The recent approval of Axsome Therapeutics' AUVELITY has transformed the agitation in Alzheimer's disease market. The emergence of investigational therapies, including IGC-AD1 (IGC Pharma), Masupirdine (SUVN-502) (Suven Life Sciences), EXV-801 ± Dextromethorphan (Exciva GmbH), COBENFY (KarXT; xanomeline-trospium chloride) (Bristol Myers Squibb/Karuna Therapeutics), and others, is also transforming the agitation in Alzheimer's disease treatment landscape through novel and diverse mechanisms of action. These advancing therapies are anticipated to broaden available treatment choices and support the ongoing evolution of the market.
LAS VEGAS, June 11, 2026 /PRNewswire/ -- Recently published Agitation in Alzheimer's Disease Market Insights report includes a comprehensive understanding of current treatment practices, agitation in Alzheimer's disease emerging drugs, market share of individual therapies, and current and forecasted market size from 2022 to 2036, segmented into leading markets [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan].
Agitation in Alzheimer's Disease Market Summary
- The market size for agitation in Alzheimer's disease was found to be USD 600 million in the 7MM in 2025.
- The United States accounted for the largest agitation in Alzheimer's disease treatment market size, approximately 83% of the total market size in the 7MM in 2025, compared to other major markets, including the EU4 countries (Germany, France, Italy, and Spain), the United Kingdom, and Japan.
- The total number of diagnosed cases of agitation in alzheimer's in the 7MM is ~11 million in 2025.
- Leading agitation in Alzheimer's disease companies, such as IGC Pharma, Suven Life Sciences, Exciva GmbH, Bristol Myers Squibb, Karuna Therapeutics, and others, are developing new agitation in Alzheimer's disease treatment drugs that can be available in the agitation in Alzheimer's disease market in the coming years.
- The promising agitation in Alzheimer's disease therapies in clinical trials include IGC-AD1, Masupirdine (SUVN-502), EXV-801 ± Dextromethorphan, COBENFY (KarXT; xanomeline-trospium chloride), and others.
Discover what is the future of the agitation in Alzheimer's disease treatment market @ https://www.delveinsight.com/report-store/agitation-in-alzheimer-disease
Key Factors Driving the Growth of the Agitation in Alzheimer's Disease Market
- Rising Prevalence of Alzheimer's Disease: The increasing global burden of Alzheimer's disease is directly contributing to a larger patient pool experiencing agitation symptoms. In 2025, the total number of diagnosed cases of agitation in Alzheimer's disease in the 7MM was around 11 million. Among the 7MM countries, the US accounted for the highest number of diagnosed prevalent cases of Alzheimer's disease, contributing around 49%, while the UK reported the lowest number of cases in 2025.
- Increasing Awareness and Early Diagnosis: Growing awareness among caregivers, physicians, and healthcare organizations is improving recognition of neuropsychiatric symptoms in Alzheimer's disease.
- Entry of Axsome Therapeutics' AUVELITY: In April 2026, Axsome Therapeutics secured FDA approval for AUVELITY to treat agitation associated with Alzheimer's-related dementia, making it the first oral non-antipsychotic therapy approved for this indication. The approval was backed by the Phase 3 ADVANCE-1 and ACCORD-2 trials. Previously approved in 2022 for MDD, the label expansion significantly enhances AUVELITY's therapeutic and commercial potential.
- Emergence of Novel Therapies: The dynamics of the agitation in Alzheimer's disease market are expected to change in the coming years due to the launch of emerging therapies such as IGC-AD1 (IGC Pharma), Masupirdine (SUVN-502) (Suven Life Sciences), EXV-801 ± Dextromethorphan (Exciva GmbH), COBENFY (KarXT; xanomeline-trospium chloride) (Bristol Myers Squibb/Karuna Therapeutics), and others.
Ramandeep Singh, a neurology expert at DelveInsight, said that with increasing clinical and commercial momentum, the space is poised for substantial evolution, and by 2036, COBENFY is expected to emerge as the leading revenue-generating therapy across the 7MM for this indication.
Agitation in Alzheimer's Disease Market Analysis
- Despite the immense burden of disease, the treatment landscape for agitation in Alzheimer's disease has long relied more on clinical improvisation than targeted therapeutic precision.
