Anebulo Pharmaceuticals' Drug in the FDA Approval Process
This section highlights FDA-related milestones and regulatory updates for drugs developed by Anebulo Pharmaceuticals (ANEB).
Over the past two years, Anebulo Pharmaceuticals has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Selonabant. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Selonabant FDA Regulatory Events
Selonabant is a drug developed by Anebulo Pharmaceuticals for the following indication: for Acute Cannabis-Induced Toxicity.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Selonabant
- Announced Date:
- September 25, 2025
- Indication:
- for Acute Cannabis-Induced Toxicity
Announcement
Anebulo Pharmaceuticals, Inc announces the first subjects dosed in its Phase 1 single ascending dose ("SAD") study of intravenous (IV) selonabant in healthy young adults. The study is supported by a collaborative grant from the National Institute on Drug Abuse (NIDA).
AI Summary
Anebulo Pharmaceuticals has dosed the first healthy young adults in its Phase 1 single ascending dose (SAD) study of intravenous (IV) selonabant. This trial, backed by a second-year National Institute on Drug Abuse (NIDA) grant of $994,300, will assess safety, tolerability and how the drug moves through the body. Participants are 18 to 25 years old and each dose level is compared against placebo in a randomized, double-blind design.
Selonabant works by blocking the CB1 receptor, which mediates cannabis’s psychoactive effects. Anebulo previously tested an oral form in Phase 2 and saw potential for reversing acute cannabinoid intoxication. The company now aims to advance the IV version to treat pediatric patients who accidentally ingest cannabis, a group at higher risk for serious outcomes like respiratory depression, coma or worse.
If successful, selonabant could become the first emergency antidote for acute cannabis-induced toxicity, offering faster relief than existing options.
Read Announcement
Anebulo Pharmaceuticals FDA Events - Frequently Asked Questions
As of now, Anebulo Pharmaceuticals (ANEB) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Anebulo Pharmaceuticals (ANEB) has reported FDA regulatory activity for Selonabant.
The most recent FDA-related event for Anebulo Pharmaceuticals occurred on September 25, 2025, involving Selonabant. The update was categorized as "Dose Update," with the company reporting: "Anebulo Pharmaceuticals, Inc announces the first subjects dosed in its Phase 1 single ascending dose ("SAD") study of intravenous (IV) selonabant in healthy young adults. The study is supported by a collaborative grant from the National Institute on Drug Abuse (NIDA)."
Currently, Anebulo Pharmaceuticals has one therapy (Selonabant) targeting the following condition: for Acute Cannabis-Induced Toxicity.
More FDA Event Resources from MarketBeat
FDA Event Stage Terminology & Abbreviation Guide
- NDA: New Drug Application
- ANDA: Abbreviated New Drug Application
- sNDA: Supplemental New Drug Application
- BLA: Biologics License Application
- sBLA: Supplemental Biologics License Application
- FDA Approved: Approved by the FDA
- EMA: European Medicines Agency
- CE Mark: European Union Certification
- NMPA: China National Medical Products Administration
- MHLW: Japanese Ministry of Health
- FDA Meeting: Consultation with FDA
- Pre-IND: Pre-Investigational New Drug Meeting
- Breakthrough Therapy: Special FDA designation for promising therapies
- Fast Track: Accelerated FDA approval pathway
- Orphan Drug: Designation for rare disease treatments
- RPD: Rare Pediatric Disease Designation
- RMAT: Regenerative Medicine Advanced Therapy
- DSMB Review: Data Safety Monitoring Board Review
- IDMC Review: Independent Data Monitoring Committee
- MAA: MHRA Marketing Authorization Application
- RTF: Refusal to File (Rejected Application)
- 510(k): FDA Clearance for Medical Devices
- Rolling Submission: Staggered regulatory review process
This page (NASDAQ:ANEB) was last updated on 9/25/2025 by MarketBeat.com Staff
