With alcohol use disorder (AUD) reaching epidemic levels worldwide and contributing to comorbidities such as diabetes, cardiovascular disease, and certain cancers, there is an increasing need for safer and more effective treatments. DelveInsight reports that over 30 pharmaceutical and biotech companies are actively developing more than 30 therapeutic candidates targeting AUD. These therapies are in various stages of clinical and preclinical development, reflecting significant innovation and a strong commitment to addressing this pressing public health challenge.
DelveInsight’s “Alcohol Use Disorder Pipeline Insight 2025” report offers a comprehensive and strategic overview of the current R&D landscape. It details clinical trial progress, emerging therapies, mechanisms of action, competitive positioning, and key company initiatives. The report serves as a valuable resource for researchers, healthcare investors, and decision-makers seeking insights into the evolving AUD therapeutics market and the breakthroughs shaping its future.
Explore the Cutting-Edge Landscape of Alcohol Use Disorder Drug Development @ https://www.delveinsight.com/report-store/alcohol-use-disorder-pipeline-insight?utm_source=abnewswire&utm_medium=market&utm_campaign=kpr
Key Takeaways from the Alcohol Use Disorder Pipeline Report
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DelveInsight’s Alcohol Use Disorder (AUD) pipeline report highlights a dynamic landscape, with over 30 companies actively developing more than 30 therapeutic candidates for AUD treatment.
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On February 14, 2025, the FDA’s Center for Drug Evaluation and Research (CDER) officially recognized a two‑level Risk Drinking Level (RDL) reduction as a valid primary endpoint for moderate-to-severe AUD trials, offering developers an alternative to endpoints based on abstinence or zero heavy drinking days.
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On May 8, 2025, the FDA granted Adial Pharmaceuticals an End-of-Phase 2 meeting, scheduled for July 25, 2025, to finalize the Phase 3 design for AD04, a genetically targeted 5‑HT3 antagonist for AUD. Regulatory feedback validated their genetic-driven strategy and bridging approach.
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Additionally, on January 20, 2025, Awakn’s pre-IND meeting with the FDA for AWKN‑002, a sublingual esketamine thin film for AUD, yielded a positive outcome. The FDA agreed that the therapy could proceed via the 505(b)(2) pathway, leveraging existing esketamine data.
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Leading companies in the AUD space—including Cybin, Indivio, BioXcel Therapeutics, BiocorRx Pharmaceuticals, Beckley Psytech, MediciNova, Adial Pharmaceuticals, and Imbrium Therapeutics—are actively developing new therapies to enhance treatment options. Promising candidates in the pipeline include AD04, Sunobinop, BICX104, and several others, reflecting ongoing innovation in the field.
Alcohol Use Disorder Overview:
Alcohol addiction, commonly referred to as alcoholism, is the most severe form of problematic drinking and is characterized by an inability to control alcohol intake. Clinically, it is known as Alcohol Use Disorder (AUD) and is highly prevalent in the United States. The exact causes of AUD are not fully understood, but multiple factors are thought to contribute, including family environment, peer influences, genetic predisposition, cognitive functioning, and coexisting personality disorders. Genetics account for roughly half of the risk for AUD, while environmental factors influence the remaining portion.
Alcohol is classified as a sedative-hypnotic, which at higher doses depresses the central nervous system. At lower doses, it can act as a stimulant, producing temporary feelings of euphoria and increased sociability. However, excessive consumption in a single session can have severe consequences, including sedation, slowed or halted breathing, unconsciousness, coma, or even death. Beyond these immediate effects, alcohol impacts nearly every organ in the body, with the severity largely determined by blood alcohol concentration over time.
Like other addictive substances, alcohol increases dopamine release in the brain, particularly from cells in the ventral tegmental area, part of the mesolimbic dopamine system that regulates motivation and reward. When alcohol is consumed, dopamine is released into regions such as the nucleus accumbens and prefrontal cortex, reinforcing alcohol-seeking behavior by making drinking feel rewarding. Recent research suggests that changes in neuroplasticity and metaplasticity within this brain circuit may contribute to learning mechanisms that drive addiction, strengthening the compulsion to drink through repeated exposure.
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Alcohol Use Disorder Pipeline Analysis
The Alcohol Use Disorder pipeline insights report 2025, provides insights into:
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Provides comprehensive insights into key companies developing therapies in the Alcohol Use Disorder Market.
