This is a sequential multiple assignment randomized trial for adults (ages > 18) with a bipolar disorder type 1 diagnosis currently experiencing a depressive episode. It is a randomized pragmatic trial that will compare four commonly prescribed treatments for bipolar depression, which includes three FDA-approved medications (Cariprazine, Quetiapine and Lurasidone) and one antipsychotic/antidepressant combination (Aripiprazole/Escitalopram).

Start Date01 Sep 2024

Sponsor / Collaborator

The General Hospital Corp.

[+1]

ChiCTR2400086634

/ SuspendedEarly Phase 1IIT

Clinical study of lurasidone combined with SSRIs in the treatment of refractory obsessive-compulsive disorder

Start Date08 Jul 2024

Sponsor / Collaborator-

NCT06328140

/ Not yet recruitingNot ApplicableIIT

Sleep Quality, Cognitive Performance, and Computerized Cognitive Training Comparison of Patients Treated With Lurasidone vs.Patients With Major Depression Receiving Selective Serotonin Reuptake Inhibitor(SSRI) Treatment as Usual

Poor sleep quality is common in neuropsychiatric conditions and some of the problems associated with poor sleep at night may be due to medication side effects or reduced efficacy of certain treatments. Poor sleep quality has been implicated in cognitive impairments, with the sleep quality to cognition association so strong that specialized assessments have been developed to examine the subjective association between poor nighttime sleep and daytime cognitive impairment.
Computerized cognitive training (CCT) is a training procedure designed to build cognitive skills, with a goal of improvement of functional outcomes. CCT is also a learning-based approach and previous studies have shown that successful CCT interventions lead to changes in brain circuitry. It is also known, however, that many cases who are treated with CCT fail to make treatment-related gains. Recent studies have suggested that this may be associated with failures to engage in the training procedures, which could be related to sleep related impairments.
Increased anticholinergic load can also substantially disrupt the process of training related gains directly. Antihistaminergic effects, common to many antidepressant and antipsychotic medications, can lead to daytime sedation and sleepiness, which both interferes with treatment but also interferes with nighttime sleep as well
In previous clinical trials, Lurasidone was associated with reductions in sleepiness and with cognitive gains that exceeded practice effects. One viable hypothesis is that Lurasidone has both direct beneficial effects on cognition and substantial indirect benefits, due to the lack of histamine receptor occupancy, lack of anticholinergic effects, and direct promotion of positive nighttime sleep outcomes.
Thus, a broad-spectrum naturalistic comparison of Lurasidone-treated patients with patients treated with other medications is proposed. This would include examining the level of engagement in CCT treatment, measurement of CCT training gains, and relating engagement and training gains with concurrent sleep quality, measured by actigraphy.

Start Date15 Apr 2024

Sponsor / Collaborator

Sumitomo Pharma America, Inc.

100 Clinical Results associated with Lurasidone Hydrochloride

100 Translational Medicine associated with Lurasidone Hydrochloride

100 Patents (Medical) associated with Lurasidone Hydrochloride

930

Literatures (Medical) associated with Lurasidone Hydrochloride

01 Apr 2025·NEUROPHARMACOLOGY

Restorative properties of chronic lurasidone treatment on emotional dysfunction in rats exposed to chronic unavoidable stress: A role for medial prefrontal cortex - nucleus accumbens network

Article

Author: Riva, Marco Andrea ; Scheggi, Simona ; Corridori, Eleonora ; Gambarana, Carla ; Begni, Veronica ; Salviati, Sara ; Marchesin, Alessia

Anhedonia, a transdiagnostic symptom prevalent in depressive and psychotic disorders, poses a significant challenge for pharmacological intervention due to its association with impaired motivation. Understanding how psychotropic drugs can modulate this pathological domain and elucidating the molecular mechanisms underlying such effects are crucial endeavors in psychiatric research. In this study, we aimed to investigate the pro-motivational properties of lurasidone in a rat (Sprague Dawley males) model of anhedonia and to unravel the interplay between lurasidone and the brain regions critical for reward processing. Exposure to unpredictable chronic stress (UCS) led to a marked reduction in motivation, a deficit that was restored by lurasidone treatment at 3 mg/kg, but not at 10 mg/kg. Interestingly, the stress-induced decrease in reactivity to negative stimuli was reversed by both doses of lurasidone. At the molecular level, stressed animals exhibited reduced expression of neuroplastic markers, that was increased following lurasidone administration. Furthermore, UCS exposure impaired the activation of the medial prefrontal cortex (mPFC) and nucleus accumbens (NAc) in response to hedonic stimuli, an effect amended by lurasidone treatment. Additionally, lurasidone restored the impaired phosphorylation of DARPP-32, a key regulator of dopamine signaling, in mPFC and NAc of UCS rats exposed to a hedonic stimulus. These findings underscore the potential of lurasidone in improving various psychopathological domains, like impaired motivation and emotional reactivity, core elements contributing to the disability associated with mental disorders. These effects highlight the therapeutic potential of lurasidone in addressing the intricate behavioral and neurochemical alterations associated with anhedonia and related mood disorders.

