Generalized Anxiety Disorder - Pipeline Insight, 2025

This “Generalized Anxiety Disorder - Pipeline Insight, 2025” report provides comprehensive insights about 12+ companies and 15+ pipeline drugs in Generalized Anxiety 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.

Generalized Anxiety Disorder: Understanding

Generalized Anxiety Disorder: Overview

Generalized Anxiety Disorder (GAD) is a common and often debilitating mental health condition characterized by excessive, uncontrollable worry about a wide range of topics, such as work, health, finances, and social interactions, lasting for six months or more. Unlike occasional worry, GAD involves persistent anxiety that significantly interferes with daily functioning. Individuals with GAD experience physical and psychological symptoms, including restlessness, fatigue, irritability, difficulty concentrating, muscle tension, and sleep disturbances. These symptoms can make it difficult to perform routine tasks, engage in social situations, and meet responsibilities. GAD is often underdiagnosed and undertreated, partly due to its subtle onset and symptom overlap with conditions like depression. It also increases the risk of other health issues, such as depression, suicidal ideation, and cardiovascular events. Primary care physicians play an essential role in diagnosing and managing GAD, with treatment typically involving Cognitive Behavioral Therapy (CBT) and medications like SSRIs and SNRIs to regulate serotonin and norepinephrine levels in the brain.

Generalized Anxiety Disorder (GAD) is a mental health condition marked by persistent and excessive worry about a wide range of everyday issues, often without a clear or realistic cause. This anxiety can significantly impair a person's ability to function in daily life, impacting areas such as work, relationships, and overall well-being. People with GAD often find themselves constantly worrying about events such as work deadlines, social interactions, health, finances, and family matters, even when no immediate threat or danger exists. This worry can become so overwhelming that it interferes with their ability to focus on tasks, make decisions, or enjoy leisure activities. Despite recognizing that their worries are irrational or exaggerated, individuals with GAD have difficulty controlling or stopping these thoughts, which only intensifies the anxiety. Restlessness and irritability are common, and even minor issues can feel intolerable, which may lead to emotional instability and strain relationships. GAD can also cause concentration problems, making it hard to focus on important tasks or remember things, which can result in missed deadlines or mistakes at work or home. In addition to the emotional and mental symptoms, GAD also brings a range of physical symptoms due to the body's constant state of heightened alertness. These may include muscle tension, particularly in the neck, shoulders, and jaw, which can lead to discomfort or tension headaches.

Diagnosing Generalized Anxiety Disorder (GAD) involves a detailed evaluation based on criteria from the DSM-5 and ICD-10, ensuring correct symptom identification, severity assessment, and exclusion of other causes. Core symptoms include excessive, uncontrollable worry lasting more than six months, along with at least three additional symptoms such as restlessness, fatigue, muscle tension, irritability, and difficulty concentrating, all of which impair daily functioning. The diagnosis also requires ruling out other conditions like panic disorder, obsessive-compulsive disorder, or medical issues like hyperthyroidism. A thorough clinical interview, along with tools like the GAD-7 scale, helps assess symptom severity, while differential diagnosis ensures the correct identification of GAD.

The treatment for Generalized Anxiety Disorder (GAD) typically involves a combination of psychotherapy, medication, and lifestyle changes aimed at reducing symptoms and improving overall well-being. Cognitive Behavioral Therapy (CBT) is the most effective psychotherapy for GAD, focusing on identifying and challenging negative thought patterns and behaviors. It helps individuals develop healthier coping mechanisms through techniques like cognitive restructuring and exposure therapy. Acceptance and Commitment Therapy (ACT) is another approach that encourages acceptance of anxiety, helping individuals live according to their values despite the presence of anxiety. Medications, such as antidepressants and anxiolytics, are often used to regulate mood and alleviate anxiety, especially when symptoms are severe or persistent.

'Generalized Anxiety Disorder- Pipeline Insight, 2025' report outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Generalized Anxiety Disorder pipeline landscape is provided which includes the disease overview and Generalized Anxiety Disorder treatment guidelines. The assessment part of the report embraces, in depth Generalized Anxiety 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, Generalized Anxiety 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 Generalized Anxiety Disorder R&D. The therapies under development are focused on novel approaches to treat/improve Generalized Anxiety Disorder.

