Alcohol Use Disorder Pipeline: 30+ Leading Companies Driving the Next Generation of Innovative Therapies and Treatments | DelveInsight

The Alcohol Use Disorder treatment market is undergoing a significant transformation, driven by trailblazers like Cybin, Indivio, BioXcel Therapeutics, BiocorRx Pharmaceuticals, Beckley Psytech, and MediciNova. With the emergence of novel pharmacotherapies, targeted treatments, and behavioral therapies, these companies are reshaping the management and recovery landscape. The pipeline is particularly focused on improving treatment adherence, reducing relapse rates, and addressing the neurological aspects of AUD. Advanced therapeutic platforms and innovative drug delivery systems offer new hope for better outcomes, aiming for long-term recovery and effective management of AUD.

DelveInsight's "Alcohol Use Disorder Pipeline Insight, 2025" comprehensively analyzes the current clinical landscape and growth prospects in the alcohol use disorder market. The report covers disease insights, treatment guidelines, and a detailed pipeline assessment from preclinical to marketed stages. It includes drug mechanisms, clinical studies, regulatory progress, and key developments such as collaborations, mergers, funding, and designations.

For emerging alcohol use disorder drugs, the alcohol use disorder pipeline analysis report provides a 360° view of the therapeutic landscape by development stage, product type, route of administration, molecule type, and mechanism of action (MOA). The pipeline research covers business opportunities, challenges, future partnerships, strong competitors, and growth strategies.

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 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.
• In January 2025, Solvonis Therapeutics CEO Anthony Tennyson discussed the company's progress with AWKN-002, a drug candidate for moderate to severe alcohol use disorder, in an interview with Proactive's Stephen Gunnion.

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Alcohol Use Disorder Overview
Alcohol Use Disorder (AUD), also known as alcoholism, is a severe form of alcohol abuse characterized by an inability to control drinking. Its causes are complex, with factors such as genetics, environment, cognitive function, and personality disorders contributing to its development. Around 50% of AUD risk is hereditary, with the other half influenced by environmental factors.

Alcohol acts as a sedative hypnotic, depressing the central nervous system at high doses and stimulating it at lower doses, which can lead to euphoria. However, excessive consumption can result in drowsiness, respiratory depression, coma, or death. Its effects depend on the blood alcohol concentration (BAC) over time, affecting various organs in the body.

Alcohol stimulates dopamine release in the brain's mesolimbic dopamine system, which is linked to reward and motivation. This can reinforce drinking behaviors, making the experience more rewarding. Alcohol's effects on dopamine are also mediated through other neurotransmitter systems, including glutamate, GABA, and opioids.

To diagnose AUD, tests such as measuring carbohydrate-deficient transferrin can indicate heavy drinking. While AUD is a complex disorder influenced by genes and environment, several effective treatments, including pharmacotherapies, target the biological mechanisms involved in alcohol misuse.

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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.

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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

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About DelveInsight
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