01 Apr 2025·PHARMACOGENOMICS JOURNAL

Genetic markers of early response to lurasidone in acute schizophrenia

Article

Author: Meltzer, Herbert Y ; Yoshikawa, Akane ; Alliey-Rodriguez, Ney ; Li, Jiang

Prediction of treatment response by genetic biomarkers has potential for clinical use and contributes to the understanding of pathophysiology and drug mechanism of action. The purpose of this study is to detect genetic biomarkers possibly associated with response to lurasidone, during the first four weeks of treatment. One-hundred and seventy-one acutely psychotic patients from two placebo-controlled clinical trials of lurasidone were included. Genetic associations with changes in Positive and Negative Syndrome Scale total score at weeks one, two, and four were examined. Genotyping was done with the Affymetrix 6.0 microarray and associations were computed using PLINK regression model. Although genome-wide significance was not reached with a limited sample size, signals of potential interest for further studies were with genes important for neurogenesis. Possible week one marker, rs6459950 (p = 7.05 × 10^-7), was close to the sonic hedgehog gene (SHH), involved in neuronal differentiation and neurogenesis. Possible week two marker, rs7435958, was a SNP of GABRB1, encoding the GABA_A Receptor β1. Notably, possible week four signals included a SNP within PTCH1, a specific receptor for the SHH, the possible week one marker. Pathway analysis supported the possibility that neurogenesis might be involved in early antipsychotic response. Tissue enrichment analysis suggested that potential signals were enriched in anterior cingulate cortex, reported to be relevant in antipsychotic action. This is the first study to examine genes possibly associated with very early response to lurasidone. Further replication studies in larger sample size should be required.

01 Mar 2025·PSYCHIATRY AND CLINICAL NEUROSCIENCES

Second‐generation antipsychotic‐induced dystonia: Analysis using the Japanese Adverse Drug Event Report (JADER) database

Article

Author: Ebina, Takumi ; Iwamoto, Kunihiro ; Ikeda, Masashi ; Ando, Masahiko

Aim:

This study aimed to explore the comparative risks for dystonia among different second‐generation antipsychotics (SGAs), the influence of sex, and the relationship between the time‐to‐onset of dystonia and its outcomes.

Methods:

We analyzed data from the Japanese Adverse Drug Event Report database from April 2004 to November 2023. Cases involving oral SGAs, excluding clozapine, were extracted. We used the odds ratios to assess the reporting proportions among SGAs and sex, analyzed the median time‐to‐onset and interquartile ranges (IQRs), and conducted a receiver operating characteristic (ROC) curve analysis to investigate the time‐to‐onset of dystonia and its relationship to outcomes.

Results:

We extracted 9837 cases involving oral SGAs. Lurasidone was associated with a significantly higher proportion of dystonia reports than risperidone, aripiprazole, quetiapine, and olanzapine. The reporting proportion of dystonia associated with aripiprazole was lower than that of paliperidone and risperidone, but higher than that of quetiapine and olanzapine. Female sex was significantly associated with a higher reporting proportion of dystonia compared with males. Among the 148 cases of oral SGA‐induced dystonia, the median time‐to‐onset was 125 days (IQR, 19.75–453.25 days). Divided into the three outcome groups (recovered, improved, and unrecovered/residual), those with better outcomes had a shorter time‐to‐onset than those with poorer outcomes. ROC curve analysis suggested a threshold of 91.5 days for discriminating outcomes, with a sensitivity of 71.7% and specificity of 69.9%.

Conclusions:

The risks of dystonia may vary among SGAs and between sexes. SGA‐induced dystonia often manifests in the tardive form.