- Real-world prescribing patterns show that atypical antipsychotics account for the majority of treatments (55.5% of prescriptions), followed by selective serotonin reuptake inhibitors (SSRIs) at 29.3% and benzodiazepines at 23.2%, all prescribed off-label for this indication.
- Agents such as risperidone, quetiapine, olanzapine, and haloperidol have traditionally formed the backbone of management strategies, despite lacking formal approval for agitation in AD. Their widespread use has been accompanied by significant safety concerns, including sedation, falls, metabolic complications, cardiovascular risks, and notably, increased mortality among elderly patients.
- A major breakthrough came in 2023, when REXULTI (brexpiprazole), jointly developed by Otsuka Pharmaceutical and Lundbeck, became the first FDA-approved therapy specifically indicated for agitation associated with Alzheimer's dementia.
- Momentum in the field accelerated further in late April 2026, when Axsome Therapeutics secured FDA approval for AUVELITY (dextromethorphan hydrobromide/bupropion hydrochloride) for agitation associated with dementia due to Alzheimer's disease. The approval marked a significant milestone, making AUVELITY the first oral non-antipsychotic therapy approved for this condition.
- The emergence of AUVELITY represents more than a single product approval; it signals an increasingly competitive and innovation-driven market. Several promising candidates are advancing through the pipeline, including IGC-AD1 (IGC Pharma), Masupirdine (SUVN-502) (Suven Life Sciences), EXV-801 ± Dextromethorphan (Exciva GmbH), and COBENFY (KarXT; xanomeline-trospium chloride) from Bristol Myers Squibb/Karuna Therapeutics, among others.
Agitation in Alzheimer's Disease Competitive Landscape
Some of the agitation in Alzheimer's disease drugs under development include IGC-AD1 (IGC Pharma), Masupirdine (SUVN-502) (Suven Life Sciences), EXV-801 ± Dextromethorphan (Exciva GmbH), COBENFY (KarXT; xanomeline-trospium chloride) (Bristol Myers Squibb/Karuna Therapeutics), and others.
IGC Pharma's IGC-AD1 (melatonin/tetrahydrocannabinol) is an investigational combination therapy for agitation linked to Alzheimer's disease. By integrating THC with melatonin, the therapy is designed to influence neuroinflammatory pathways, neuronal communication, and circadian rhythm regulation, to alleviate agitation and improve behavioral outcomes in patients who currently have limited therapeutic options.
Suven Life Sciences' Masupirdine, a selective 5-HT6 receptor antagonist, represents a non-dopaminergic strategy aimed at stabilizing symptoms through serotonin pathway modulation. Its global Phase III study had reached nearly 50% enrollment by November 2025, and topline findings are expected in Q1/Q2 2027.
Meanwhile, Bristol Myers Squibb/Karuna Therapeutics' COBENFY, which has already generated significant interest in schizophrenia treatment, is being explored for agitation in Alzheimer's disease via muscarinic receptor modulation, offering a cholinergic mechanism that may also support cognitive function.
Exciva GmbH's EXV-802, an advanced Phase II/III neuroactive therapy candidate under investigation both as a standalone treatment and in combination with EXV-801 to address multiple CNS signaling pathways associated with agitation. This reflects an industry-wide move toward multi-target and combination-based therapeutic strategies intended to enhance efficacy while maintaining functional tolerability in complex neurobehavioral conditions. In November 2024, EXV-802 also received Fast Track Designation from the US FDA for the treatment of agitation associated with Alzheimer's disease.
The anticipated launch of these emerging therapies are poised to transform the agitation in Alzheimer's disease market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the agitation in Alzheimer's disease market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth.
Discover more about which pipeline drugs could transform agitation in Alzheimer's disease treatment @ Agitation in Alzheimer's Disease Drugs
Recent Developments in the Agitation in Alzheimer's Disease Market
- In April 2026, Axsome Therapeutics, Inc. announced that the FDA had approved AUVELITY for managing agitation linked to dementia caused by Alzheimer's disease. AUVELITY becomes the first treatment of its kind for Alzheimer's-related agitation, acting through modulation of the NMDA and sigma-1 receptors.
