Generalized Anxiety Disorder (GAD) – Drug Pipeline Landscape, 2023
Generalized Anxiety Disorder (GAD) is a mental health condition, characterized by excessive, frequent and unrealistic worry about everyday things. People with Generalized Anxiety Disorder anticipates disaster and overly concerned about health, family, work, money or other issues when there is no apparent reason for concern and find it difficult to control their worry.
The Generalized Anxiety Disorder (GAD) mainly caused by internal stress. It can also be a result of side effects due to medicine or substance use, medical conditions such as hyperthyroidism which increase hormones, chronic illness/diseases and personal or environmental stress, genetics or experienced any traumatic event.
The most common symptoms of Generalized Anxiety Disorder include restlessness, difficulty falling asleep and/or staying asleep, sweating, trouble breathing, difficulty concentrating, heart palpitations, headaches, muscle aches, stomach aches or unexplained pains, trembling or twitching.
Generalized Anxiety Disorder can be diagnosed by the doctors or mental health professionals based on symptoms persist for at least six months, family history, and medical history along with DSM-5 criteria or various questionnaires such as the GAD-7 and by conducting a physical exam.
The most common treatments for Generalized Anxiety Disorder are cognitive behavioral therapy or psychotherapy, medications like Buspirone, Benzodiazepines and antidepressants along with lifestyle changes to reduce stress.
The pipeline of Generalized Anxiety Disorder (GAD) treatment market consists of a great variable of drugs.
5-hydroxytryptamine type 1A (5-HT1A) Agonists, Trace Amine-associated Receptor 1 (TAAR1) Agonists, Serotonin 2A receptor (5-HT2A) Agonists, Gamma-aminobutyric Acid A Receptor α2,3,5 Positive Allosteric Modulators, and some others are the most highlighted class of this indication. Ongoing research and current trials have the potential to change the market.
More than 9 key players, including pharma giants such as Sunovion Pharmaceuticals Inc, Mind Medicine Inc, AbbVie, and others are working to bring novel therapies that overcome the roadblocks of Generalized Anxiety Disorder treatment pipeline.
Report Highlights
Global Insight Service’s, “Generalized Anxiety Disorder (GAD) – Drug Pipeline Landscape, 2023,” is an overview of the Generalized Anxiety Disorder pipeline drugs. This report covers detailed insights on Generalized Anxiety Disorder drugs under development, assessment by target, mechanism of action, route of administration and molecule type. Product pipeline by companies, stage of development and key regulatory designations, deals and milestones have been presented to gain insights and thus help industry participants for decision making. Generalized Anxiety Disorder pipeline report helps gaining insights on drugs which are under development stage of drug development process across globally. Global Insight Services aims to cover all the drug attributes, deals, regulatory milestones and all the upcoming milestones.
Recent Developments
In January 2022, MindMed got U.S. Food and Drug Administration (FDA) has clearance of Investigational New Drug (IND) application, allowing the Company’s Phase 2b dose-optimization trial of MM-120 for the treatment of generalized anxiety disorder (GAD).
In September 2021, Sunovion Pharmaceuticals Inc, Sumitomo Dainippon Pharma Co., Ltd and Otsuka Pharmaceutical Co., Ltd companies have entered into a worldwide license agreement for the joint development and commercialization of four compounds including Ulotaront (SEP-363856).
In April 2020, MindMed acquires exclusive license to eight clinical trials of LSD and partnered with world-leading Psychedelic Research Laboratory at University Hospital Basel.
Key Products
Ulotaront (SEP-363856) is under development for the treatment of Generalized Anxiety Disorder (GAD). Sunovion discovered Ulotaront in collaboration with PsychoGenics using the in vivo phenotypic SmartCube platform and associated artificial intelligence algorithms. In September 2021, Sunovion, Sumitomo Dainippon Pharma and Otsuka Pharma companies have entered into a worldwide license agreement for the joint development and commercialization of four compounds including Ulotaront.
