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Alcohol Use Disorder - Pipeline Insight, 2020

  • ID: 5182095
  • Clinical Trials
  • October 2020
  • Region: Global
  • 90 Pages
  • DelveInsight

FEATURED COMPANIES

  • ADial Pharmaceuticals
  • Bioprojet
  • Gilead Sciences
  • Laboratorio Farmaceutico
  • Opiant Pharmaceuticals
  • Pfizer

"This “Alcohol Use Disorder - Pipeline Insight, 2020,” 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 the 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: MediciNova


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 20 years ago.


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 of stress.


GET73: Laboratorio Farmaceutico


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


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 of development.


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

The 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 Questions


  • 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 Questions


  • 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
Note: Product cover images may vary from those shown

FEATURED COMPANIES

  • ADial Pharmaceuticals
  • Bioprojet
  • Gilead Sciences
  • Laboratorio Farmaceutico
  • Opiant Pharmaceuticals
  • Pfizer


IntroductionExecutive Summary
Alcohol Use Disorder: Overview
  • Causes
  • Mechanism of Action
  • Signs and Symptoms
  • Diagnosis
  • Disease Management


Pipeline Therapeutics
  • Comparative Analysis


Therapeutic Assessment
  • Assessment by Product Type
  • Assessment by Stage and Product Type
  • Assessment by Route of Administration
  • Assessment by Stage and Route of Administration
  • Assessment by Molecule Type
  • Assessment by Stage and Molecule Type


Alcohol Use Disorder - Analytical Perspective
In-depth Commercial Assessment
  • Alcohol Use Disorder companies’ collaborations, Licensing, Acquisition -Deal Value Trends


Alcohol Use Disorder Collaboration Deals
  • Company-Company Collaborations (Licensing / Partnering) Analysis


Late Stage Products (Phase III)
  • Comparative Analysis


Ondansetron: Adial Pharmaceuticals
  • Product Description
  • Research and Development
  • Product Development Activities


Mid Stage Products (Phase II)
  • Comparative Analysis


MN-166: MediciNova
  • Product Description
  • Research and Development
  • Product Development Activities


ANS-6637: Amygdala Neurosciences
  • Product Description
  • Research and Development
  • Product Development Activities


Early Stage Products (Phase I)
  • Comparative Analysis


PT150: Pop Test Oncology
  • Product Description
  • Research and Development
  • Product Development Activities


Pre-clinical and Discovery Stage Products
  • Comparative Analysis


Drug Name: Company Name
  • Product Description
  • Research and Development
  • Product Development Activities


Inactive Products
  • Comparative Analysis


Alcohol Use Disorder Key CompaniesAlcohol Use Disorder Key ProductsAlcohol Use Disorder- Unmet NeedsAlcohol Use Disorder- Market Drivers and BarriersAlcohol Use Disorder- Future Perspectives and ConclusionAlcohol Use Disorder Analyst ViewsAlcohol Use Disorder Key CompaniesAppendix
List of Tables
Table 1 Total Products for Alcohol Use Disorder
Table 2 Late Stage Products
Table 3 Mid Stage Products
Table 4 Early Stage Products
Table 5 Pre-clinical & Discovery Stage Products
Table 6 Assessment by Product Type
Table 7 Assessment by Stage and Product Type
Table 8 Assessment by Route of Administration
Table 9 Assessment by Stage and Route of Administration
Table 10 Assessment by Molecule Type
Table 11 Assessment by Stage and Molecule Type
Table 12 Inactive Products


List of Figures
Figure 1 Total Products for Alcohol Use Disorder
Figure 2 Late Stage Products
Figure 3 Mid Stage Products
Figure 4 Early Stage Products
Figure 5 Preclinical and Discovery Stage Products
Figure 6 Assessment by Product Type
Figure 7 Assessment by Stage and Product Type
Figure 8 Assessment by Route of Administration
Figure 9 Assessment by Stage and Route of Administration
Figure 10 Assessment by Molecule Type
Figure 11 Assessment by Stage and Molecule Type
Figure 12 Inactive Products
Note: Product cover images may vary from those shown

A selection of companies mentioned in this report includes:

  • ADial Pharmaceuticals
  • Arbor Pharmaceuticals
  • Bioprojet
  • Confluence Pharmaceuticals
  • Corcept Therapeutics
  • Dicerna Pharmaceuticals, Inc.
  • Gilead Sciences
  • Kinnov Therapeutics
  • Laboratorio Farmaceutico
  • MediciNova
  • Opiant Pharmaceuticals
  • Organon
  • Pfizer
  • R-Pharm|Synergy Research
Note: Product cover images may vary from those shown