- In February 2026, IGC Pharma reported that approximately 70% of the planned enrollment in its ongoing randomized, double-blind, placebo-controlled Phase II CALMA trial evaluating IGC-AD1 for agitation associated with Alzheimer's disease had been completed.
- In November 2025, Suven Life Sciences reported that its global Phase III clinical trial of masupirdine (SUVN-502) achieved 50% patient enrollment for agitation in Alzheimer's disease, with the multicenter, randomized, double-blind, placebo-controlled study ongoing across North America and Europe.
What is Agitation in Alzheimer's Disease?
Agitation in Alzheimer's disease refers to a cluster of behavioral and emotional symptoms characterized by excessive restlessness, irritability, aggression, emotional distress, or inappropriate verbal and physical behaviors that occur in individuals with Alzheimer's-related dementia. It is one of the most common neuropsychiatric manifestations of the disease and can include pacing, shouting, resistance to care, wandering, verbal outbursts, or physical aggression. Agitation often arises from a combination of cognitive decline, impaired communication, environmental stressors, unmet physical or emotional needs, and underlying neurobiological changes associated with disease progression. These symptoms can significantly impair quality of life, increase caregiver burden, accelerate institutionalization, and complicate disease management, making agitation a major clinical challenge in Alzheimer's disease care.
Agitation in Alzheimer's Disease Epidemiology Segmentation
The agitation in Alzheimer's disease epidemiology section provides insights into the historical and current agitation in Alzheimer's disease patient pool and forecasted trends for the leading markets. According to DelveInsight's estimates, in the United States, diagnosed cases of agitation in Alzheimer's disease are predominantly made up of females, accounting for ~3 million cases in 2025.
The agitation in Alzheimer's disease treatment market report proffers epidemiological analysis for the study period 2022-2036 in the leading markets, segmented into:
- Total Diagnosed Prevalent Cases of Alzheimer's Disease.
- Total Diagnosed Prevalent Cases of Agitation in Alzheimer's disease.
- Gender-specific Diagnosed Prevalent Cases of Agitation in Alzheimer's disease.
- Age-specific Diagnosed Prevalent Cases of Agitation in Alzheimer's disease.
- Total Treated Cases of Agitation in Alzheimer's Disease
Agitation in Alzheimer's Disease Market Report Metrics | Details |
Study Period | 2022-2036 |
Coverage | 7MM [The United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]. |
Agitation in Alzheimer's Disease Market CAGR | 14.9 % |
Agitation in Alzheimer's Disease Market Size in 2025 | USD 600 Million |
Key Agitation in Alzheimer's Disease Companies | IGC Pharma, Suven Life Sciences, Exciva GmbH, Bristol Myers Squibb, Karuna Therapeutics, Otsuka Pharmaceutical, Lundbeck, Axsome Therapeutics, and others |
Key Agitation in Alzheimer's Disease Therapies | IGC-AD1, Masupirdine (SUVN-502), EXV-801 ± Dextromethorphan, COBENFY (KarXT; xanomeline-trospium chloride), REXULTI, AUVELITY, and others |
Scope of the Agitation in Alzheimer's Disease Market Report
- Agitation in Alzheimer's Disease Patient Population Forecast
- Agitation in Alzheimer's Disease Therapeutics Market Size
- Agitation in Alzheimer's Disease Pipeline Analysis
- Agitation in Alzheimer's Disease Market Size and Trends
- Agitation in Alzheimer's Disease Market Opportunity
- Agitation in Alzheimer's Disease Market Unmet Needs
- KOL's Views on Agitation in Alzheimer's Disease
- Agitation in Alzheimer's Disease Market Access and Reimbursement
Download the report to understand the top emerging therapies in agitation in Alzheimer's disease @ Agitation in Alzheimer's Disease Market Analysis
Table of Contents