News (Medical) associated with Lurasidone Hydrochloride

11 Feb 2025

·medcitynews.com

RxSaveCard Wants to Redesign Pharmacy Benefits to Make Prescription Drugs Cheaper for Employers - MedCity News

presented by As healthcare costs rise, prescription drugs can be one of the costliest aspects of the healthcare experience. In an interview, RxSaveCard CEO and Founder Chris Crawford talked about his new business and its mission to bring down the cost of prescription medication. Crawford’s background is in employer benefits consulting, starting with Mercer. He later launched his own consulting business before Cottingham & Butler acquired it in 2015. Since then, Crawford has worked as a chief growth officer with pharmacy benefit consulting firms HealthStrategy and VIVIO before launching RxSaveCard last year. The rising costs of prescription drug spend “The rising cost of healthcare particularly impacts self-insured employers and they’re looking for ways to pare down healthcare costs. Prescription drugs are the most used employee benefit,” Crawford observed. Emerging technologies such as cell and gene therapies have come to market with hefty price tags, but the groups of patients who use them are relatively small. “On the other hand, the rise of GLP-1 drugs to treat obesity, considered a chronic condition, means these medications costing $11,000 to $13,000 are in high demand,” Crawford said. “Only 18% of employers with 200+ employees are currently able to cover GLP-1s due to the high cost, even though approximately 35% to 45% of employees could be prescribed one of these medications.” Crawford explained that pharmacy benefit managers (PBMs) compound the problem, as they make money by marking up the cost of drugs (known as “spread pricing”), often making drugs more expensive with insurance. He founded RxSaveCard because drug prescriptions often cost less when individuals use cash instead of insurance to pay for them. Chris Crawford How it works Working in collaboration with retail pharmacies, Mark Cuban’s Cost Plus Drugs and other pharmacy partners, RxSaveCard helps employers access cash prices at over 65,000 pharmacies without changing their PBM. The rise and influence of the three major PBMs, each aligned with an insurer, is tough to counter. Critics are vexed by the lack of transparency by PBMs. Although a new generation of PBMs tend to be smaller and more transparent, their market share is less than 10%, according to Crawford. “Ninety percent of employers do business with the major PBMs. That’s not changing anytime soon,” Crawford acknowledged. “We’re not asking employers to change their relationships. RxSaveCard is a much-needed companion to the employer’s PBM.” RxSaveCard is accomplishing this through an innovative payment model. Employers decide the pharmacies where they would like the RxSaveCard to be authorized to purchase prescriptions for their employees. They control how much they want to contribute towards each prescription and how often. There is no pre-funding required of the cards, so employers only spend money when the RxSaveCard is used to purchase lower-cost drugs. The card gives employees the power to find the lowest prices on their medications at pharmacies, including online programs like Mark Cuban’s Cost Plus Drugs, according to the company’s website. At the pharmacy counter, the RxSaveCard instantly compares the cash price from multiple discount cards, ensuring the lowest cost. Employees receive lower out-of-pocket costs, in many cases getting their prescriptions for free. Case studies Crawford offered some use cases to illustrate how the card works. In one scenario, an employee diagnosed with bipolar disorder relies on Lurasidone (Latuda) to manage his symptoms. The cost of his medication through his employer’s PBM is $1,664.77 for a 90-day supply. Of that, the employee paid $332.95 out-of-pocket, while his employer covered $1,331.82. This same exact drug costs $23.50 with RxSaveCard. His employer saves $1,308.32 per fill ($5,233 annually), while the employee saves $332.95 per 90-day fill — saving $1,331 in a year. This reduced financial burden allows the employee to focus on his health without the stress of being able to afford his medication. In another scenario, an employee actively battling cancer relies on an oral medication, Imatinib (Gleevac), as part of his treatment. While dealing with the challenges of cancer, a 30-day supply of his medication costs $6,067.69 through his employer’s PBM. Of that, the employee paid $1,213.54 out-of-pocket, while his employer covered $4,854.15. With RxSaveCard, the total cost of the drug is just $13.18 through Cost Plus Drugs. His employer pays $13.18 and the employee gets his cancer medication for free. “When things are run through insurance, you are often shielded from the true costs of what drugs such as insulin are while there are discount cards that let you buy insulin for $35 — so our view is this should be the market price for it,” Crawford said. “When things run through a PBM, [the PBMs] make money by adding costs to the drug. I think what we’ve seen with this emergence of the cash marketplace is if you take the middleman out and just allow pharmacies to sell directly to consumers at that cash price, that’s often where you see things being less expensive.” Picture:

14 Nov 2024

·www.prnewswire.com

NRx Pharmaceuticals (NASDAQ:NRXP) Reports Third Quarter and Year to Date 2024 Financial Results and Provides Business Update

