A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of Lumateperone in the Treatment of Irritability Associated with Autism Spectrum Disorder in Pediatric Patients 5 to 17 Years of Age - NIL

Start Date12 Mar 2026

Sponsor / Collaborator

Intra-Cellular Therapies, Inc.

[+1]

CTR20253446

/ RecruitingPhase 3

评价甲苯磺酸卢美哌隆胶囊治疗精神分裂症的有效性和安全性的多中心、随机、双盲双模拟、平行、阳性对照的III期临床试验

[Translation] A multicenter, randomized, double-blind, double-dummy, parallel, positive-controlled phase III clinical trial to evaluate the efficacy and safety of lumepirone tosylate capsules in the treatment of schizophrenia

评价甲苯磺酸卢美哌隆胶囊治疗成人精神分裂症的有效性和安全性

[Translation]

To evaluate the efficacy and safety of lumepirone tosylate capsules in the treatment of schizophrenia in adults

Start Date28 Oct 2025

Sponsor / Collaborator

Wuhan Renfulikang Pharmaceutical Co., Ltd.

[+1]

CTRI/2025/05/087417

/ Not yet recruitingPhase 3

An Open-label, Multicenter Trial to Assess the Safety and Tolerability of Lumateperone in the Treatment of Pediatric Patients with Schizophrenia, Bipolar Disorder, or autism spectrum disorder - NIL

Start Date30 Jun 2025

Sponsor / Collaborator

Intra-Cellular Therapies, Inc.

[+1]

100 Clinical Results associated with Lumateperone Tosylate

100 Translational Medicine associated with Lumateperone Tosylate

100 Patents (Medical) associated with Lumateperone Tosylate

113

Literatures (Medical) associated with Lumateperone Tosylate

01 Dec 2025·INTERNATIONAL IMMUNOPHARMACOLOGY

Role of PI3K/Akt axis in cognitive impact of lumateperone in schizophrenia rat model induced by ketamine

Article

Author: Abdel Mageed, Sherif S ; Kamel, Ahmed S ; Nassar, Noha N ; Moawad, Helmy ; Mangoura, Safwat A

Schizophrenia (SCZ) is a complex, debilitating mental illness marked by cognitive deficits that impair functionality and quality of life. While traditional research has focused on dopaminergic and glutamatergic abnormalities in SCZ, emerging evidence highlights the crucial role of serotonergic dysregulation. Lumateperone (LUM), a recently FDA-approved atypical antipsychotic, exhibits a distinctive multimodal pharmacological profile characterized by combined antagonism of 5-HT_2A and D2 receptors alongside serotonin reuptake inhibitory activity. This study investigated the procognitive effects of LUM mediated via 5-HT_1A receptor activation in ketamine (Ket)-induced SCZ-like rat model. To this end, Male Wistar rats were administered 5 days Ket (30 mg/kg/day, i.p.), followed by LUM (10 mg/kg/day, p.o) for 14 days. To evaluate the proposed mechanistic pathway, a selective PI3K inhibitor (15 μg/kg/day, iv) Wortmannin (WM) was administered 30 min prior to LUM. Four days before the termination, animals underwent behavioral assessments, including the open field test, novel object recognition task, social interaction, Y-maze, and Morris water maze test. LUM restored hippocampal/cortical architecture, improved Ket-induced behavioral/cognitive deficits, reduced cortical CD86/GFAP, and increased CD163 immunoreactivity. Additionally, LUM decreased SERT expression and corrected the dysregulated expression of cortical 5-HT_2A and hippocampal 5-HT_1A receptors. LUM restored hippocampal 5-HT,5-HIAA, and DA levels while amending cortical GAD67 and VGLUT1 immunoexpression. Alongside restoring PI3K/AKT/GSK-3β survival proteins and reinstating pCREB and BDNF levels. WM pre-administration nullified LUM's effects, proving the involvement of the 5-HT_1A/PI3K/Akt pathway. LUM demonstrates promising procognitive potential, offering insights into its therapeutic applications for cognitive dysfunction in SCZ.

