Alcohol Use Disorder - Pipeline Insight, 2024

This “Alcohol Use Disorder - Pipeline Insight, 2024,” 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 Use Disorder (AUD), 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 Addiction. These are common and potentially lethal disorders that mimic and exacerbate a wide range of additional medical and psychiatric conditions, and thereby shorten the lifespans of affected people by more than a decade.

Symptoms
People with alcohol use disorder may engage in the following behaviors:

• Slurred speech
• Unsteady walking
• Nausea
• Double vision
• Increased heart rate
• Drowsiness
• Some impairment in motor coordination and thinking ability
• Talkativeness
• Relaxation

Diagnosis
Although they are not a substitute for a careful clinical interview, a range of self-administered questionnaires can be used to screen for heavy drinking and alcohol-use disorders in clinical settings. The shortest of the most widely-used instruments is the CAGE questionnaire, which is an acronym for whether a patient has ever felt the need to cut down on drinking; felt Annoyed when criticized about alcohol use; felt Guilty about drinking, or ever needed an Eye-opener on awakening. Although not as sensitive as questionnaires, blood tests for markers that are likely to change in the context of heavy drinking can also help to identify patients who consume hazardous amounts of alcohol. Tests of liver function that measure alanine and aspartate aminotransferases can identify heavy drinking and alcohol-use disorders with sensitivities of between 25% and 45% and specificities as high as 90%.

Treatment
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. The main goal of AUD treatment is to help patients avoid alcohol entirely (abstinence) or to reduce alcohol drinking (harm reduction).

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

Ondansetron: Adial Pharmaceuticals Ondansetron is a 5-HT3 receptor antagonist which is being developed by Adial Pharmaceuticals. Preclinical and pharmacobehavioral studies suggest that blockade of serotonin-3 receptors will influence the dopamine reward system activated by alcohol, decreasing dopamine release and attenuating craving for alcohol. Early clinical studies found that the efficacy of ondansetron is limited to certain subgroups of the alcohol-dependent population and suggested the differential effect could be predicted based on age of onset of alcoholism, an indistinct concept likely confounded by genetic, regional and ethnic differences. The drug is currently in phase III stage of development for the treatment of Alcohol addiction.

MN-166: Medici Nova MN-166 (ibudilast) portfolio, which includes the phase II-staged lead drug compound and proprietary analogs, represents novel, first-in-class, non-opioid drugs for the treatment of drug addiction, progressive multiple sclerosis and pain. MN-166 is a first-in-class, orally bioavailable, small molecule glial attenuator that suppresses pro-inflammatory cytokines IL-1ß, TNF-a, and IL-6, and may upregulate the anti-inflammatory cytokine IL-10. It has additionally been shown to be a toll-like receptor 4 (TLR4) functional antagonist that may contribute to its attenuation of neuroinflammation. While considered a New Molecular Entity, or NME, in the United States and Europe, it involves redirection of an approved drug, ibudilast, which was first approved in Japan more than 20yearsago.

ANS-6637: Amygdala Neurosciences ANS-6637 is a new chemical entity selective and reversible ALDH2 inhibitor. Based on its mechanism of action in the brain to prevent pathophysiologic dopamine surge without changes to basal dopamine, ANS-6637 has the potential to prevent drug seeking behavior, craving and relapse. In preclinical studies, ALDH2 inhibition reduced self-administration, cue- and drug-primed relapse in nicotine, alcohol, cocaine, heroin, methamphetamine and binge eating models and also demonstrated anti-anxiety properties in models ofstress.

GET73: Laboratorio Farmaceutico GET73 is being developed by Laboratorio Farmaceutico for the treatment of Alcohol Use Disorder. It is currently in phase II stage ofdevelopment.

PT150: Pop Test Oncology PT150 is being developed by Pop Test Oncology LLC for the treatment of Alcohol Dependence. It is currently in phase I stage ofdevelopment.

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 and others

Phases

This report covers around 30+ products under different phases of clinical development like

• Late-stage products (Phase III)
• Mid-stage products (Phase II)
• Early-stage products (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

• Infusion
• Intradermal
• Intramuscular
• Intranasal
• Intravenous
• Oral
• Parenteral
• Subcutaneous
• Topical

Molecule Type

Products have been categorized under various Molecule types such as

• Gene therapies
• Small molecule
• Vaccines
• Polymers
• Peptides
• Monoclonal antibodies

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.

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.

• In July 2020, Adial Pharmaceuticals announced that the European Medicines Agency (EMA) has accepted its Pediatric Investigation Plan (PIP) for development of the Company's lead drug candidate, AD04, for the treatment of Alcohol Use Disorder (AUD) in the pediatric population, ages 12 to 17. The approved PIP does not require additional clinical trials, and all requirements can be accommodated in the current phase III program.
• Amygdala acquired the asset ANS-6637 as a spin out from Gilead Sciences.
• ORG34517, first developed as a therapy for major depressive disorder, was first formulated by Organon. In 2007, ORG34517 was acquired by Schering-Plough, then Merck, and ultimately acquired by Pop Test Cortisol LLC in December of 2010.

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

• ADial Pharmaceuticals
• R-Pharm|Synergy Research
• Arbor Pharmaceuticals
• Laboratorio Farmaceutico
• Gilead Sciences
• Kinnov Therapeutics
• Opiant Pharmaceuticals
• MediciNova
• Bioprojet
• Corcept Therapeutics
• Pfizer
• Dicerna Pharmaceuticals, Inc.
• Organon
• Confluence Pharmaceuticals

Key Products

• AD04
• Odelepan|Placebo
• gabapentin enacarbil|Placebo

GET73|Other: Placebo- ANS 6637

• KT 110
• OPNT 002
• Ibudilast
• BPI.3656B
• Mifepristone + Behavioral Therapy
• PF-05190457
• ALDH2-Targeting RNAi
• PT 150
• ACP SR Sprinkles