On track to file New Drug Applications (NDAs) for NRX-100 (IV Ketamine) in treating suicidal ideation in depression, including bipolar depression and NRX-101 (Oral D-Cycloserine/Lurasidone) for Accelerated Approval in bipolar depression with suicidality or akathisia by year end 2024 with 2025 PDUFA date forecast. HOPE Therapeutics acquiring Interventional Psychiatry Clinics; key to developing a best-in-class network of care to prevent suicide, continues to expect first revenue by year-end 2024. 74% reduction in net operating losses compared to 3rd quarter 2023 with profitability forecast in 2025 from HOPE Therapeutics and from sales of medication. Management to host a conference call November 18, 2024 at 4:30 PM ET WILMINGTON, Del., Nov. 14, 2024 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", the "Company"), a clinical-stage biopharmaceutical company, today announced its financial results for the quarter and year to date ended September 30, 2024 and provided a business update. Key Clinical and Business Activities Continue Reading Akathisia rating by study day: A consistent effect is seen commencing at the first post-randomization visit and continued throughout the study (Mixed Model Repeated Measures Regression Effect size =.37; P=0.025). HOPE Therapeutics, Inc. (PRNewsfoto/NRx Pharmaceuticals, Inc.)

Financial Statement

26 Aug 2024

·www.prnewswire.com

Schizophrenia Market: RISVAN's Approval Has Sparked a Competitive Race Among Pharmaceutical Companies | DelveInsight