03 Nov 2025·INTERNATIONAL JOURNAL OF NEUROPSYCHOPHARMACOLOGY

Partial agonist antipsychotic drugs differentially interact with a secondary binding site at the dopamine D2 receptor

Article

Significance Statement Aripiprazole and brexpiprazole showed significantly increased dissociation from the dopamine D2 receptor upon L94A mutation, indicating that their (similar) secondary pharmacophores interact with the secondary binding pocket.Cariprazine, sharing an identical primary pharmacophore with aripiprazole, but with a distinct secondary pharmacophore, was unaffected by the secondary binding pocket mutation. In summary, these data are congruent with a canonical binding pose of phenylpiperazine dopamine D2 partial agonists.In contrast to aripiprazole, cariprazine, and brexpiprazole, lumateperone lacked detectable dopamine D2 receptor efficacy in our assay.

02 Sep 2025·Expert Opinion On Drug Safety

Analysis of lumateperone data for patients with schizophrenia using related adverse events from the FDA adverse reporting system

Article

Author: Wu, Hongyun ; Sun, Shengzhu ; Peng, Wei ; Zhang, Ying

BACKGROUND:

Our study utilized the U.S. Food and Drug Administration's Adverse Event Reporting System (FAERS) to analyze and study the adverse event (AEs) signals of second-generation antipsychotic drug lumateperone, providing a reference for clinical safety monitoring in the treatment of schizophrenia.

METHODS:

The International Dictionary of Medical Terminology (version 26.0) was used to standardize the preferred system organ category (SOC) and preferred terminology (PT) for adverse drug events (ADE) data related to lumateperone. ADE signals were classified and described using four algorithms: reporting odds ratios (ROR), proportional reporting ratios (PRR), Bayesian confidence-propagation neural network (BCPNN) and Multinomial gamma-poisson shrinkage (MGPS).

RESULT:

Among the 2542 case reports collected from the FAERS database, 1762 reports with lumateperone as a 'principal suspect(PS)' AEs were identified. Lumateperone-induced AEs occurred in 26 system organ categories (SOC). A total of 118 significant disproportionate preferred terms (PTs) meeting the requirements of 4 algorithms were retained, and unexpected major events, such as burning sensation, tremor, migraine etc. may also occur. The median time to onset of lumateperone-related adverse events was 9 days (interquartile range [IQR] 2-31.25 days), and most AEs occurred within the first 10 days and 1 month after initiation of lumateperone therapy.

CONCLUSION:

Our research may provide a better understanding of the potential adverse events that may be caused by lumateperone and those not recorded in the drug instructions, providing valuable signals for clinical use.

137

News (Medical) associated with Lumateperone Tosylate

13 Jan 2026

·www.prnewswire.com

Johnson & Johnson elevates leadership in depression with new data at 2026 American College of Neuropsychopharmacology Annual Meeting

