CAPLYTA’s Strong Market Adoption Propels Its Rise as a Leading Antipsychotic Therapy | DelveInsight

Intra-Cellular Therapies’ CAPLYTA is making waves in the antipsychotic market, gaining traction as a novel treatment for schizophrenia and bipolar depression. With its differentiated safety profile and broad efficacy, it’s rapidly expanding its market share.

/EIN News/ -- New York, USA, Feb. 21, 2025 (GLOBE NEWSWIRE) -- CAPLYTA’s Strong Market Adoption Propels Its Rise as a Leading Antipsychotic Therapy | DelveInsight

Intra-Cellular Therapies’ CAPLYTA is making waves in the antipsychotic market, gaining traction as a novel treatment for schizophrenia and bipolar depression. With its differentiated safety profile and broad efficacy, it’s rapidly expanding its market share.

DelveInsight’s “CAPLYTA Market Size, Forecast, and Market Insight Report” highlights the details around lumateperone, which is a novel dopamine D3-preferring D3/D2 receptor partial agonist and a 5-HT1A receptor partial agonist medication indicated for the treatment of schizophrenia, bipolar I disorder and major depressive disorder (MDD) in adults. The report provides product descriptions, patent details, and competitor products (marketed and emerging therapies) of CAPLYTA. 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].

Intra-Cellular Therapies’ CAPLYTA (lumateperone) Overview

CAPLYTA (lumateperone), developed by Intra-Cellular Therapies, is an atypical antipsychotic approved in the U.S. for treating schizophrenia in adults and depressive episodes associated with bipolar I or II disorder (bipolar depression). It can be administered as a standalone treatment or in combination with lithium or valproate for bipolar depression.  

Taken orally, CAPLYTA’s exact mechanism of action in schizophrenia and bipolar depression is not fully understood. However, its effectiveness is thought to result from a combination of serotonin 5-HT2A receptor antagonism and postsynaptic dopamine D2 receptor antagonism. 

CAPLYTA generated net product sales of $175.2 million in Q3 2024, reflecting an increase from $125.8 million in the same quarter of 2023. Total prescriptions for CAPLYTA grew by 38% year-over-year in Q3 2024 and rose by 9% compared to Q2 2024. 

CAPLYTA’s efficacy in schizophrenia was evaluated in two placebo-controlled trials. Study 1 (NCT01499563) was a four-week, randomized, double-blind, multicenter trial involving adults diagnosed with schizophrenia under DSM-IV-TR criteria, measuring changes in the PANSS total score at Week 4. Study 2 (NCT02282761) followed a similar design but included patients diagnosed using DSM-5 criteria, with the PANSS total score at Week 4 as the primary efficacy endpoint.

Intra-Cellular Therapies is currently evaluating lumateperone for major depressive disorder as adjunctive therapy, pediatric indications, and a long-acting injectable program for patients with schizophrenia or schizoaffective disorder.

Drug Name	CAPLYTA (lumateperone)
Approved year	US: 2019
Molecule type	Small molecule
Developer	Johnson and Johnson (Intra-Cellular Therapies)
Indication	Schizophrenia; bipolar I or II disorder
Route of administration	Oral
Mechanism of action	Dopamine D2 receptor modulators; Glutamate modulators; Serotonin 5-HT2A receptor antagonists; Serotonin uptake inhibitors

Learn more about CAPLYTA projected market size for schizophrenia and bipolar disorder @ CAPLYTA Market Potential 

Schizophrenia is a serious mental disorder that affects cognition, emotions, decision-making, and social interactions. It typically emerges in late adolescence to early adulthood in men and later, in the late 20s to early 30s, in women. According to DelveInsight’s analysis, there were 3.8 million diagnosed prevalent cases of schizophrenia across the 7MM in 2023, with the US accounting for nearly 1.4 million cases.  