The recent approval of Rovi Pharmaceuticals Laboratories' OKEDI/RISVAN (risperidone ISM) has spiked the competition among the other pharmaceutical companies that are developing novel therapies to improve the treatment landscape. RISVAN has the potential to become a blockbuster drug. LAS VEGAS, Aug. 26, 2024 /PRNewswire/ -- Schizophrenia is a severe mental illness affecting about 1% of Americans, cognitive functions, emotional responses, decision-making, and social interaction. Onset typically occurs in late teens to early 20s for men and late 20s to early 30s for women. Currently, as per the WHO, the vast majority of schizophrenia patients around the world are not receiving mental health care. Approximately 50% of people in mental hospitals have a schizophrenia diagnosis, and only 31.3% of people with psychosis receive specialist mental health care. As per DelveInsight analysis, in 2023 the total diagnosed prevalent cases of schizophrenia in the 7MM were found to be approximately 4 million cases out of which the US accounted for nearly 1.5 million cases. It is anticipated that these numbers will rise by 2034 due to several factors, including population growth, improved diagnostic techniques, increased awareness, and reduced stigma around mental health issues prompting more individuals to seek diagnosis, and potentially, environmental stressors contributing to a higher occurrence of the disorder. Schizophrenia treatment involves a blend of medication, psychological counseling, and social support. However, nearly one-third of patients do not respond sufficiently to standard treatments. Relapses, characterized by psychotic symptoms and functional impairments, are significant. Schizophrenia treatment mainly consists of antipsychotic medications that target dopamine neurotransmitters. Second-generation medications are favored because they lower the risk of severe side effects. Long-acting injectable antipsychotics can enhance adherence and improve treatment outcomes. High-dose regimens of specific medications may be advantageous for patients with severe, treatment-resistant schizophrenia. Additionally, hospitalization and electroconvulsive therapy might be necessary for patients who do not respond to medication therapy or during severe episodes. First-generation antipsychotics like chlorpromazine, fluphenazine, haloperidol, and perphenazine are effective in treating positive symptoms such as hallucinations and delusions but do not alleviate negative symptoms or cognitive impairments. Second-generation antipsychotics, including REXULTI/RXULTI (brexpiprazole), CAPLYTA (lumateperone), LATUDA (lurasidone hydrochloride), SAPHRIS (asenapine), ABILIFY MYCITE (aripiprazole tablets with sensor), VRAYLAR/REAGILA (cariprazine), SECUADO (asenapine), INVEGA SUSTENNA/TRINZA/HAYFERA (paliperidone palmitate), ARISTADA/ARISTADA INITIO (aripiprazole lauroxil), PERSERIS (risperidone), FANAPT (iloperidone), and LYBALVI (olanzapine and samidorphan), were developed to address both positive and negative symptoms, as well as cognitive symptoms. Although these medications typically have fewer extrapyramidal side effects, they can cause weight gain, sexual dysfunction, and other metabolic disorders. Additionally, elderly patients using FGAs and SGAs are at an increased risk of developing pneumonia. Learn more about the FDA-approved schizophrenia drugs @ Drugs for Schizophrenia Treatment REXULTI (brexpiprazole) is an oral tablet available in strengths from 0.25 mg to 4 mg, containing various inactive ingredients. While its exact mechanism of action is not fully understood, it work as a partial agonist at serotonin 5-HT1A and dopamine D2 receptors and as an antagonist at serotonin 5-HT2A receptors. REXULTI was first approved in the US in July 2015 for use in adults with MDD and schizophrenia. In January 2022, it received FDA approval for pediatric patients aged 13–17. The EMA approved it in July 2018, and Japan approved it in tablet form in January 2018 and as an oral-disintegrating dose in August 2021. Generic versions of REXULTI have now been approved, which may affect its market presence. Janssen Pharmaceutical's INVEGA SUSTENNA/INVEGA TRINZA/INVEGA HAFYERA (paliperidone palmitate) is an SGA agent that seems to act as a D2 partial agonist and a 5-HT-2A receptor antagonist. INVEGA SUSTENNA is administered monthly, INVEGA TRINZA every three months, and INVEGA HAFYERA twice yearly. Paliperidone is a benzisoxazole derivative. In the EU and Japan, INVEGA SUSTENNA is marketed as XEPLION. In the EU, INVEGA TRINZA is sold as TREVICTA, and in Japan as XEPLION TRI. INVEGA HAFYERA is a long-acting injectable treatment administered in the upper buttocks every six months, providing continuous treatment and symptom control over this period. Additionally, the recent approval of RISVAN (Risperidone ISM) has intensified the competition in the schizophrenia treatment space. Risperidone ISM is a long-acting injectable antipsychotic created and patented by ROVI for treating schizophrenia in adults. From the first injection, it delivers immediate and sustained plasma drug levels without the need for loading doses or additional oral risperidone. This approval is based on the positive outcomes of the pivotal PRISMA-3 study, which assessed the efficacy and safety of Risperidone ISM in patients with schizophrenia. The study's findings demonstrate that the two doses tested (75 mg and 100 mg administered once monthly) successfully met the predetermined primary and secondary efficacy endpoints for treating patients with moderate to severe schizophrenia symptoms. Furthermore, OKEDI (risperidone ISM) was launched in Germany, the UK, and Spain in 2022. The approval was based on the positive results of the pivotal PRISMA-3 study on the efficacy and safety of risperidone ISM in schizophrenia patients. As per the estimates by Delveinsight analysts, this drug has blockbuster potential in the schizophrenia market with medium-fast uptake. To know more about schizophrenia treatment options, visit @ New Treatment for Schizophrenia The schizophrenia market is crowded with so many companies working in the domain. Various potential therapies that are projected to enter during the forecast period include Boehringer Ingelheim's Iclepertin (BI-425809), Sumitomo Pharma/Otsuka's Ulotaront (SEP-363856), Reviva Pharmaceuticals' Brilaroxazine (RP5063), Minerva Neurosciences/Mitsubishi Tanabe Pharma's Roluperidone (MIN-101/MT-210), Karuna Therapeutics (Bristol Myers Squibb)/Royalty Pharma's KarXT (xanomeline-trospium), ACADIA Pharmaceuticals' NUPLAZID (pimavanserin), Teva Pharmaceutical/MedinCell/Royalty Pharma's Olanzapine LAI (mdc-TJK/TV-44749), Neurocrine Biosciences/Mitsubishi Tanabe Pharma's Valbenazine (NBI-98854), Lyndra Therapeutics' LYN-005 (long-acting oral risperidone), Newron Pharmaceuticals' Evenamide (NW-3509), Luye Pharma's LY03010 (ER paliperidone palmitate), and others. Discover which therapies are expected to grab major schizophrenia market share @ Schizophrenia Market Report Iclepertin (BI 425809) is an investigational drug and a glycine transporter 1 (GlyT1) inhibitor aimed at addressing the brain biology related to cognitive symptoms in schizophrenia (CIAS). Abnormalities in glutamatergic signaling downstream of neuronal NMDA receptors contribute to cognitive impairment in this condition. Enhancing NMDA receptor function could potentially improve synaptic plasticity and cognition. Glycine, an essential NMDA receptor co-agonist, is modulated by glycine transporters GlyT-1 and GlyT-2, which are located in presynaptic and astrocyte membranes. These transporters regulate glycine levels by taking it up into nerve terminals and adjacent glial cells, affecting synaptic