Alcohol Use Disorder Clinical Trials Analysis 2025: Psychedelic-Assisted Therapy, GLP-1 Agonists, and Precision Pharmacotherapies Aim to Reduce Relapse and Restore Function | DelveInsight

DelveInsight's "Alcohol Use Disorder - Clinical Trials Analysis, 2025" describes a broad, rapidly evolving trial landscape that pairs novel pharmacology with behavioral interventions to reduce heavy drinking, prevent relapse, and improve functioning. Trials now prioritize both objective drinking outcomes (percent heavy drinking days, abstinence, biomarker-verified consumption) and patient-centered endpoints (craving, quality of life, treatment retention).

Late-stage and registration-enabling programs span three complementary strategies: psychedelic-assisted psychotherapy (psilocybin) for relapse prevention and reduced alcohol use; metabolic/neurobehavioral modulators (GLP-1 receptor agonists such as semaglutide) showing early signals for reduced craving and consumption; and precision or repurposed pharmacotherapies (genotype-targeted ondansetron/AD04, long-acting naltrexone formulations, gabapentin and other anti-craving agents) aimed at tailored relapse prevention. These approaches are commonly tested together with psychotherapy or digital therapeutics to maximize durable behaviour change.

Complementary neuromodulation and host-targeted strategies are also entering early clinical testing - from deep brain stimulation/implantable neuromodulation trials for severe, treatment-refractory addiction to continuing work on vaccine and antibody approaches for substance use disorders - reflecting a willingness to test invasive and immunologic strategies in highly refractory populations.

Trial designs increasingly use biomarker-anchored and precision-medicine approaches (genotype-guided ondansetron/AD04, RT-verified drinking outcomes) and combine pharmacologic readouts with structured psychotherapy, functional endpoints, and digital monitoring to demonstrate clinically meaningful, sustained reductions in harm. Several pivotal and Phase II readouts (psilocybin relapse-prevention trials, larger GLP-1 randomized studies, and confirmatory precision-drug trials) are expected over the next 12-24 months and will be critical in defining whether these novel strategies can move from promising signals to regulatory-grade treatment options.

Explore the full pipeline analysis for Alcohol Use Disorder and uncover key opportunities @ https://www.delveinsight.com/report-store/alcohol-use-disorder-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Key Takeaways from the Alcohol Use Disorder Pipeline Report
• DelveInsight's alcohol use disorder pipeline analysis depicts a strong space with 30+ active players working to develop 30+ pipeline drugs for alcohol use disorder treatment.
• The leading alcohol use disorder companies include Cybin, Indivio, BioXcel Therapeutics, BiocorRx Pharmaceuticals, Beckley Psytech, MediciNova, Adial Pharmaceuticals, Imbrium Therapeutics, and others are evaluating their lead assets to improve the alcohol use disorder treatment landscape.
• Key alcohol use disorder pipeline therapies in various stages of development include CYB003, INDV1000, BXCL501, BICX104, BPL-003, MN-166, AD04, Sunobinop, and others.
• In August 2025, Adial Pharmaceuticals completed an End of Phase 2 meeting with the FDA and received guidance to advance AD04, a serotonin-3 receptor antagonist, into a Phase 3 trial for Alcohol Use Disorder (AUD) in patients with heavy drinking and select genotypes, particularly AG+.
• In August 2025, Adial Pharmaceuticals (NASDAQ: ADIL) announced completion of a successful End of Phase 2 meeting with the FDA, receiving guidance on its AD04 Phase 3 adaptive trial. AD04, a serotonin-3 receptor antagonist, will advance into Phase 3 for treating Alcohol Use Disorder (AUD) in heavy drinkers, focusing on patients with the AG+ genotype.
• In May 2025, Adial Pharmaceuticals (Nasdaq: ADIL) announced that the FDA has granted its request for an End of Phase 2 meeting, scheduled for July 25, to review the proposed Phase 3 trial design of AD04 for treating Alcohol Use Disorder (AUD) in heavy-drinking patients. AD04 is a genetically targeted serotonin-3 receptor antagonist.
• In May 2025, Adial Pharmaceuticals (Nasdaq: ADIL) announced that the FDA has granted an End of Phase 2 meeting for July 25 to review the Phase 3 trial design of AD04, its lead investigational therapy for Alcohol Use Disorder (AUD) in heavy-drinking patients. AD04 is a genetically targeted serotonin-3 receptor antagonist.
• In February 2025, Adial Pharmaceuticals (NASDAQ: ADIL) announced it has begun manufacturing clinical supplies for its upcoming Phase III program of AD04 for alcohol use disorder, following a positive FDA response to its proposed in vitro bridging strategy.