Treatment primarily relies on antipsychotic medications that target dopamine neurotransmitters. Second-generation antipsychotics are preferred due to their lower risk of severe side effects. Long-acting injectable formulations can enhance adherence and improve treatment outcomes. For patients with severe or treatment-resistant schizophrenia, high-dose medication regimens may be beneficial. In cases where medication is ineffective or during acute episodes, hospitalization and electroconvulsive therapy may be necessary.  

Several promising therapies are expected to enter the market during the forecast period. As a result of this, the schizophrenia market size in the 7MM will surge from USD 7.9 billion in 2023 and is projected to grow further by 2034.  Additionally, rising awareness and an increasing prevalence of schizophrenia are likely to drive market expansion in the coming years.

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

Emerging Competitors of CAPLYTA

The schizophrenia market is very crowded and as a result, CAPLYTA will be getting fierce competition from several drugs. In September 2024, the FDA approved Bristol Myers Squibb's COBENFY (xanomeline and trospium chloride) formerly KarXT for treating schizophrenia in adults. COBENFY is the first new schizophrenia medication in decades, uniquely targeting M1 and M4 receptors in the brain without blocking D2 receptors.

Among the emerging therapies, CAPLYTA will get competition from Boehringer Ingelheim’s Iclepertin (BI-425809). Iclepertin is an experimental drug designed to inhibit glycine transporter 1 (GlyT1) and target brain mechanisms associated with cognitive impairment in schizophrenia (CIAS). Dysfunction in glutamatergic signaling, specifically downstream of neuronal NMDA receptors, plays a role in cognitive deficits in this condition. Enhancing NMDA receptor activity may support synaptic plasticity and cognitive function.  

Glycine, a crucial co-agonist for NMDA receptors, is regulated by GlyT-1 and GlyT-2 transporters found in presynaptic and astrocyte membranes. These transporters control glycine levels by facilitating its uptake into nerve terminals and surrounding glial cells, thereby influencing synaptic glycine availability. By inhibiting GlyT-1, BI 425809 aims to elevate glycine levels and enhance NMDA receptor function.  

Administered orally, this selective and potent GlyT1 inhibitor has also been studied for Alzheimer’s disease. However, Phase II trial results in early 2020 did not support further development for that condition. Research efforts are now focused on schizophrenia, with multiple Phase III trials in progress.  

Since schizophrenia patients often overlook cognitive symptoms, there are currently no approved pharmacotherapies for CIAS. If approved, BI 425809 would become the first treatment specifically targeting cognitive impairment in schizophrenia.

Various potential therapies that are projected to enter the schizophrenia market and give tough competition to CAPLYTA include Teva Pharmaceutical/MedinCell/Royalty Pharma’s Olanzapine LAI (TEV-‘749), Sunovion Pharmaceutical (Sumitomo Pharma)/Otsuka’s Ulotaront (SEP-363856), Reviva Pharmaceuticals’ Brilaroxazine (RP5063), Minerva Neurosciences/Mitsubishi Tanabe Pharma’s Roluperidone (MIN-101/MT-210), Rovi Pharmaceuticals Laboratories’ (Laboratorios Farmacéuticos Rovi) OKEDI/RISVAN (risperidone ISM), Neurocrine Biosciences/Mitsubishi Tanabe Pharma’s Valbenazine (NBI-98854), Lyndra Therapeutics’ LYN-005 (long-acting oral risperidone), and Newron Pharmaceuticals’ Evenamide (NW-3509), among others.