cleft glycine concentration. By inhibiting these transporters, BI 425809 aims to increase glycine levels, thereby modulating NMDA receptor function. Administered orally, this potent and selective GlyT1 inhibitor is also under investigation for Alzheimer's disease. However, early 2020 Phase II trial results did not support its continued development for this indication, and the focus has now shifted to schizophrenia, with multiple Phase III trials currently underway. Since schizophrenia, patients frequently ignore certain symptoms, such as cognitive impairment. Therefore, if approved, BI-425809 will be the first approved pharmacotherapy for the treatment of CIAS. Ulotaront (SEP-363856), developed by Sumitomo Pharma and Otsuka Pharmaceuticals, is a trace amine-associated receptor 1 (TAAR1) agonist with serotonin 5-HT1A agonist activity. It is a small-molecule oral agent that does not bind to dopamine D2 or serotonin 5-HT2A receptors. Sunovion discovered Ulotaront in collaboration with PsychoGenics using the in vivo phenotypic SmartCube platform and associated artificial intelligence algorithms. Ulotaront is currently in late-stage development for schizophrenia and generalized anxiety disorder (GAD) in Japan and as an adjunctive treatment for major depressive disorder, schizophrenia, and GAD in the US. Top-line results from Phase III DIAMOND 1 and DIAMOND 2 trials in schizophrenia have been released, but the Phase III DIAMOND 3 trial in the US has been halted. Sumitomo Pharma has also stopped a Phase III trial for schizophrenia in Japan and another Phase II/III trial in China, Japan, Taiwan, and the Philippines, citing business strategy reasons. Despite this, two Phase III trials are still ongoing. Recently, Otsuka and Sumitomo revised their licensing agreement, excluding SEP-4199 and SEP-378614. Under this revision, Otsuka gained exclusive rights from SMPA to develop, manufacture, and commercialize ulotaront worldwide. If Otsuka successfully develops and commercializes ulotaront, they will pay up to 30 million USD (approximately 4.5 billion yen) in milestones, along with royalties based on sales, without any upfront payment. Starting January 2024, Otsuka will cover the full cost of studies conducted by both Sumitomo Pharma Group and Otsuka, except for certain studies. KarXT (xanomeline–trospium) is an oral modulator targeting muscarinic receptors found in both the central nervous system (CNS) and various peripheral tissues. This proprietary product combines xanomeline, a novel muscarinic agonist, with trospium, an approved muscarinic antagonist, to preferentially stimulate muscarinic receptors in the CNS. As a dual M1/M4 muscarinic acetylcholine receptor agonist, KarXT aims to improve the positive, negative, and cognitive symptoms of schizophrenia. The US FDA has accepted Karuna Therapeutics' NDA for KarXT for adult schizophrenia treatment, with a PDUFA date of September 26, 2024. Additionally, KarXT is undergoing multiple Phase III trials as an adjunctive treatment with standard-of-care agents for schizophrenia and is being evaluated for psychosis treatment in Alzheimer's disease patients. Following Bristol Myers Squibb's acquisition of Karuna Therapeutics, Karuna is now a wholly-owned subsidiary of BMS. At the Annual Congress of the Schizophrenia International Research Society (SIRS) in April 2024 in Italy, BMS presented promising results from the latest interim analysis of the Phase III EMERGENT-4 open-label extension trial, showing KarXT's efficacy in reducing symptoms in adults with schizophrenia. BMS plans to continue discussions with the US FDA and will release more data from the EMERGENT program later this year. Discover more about drugs for schizophrenia in development @ Schizophrenia Clinical Trials The anticipated launch of these emerging therapies for schizophrenia are poised to transform the market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the schizophrenia market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. DelveInsight estimates that the market size for schizophrenia is expected to grow from USD 2.6 billion in 2023 with a significant CAGR by 2034. This growth can be attributed to the introduction of upcoming therapies and the rising prevalence of the disease. The anticipated launch of these therapies is also expected to attract new entrants to the Schizophrenia market, resulting in increased competition and innovation. DelveInsight's latest published market report titled as Schizophrenia Market Insight, Epidemiology, and Market Forecast – 2034 will help you to discover which market leader is going to capture the largest market share. The report provides comprehensive insights into the schizophrenia country-specific treatment guidelines, patient pool analysis, and epidemiology forecast to help understand the key opportunities and assess the market's underlying potential. The schizophrenia market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into: Total Prevalent Cases of Schizophrenia Total Diagnosed Prevalent Cases of Schizophrenia Gender-specific Diagnosed Prevalent Cases of Schizophrenia Severity-specific Diagnosed Prevalent Cases of Schizophrenia The report provides an edge while developing business strategies by understanding trends shaping and driving the 7MM schizophrenia market. Highlights include: 11-year Forecast 7MM Analysis Epidemiology-based Market Forecasting Historical and Forecasted Market Analysis upto 2034 Emerging Drug Market Uptake Peak Sales Analysis Key Cross Competition Analysis Industry Expert's Opinion Access and Reimbursement Download this schizophrenia market report to assess the epidemiology forecasts, understand the patient journeys, know KOLs' opinions about the upcoming treatment paradigms, and determine the factors contributing to the shift in the schizophrenia market. Also, stay abreast of the mitigating factors to improve your market position in the schizophrenia therapeutic space. Related Reports Schizophrenia Pipeline Schizophrenia Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key schizophrenia companies, including Otsuka Pharmaceutical Development & Commercialization, Inc., Gedeon Richter Ltd., Lyndra Therapeutics, Neurocrine Bioscience, Takeda Pharmaceutical Company, Memory Pharmaceuticals, Hoffmann-La Roche, Neurocrine Biosciences, Boehringer Ingelheim, Meiji Seika Pharma Co., Ltd., SK Life Science, Inc., Alkermes, Inc. , Solvay Pharmaceuticals, Mitsubishi Tanabe Pharma Corporation, SyneuRx International (Taiwan) Corp, BioXcel Therapeutics Inc, Cognitive Research Corporation, Amarex Clinical Research, Forum Pharmaceuticals Inc, Amneal Pharmaceuticals, LLC, Recognify Life Sciences, Accutest Research Laboratories (I) Pvt. Ltd., Eli Lilly and Company, Johnson & Johnson Pharmaceutical Research & Development, L.L.C, Janssen, LP, Delpor, Inc., Jiangsu Hansoh Pharmaceutical, Cerevel Therapeutics, LLC, Zogenix, Inc., Luye Pharma, Reviva Pharmaceuticals, Alkermes, Inc., Karuna Therapeutics, Autifony Therapeutics, Neumora Therapeutics, Adex Therapeutics, among others. Schizophrenia Epidemiology Forecast Schizophrenia Epidemiology Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, and schizophrenia epidemiology trends. Dementia Market Dementia Market Insights, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key dementia companies, including Hoffmann-La Roche, Forest Laboratories, Inc., Janssen Pharmaceuticals, Inc., Merck and Co., Inc., Novartis, among others. Bipolar Depression Market Bipolar Depression Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key bipolar depression companies, including Intra-Cellular Therapies, Sunovion Pharmaceuticals, COMPASS Pathways, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP

