IGALMI Marks Significant Market Growth, Reaching New Heights in Treatment Accessibility | DelveInsight

With the increasing prevalence of mental health conditions, especially within the schizophrenia and bipolar disorder populations, IGALMI holds strong market potential. The drug's unique sublingual formulation offers a rapid onset of action, which could position it as a valuable option in the behavioral health market.

LAS VEGAS, May 1, 2025 /PRNewswire/ -- DelveInsight's 'IGALMI Market Size, Forecast, and Market Insight Report' highlights the details around IGALMI, a sublingual film formulation of the approved alpha2-adrenergic receptor agonist dexmedetomidine indicated for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults. The report provides product descriptions, patent details, and competitor products (marketed and emerging therapies) of IGALMI. The report also highlights the historical and forecasted sales from 2020 to 2034 segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan].

BioXcel Therapeutics' IGALMI (dexmedetomidine) Overview

IGALMI is the first newly approved acute treatment in over ten years for managing agitation linked to schizophrenia or bipolar disorder. It offers a unique approach to addressing this challenging and often distressing symptom. Agitation frequently occurs in individuals with bipolar I or II disorder or schizophrenia and can be difficult to control. Timely recognition and intervention are critical to prevent the symptom from escalating and leading to aggression. The FDA approved IGALMI based on findings from two key Phase III clinical trials—SERENITY I and SERENITY II—which were randomized, double-blind, placebo-controlled studies assessing its effectiveness in treating agitation in schizophrenia and bipolar disorder, respectively. IGALMI is administered sublingually or buccally. Patients should avoid chewing or swallowing the medication and must refrain from eating or drinking for at least 15 minutes after sublingual use or one hour after buccal use.

Apart from its FDA-approved use as IGALMI sublingual film, BXCL501 is an experimental, proprietary oral film formulation of dexmedetomidine, a selective alpha-2 adrenergic receptor agonist. BioXcel Therapeutics is currently studying BXCL501 for potential use in treating acute agitation related to Alzheimer's dementia, as well as agitation linked to bipolar I or II disorder and schizophrenia in a home setting. These investigational uses have not yet been proven safe or effective. The FDA has granted BXCL501 Breakthrough Therapy designation for agitation associated with dementia and fast-track designation for treating agitation in schizophrenia, bipolar disorders, and dementia.

Learn more about IGALMI projected market sales @ IGALMI Market Potential 

Schizophrenia is a severe mental illness that impacts a person's thinking, emotions, decision-making abilities, and social functioning. It often begins in late adolescence or early adulthood in men and tends to appear later in women, typically in their late 20s to early 30s. Based on DelveInsight's analysis, there were 3.8 million diagnosed prevalent cases of schizophrenia across the 7MM in 2023, with the United States alone accounting for nearly 1.4 million cases.

The mainstay of treatment involves antipsychotic medications that act on dopamine pathways. Second-generation antipsychotics are generally favored due to their reduced risk of serious side effects. Long-acting injectable options can help improve patient adherence and overall outcomes. For individuals with severe or treatment-resistant forms of the disorder, high-dose medications may be necessary. In more critical situations, or when medications are ineffective, hospitalization or electroconvulsive therapy (ECT) may be required.

Several innovative treatments are expected to launch over the forecast period, leading to significant market growth. The schizophrenia market in the 7MM, valued at USD 7.9 billion in 2023, is projected to expand substantially by 2034. This growth will be fueled by increasing awareness and a rising number of cases worldwide.

Discover more about the schizophrenia market in detail @ Schizophrenia Market Report

Emerging Competitors of IGALMI

Several emerging therapies are expected to enter the schizophrenia market and pose strong competition to IGALMI. These include Olanzapine LAI (TEV-'749) from Teva Pharmaceutical/MedinCell/Royalty Pharma, Ulotaront (SEP-363856) from Sunovion Pharmaceutical (Sumitomo Pharma)/Otsuka, Brilaroxazine (RP5063) from Reviva Pharmaceuticals, Roluperidone (MIN-101/MT-210) from Minerva Neurosciences/Mitsubishi Tanabe Pharma, OKEDI/RISVAN (risperidone ISM) from Rovi Pharmaceuticals Laboratories, Valbenazine (NBI-98854) from Neurocrine Biosciences/Mitsubishi Tanabe Pharma, LYN-005 (long-acting oral risperidone) from Lyndra Therapeutics, and Evenamide (NW-3509) from Newron Pharmaceuticals, among others.

