Alcohol Use Disorder Pipeline Insight

DelveInsight’s, “Alcohol Use Disorder (AUD) - Pipeline Insight, 2025” report provides comprehensive insights about 20+ companies and 25+ pipeline drugs in Alcohol Use Disorder (AUD) 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 (AUD): Understanding

Alcohol Use Disorder (AUD): Overview

Alcohol addiction, also known as alcoholism, represents the most severe form of alcohol misuse and is characterized by a loss of control over drinking behavior. Medically, it is referred to as Alcohol Use Disorder, a condition that is notably prevalent in the United States. While the exact causes of AUD remain unclear, multiple contributing factors have been identified, including environmental influences, peer pressure, genetic predisposition, cognitive functioning levels, and the presence of certain personality disorders. Approximately 50% of the risk for developing AUD is considered hereditary, with the remaining risk influenced by environmental factors.

Alcohol is classified as a sedative-hypnotic substance, meaning it depresses the central nervous system, particularly at higher doses. At lower levels, alcohol may have a stimulant effect, promoting euphoria and increased sociability. However, excessive alcohol intake can result in drowsiness, slowed or stopped breathing (respiratory depression), coma, or even death. Alcohol affects nearly every organ in the body, and its impact depends largely on blood alcohol concentration (BAC) over time.

Like other addictive substances, alcohol triggers the release of dopamine from neurons in the ventral tegmental area (VTA)—a brain region involved in the mesolimbic dopamine system, which plays a key role in reward and motivation. Dopamine release into the nucleus accumbens (NAc) and prefrontal cortex is believed to reinforce drinking behaviors and increase the perceived reward of alcohol. Emerging research has shown that neuronal plasticity and metaplasticity in this system may enhance reward-based learning and promote addiction.

Although alcohol does not bind directly to dopamine receptors, its effects on dopamine signaling are thought to occur through modulation of other neurotransmitter systems, including glutamate, GABA, serotonin (5-HT), corticotropin-releasing factor, and the endogenous opioid system (e.g., endorphins, enkephalins). A commonly used biomarker for chronic heavy drinking is carbohydrate-deficient transferrin (CDT), which measures structural changes in transferrin due to prolonged alcohol consumption. A CDT level of 20 units per liter or more typically indicates sustained heavy drinking. The sensitivity of CDT for detecting AUD ranges between 30% and 75%, with higher accuracy in men, and specificity can be as high as 90%, though results may be confounded by iron deficiency.

Overall, AUD is a heterogeneous disorder involving a complex interplay of genetic and environmental factors. Fortunately, several evidence-based treatments—including targeted pharmacotherapies—are available to help manage and treat this condition by addressing key biological mechanisms underlying problematic alcohol use.

"Alcohol Use Disorder (AUD)- 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 (AUD) pipeline landscape is provided which includes the disease overview and Alcohol Use Disorder (AUD) treatment guidelines. The assessment part of the report embraces, in depth Alcohol Use Disorder (AUD) 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 (AUD) 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 (AUD) R&D. The therapies under development are focused on novel approaches to treat/improve Alcohol Use Disorder (AUD).

Alcohol Use Disorder (AUD) Emerging Drugs Chapters

This segment of the Alcohol Use Disorder (AUD) 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 (AUD) Emerging Drugs

• SVN-001: Solvonis Therapeutics

SVN-001 is a first-of-its-kind combination therapy combining IV ketamine (an NMDA receptor antagonist) with copyrighted manualised relapse prevention cognitive behavioural therapy, targeting both the biological and psychosocial aspects of alcohol use disorder. Phase II results demonstrated a 50% reduction in Heavy Drinking Days vs a placebo. A full mixed marketing authorisation in the UK and EU is planned, which, if successful, will provide regulatory protection to include eight years of data exclusivity in the EU and ten years of concurrent market exclusivity in both regions. According to the company’s pipeline, the drug is in the Phase III stage of its development for the treatment of Alcohol Use Disorder.

 

• KT 110: Kinnov Therapeutics

KT 110 (Cyproheptadine/Prazosin combination therapy), is an investigational drug being developed by Kinnov Therapeutics. Cyproheptadine + Prazosin in combination (KT-110 of Kinnov Therapeutics) reverses preference to alcohol and induces a strong alcohol aversion. KT-110 antagonizes behavioral sensitization induced by nicotine. Cyproheptadine: Antagonist of 5HT2 and 5HT1C receptors used in the treatment of allergy and prazosin: Antagonist of alpha1-adrenergic receptors used in the treatment of arterial high blood pressure. KT-110 composition is better than other drugs such as acomposate, naltrexone or nalmefene. Patented protection of the composition and patent on new BID formulation is being filed. Currently, the drug is in Phase II stage of Clinical trial evaluation for the treatment of Alcohol Use Disorder.

 

• BPL-003: Beckley Psytech Limited

BPL-003 is a novel intranasal formulation of synthetic 5-MeO-DMT benzoate developed to offer a rapid-acting psychedelic therapy for mental health conditions, including Alcohol Use Disorder (AUD). Designed for administration in a controlled clinical environment, BPL-003 aims to deliver profound therapeutic effects with a brief in-clinic duration of approximately two hours. By addressing limitations of first-generation psychedelics and conventional AUD treatments, BPL-003 seeks to induce rapid and sustained behavioral change through a combination of pharmacological action and structured psychological support. Currently, the drug is in the Phase II stage of its development for the treatment of Alcohol Use Disorder.

 

• BXCL501: BioXcel Therapeutics

BXCL501, is a proprietary, sublingual film formulation of dexmedetomidine being developed for the acute treatment of agitation associated with Alzheimer’s disease and as an adjunctive treatment for Major Depressive Disorder.  BXCL501 is a sublingual film containing dexmedetomidine. Dexmedetomidine is an alpha-2 adrenergic receptor agonist and has higher intrinsic activity and is more potent in vitro than either clonidine or lofexidine. The drug has a high free brain to free plasma ratio after dosing in rats that persists after plasma concentrations are cleared. Currently, it is in Phase I stage of clinical trial evaluation to treat Alcohol Use Disorder (AUD).

 

• LPH-48: Lophora

LPH-48 is designed as a fast-follower to LPH-5, LPH-48 shows significantly faster metabolism, indicating a much shorter activity profile in man. LPH-48 is a representative of the same proprietary compound class as LPH-5 and is therefore endowed with the same optimized characteristics including drug-like properties and safety pharmacological profile. According to the company’s pipeline, the drug is currently in the preclinical stage of its development for the treatment of Alcohol Use Disorder.

Further product details are provided in the report……..

 

Alcohol Use Disorder (AUD): Therapeutic Assessment

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

• Major  Players in Alcohol Use Disorder (AUD)
• There are approx. 20+ key companies which are developing the therapies for Alcohol Use Disorder (AUD). The companies which have their Alcohol Use Disorder (AUD) drug candidates in the most advanced stage, i.e. Phase III include, Solvonis Therapeutics.

 

Phases

DelveInsight’s report covers around 25+ 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 (AUD) 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 (AUD): 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 (AUD) 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 (AUD) drugs.

 

Alcohol Use Disorder (AUD) Report Insights

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

 

Alcohol Use Disorder (AUD) 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 (AUD) drugs?
• How many Alcohol Use Disorder (AUD) 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 (AUD)?
• What are the key collaborations (Industry–Industry, Industry–Academia), Mergers and acquisitions, licensing activities related to the Alcohol Use Disorder (AUD) 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 (AUD) and their status?
• What are the key designations that have been granted to the emerging drugs?