MM-120 (LSD D-Tartrate) is a pharmaceutically optimized form of lysergic acid diethylamide (LSD) is under development for the treatment of Generalized Anxiety Disorder (GAD). MindMed acquires exclusive license to clinical trials of LSD and partnered with Psychedelic Research Laboratory at University Hospital Basel.
ENX-102 is a precision-targeted GABAA positive allosteric modulator and is under development by Engrail Therapeutics for the treatment of generalized anxiety disorder (GAD). Engrail Therapeutics plans ENX-102 to enter into Phase 2 in 2023.
| Drugs | Company | Phase | Molecule Type | MoA | RoA |
|---|---|---|---|---|---|
| Ulotaront | Sunovion Pharmaceuticals Inc | Phase III | Small Molecule | 5-hydroxytryptamine type 1A (5-HT1A) Agonist; Trace Amine-associated Receptor 1 (TAAR1) Agonist | Oral |
| MM-120 | Mind Medicine, Inc. | Phase II | Small Molecule | Serotonin 2A receptor (5-HT2A) Agonist | Oral |
| ENX-102 | Engrail therapeutics | Phase I | NA | Gamma-aminobutyric Acid A Receptor α2,3,5 Positive Allosteric Modulator (PAM); Alpha 1 Antagonist | Oral |
Figure: Number of Drugs For The Treatment of Generalized Anxiety Disorder (GAD) Under Each Stage of Development
Methodology
The research process includes extensive secondary research on public domain and other authentic sources carried out to add or update the pipeline products information. The secondary research sources include, but are not limited to company websites, annual reports, financial reports, company pipeline chart, investor presentations and SEC filings, journals and conferences, clinical trials registries.
Scope
The pipeline landscape report consists of pipeline product based on several stages of development ranging from discovery to Pre-Registration. The report provides a review of pipeline therapeutics for Generalized Anxiety Disorder (GAD) by companies based on information derived from company and industry-specific sources. The pipeline report covers assessment of Generalized Anxiety Disorder therapeutics by mechanism of action (MoA), drug target, route of administration (RoA) and molecule type. Comprehensive profiles of the pipeline products with details such as company overview, development stage; molecule type, target, mechanism of action, route of administration, dosage form, regulatory designations, key deals and key upcoming milestones.
Reasons to Buy
Helps to find and recognize significant therapeutics under development for Generalized Anxiety Disorder (GAD). Thorough understanding of Generalized Anxiety Disorder pipeline structure and helps in developing corrective measures for pipeline projects.
Effective R&D strategies can be developed with deep knowledge on competitor information, analysis, and insights.
Plan of collaborations from various industry partners that have role in some or the other stage of drug development like contract manufacturing, co-development, contract research organization and commercialization etc.
Helps to create in-licensing and out-licensing opportunities by identifying prospective partners with attractive projects to expand business potential and scope.
Frequently Asked Questions
• What is Generalized Anxiety Disorder (GAD)?
• What are the Causes, Signs and Symptoms of Generalized Anxiety Disorder (GAD)?
• How is Generalized Anxiety Disorder (GAD) diagnosed?
• What are the most common treatments available for Generalized Anxiety Disorder (GAD)?
• How many/which companies are developing Generalized Anxiety Disorder (GAD) drugs?
• How many Generalized Anxiety Disorder (GAD) drugs are under development by each company and their stage of development?
• How many emerging drugs are in late-stage, mid-stage and early-stage of development for the Generalized Anxiety Disorder (GAD) treatment?
• What are the key collaborations, mergers and acquisitions, licensing activities related to the Generalized Anxiety Disorder (GAD) therapeutics?
• What are the molecule types, target, mechanism of action and route of administration of emerging drugs under development for the treatment of Generalized Anxiety Disorder (GAD)?
• What are the clinical studies available for Generalized Anxiety Disorder (GAD) and their status?
• What are the key regulatory designations that have been granted to the treatment emerging drugs?
• What are the key upcoming milestones for Generalized Anxiety Disorder (GAD) drugs?
