Alcohol Use Disorder Pipeline 2025: Groundbreaking Clinical Advancements by 30+ Global Leaders - DelveInsight | Featuring Cybin, Indivio, BioXcel Therapeutics, BiocorRx Pharmaceuticals, Beckley Psytech, MediciNova, Adial Pharmaceuticals, Imbrium Therapeut

With Alcohol Use Disorder reaching epidemic proportions globally and contributing significantly to comorbid conditions such as diabetes, cardiovascular disease, and certain cancers, there is a growing demand for safer, more effective treatment options. According to DelveInsight, the Alcohol Use Disorder pipeline comprises 30+ pharmaceutical and biotech companies actively developing 30+ therapeutic candidates targeting Alcohol Use Disorder. These therapies span various stages of clinical and non-clinical development, underscoring the intense innovation and commitment to addressing one of the most pressing public health challenges of our time.
DelveInsight's "Alcohol Use Disorder Pipeline Insight 2025" report provides a detailed and strategic evaluation of the ongoing R&D landscape. It covers clinical trial progression, emerging therapies, mechanisms of action, competitive positioning, and key company initiatives. The report serves as a crucial resource for stakeholders-including researchers, healthcare investors, and decision-makers, seeking insights into the evolving Alcohol Use Disorder Therapeutics Market and the breakthroughs shaping its future trajectory.

Explore the Cutting-Edge Landscape of Alcohol Use Disorder Drug Development @ https://www.delveinsight.com/report-store/alcohol-use-disorder-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=kpr

Key Takeaways from the Alcohol Use Disorder Pipeline Report

DelveInsight's Alcohol Use Disorder pipeline report depicts a robust space with 30+ active players working to develop 30+ pipeline therapies for Alcohol Use Disorder treatment.
In Feb 14, 2025, FDA's CDER officially qualified a two‐level Risk Drinking Level (RDL) reduction as a valid primary endpoint for moderate-to-severe AUD trials. This gives developers an alternative to abstinence or zero heavy drinking days.
In May 8, 2025, FDA granted Adial Pharmaceuticals an End‐of‐Phase 2 meeting (scheduled for July 25, 2025) to finalize its Phase 3 design for AD04, a genetically targeted 5‐HT3 antagonist for AUD. Regulatory input confirmed their genetic-driven strategy and bridging approach.
In Jan 20, 2025, Awakn's pre-IND meeting with FDA for AWKN‐002 (sublingual esketamine thin film for AUD) had a positive outcome, with FDA agreeing it can proceed via the 505(b)(2) pathway, incorporating existing esketamine data.
Key Alcohol Use Disorder companies such as Cybin, Indivio, BioXcel Therapeutics, BiocorRx Pharmaceuticals, Beckley Psytech, MediciNova, Adial Pharmaceuticals, Imbrium Therapeutics, and others are evaluating new drugs for Alcohol Use Disorder to improve the treatment landscape.
Promising Alcohol Use Disorder pipeline therapies in various stages of development include AD04, Sunobinop, BICX104, and others.

Alcohol Use Disorder Overview:

Alcohol addiction, also known as alcoholism, represents the most severe form of problematic drinking behavior and is marked by an inability to control alcohol consumption. Clinically, it is termed **Alcohol Use Disorder (AUD)** and is a prevalent condition in the United States. While the precise causes of AUD remain unclear, a range of factors are believed to contribute to its onset, including family environment, peer influences, genetic predisposition, cognitive functioning, and coexisting personality disorders. Genetics play a substantial role, with approximately 50% of the risk for AUD being inherited, while the remaining 50% is influenced by environmental conditions.

Alcohol is categorized as a **sedative-hypnotic**, meaning that at higher doses, it depresses the central nervous system. At lower doses, it can temporarily act as a stimulant, producing feelings of euphoria and increased sociability. However, excessive consumption in a single session can lead to serious outcomes such as sedation, slowed or halted breathing (respiratory depression), unconsciousness, coma, or even death. Beyond its immediate effects, alcohol impacts nearly every organ in the body, with the extent of these effects largely dependent on the **blood alcohol concentration (BAC)** over time.