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Categorizes Alcohol Use Disorder therapeutic companies by development stage: early, mid, and late-stage.
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Highlights major companies involved in targeted therapy development, including both active and inactive (paused/discontinued) projects.
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Reviews emerging Alcohol Use Disorder drugs under development based on:
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Stage of development
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Alcohol Use Disorder Route of administration
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Target receptor
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Monotherapy vs. combination therapy
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Alcohol Use Disorder Mechanism of action
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Molecular type
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Offers detailed analysis of:
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Company-to-company and company-academia collaborations
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Alcohol Use Disorder Licensing agreements
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Funding and investment activities supporting future Alcohol Use Disorder market advancement.
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Unlock key insights into emerging Alcohol Use Disorder therapies and market strategies here: https://www.delveinsight.com/report-store/alcohol-use-disorder-pipeline-insight?utm_source=abnewswire&utm_medium=market&utm_campaign=kpr
Alcohol Use Disorder Emerging Drugs
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AD04: Adial Pharmaceuticals
AD04, developed by Adial Pharmaceuticals, is a genetically targeted therapy designed to treat Alcohol Use Disorder (AUD). It works by modulating key neurotransmitter systems in the brain’s reward and reinforcement pathways linked to alcohol consumption. The treatment is tailored for individuals with specific genetic profiles, identified through Adial’s proprietary companion diagnostic test. In Phase III clinical trials, AD04 showed promise in reducing the number of heavy drinking days in this genetically defined patient subgroup. Its mechanism is believed to involve balancing serotonergic and dopaminergic activity, potentially helping to lower alcohol cravings and overall intake.
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Sunobinop: Imbrium Therapeutics
Sunobinop is an investigational oral therapy with a novel mechanism of action, potentially making it a first-in-class treatment. It is designed to selectively target and activate the nociceptin/orphanin FQ peptide (NOP) receptor, which is widely expressed throughout the central and peripheral nervous systems and plays a role in multiple physiological functions. Sunobinop is currently undergoing evaluation in a Phase II clinical trial for the treatment of Alcohol Use Disorder (AUD).
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BICX104: BiocorRx Pharmaceuticals
BICX104 is a long-acting, biodegradable subcutaneous pellet formulation of naltrexone, developed to improve treatment adherence in individuals with opioid use disorder (OUD) compared to existing options. Created by BioCorRx Pharmaceuticals Inc., a clinical-stage subsidiary of BioCorRx Inc., BICX104 is designed to deliver sustained therapeutic effects while offering greater convenience for patients. In a Phase I open-label, single-center study with two parallel groups of healthy volunteers, the pharmacokinetics and safety of BICX104 were compared with the monthly intramuscular naltrexone injection (Vivitrol). The study demonstrated that BICX104 was well tolerated, with no serious adverse events, and maintained therapeutic plasma levels of naltrexone for up to 84 days. The therapy is currently being evaluated in Phase I clinical trials for the treatment of Alcohol Use Disorder (AUD).
Alcohol Use Disorder Pipeline Therapeutic Assessment
Alcohol Use Disorder Assessment by Product Type
• Mono
• Combination
• Mono/Combination
Alcohol Use Disorder 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
Alcohol Use Disorder Assessment by Route of Administration
• Oral
• Parenteral
• Intravenous
• Subcutaneous
• Topical
Alcohol Use Disorder Assessment by Molecule Type
• Recombinant fusion proteins
• Small molecule
• Monoclonal antibody
• Peptide
• Polymer
• Gene therapy
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Table of Contents
1. Report Introduction
2. Executive Summary
3. Alcohol Use Disorder Current Treatment Patterns
4. Alcohol Use Disorder – DelveInsight’s Analytical Perspective
5. Therapeutic Assessment
6. Alcohol Use Disorder Late-Stage Products (Phase-III)
7. Alcohol Use Disorder Mid-Stage Products (Phase-II)
8. Early Stage Products (Phase-I)
9. Pre-clinical Products and Discovery Stage Products
10. Inactive Products
11. Dormant Products
12. Alcohol Use Disorder Discontinued Products
13. Alcohol Use Disorder Product Profiles
14. Alcohol Use Disorder Key Companies
15. Alcohol Use Disorder Key Products
16. Dormant and Discontinued Products
17. Alcohol Use Disorder Unmet Needs
18. Alcohol Use Disorder Future Perspectives
19. Alcohol Use Disorder Analyst Review
20. Appendix
21. Report Methodology
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