clinical trial landscape

ENX-102 · 1 trial · 1 indication

Phase 2 1
NCT06653296A Dose-Response Safety Study of ENX-102 in Patients With GADGeneral Anxiety Disorder
COMPLETED38 Analytics
PHASE2COMPLETED
A Dose-Response Safety Study of ENX-102 in Patients With GAD
General Anxiety DisorderUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety and tolerability
4 weeks

• Incidence and severity of treatment-emergent AEs (TEAEs)

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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
PlaceboPLACEBO_COMPARATORPlacebo
ENX-102 low-doseEXPERIMENTALENX-102
ENX-102 mid-doseEXPERIMENTALENX-102
ENX-102 high-doseEXPERIMENTALENX-102

Interventions

NameTypeDescription
ENX-102DRUGFour weeks of ENX-102 (0.5, 1, or 3 mg) in capsule form followed by 2 weeks of tapered dose, taken orally once daily in the evening for a 6-week total treatment period
PlaceboDRUGSix weeks of placebo in capsule form taken orally once daily in the evening for a 6-week total treatment period
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites3

Key Inclusion Criteria: * Male or female, inclusive of any gender identity, aged 18 to 65 years, inclusive * Diagnosed with GAD according to the DSM-V, confirmed by MINI * Experiencing clinically significant generalized anxiety as measured by HAM-A score ≥18 and at least moderately severe core symp...

Countries:United Kingdom
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Frequently asked questions about ENX-102

What is ENX-102 used for?

ENX-102 is an investigational small molecule being developed for the treatment of Generalized Anxiety Disorder (GAD). It is currently in Phase 2 clinical development and has not been approved by regulatory authorities. The drug is being studied for its potential to address symptoms of anxiety in adult patients.

Who makes ENX-102?

ENX-102 is being developed by cbdMD, Inc., a company traded on the NYSE American under the ticker symbol YCBD. The company is conducting clinical research to evaluate the safety and efficacy of this investigational drug for Generalized Anxiety Disorder.

What phase is ENX-102 in?

ENX-102 is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. A Phase 2 clinical trial has been completed to evaluate the drug's safety and dose-response in patients with Generalized Anxiety Disorder.

What clinical trials is ENX-102 in?

ENX-102 has one completed Phase 2 clinical trial registered as NCT06653296, titled "A Dose-Response Safety Study of ENX-102 in Patients With GAD." This randomized, double-blind, placebo-controlled study enrolled 38 adult participants in the United Kingdom and evaluated the drug's safety in Generalized Anxiety Disorder.

Is ENX-102 FDA approved?

No, ENX-102 is not FDA approved. It is an investigational drug currently in Phase 2 clinical development for Generalized Anxiety Disorder. The drug has completed a Phase 2 safety study, but it has not yet received regulatory approval and remains under clinical investigation.