New CAPLYTA® (lumateperone) Phase 3 analyses evaluating efficacy in achieving remission in adjunctive major depressive disorder (aMDD) to be presented SPRAVATO® (esketamine) effects on anhedonia in treatment-resistant depression (TRD) – Phase 3 data post-hoc analyses to be presented Comparative tolerability of adjunctive seltorexant vs. adjunctive quetiapine XR in major depressive disorder (MDD) with insomnia symptoms – new Phase 3 metabolic analyses will also be presented TITUSVILLE, N.J., Jan. 13, 2026 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) announced today that 11 abstracts featuring new data on its robust portfolio and pipeline in neuropsychiatry will be presented at the 64th Annual Meeting of the American College of Neuropsychopharmacology (ACNP), held from January 12-15, in Nassau, Bahamas. Presentations include the latest research from across the Company's neuropsychiatry portfolio, including major depressive disorder (MDD) and treatment-resistant depression (TRD), as well as preclinical and translational neuropsychiatric research. "At Johnson & Johnson, we are tackling the greatest unmet needs for patients living with depression, schizophrenia and bipolar disorder – with the ultimate goal of remission from disease," said Bill Martin, Ph.D., Global Therapeutic Area Head, Neuroscience, Johnson & Johnson Innovative Medicine. "Our data at ACNP this year showcases how we are boldly advancing our portfolio, from clinical findings on remission and tolerability to preclinical research on novel mechanisms and AI-driven precision tools, reflecting our commitment to redefining standards of care." Key presentations include: A new analysis of Phase 3 clinical trials evaluating the efficacy of CAPLYTA® (lumateperone) in combination with antidepressants for remission of MDD symptoms in adults (Poster TH66).1 New metabolic analyses of Phase 3 data evaluating the tolerability of seltorexant adjunctive to SSRI/SNRI, an investigational first-in-class therapy, compared to adjunctive quetiapine extended release (XR) in patients with MDD with insomnia symptoms (Poster TH67).2 Findings from post-hoc analyses of two Phase 3 studies, TRANSFORM-2 and SUSTAIN-2, exploring the effects of SPRAVATO® (esketamine) CIII nasal spray on anhedonia in patients with TRD (Poster W123).3 Preclinical and translational research showcasing novel AI platforms for precision medicine (Poster W117), investigating biology associated with neuropsychiatric diseases (Poster TU30), and early-stage work on new therapeutic mechanisms for depression (Poster TH202).4,5,6 Johnson & Johnson will present the following posters at the ACNP meeting on January 14 at 5:00 – 7:00 p.m. ET and January 15 at 5:00 – 7:00 p.m. ET in the Exhibit Halls: ABOUT MAJOR DEPRESSIVE DISORDER (MDD) MDD is one of the most common psychiatric disorders and a leading cause of disability worldwide, impacting an estimated 332 million people – or about 4 percent of the population.7,8 In 2023, approximately 22 million adults in the U.S. had at least one major depressive episode.9 While depression is typically treated with a "one-size-fits-all" approach, no two cases are the same. MDD is a complex, heterogeneous disorder involving multiple regions of the brain and presenting with as many as 256 unique symptom combinations.10,11 As a result, responses to treatment vary widely. Only 1 in 3 patients reach remission with their first antidepressant – and rates continue to decline further with each subsequent treatment, leaving many to spend years cycling through multiple treatments trying to find complete, sustained symptom relief.12 Moreover, MDD is a risk factor for the development and worsening of a range of comorbidities, illustrating the importance of integrating mental and general health care.13 MDD often includes sleep disturbances such as insomnia or hypersomnia, with approximately 60 percent of MDD patients experiencing clinically relevant insomnia symptoms despite being on an SSRI/SNRI.14 Disturbed sleep and insomnia symptoms have a significant impact on a patient's quality of life and exacerbate the risk of depressive relapse and suicide.15,16 Approximately one-third of adults with MDD will not respond to oral antidepressants alone and are considered to have treatment-resistant depression (TRD), which is often defined as inadequate response to two or more oral antidepressants that were administered at an adequate dose for an adequate duration.17,18 TRD has a significant negative impact on the lives of those affected and has one of the highest economic burdens of all psychiatric disorders.18 Patients often cycle through multiple oral medications, waiting 4-6 weeks for potential relief.19 Based on the STAR*D study, after trying their third oral antidepressant, approximately 86 percent of patients do not achieve remission.19 About CAPLYTA ® (lumateperone) CAPLYTA® 42 mg is an oral, once daily atypical antipsychotic approved in adults as an adjunctive therapy with antidepressants for major depressive disorder (MDD), schizophrenia, and depressive episodes associated with bipolar I or II