Alcohol Use Disorder - Pipeline Insight, 2025

DelveInsight's, "Alcohol Use Disorder - Pipeline Insight, 2025" report provides comprehensive insights about 30+ companies and 30+ pipeline drugs in Alcohol Use Disorder pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

Geography Covered:

• Global coverage

Alcohol Use Disorder: Understanding

Alcohol Use Disorder: Overview

Alcohol Addiction, also referred to as Alcoholism is the most severe form of alcohol abuse and involves the inability to manage drinking habits. It is also commonly referred to as Alcohol Use Disorder (AUD). Alcohol use disorder is very common in the United States. The cause of alcohol use disorder is not well understood; however, several factors are thought to contribute to its development. These include the home environment, peer interactions, genetic factors, level of cognitive functioning, and certain existing personality disorders. Nearly 50% of AUD risk is heritable, i.e., transmissible from parent to offspring, with the other 50% attributable to environmental factors.

Alcohol is classed as a 'sedative hypnotic' drug, which means it acts to depress the central nervous system at high doses. At lower doses, alcohol can act as a stimulant, inducing feelings of euphoria and talkativeness, but drinking too much alcohol at one session can lead to drowsiness, respiratory depression (where breathing becomes slow, shallow or stops entirely), coma or even death. As well as its acute and potentially lethal sedative effect at high doses, alcohol has effects on every organ in the body, and these effects depend on the blood alcohol concentration (BAC) over time.

Alcohol, like other addictive drugs, stimulates release of the neurotransmitter dopamine from cells originating in a region of the brain called the ventral tegmental area (VTA). The VTA is a component of a neuronal circuit called the mesolimbic dopamine system that has been associated with behavioral motivation and reward. Following exposure to alcohol, dopamine released into the nucleus accumbens (NAc) and prefrontal cortex has been postulated to reinforce drinking behaviors or make the experience of drinking more salient. Recent reviews of the neurobiological literature have described evidence that neuronal plasticity and metaplasticity in the mesolimbic system can promote reward-based learning and the development of addiction.

Whereas alcohol does not appear to selectively bind dopamine receptors, its effects on dopamine release are likely mediated through interactions with other neurotransmitter systems, such as glutamate, GABA, corticotropin-releasing factor, and 5-HT, as well as through interactions with the endogenous opioid system (e.g., endorphins, enkephalins). A useful test is for carbohydrate-deficient transferrin, which measures a change in the structure of a proportion of transferrin that is likely to occur with heavy drinking over a long period; a result of 20 units per L or more indicates heavy drinking. The sensitivities for identification of heavy drinking and alcohol-use disorders range from 30% to 75% across studies (with higher figures for men), and specificities are as high as 90%, although results might be difficult to interpret in the context of iron deficiency. Alcohol use disorder is a heterogeneous illness with a complex biology that is controlled by many genes and gene-by-environment interactions. Several efficacious, evidence-based treatments currently exist for treating and managing alcohol use disorder, including a number of pharmacotherapies that target specific aspects of biology that initiate and maintain dangerous alcohol misuse.

"Alcohol Use Disorder- Pipeline Insight, 2025" report by DelveInsight outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Alcohol Use Disorder pipeline landscape is provided which includes the disease overview and Alcohol Use Disorder treatment guidelines. The assessment part of the report embraces, in depth Alcohol Use Disorder commercial assessment and clinical assessment of the pipeline products under development. In the report, detailed description of the drug is given which includes mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, Alcohol Use Disorder collaborations, licensing, mergers and acquisition, funding, designations and other product related details.

Report Highlights:

• The companies and academics are working to assess challenges and seek opportunities that could influence Alcohol Use Disorder R&D. The therapies under development are focused on novel approaches to treat/improve Alcohol Use Disorder.

Alcohol Use Disorder Emerging Drugs Chapters

This segment of the Alcohol Use Disorder report encloses its detailed analysis of various drugs in different stages of clinical development, including Phase III, II, I, Preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases.