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

Key Milestones of CAPLYTA

• In January 2025, Intra-Cellular Therapies and Johnson & Johnson reached a definitive agreement, under which Johnson & Johnson would acquire all outstanding shares of Intra-Cellular Therapies for USD 132.00 per share, totaling an equity value of around USD 14.6 billion.
• In January 2025, Intra-Cellular Therapies settled patent litigation with Sandoz over CAPLYTA, allowing Sandoz to sell a generic version starting in July 2040, or earlier under certain conditions. The settlement will be submitted to the US Federal Trade Commission and the US Department of Justice. Similar patent disputes are still pending in the US District Court for the District of New Jersey.
• In December 2024, Intra-Cellular Therapies announced its presentations at the 63rd Annual Meeting of the American College of Neuropsychopharmacology (ACNP), showcasing new analyses on the efficacy, safety, and tolerability from its pivotal CAPLYTA adjunctive treatment program for MDD.
• In December 2024, Intra-Cellular Therapies submitted a supplemental New Drug Application (sNDA) to the US FDA for CAPLYTA, seeking approval for its use as adjunctive therapy to antidepressants in the treatment of MDD in adults.
• In December 2021, the US FDA approved CAPLYTA for the treatment of depressive episodes associated with bipolar I or II disorder in adults, both as monotherapy and as an adjunctive treatment with lithium or valproate.
• In December 2019, the US FDA approved CAPLYTA for the treatment of schizophrenia in adults.

Discover how CAPLYTA is shaping the schizophrenia and bipolar disorder treatment landscape @ CAPLYTA Schizophrenia

CAPLYTA Patent Details

Intra-Cellular Therapies own or control approximately 39 patent families for lumateperone, covering various salt forms, polymorphs, formulations, and new indications. As of February 2024, it holds 56 issued US patents and 240 foreign patents, with protection extending through 2043 for certain indications. 

CAPLYTA Market Dynamics

CAPLYTA's excellent safety profile and effectiveness make it a preferred choice for patients with mood disorders, especially those experiencing side effects from other treatments. Ongoing clinical trials for its use as an adjunctive treatment for major depressive disorder could significantly expand its total addressable market and annual sales forecasts. 

The rising prevalence of schizophrenia and bipolar disorder, along with the demand for better-tolerated treatments, supports its market growth. Increased insurance coverage and favorable reimbursement policies could enhance patient access and drive sales, while growing awareness among psychiatrists and general practitioners may expand its adoption beyond the initial prescriber base. Additionally, as a newer entrant with a differentiated mechanism of action compared to some legacy medications, CAPLYTA is well-positioned for continued uptake.

However, the company remains highly reliant on CAPLYTA, making it vulnerable to market fluctuations and competitive pressures, while the expiration of patent protections could lead to the introduction of generic versions that may significantly impact sales and market share. Additionally, the high cost of branded psychiatric medications could limit adoption, particularly in markets with stringent cost-containment measures. Uncertainty in the approval process for new indications, such as adjunctive MDD treatment, may further delay market expansion. 

Although CAPLYTA has a strong tolerability profile, emerging safety concerns or long-term side effects could hinder prescribing trends. Furthermore, competition from existing atypical antipsychotics and new pipeline therapies with potentially superior efficacy or safety, along with limited awareness among healthcare providers and patients regarding CAPLYTA’s benefits and differentiators, may further challenge its adoption and market position.

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

Table of Contents

1	Report Introduction
2	CAPLYTA (lumateperone): Johnson and Johnson (Intra-Cellular Therapies)
2.1	Product Overview
2.2	Other Development Activities
2.3	Clinical Development
2.4	Clinical Trials Information
2.5	Safety and Efficacy
2.6	Product Profile
2.7	Market Assessment
2.7.1	The 7MM Analysis
2.7.1.1	Cost Assumptions and Rebate
2.7.1.2	Pricing Trends
2.7.1.3	Analogue Assessment
2.7.1.4	Launch Year and Therapy Uptake
2.7.2	The United States Market Analysis
2.7.3	EU4 and the United Kingdom Market Analysis
2.7.3.1	Germany
2.7.3.2	France
2.7.3.3	Italy
2.7.3.4	Spain
2.7.3.5	UK
2.7.4	Japan Market Analysis
2.8	Market Drivers
2.9	Market Barriers
2.10	SWOT Analysis
3	Key Cross of Marketed Competitors of CAPLYTA
4	Key Cross of Emerging Competitors of CAPLYTA

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