Generalized Anxiety Disorder Emerging Drugs Chapters

This segment of the Generalized Anxiety 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.

Generalized Anxiety Disorder Emerging Drugs

EXXUA: Fabre-Kramer Pharmaceuticals, Inc.

EXXUA is a 5HT1A partial agonist. This means it is an agonist at the serotonin 1A receptor site but its potency is less than endogenous serotonin. This ability to occupy the 5HT1A receptor sites and have an effect less than that of serotonin allows EXXUA to function as an inhibitor. Inhibition at the 5HT1A site results in anxiolytic activity. A dose higher than the optimal dose would also result in less anxiolytic activity. EXXUA is a significantly stronger anxiolytic than buspirone, with no dopaminergic effects. Currently, the drug is in the Phase III stage of its development for the treatment of Generalized Anxiety Disorder.

MM120: Mind Medicine, Inc.

MM120 orally disintegrating tablet (ODT) is MindMed’s proprietary and pharmaceutically optimized form of Lysergide D-tartrate (LSD). MM120 is a synthetic ergotamine belonging to the group of classic, or serotonergic, psychedelics, which acts as a partial agonist at specific serotonin receptors, causing its distinctive transient perceptual and emotional effects. MM120 increases connections between areas of the brain that aren’t normally connected, enabling changes that could treat depression, anxiety and other brain health disorders. Currently, the drug is in the Phase II stage of its development for the treatment of Generalized Anxiety Disorder.

ABBV-932: AbbVie

ABBV 932 is an investigational small molecule, selective D3 dopamine receptor modulator being investigated for the treatment of bipolar depression and generalized anxiety disorder. Developed in partnership with Gedeon Richter. It functions as a selective modulator of dopamine D2 and D3 receptors, targeting neurological pathways involved in mood and anxiety disorders. Currently, the drug is in the Phase I stage of its development for the treatment of Generalized Anxiety Disorder.

PSY-05: Psy Therapeutics Inc

PSY-05 is a novel therapeutic candidate targeting Generalized Anxiety Disorder (GAD) and Post-Traumatic Stress Disorder (PTSD) being developed by Psy Therapeutics. PSY-05 aims to address the limitations of current GAD treatments, which often suffer from suboptimal efficacy and undesirable side effects. The company positions PSY-05 as a first-in-class solution with a focus on sustained benefits and an improved safety profile. Currently, the drug is in the Preclinical stage of its development for the treatment of Generalized Anxiety Disorder.

Generalized Anxiety Disorder: Therapeutic Assessment

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

Major Players in Generalized Anxiety Disorder

• There are approx. 12+ key companies which are developing the therapies for Generalized Anxiety Disorder. The companies which have their Generalized Anxiety Disorder drug candidates in the most advanced stage, i.e. Phase III include, Fabre-Kramer Pharmaceuticals, Inc.

Phases

The report covers around 15+ 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

Generalized Anxiety 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.

Generalized Anxiety Disorder: Pipeline Development Activities

The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Generalized Anxiety 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 Generalized Anxiety Disorder drugs.

Generalized Anxiety Disorder Report Insights

• Generalized Anxiety Disorder Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

Generalized Anxiety 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 Generalized Anxiety Disorder drugs?
• How many Generalized Anxiety Disorder drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Generalized Anxiety Disorder?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Generalized Anxiety 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 Generalized Anxiety Disorder and their status?
• What are the key designations that have been granted to the emerging drugs?

Key Players

• Fabre-Kramer Pharmaceuticals, Inc.

Luye Pharma Group Ltd.

Otsuka Pharmaceutical Co., Ltd.

Engrail therapeutics

• Intra-Cellular Therapies Inc.

Incannex

• AbbVie
• GABA Therapeutics, Inc

Key Products

• EXXUA
• LY03005
• SEP-363856
• ENX-102
• ITI-1284
• PSX-001
• ABBV 932
• GRX-917

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