Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ANEB-001 · 1 trial · 1 indication
Feeling High on a visual analog scale (mm)
Body sway (mm);
Alertness on a visual analog scale (mm)
Heart Rate in beats/min
| 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 |
| Name | Type | Description |
|---|---|---|
| ANEB-001 | DRUG | Experimental Treatment |
| Placebo | DRUG | Placebo comparator |
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 an investigational small molecule being developed for the treatment of acute cannabinoid intoxication, a condition caused by cannabis use. It is designed to address the effects of THC, the psychoactive component of cannabis. The drug is currently in clinical development and has not been approved by regulatory authorities.
ANEB-001 is a CB1 receptor antagonist, meaning it blocks the cannabinoid type 1 receptor. By targeting this receptor, it is intended to counteract the effects of THC, which binds to CB1 receptors and causes the symptoms of acute cannabinoid intoxication. This mechanism is central to its investigational use.
ANEB-001 is being developed by Anebulo Pharmaceuticals, Inc., a biopharmaceutical company. The company is listed on the stock exchange under the ticker symbol ANEB. Anebulo Pharmaceuticals is focused on advancing this investigational therapy for acute cannabinoid intoxication.
ANEB-001 is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory agencies. The drug is being studied for safety, tolerability, pharmacokinetics, and pharmacodynamics in a clinical trial setting, and it remains under investigation.
ANEB-001 has one completed Phase 2 clinical trial, identified as NCT05282797. This study evaluated the safety, tolerability, pharmacokinetics, and pharmacodynamics of ANEB-001 in a THC challenge test. The trial enrolled 154 participants in the Netherlands and was randomized, double-blind, and placebo-controlled.
Yes, ANEB-001 is a CB1 receptor antagonist. This means it works by blocking the cannabinoid type 1 receptor, which is the primary target of THC. By antagonizing this receptor, ANEB-001 is being investigated as a potential treatment for acute cannabinoid intoxication.