Phase 3Phase 2Clinical ResultDrug ApprovalLicense out/in

100 Deals associated with Lurasidone Hydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
D04820	Lurasidone Hydrochloride	N05AE05	DB08815

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Depressive Disorder, Major	South Korea	Bukwang Pharmaceutical Co., Ltd.	23 Nov 2023
Bipolar Disorder	Japan	Sumitomo Pharma Co., Ltd.	25 Mar 2020
Bipolar I disorder	United States	Sumitomo Pharma America, Inc.	27 Jan 2017
Schizophrenia	United States	Sumitomo Pharma America, Inc.	28 Oct 2010

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Bipolar and Related Disorders	Phase 3	China	Sumitomo Pharmaceuticals (Suzhou) Co., Ltd.	30 Jan 2022
Autistic Disorder	Phase 3	United States	Sumitomo Pharma America, Inc.	01 Aug 2013
Irritable Mood	Phase 3	United States	Sumitomo Pharma America, Inc.	01 Aug 2013
Recurrent major depressive disorder with atypical features	Phase 3	United States	Sumitomo Pharma America, Inc.	01 Sep 2011
Recurrent major depressive disorder with atypical features	Phase 3	Russia	Sumitomo Pharma America, Inc.	01 Sep 2011
Recurrent major depressive disorder with atypical features	Phase 3	Serbia	Sumitomo Pharma America, Inc.	01 Sep 2011
Recurrent major depressive disorder with atypical features	Phase 3	Ukraine	Sumitomo Pharma America, Inc.	01 Sep 2011
Recurrent major depressive disorder with atypical features	Phase 3	United Kingdom	Sumitomo Pharma America, Inc.	01 Sep 2011
Depressive Disorder	Phase 3	United States	Sumitomo Pharma America, Inc.	01 Apr 2009
Depressive Disorder	Phase 3	Canada	Sumitomo Pharma America, Inc.	01 Apr 2009