To know more about the number of competing drugs in development, visit @ IGALMI Market Positioning Compared to Other Drugs

Key Milestones of IGALMI

• In March 2025, BioXcel Therapeutics, Inc. announced that, after successfully raising $14 million in gross proceeds through equity financing completed on March 4, 2025, it now holds approximately $35 million in cash. This enhanced financial position will help support the ongoing progress of the Company's pivotal Phase III SERENITY At-Home trial. The trial aims to assess the safety of BXCL501—BioXcel's proprietary, orally dissolving film formulation of dexmedetomidine—for the acute treatment of agitation related to bipolar disorders or schizophrenia in a home setting.
• In November 2024, BioXcel Therapeutics, Inc. announced significant clinical and regulatory advancements in its pivotal Phase III trials of BXCL501, targeting the acute treatment of agitation related to bipolar disorders or schizophrenia (SERENITY At-Home) and agitation linked to Alzheimer's dementia (TRANQUILITY In-Care).
• In April 2022, BioXcel Therapeutics, Inc. announced that the FDA had approved IGALMI sublingual film for the acute treatment of agitation in adults with schizophrenia or bipolar I or II disorder.
• In May 2021, BioXcel Therapeutics, Inc. announced that the FDA has accepted for review the New Drug Application for BXCL501—its proprietary investigational orally dissolving thin film formulation of dexmedetomidine—intended for the acute treatment of agitation linked to schizophrenia and bipolar I and II disorders.

Discover how IGALMI is shaping the agitation associated with schizophrenia and bipolar disorder treatment landscape @ IGALMI Approval

IGALMI Market Dynamics

IGALMI is an oromucosal film formulation approved by the FDA for the acute treatment of agitation associated with schizophrenia or bipolar I and II disorders in adults. Market dynamics for IGALMI are influenced by its unique mechanism of action, innovative delivery method, and the unmet need in psychiatric emergency settings. Unlike traditional antipsychotics or benzodiazepines, IGALMI is a selective alpha-2 adrenergic receptor agonist, offering a non-dopaminergic pathway for calming agitation without causing extrapyramidal symptoms or significant sedation, making it an attractive option for clinicians prioritizing patient safety and rapid control.

One of the key drivers of IGALMI's market potential is the increasing prevalence of psychiatric disorders and the rising demand for safe, fast-acting interventions in emergency rooms and inpatient psychiatric units. With agitation being a common symptom leading to hospitalization and often requiring immediate intervention, there is a strong clinical and economic incentive for medications that can be administered quickly and safely without the need for injections or IV access. IGALMI's sublingual film offers ease of administration, particularly valuable in settings where patient cooperation may be limited.

However, IGALMI also faces market challenges. The adoption of new psychiatric treatments often encounters resistance due to ingrained clinical practices, particularly the widespread use of intramuscular antipsychotics and benzodiazepines. Cost considerations and payer coverage will also influence uptake, as IGALMI may be priced higher than generic alternatives. Additionally, some prescribers may remain cautious about alpha-2 agonist side effects like hypotension and bradycardia, especially in medically complex patients.

Strategically, the success of IGALMI hinges on effective provider education, evidence of real-world effectiveness, and strong pharmacoeconomic data demonstrating reduced hospitalizations or restraints. Ongoing post-marketing studies and partnerships with psychiatric institutions could help establish its value proposition more clearly. If these hurdles are addressed successfully, IGALMI has the potential to redefine the standard of care for managing acute agitation in psychiatric populations.

Dive deeper to get more insight into IGALMI's strengths & weaknesses relative to competitors @ IGALMI Market Drug Report

Table of Contents

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