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selonabant

Phase 2

Undisclosed | Small molecule | Other |Anebulo Pharmaceuticals, Inc.|Trials Updated: May 8, 2026

selonabant development status

Highest phase Phase 2 (NCT05282797)
Phase scored for ANEBPhase 1
Registered trials 2 across 1 sponsor since Mar 2022

selonabant target and mechanism

ModalitySmall molecule

Also known as ANEB-001

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLEDDMC
Total Trials2
Total Enrollment194

FDA Designations

No designations recorded

selonabant clinical trials

selonabant · 2 trials · 2 indications

Phase 2 1Phase 1 1
NCT05282797Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CB1 Antagonist ANEB-001 in a THC Challenge TestAcute Cannabinoid Intoxication
COMPLETED154 Analytics
PHASE2COMPLETED
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CB1 Antagonist ANEB-001 in a THC Challenge Test
Acute Cannabinoid IntoxicationUnlock trial analytics

Study Endpoints

Primary Endpoints

Subjective Feeling High
Day 1

Feeling High on a visual analog scale (mm)

Postural stability
Day 1

Body sway (mm);

Subjective Alertness
Day 1

Alertness on a visual analog scale (mm)

Heart Rate
Day 1

Heart Rate in beats/min

Number of Participants with Adverse Events
28 days
Number of Participants with Clinically Significant Laboratory Test Results
28 days
Number of Participants with Clinically Significant Vital Signs Values
28 days
Number of Participants with Clinically Significant Abnormal ECG Findings
28 days
Number of Participants with Clinically Significant Abnormal Physical Exam Findings
28 days
Change from Baseline in Beck Depression Inventory (BDI)
28 days

The minimum possible Beck Depression Inventory (BDI) score is 0, and the maximum score is 63. This score is determined by summing the ratings from the 21 questions, with each question scoring from 0 to 3, indicating the severity of depressive symptoms over the past two weeks. Lower score means less depression

Change from Baseline in Columbia Suicide Severity Rating Scale (C-SSRS)
28 days

The Columbia-Suicide Severity Rating Scale (C-SSRS) does not have a single minimum or maximum score, as it is not a traditional cumulative-score test. Instead, it uses a series of "yes" or "no" questions to place an individual into distinct categories of risk based on their specific responses. Lower score means less suicidal ideation.

Area Under the Concentration-time Curve From Zero Time to Time of Last Quantifiable Concentration
28 days
Terminal Elimination Phase Half-life (T1/2)
28 days
Maximum Observed Concentration (Cmax)
28 days
Pharmacokinetic Clearance (CL)
28 days

Pharmacokinetic clearance (\\(CL\\)) is a quantitative measure of how efficiently the body removes a drug from the bloodstream. It is defined as the volume of plasma from which a drug is completely and irreversibly removed per unit of time and is typically expressed in units like milliliters per minute (mL/min) or liters per hour (L/h).

Secondary Endpoints

Subjective Mood
Day 1
Subjective Calmness
Day 1
Feeling of Drug Effect
Day 1
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Part A - ANEB-001EXPERIMENTALSubjects receive THC and varying amounts of ANEB-001
Part A - PlaceboPLACEBO_COMPARATORSubjects receive THC and placebo
Part B - Cohort 1 - ANEB-001EXPERIMENTALSubjects receive 21 mg of THC and 30 mg of ANEB-001
Part B - Cohort 1 - PlaceboPLACEBO_COMPARATORSubjects receive 21 mg of THC and placebo
Part B - Cohort 2 - ANEB-001EXPERIMENTALSubjects receive 21 mg of THC and 10 mg of ANEB-001
Part B - Cohort 2 - PlaceboPLACEBO_COMPARATORSubjects receive 21 mg of THC and placebo
Part B - Cohort 3 - ANEB-001EXPERIMENTALSubjects receive 21 mg of THC and 1 hour later, 30 mg ANEB-001
Part B - Cohort 3 - PlaceboPLACEBO_COMPARATORSubjects receive 21 mg THC and 1 hour later, placebo
Part B - Cohort 4 - ANEB-001EXPERIMENTALSubjects receive 40 mg of THC and 1 hour later, 10 mg of ANEB-001
Part B - Cohort 4 - PlaceboPLACEBO_COMPARATORSubjects receive 40 mg of THC and 1 hour later, placebo
Part B - Cohort 5 - ANEB-001EXPERIMENTALSubjects receive 30 mg of THC and 1 hour later, 10 mg of ANEB-001
Part B - Cohort 5 - PlaceboPLACEBO_COMPARATORSubjects receive 30 mg of THC and 1 hour later, 10 mg of ANEB-001
Part B - Cohort 6 - ANEB-001EXPERIMENTALSubjects will consume a high fat meal prior to receiving 30 mg of THC and 1 hour later, 10 mg of ANEB-001
Part B - Cohort 6 - PlaceboPLACEBO_COMPARATORSubjects will consume a high fat meal prior to receiving 30 mg of THC and 1 hour later, placebo
Part C - Cohort 7 - ANEB-001EXPERIMENTALSubjects receive a 40 mg dose of THC and a 10 mg dose of ANEB-001
Part C - Cohort 8 - ANEB-001EXPERIMENTALSubjects receive a 60 mg dose of THC and a 20 mg dose of ANEB-001
Experimental Cohort 1EXPERIMENTALSingle intravenous dose of 1 mg of selonabant or placebo
Experimental Cohort 2EXPERIMENTALSingle intravenous dose of 2 mg of selonabant or placebo
Experimental Cohort 3EXPERIMENTALSingle intravenous dose of 5 mg of selonabant or placebo
Experimental Cohort 4EXPERIMENTALSingle intravenous dose of 10 mg of selonabant or placebo
Experimental Cohort 5EXPERIMENTALSingle intravenous dose of 20 mg of selonabant or placebo

Interventions

NameTypeDescription
ANEB-001DRUGExperimental Treatment
PlaceboDRUGPlacebo comparator
selonabantDRUGIntravenous infusion of selonabant
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Eligibility Criteria

Age Range18 Years to 45 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Signed informed consent prior to any study-mandated procedure * BMI between 18 and 30 kg/m2 * Minimum weight 50 kg * Occasional cannabis user Exclusion Criteria: * Evidence of active or chronic condition that could interfere with, or which the treatment of might interfere wi...

Countries:NetherlandsUnited States
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Frequently asked questions about selonabant

What is selonabant?

Selonabant is an investigational small molecule being developed by Anebulo Pharmaceuticals, Inc. (ticker ANEB). It has been studied in a Phase 1 clinical trial in healthy adult volunteers. The specific medical conditions it is intended to treat have not been disclosed.

Who is developing selonabant?

Selonabant is being developed by Anebulo Pharmaceuticals, Inc., which trades under the ticker ANEB. The company is the sponsor of the clinical program for this small molecule.

What phase is selonabant in?

Selonabant is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. It is an investigational drug and has not been approved by the FDA.

What clinical trials is selonabant in?

Selonabant has been evaluated in a single Phase 1 trial, NCT07211607, titled I.V. Selonabant in Healthy Adult Subjects. The trial was completed, enrolled 40 participants, and was conducted in the United States.

What does selonabant target?

The molecular target of selonabant has not been disclosed. It is a small molecule, but no target or mechanism of action information is available.