disorder (bipolar depression), as monotherapy, and as adjunctive therapy with lithium or valproate. While the mechanism of action of CAPLYTA® is unknown, the efficacy of CAPLYTA® could be mediated through a combination of antagonist activity at central serotonin 5-HT2A receptors and partial agonist activity at central dopamine D2 receptors. About Seltorexant Seltorexant, an investigational first-in-class therapy, is a selective antagonist of the human orexin-2 receptor currently being developed as an adjunctive treatment for adults with MDD with insomnia symptoms. Seltorexant selectively antagonizes the orexin-2 receptors, potentially improving mood symptoms associated with depression and restoring sleep without next-day sedation in patients with depression.20 When orexin-2 receptors are stimulated for too long or at inappropriate times, their activation can cause hyperarousal manifestations, including insomnia and excessive cortisol release, which may contribute to depression and insomnia.21,22 Seltorexant is the only investigational therapy under study for the treatment of MDD that is believed to work by normalizing the overactivation of the orexin-2 receptors, thereby targeting the underlying biology that contributes to depression and insomnia symptoms. ABOUT SPRAVATO ® SPRAVATO® (esketamine) CIII nasal spray is approved by the U.S. Food and Drug Administration alone or in conjunction with an oral antidepressant for adults with MDD when they have inadequate response to at least two oral antidepressants (TRD) and depressive symptoms in adults with major depressive disorder with acute suicidal ideation or behavior in conjunction with an oral antidepressant. It is a non-selective, non-competitive antagonist of the N-methyl-D-aspartate (NMDA) receptor and is believed to work differently than traditional antidepressants by acting on a pathway in the brain that affects glutamate. The mechanism by which esketamine exerts its antidepressant effect is unknown. To date, SPRAVATO® has been approved in 79 markets and administered to more than 150,000 patients worldwide. CAPLYTA ® IMPORTANT SAFETY INFORMATION CAPLYTA® (lumateperone) is a prescription medicine used in adults along with an antidepressant to treat major depressive disorder (MDD); to treat depressive episodes associated with bipolar I or bipolar II disorder (bipolar depression) alone or with lithium or valproate; or to treat schizophrenia. It is not known if CAPLYTA is safe and effective in children. IMPORTANT SAFETY INFORMATION Medicines like CAPLYTA can raise the risk of death in elderly people who have lost touch with reality (psychosis) due to confusion and memory loss (dementia). CAPLYTA is not approved for treating people with dementia-related psychosis. CAPLYTA and antidepressant medicines increase the risk of suicidal thoughts and actions in people 24 years of age and younger, especially within the first few months of treatment or when the dose is changed. Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. Patients and their families or caregivers should watch for new or worsening depression symptoms, especially sudden changes in mood, behaviors, thoughts, or feelings. This is very important when CAPLYTA or an antidepressant medicine is started or when the dose is changed. Report any changes in these symptoms to your healthcare provider immediately. Do not take CAPLYTA if you are allergic to any of its ingredients. Get emergency medical help if you are having an allergic reaction (e.g., rash, itching, hives, swelling of the tongue, lip, face, or throat). CAPLYTA may cause serious side effects, including: Stroke (cerebrovascular problems) in elderly people with dementia-related psychosis that can lead to death. Neuroleptic malignant syndrome (NMS): high fever, confusion, changes in your breathing, heart rate, and blood pressure, stiff muscles, and increased sweating; these may be symptoms of a rare but potentially fatal condition. Contact your healthcare provider or go to the emergency room if you experience signs and symptoms of NMS. Uncontrolled body movements (tardive dyskinesia, TD) in your face, tongue, or other body parts. TD may not go away, even if you stop taking CAPLYTA. It may also occur after you stop taking CAPLYTA. Problems with your metabolism including high blood sugar, diabetes, increased fat (cholesterol and triglyceride) levels in your blood and weight gain. Your healthcare provider should check your blood sugar, fat levels, and weight before you start and during your treatment with CAPLYTA. Extremely high blood sugar levels can lead to coma or death. Call your healthcare provider if you have any of the following symptoms of high blood sugar: feeling very thirsty, hungry, sick to your stomach, needing to urinate more than usual, weak/tired, or confused, or your breath smells fruity. Low white blood cell count. Your healthcare provider may do blood tests during the first few months of treatment with CAPLYTA. Decreased blood pressure (orthostatic hypotension). You may feel lightheaded, dizzy, or faint when you rise too quickly from a sitting or lying