Anebulo Pharmaceuticals (ANEB) FDA Approvals $0.40 +0.02 (+6.64%) As of 01:26 PM Eastern Add Compare Share Share FDA Events Stock AnalysisAnalyst ForecastsChartCompetitorsEarningsFDA EventsHeadlinesInsider TradesOwnershipSEC FilingsShort InterestTrendsBuy This Stock Anebulo Pharmaceuticals' Drug in the FDA Approval ProcessThis 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. Dose Update - September 25,2025Dose Update Phase 1Drug: SelonabantAnnounced Date: September 25, 2025Indication: for Acute Cannabis-Induced ToxicityAnnouncementAnebulo 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 SummaryAnebulo 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 Has Anebulo Pharmaceuticals received FDA approval? As of now, Anebulo Pharmaceuticals (ANEB) has not received any FDA approvals for its therapy in the last two years. What drugs has Anebulo Pharmaceuticals submitted to the FDA? In the past two years, Anebulo Pharmaceuticals (ANEB) has reported FDA regulatory activity for Selonabant. What is the most recent FDA event for Anebulo Pharmaceuticals? 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)." What conditions do Anebulo Pharmaceuticals' current drugs treat? Currently, Anebulo Pharmaceuticals has one therapy (Selonabant) targeting the following condition: for Acute Cannabis-Induced Toxicity. More FDA Event Resources from MarketBeat FDA Calendars Recent FDA Drug Approval Calendar Upcoming FDA Events & PDUFA Dates Calendar Companies With Recent FDA Events Axsome Therapeutics FDA EventsBiogen FDA EventsFate Therapeutics FDA EventsGH Research FDA EventsIncyte FDA EventsJazz Pharmaceuticals FDA EventsMoleculin Biotech FDA EventsMirum Pharmaceuticals FDA EventsNextCure FDA EventsPharming Group FDA EventsRegeneron Pharmaceuticals FDA Eventsargenex FDA EventsCabaletta Bio FDA EventsDyne Therapeutics FDA EventsFibroBiologics FDA Events 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 Related Companies Seres Therapeutics FDA Events Lixte Biotechnology FDA Events TScan Therapeutics FDA Events Cassava Sciences FDA Events MediciNova FDA Events Prima BioMed FDA Events PMV Pharmaceuticals FDA Events Cingulate FDA Events BeyondSpring FDA Events ImageneBio FDA Events Stock Lists Biotechnology StocksCompare Biotech StocksCompare Healthcare StocksCompare Pharmaceutical StocksHealthcare and Medical Stocks FDA progress for NASDAQ:ANEB last updated on 9/25/2025 by MarketBeat.com Staff. 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Dose Update - September 25,2025Dose Update Phase 1Drug: SelonabantAnnounced Date: September 25, 2025Indication: for Acute Cannabis-Induced ToxicityAnnouncementAnebulo 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 SummaryAnebulo 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