• How many drugs are under Inactive or Discontinued for the treatment of Generalized Anxiety Disorder (GAD)?
Table of Contents
List of Tables
List of Figures
1. Introduction
1.1 Generalized Anxiety Disorder (GAD) – Pipeline Drugs, 2023 – Coverage
2. Disease Overview – Generalized Anxiety Disorder (GAD)
2.1 Causes
2.2 Signs and Symptoms
2.3 Diagnosis
2.4 Disease Management
3. Generalized Anxiety Disorder (GAD) – Pipeline Drugs Development – Overview
3.1 Comparative Analysis by Stage of Development
3.2 Number of Products under Development by Companies, 2023
3.3 Products under Development by Companies, 2023
4. Assessment of Therapeutics
4.1 Assessment by Target
4.2 Assessment by Mechanism of Action
4.3 Assessment by Molecule Type
4.3 Assessment by Route of Administration
5. Drug Profiles
5.1 Clinical Stage Drugs – Phase III
5.1.1 Cannabidiol (CBD)
5.1.2 Toludesvenlafaxine Hydrochloride
5.1.3 Ulotaront
5.2 Clinical Stage Drugs – Phase II
5.2.1 EXXUA
5.2.2 FKW 00GA
5.2.3 MM-120
5.3 Clinical Stage Drugs – Phase I
5.3.1 ENX-102
5.3.2 Zuranolone
5.4 Early Stage Drugs – Preclinical
5.4.1 ABBV-932
5.4.2 Duloxetine Hydrochlroide (Powder for Oral Liquid Formulation)
5.4.3 PSY-05
5.5 Early Stage Drugs – Discovery
5.5.1 Undisclosed Drug
6. Key Regulatory Designations
7. Key Deals
8. Key Upcoming Milestones
9. Key Companies Involved
9.1 AbbVie
9.2 Engrail therapeutics
9.3 Fabre-Kramer Pharmaceuticals
9.4 Luye Pharma
9.5 Mind Medicine, Inc.
9.6 OWP Pharmaceuticals
9.7 PSY Therapeutics
9.8 Sage Therapeutics
9.9 Seed Health
9.10 Sunovion Pharmaceuticals Inc
9.11 Tilray
10. Dormant Drugs
10.1 Inactive Drugs
10.2 Discontinued Drugs
11. Appendix
List of Tables
Table 1.1 Number of Products under Development by Generalized Anxiety Disorder (GAD)
Table 1.2 Number of Products under Development by Companies
Table 1.3 Products under Development by Companies
Table 1.4 Products by Targets
Table 1.5 Products by Mechanism of Action
Table 1.6 Products by Molecule Type
Table 1.7 Products by Route of Administration
Table 2.1 Clinical Trial Details – Cannabidiol (CBD)/Tilray
Table 2.2 Clinical Trial Details – Ulotaront/Sunovion Pharmaceuticals Inc
Table 2.3 Clinical Trial Details – MM-120/Mind Medicine, Inc.
Table 2.4 Clinical Trial Details – ENX-102/Engrail therapeutics
Table 2.5 Clinical Trial Details – ABBV-932/AbbVie
Table 3.1 Regulatory Designations
Table 4.1 Inactive Drugs
Table 4.2 Discontinued Drugs
List of Figures
Figure 1.1 Number of Products under Development for Generalized Anxiety Disorder (GAD), 2023
Figure 1.2 Products by Top 5 Targets and Stage of Development for Generalized Anxiety Disorder (GAD), 2023
Figure 1.3 Products by Top 5 Mechanism of Action for Generalized Anxiety Disorder (GAD), 2023
Figure 1.4 Products by Top 5 Molecule Type for Generalized Anxiety Disorder (GAD), 2023
Figure 1.5 Products by Top 5 Route of Administration for Generalized Anxiety Disorder (GAD), 2023
Key Players
Report Segmentation
- Assessment by Stage of Development
- Assessment by Companies
- Assessment by Target
- Assessment by Mechanism of Action
- Assessment by Molecule Type
- Assessment by Route of Administration