Alcohol Use Disorder Emerging Drugs

AD04: Adial Pharmaceuticals

AD04, developed by Adial Pharmaceuticals, is a genetically targeted therapeutic agent designed to treat Alcohol Use Disorder (AUD). It works by modulating specific neurotransmitter pathways that are implicated in the brain's reward and reinforcement circuits related to alcohol consumption. The drug is being developed for patients with particular genetic markers, identified through a proprietary companion diagnostic genetic test, and has shown promise in reducing heavy drinking days in a subgroup of patients during a Phase III clinical trial. AD04's mechanism of action is believed to involve balancing the activity of the serotonergic and dopaminergic systems, potentially reducing alcohol cravings and consumption.

Sunobinop: Imbrium Therapeutics

Sunobinop is an investigational, novel and potential first-in-class oral compound designed to bind to and activate the nociceptin/orphanin-FQ peptide receptor (NOP), a protein that is widely expressed in the central and peripheral nervous system and involved in a range of biological functions. Currently, the drug is in Phase II stage of its clinical trial for the treatment of alcohol use disorder.

BICX104: BiocorRx Pharmaceuticals

BICX104 is a biodegradable, long-acting subcutaneous pellet of naltrexone for the treatment of opioid use disorder (OUD) being developed to improve patient compliance to naltrexone therapy compared to other marketed treatments. In Phase I, an open-label, single-center study in two parallel groups of randomized healthy volunteers to evaluate the PK and safety of BICX104 and the once-a-month intramuscular naltrexone injection (Vivitrol), BICX104 was well tolerated with no serious adverse events and achieved 84 days of therapeutic naltrexone plasma concentrations. BICX104 is being developed under BioCorRx Pharmaceuticals Inc., the Company's majority-owned clinical-stage pharmaceutical subsidiary. Currently, the drug is in Phase I stage of its clinical trial for the treatment of Alcohol Use Disorder.

Alcohol Use Disorder: Therapeutic Assessment

This segment of the report provides insights about the different Alcohol Use Disorder drugs segregated based on following parameters that define the scope of the report, such as:

• Major Players in Alcohol Use Disorder
• There are approx. 30+ key companies which are developing the therapies for Alcohol Use Disorder. The companies which have their Alcohol Use Disorder drug candidates in the most advanced stage, i.e. Phase III include, Adial Pharmaceuticals.
• Phases

DelveInsight's report covers around 30+ products under different phases of clinical development like

• 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
• Route of Administration

Alcohol Use Disorder pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as

• Oral
• Intravenous
• Subcutaneous
• Parenteral
• Topical
• Molecule Type

Products have been categorized under various Molecule types such as

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

Drugs have been categorized under various product types like Mono, Combination and Mono/Combination.

Alcohol Use Disorder: Pipeline Development Activities

The report provides insights into different therapeutic candidates in Phase III, II, I, preclinical and discovery stage. It also analyses Alcohol Use Disorder therapeutic drugs key players involved in developing key drugs.

Pipeline Development Activities

The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Alcohol Use Disorder drugs.

Alcohol Use Disorder Report Insights

• Alcohol Use Disorder Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

Alcohol Use Disorder Report Assessment

• Pipeline Product Profiles
• Therapeutic Assessment
• Pipeline Assessment
• Inactive drugs assessment
• Unmet Needs

Key Questions:

Current Treatment Scenario and Emerging Therapies:

• How many companies are developing Alcohol Use Disorder drugs?
• How many Alcohol Use Disorder drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Alcohol Use Disorder?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Alcohol Use Disorder therapeutics?
• What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for Alcohol Use Disorder and their status?
• What are the key designations that have been granted to the emerging drugs?

Key Players

• Cybin
• Indivio
• BioXcel Therapeutics
• BiocorRx Pharmaceuticals
• Beckley Psytech
• MediciNova
• Adial Pharmaceuticals
• Imbrium Therapeutics

Key Products

• CYB003
• INDV1000
• BXCL501
• BICX104
• BPL-003
• MN-166
• AD04
• Sunobinop