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Alcohol Use Disorder Overview
Alcohol Use Disorder (AUD), commonly referred to as alcoholism, is a chronic and severe form of alcohol misuse marked by the inability to control drinking. Its development is influenced by a combination of genetic and environmental factors, with hereditary components accounting for about 50% of the risk. Psychological traits, cognitive function, and environmental influences also play significant roles. Alcohol functions as a sedative-hypnotic drug, stimulating the central nervous system at low doses and depressing it at higher levels. While it can initially cause euphoria, excessive intake may lead to serious outcomes such as drowsiness, respiratory depression, coma, or even death, depending on blood alcohol concentration (BAC) and its impact on vital organs.

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Alcohol Use Disorder Treatment Analysis: Drug Profile
AD04: Adial Pharmaceuticals
AD04, developed by Adial Pharmaceuticals, is a genetically targeted treatment for Alcohol Use Disorder (AUD). It works by modulating neurotransmitter pathways involved in the brain's reward and reinforcement circuits related to alcohol consumption. Designed for patients with specific genetic markers identified through a proprietary companion diagnostic test, AD04 has shown potential in reducing heavy drinking days in Phase III trials. The drug is believed to balance the serotonergic and dopaminergic systems, which may help reduce alcohol cravings and consumption.

Sunobinop: Imbrium Therapeutics
Sunobinop is a novel, investigational oral compound being developed as a potential first-in-class treatment for Alcohol Use Disorder. It activates the nociceptin/orphanin-FQ peptide receptor (NOP), a protein involved in various biological functions throughout the central and peripheral nervous systems. Currently in Phase II trials, Sunobinop is designed to address alcohol use disorder by modulating the NOP receptor.

Learn more about the novel and emerging alcohol use disorder pipeline therapies @ https://www.delveinsight.com/report-store/alcohol-use-disorder-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Alcohol Use Disorder Therapeutics Assessment
By Product Type
• Mono
• Combination
• Mono/Combination.

By Stage
• Late-stage products (Phase III)
• Mid-stage products (Phase II)
• Early-stage product (Phase I) along with the details of
• Pre-clinical and Discovery stage candidates
• Discontinued & Inactive candidates

By Route of Administration
• Oral
• Intravenous
• Subcutaneous
• Parenteral
• Topical

By Molecule Type
• Recombinant fusion proteins
• Small molecule
• Monoclonal antibody
• Peptide
• Polymer
• Gene therapy

Scope of the Alcohol Use Disorder Pipeline Report
• Coverage: Global
• Key Alcohol Use Disorder Companies: Cybin, Indivio, BioXcel Therapeutics, BiocorRx Pharmaceuticals, Beckley Psytech, MediciNova, Adial Pharmaceuticals, Imbrium Therapeutics, and others.
• Key Alcohol Use Disorder Pipeline Therapies: CYB003, INDV1000, BXCL501, BICX104, BPL-003, MN-166, AD04, Sunobinop, and others.

Dive deep into rich insights for drugs used for alcohol use disorder treatment; visit @ https://www.delveinsight.com/report-store/alcohol-use-disorder-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Table of Contents
1. Introduction
2. Executive Summary
3. Alcohol Use Disorder Pipeline: Overview
4. Analytical Perspective In-depth Commercial Assessment
5. Alcohol Use Disorder Pipeline Therapeutics
6. Alcohol Use Disorder Pipeline: Late-Stage Products (Phase III)
7. Alcohol Use Disorder Pipeline: Mid-Stage Products (Phase II)
8. Alcohol Use Disorder Pipeline: Early Stage Products (Phase I)
9. Therapeutic Assessment
10. Inactive Products
11. Company-University Collaborations (Licensing/Partnering) Analysis
12. Key Companies
13. Key Products
14. Unmet Needs
15. Market Drivers and Barriers
16. Future Perspectives and Conclusion
17. Analyst Views
18. Appendix

Contact Us:
Jatin Vimal
jvimal@delveinsight.com
+14699457679
Healthcare Consulting
https://www.delveinsight.com/consulting-services

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This release was published on openPR.