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01569659 (HDL, CTgov)	Phase 4	Schizophrenia, Treatment-Resistant	101	Lurasidone (Standard Dose of Lurasidone)	adwvazplfl(jfjetibhiz) = mvjhlsdpuo kzkijdkfaw (izrgmsftbo, 3.3) View more	-	28 Feb 2025
NCT01569659 (HDL, CTgov)	Phase 4	Schizophrenia, Treatment-Resistant	101	Lurasidone (High Dose of Lurasidone)	adwvazplfl(jfjetibhiz) = gdhzhnelno kzkijdkfaw (izrgmsftbo, 4.3) View more	-	28 Feb 2025
NCT06527885 (Pubmed \| Ann Gen Psychiatry)	Not Applicable	Schizophrenia	-	Lurasidone	fdygpjkqtl(idebyahckh) = reaching a mean change from baseline of 9.8 at the end of the study zonhdvkhkm (zofrdrubot ) View more	Positive	05 Nov 2024
NCT01986101 (Pubmed)	Not Applicable	Bipolar Disorder	-	Lurasidone	svrygrkgft(osiarlggqa) = wslsknalcl hyifaikmdy (gpcveatnwt ) View more	-	12 Jan 2023
EUCTR2016-000060-42-SK \| EUCTR2016-000060-42-PL (Pubmed) Manual	Phase 3	Schizophrenia	289	Lurasidone Hydrochloride (80 mg/day)	lqvsfjzepu(rdokcutiyf) = vpgtbwsggs hgyvnnwrex (lwcmwevgez ) View more	Positive	09 Nov 2022
	Phase 3	Schizophrenia	289	Lurasidone Hydrochloride (40 mg/day)	lqvsfjzepu(rdokcutiyf) = kksdsqvjts hgyvnnwrex (lwcmwevgez ) View more	Positive	09 Nov 2022
NCT01914393 (Pubmed \| J Child Adolesc Psychopharmacol) Manual	Phase 3	Depressive Disorder	306	Lurasidone	ksatowkzun(jyqkrofuen) = xuzvcjlsbn btusaujbst (tykmtcoczt ) View more	Positive	01 Sep 2021
NCT01986114 (Pubmed \| Int J Bipolar Disord) Manual	Phase 3	Bipolar I disorder	-	lurasidone	ldoeesylcr(bhlyzzfiuy) = akathisia (30.7%), nasopharyngitis (26.6%), nausea (12.1%), and somnolence (12.1%) jwdzzqcmwq (ersashjyrc ) View more	Positive	02 Aug 2021
NCT02199743 (CTgov)	Phase 4	Schizoaffective disorder \| Schizophrenia	35	Perphenazine+Lurasidone+Haloperidol	xqdrmagcsa(iaqfapvrxn) = mgkrozentz hdxspclkpu (knxwbhquid, 0.741430931) View more	-	01 Mar 2021
NCT00641745 (Pubmed \| BMC Psychiatry)	Phase 3	Schizoaffective disorder \| Schizophrenia	223	Continuing Lurasidone	lntwarjpat(pyzpjypfdh) = jsthhykbqm urwtdmytdv (otyozjhurk ) View more	-	01 Dec 2020
NCT00641745 (Pubmed \| BMC Psychiatry)	Phase 3	Schizoaffective disorder \| Schizophrenia	223	Switching from Risperidone to Lurasidone	kamwtxlhlo(imgdtkpmel) = gtlhzzhufp nbyuoldvbq (yczmruubgc ) View more	-	01 Dec 2020
NCT00641745 (Pubmed \| Neurol Ther)	Phase 3	Schizophrenia	629	Lurasidone	dcpwaaafba(lichpknmmv) = xzicbldyjq jbxeegpdtp (hewzagramb )	-	24 Oct 2020
NCT00641745 (Pubmed \| Neurol Ther)	Phase 3	Schizophrenia	629	Risperidone	dcpwaaafba(lichpknmmv) = fdjiigmytx jbxeegpdtp (hewzagramb )	-	24 Oct 2020
NCT03902613 (CTgov)	Phase 4	Bipolar Disorder	1	Lurasidone	ovruubcyfl(qiwpcmwuxo) = ffmhqkejra iwxbocmgqz (urmkqvdwnh, ghbclbexoz - dlaxsqhnua) View more	-	06 Oct 2020

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