Similar to other addictive substances, alcohol increases dopamine release in the brain, particularly from cells in the **ventral tegmental area (VTA)**-a part of the **mesolimbic dopamine system**, which governs motivation and reward processing. When alcohol is consumed, dopamine is released into areas like the **nucleus accumbens (NAc)** and the **prefrontal cortex**, reinforcing alcohol-seeking behavior by making the act of drinking feel more rewarding. Emerging research highlights how **neuroplasticity** and **metaplasticity** within this brain circuit may contribute to learning mechanisms that underlie addiction, strengthening the drive to continue drinking through repeated exposure.

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Alcohol Use Disorder Pipeline Analysis
The Alcohol Use Disorder pipeline insights report 2025, provides insights into:
Provides comprehensive insights into key companies developing therapies in the Alcohol Use Disorder Market.

Categorizes Alcohol Use Disorder therapeutic companies by development stage: early, mid, and late-stage.

Highlights major companies involved in targeted therapy development, including both active and inactive (paused/discontinued) projects.

Reviews emerging Alcohol Use Disorder drugs under development based on:

Stage of development

Alcohol Use Disorder Route of administration

Target receptor

Monotherapy vs. combination therapy

Alcohol Use Disorder Mechanism of action

Molecular type

Offers detailed analysis of:

Company-to-company and company-academia collaborations

Alcohol Use Disorder Licensing agreements

Funding and investment activities supporting future Alcohol Use Disorder market advancement.

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=openpr&utm_medium=pressrelease&utm_campaign=kpr

Alcohol Use Disorder Emerging Drugs

AD04: Adial Pharmaceuticals
AD04, developed by Adial Pharmaceuticals, is a genetically tailored treatment aimed at addressing Alcohol Use Disorder (AUD). It functions by influencing key neurotransmitter systems involved in the brain's reward and reinforcement pathways associated with alcohol use. The therapy is intended for individuals with specific genetic profiles, identified using Adial's proprietary companion diagnostic test. In a Phase III clinical trial, AD04 demonstrated potential in reducing the number of heavy drinking days within a genetically defined patient subgroup. Its mechanism is thought to involve regulating the balance between serotonergic and dopaminergic activity, which may help decrease alcohol cravings and overall consumption.

Sunobinop: Imbrium Therapeutics

Sunobinop is an experimental oral drug candidate with a novel mechanism of action, potentially representing a first-in-class therapy. It is designed to selectively bind to and activate the nociceptin/orphanin FQ peptide (NOP) receptor-a protein broadly distributed throughout the central and peripheral nervous systems and involved in various physiological processes. Sunobinop is currently being evaluated in a Phase II clinical trial for its effectiveness in treating Alcohol Use Disorder (AUD).

BICX104: BiocorRx Pharmaceuticals

BICX104 is a long-acting, biodegradable subcutaneous pellet formulation of naltrexone, designed to enhance treatment adherence in individuals with opioid use disorder (OUD) compared to existing therapies. Developed by BioCorRx Pharmaceuticals Inc., a majority-owned clinical-stage subsidiary of BioCorRx Inc., BICX104 aims to provide sustained therapeutic effects with improved patient convenience. In a Phase I open-label, single-center study involving two parallel groups of healthy volunteers, the pharmacokinetics and safety of BICX104 were compared to the monthly intramuscular naltrexone injection (Vivitrol). The results showed that BICX104 was well tolerated, with no serious adverse events, and maintained therapeutic plasma levels of naltrexone for up to 84 days. The drug is currently 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

Download sample pages to get an in-depth assessment of the emerging Alcohol Use Disorder therapies and key Alcohol Use Disorder companies: https://www.delveinsight.com/sample-request/alcohol-use-disorder-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=kpr

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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Contact Info:
Kritika Rehani
Assistant Manager, Marketing & Branding
krehani@delveinsight.com
info@delveinsight.com
+14699457679

About DelveInsight

DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance.

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