1 | Agitation in Alzheimer's Disease Market Key Insights |
2 | Agitation in Alzheimer's Disease Market Report Introduction |
3 | Agitation in Alzheimer's Disease Market Overview at a Glance |
3.1 | Market Share (%) Distribution of Agitation in Alzheimer's Disease by Therapies in the 7MM in 2025 |
3.2 | Market Share (%) Distribution of Agitation in Alzheimer's Disease by Therapies in the 7MM in 2036 |
4 | Executive Summary |
5 | Key Events |
5.1 | Key Transactions and Collaborations |
5.2 | News Flow |
6 | Disease Background and Overview |
6.1 | Introduction |
6.2 | Type and Severity |
6.3 | Etiology |
6.4 | Risk Factors |
6.5 | Signs and Symptoms |
6.6 | Common Manifestations of Agitation |
6.7 | Pathophysiology |
6.8 | Diagnosis |
6.9 | Treatment and Management |
6.10 | Diagnosis and Treatment Guidelines |
7 | Epidemiology and Market Forecast Methodology |
8 | Epidemiology and Patient Population |
8.1 | Key Findings |
8.2 | Assumptions and Rationale: The 7MM |
8.2.1 | Diagnosed Prevalent Cases of Alzheimer's Disease |
8.2.2 | Diagnosed Prevalent Cases of Agitation in Alzheimer's Disease |
8.2.3 | Gender-specific Diagnosed Prevalent Cases |
8.2.4 | Age-specific Diagnosed Prevalent Cases |
8.2.5 | Total Diagnosed Prevalent Cases of Agitation in Alzheimer's Disease in the 7MM |
8.3 | The US |
8.3.1 | Total Diagnosed Prevalent Cases of Alzheimer's Disease in the US |
8.3.2 | Total Diagnosed Prevalent Cases of Agitation in Alzheimer's Disease in the US |
8.3.3 | Gender-specific Diagnosed Prevalent Cases of Agitation in Alzheimer's Disease in the US |
8.3.4 | Age-specific Diagnosed Prevalent Cases of Agitation in Alzheimer's Disease in the US |
8.3.5 | Total Treated Cases of Agitation in Alzheimer's Disease in the US |
8.4 | EU4 and the UK |
8.5 | Japan |
9 | Patient Journey |
10 | Marketed Agitation in Alzheimer's Disease Therapies |
10.1 | Brexpiprazole (REXULTI): Otsuka Pharmaceutical/Lundbeck |
10.1.1 | Product Description |
10.1.2 | Regulatory Milestones |
10.1.3 | Other Developmental Activities |
10.1.4 | Summary of Pivotal Trials |
10.1.5 | Analyst Views |
10.2 | AUVELITY: Axsome Therapeutics |
The list will be continued in the final report.. | |
11 | Emerging Agitation in Alzheimer's Disease Drugs |
11.1 | Competitive Landscape: Emerging Drugs |
11.2 | IGC-AD1: IGC Pharma |
11.2.1 | Drug Description |
11.2.2 | Other Developmental Activities |
11.2.3 | Clinical Development Activity |
11.2.4 | Safety and Efficacy |
11.2.5 | Analyst Views |
11.3 | Masupirdine (SUVN-502): Suven Life Sciences |
11.4 | EXV-801 ± Dextromethorphan: Exciva GmbH |
11.5 | COBENFY (KarXT; xanomeline-trospium chloride): Bristol Myers Squibb/Karuna Therapeutics |
The list will be continued in the final report.. | |
12 | Agitation in Alzheimer's Disease Market - The 7MM Market Analysis |
12.1 | Key Findings |
12.2 | Key Agitation in Alzheimer's Disease Market Forecast Assumptions |
12.3 | Market Outlook |
12.4 | Conjoint Analysis |
12.5 | Market Size of Agitation in Alzheimer's Disease in the 7MM |
12.6 | Market Size of Agitation in Alzheimer's Disease by Therapies in the 7MM |
12.7 | The United States Agitation in Alzheimer's Disease Market Size |
12.7.1 | Total Market Size of Agitation in Alzheimer's Disease in the US |
12.7.2 | Market Size of Agitation in Alzheimer's Disease by Therapies in the US |
12.8 | EU4 and the UK Agitation in Alzheimer's Disease Market Size |
12.9 | Japan Agitation in Alzheimer's Disease Market Size |
13 | Key Opinion Leaders' Views |
14 | Unmet Needs |
15 | SWOT Analysis |
16 | Market access and reimbursement |
16.1 | The United States |
16.2 | EU4 and the UK |
16.3 | Japan |
16.4 | Market Access and Reimbursement of Agitation in Alzheimer's Disease Therapies |
17 | Bibliography |
18 | Agitation in Alzheimer's Disease Market Report Methodology |
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