Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as selonabant
ANEB-001 · 2 trials · 2 indications
Feeling High on a visual analog scale (mm)
Body sway (mm);
Alertness on a visual analog scale (mm)
Heart Rate in beats/min
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
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.
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).
| Arm | Type | Description |
|---|---|---|
| Part A - ANEB-001 | EXPERIMENTAL | Subjects receive THC and varying amounts of ANEB-001 |
| Part A - Placebo | PLACEBO_COMPARATOR | Subjects receive THC and placebo |
| Part B - Cohort 1 - ANEB-001 | EXPERIMENTAL | Subjects receive 21 mg of THC and 30 mg of ANEB-001 |
| Part B - Cohort 1 - Placebo | PLACEBO_COMPARATOR | Subjects receive 21 mg of THC and placebo |
| Part B - Cohort 2 - ANEB-001 | EXPERIMENTAL | Subjects receive 21 mg of THC and 10 mg of ANEB-001 |
| Part B - Cohort 2 - Placebo | PLACEBO_COMPARATOR | Subjects receive 21 mg of THC and placebo |
| Part B - Cohort 3 - ANEB-001 | EXPERIMENTAL | Subjects receive 21 mg of THC and 1 hour later, 30 mg ANEB-001 |
| Part B - Cohort 3 - Placebo | PLACEBO_COMPARATOR | Subjects receive 21 mg THC and 1 hour later, placebo |
| Part B - Cohort 4 - ANEB-001 | EXPERIMENTAL | Subjects receive 40 mg of THC and 1 hour later, 10 mg of ANEB-001 |
| Part B - Cohort 4 - Placebo | PLACEBO_COMPARATOR | Subjects receive 40 mg of THC and 1 hour later, placebo |
| Part B - Cohort 5 - ANEB-001 | EXPERIMENTAL | Subjects receive 30 mg of THC and 1 hour later, 10 mg of ANEB-001 |
| Part B - Cohort 5 - Placebo | PLACEBO_COMPARATOR | Subjects receive 30 mg of THC and 1 hour later, 10 mg of ANEB-001 |
| Part B - Cohort 6 - ANEB-001 | EXPERIMENTAL | Subjects 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 - Placebo | PLACEBO_COMPARATOR | Subjects will consume a high fat meal prior to receiving 30 mg of THC and 1 hour later, placebo |
| Part C - Cohort 7 - ANEB-001 | EXPERIMENTAL | Subjects receive a 40 mg dose of THC and a 10 mg dose of ANEB-001 |
| Part C - Cohort 8 - ANEB-001 | EXPERIMENTAL | Subjects receive a 60 mg dose of THC and a 20 mg dose of ANEB-001 |
| Experimental Cohort 1 | EXPERIMENTAL | Single intravenous dose of 1 mg of selonabant or placebo |
| Experimental Cohort 2 | EXPERIMENTAL | Single intravenous dose of 2 mg of selonabant or placebo |
| Experimental Cohort 3 | EXPERIMENTAL | Single intravenous dose of 5 mg of selonabant or placebo |
| Experimental Cohort 4 | EXPERIMENTAL | Single intravenous dose of 10 mg of selonabant or placebo |
| Experimental Cohort 5 | EXPERIMENTAL | Single intravenous dose of 20 mg of selonabant or placebo |
| Name | Type | Description |
|---|---|---|
| ANEB-001 | DRUG | Experimental Treatment |
| Placebo | DRUG | Placebo comparator |
| selonabant | DRUG | Intravenous infusion of selonabant |
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...
ANEB-001 is being developed for acute cannabinoid intoxication, a condition caused by excessive exposure to THC, the psychoactive component of cannabis. It is an investigational small molecule that has been studied in a Phase 2 human trial in the Netherlands. It is not approved for commercial use.
ANEB-001 targets the CB1 receptor, the cannabinoid receptor in the brain that mediates the psychoactive effects of THC. ANEB-001 is a small molecule CB1 antagonist, meaning it is designed to block this receptor. Blocking CB1 is the proposed approach for counteracting the effects of acute cannabinoid intoxication.
ANEB-001 is being developed by Anebulo Pharmaceuticals, Inc., which trades on the Nasdaq under the ticker ANEB. The company is advancing the compound as a potential treatment for acute cannabinoid intoxication.
ANEB-001 is in Phase 2 clinical development. Its single reported trial, NCT05282797, was a Phase 2 study that has been completed. ANEB-001 is investigational and has not been approved by the FDA or any other regulatory agency for acute cannabinoid intoxication.
ANEB-001 has been studied in one clinical trial, NCT05282797, titled "Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CB1 Antagonist ANEB-001 in a THC Challenge Test." The Phase 2 trial enrolled 154 participants in the Netherlands, was randomized, double-blind, and placebo-controlled, and has been completed.