position. Falls. CAPLYTA may make you sleepy or dizzy, may cause a decrease in your blood pressure when changing position (orthostatic hypotension), and can slow your thinking and motor skills which may lead to falls that can cause broken bones or other injuries. Seizures (convulsions). Sleepiness, drowsiness, feeling tired, difficulty thinking and doing normal activities. Until you know how CAPLYTA affects you, do not drive, operate heavy machinery, or do other dangerous activities. Problems controlling your body temperature so that you feel too warm. Avoid getting overheated or dehydrated while taking CAPLYTA. Difficulty swallowing that can cause food or liquid to get into the lungs. The most common side effects of CAPLYTA include sleepiness, dizziness, nausea, dry mouth, feeling tired, and diarrhea. These are not all the possible side effects of CAPLYTA. Tell your healthcare provider if you have or have had heart problems or a stroke, high or low blood pressure, diabetes, or high blood sugar, problems with cholesterol, have or have had a low white blood cell count, seizures (convulsions), or kidney or liver problems. CAPLYTA may cause fertility problems in females and males. You should notify your healthcare provider if you become pregnant or intend to become pregnant while taking CAPLYTA. There is a pregnancy registry for females who are exposed to CAPLYTA during pregnancy. CAPLYTA may cause abnormal involuntary movements and/or withdrawal symptoms in newborn babies exposed to CAPLYTA during the third trimester. Talk to your healthcare provider if you breastfeed or are planning to breastfeed as CAPLYTA passes into breast milk. Tell your healthcare provider about all the medicines you're taking. CAPLYTA may affect the way other medicines work, and other medicines may affect how CAPLYTA works, causing possible serious side effects. Do not start or stop any medicines while taking CAPLYTA without talking to your healthcare provider. You are encouraged to report negative side effects of prescription drugs. Contact Intra-Cellular Therapies, Inc. at 1-888-611-4824 or FDA at 1-800-FDA-1088 or . CAPLYTA is available in 42 mg, 21 mg, and 10.5 mg capsules. US-CAP-2500827 Please see full Prescribing Information , including Boxed WARNINGS, and Medication Guide for CAPLYTA. SPRAVATO ® IMPORTANT SAFETY INFORMATION What is SPRAVATO ® (esketamine) CIII nasal spray? SPRAVATO® is a prescription medicine used: with or without an antidepressant taken by mouth, to treat adults with treatment-resistant depression (TRD) with an antidepressant taken by mouth, to treat depressive symptoms in adults with major depressive disorder (MDD) with suicidal thoughts or actions SPRAVATO® is not for use as a medicine to prevent or relieve pain (anesthetic). It is not known if SPRAVATO® is safe or effective as an anesthetic medicine. It is not known if SPRAVATO® is safe and effective for use in preventing suicide or in reducing suicidal thoughts or actions. SPRAVATO® is not for use in place of hospitalization if your healthcare provider determines that hospitalization is needed, even if improvement is experienced after the first dose of SPRAVATO®. It is not known if SPRAVATO® is safe and effective in children. IMPORTANT SAFETY INFORMATION What is the most important information I should know about SPRAVATO ® ? SPRAVATO ® can cause serious side effects, including: Sedation, dissociation, and respiratory depression. SPRAVATO® may cause sleepiness (sedation), fainting, dizziness, spinning sensation, anxiety, or feeling disconnected from yourself, your thoughts, feelings, space and time (dissociation), breathing problems (respiratory depression and respiratory arrest) Tell your healthcare provider right away if you feel like you cannot stay awake or if you feel like you are going to pass out. Your healthcare provider must monitor you for serious side effects for at least 2 hours after taking SPRAVATO®. Your healthcare provider will decide when you are ready to leave the healthcare setting. Abuse and misuse. There is a risk for abuse and misuse with SPRAVATO®, which may lead to physical and psychological dependence. Your healthcare provider should check you for signs of abuse, misuse, and dependence before and during treatment. Tell your healthcare provider if you have ever abused or been dependent on alcohol, prescription medicines, or street drugs. Your healthcare provider can tell you more about the differences between physical and psychological dependence and drug addiction. SPRAVATO® Risk Evaluation and Mitigation Strategy (REMS). Because of the risks for sedation, dissociation, respiratory depression and abuse and misuse, SPRAVATO® is only available through a restricted program called the SPRAVATO® Risk Evaluation and Mitigation Strategy (REMS) Program. SPRAVATO® can only be administered at healthcare settings certified in the SPRAVATO® REMS Program. Patients treated in outpatient healthcare settings (such as medical offices and clinics) must be enrolled in the program. Increased risk of suicidal thoughts and actions. Antidepressant medicines may increase suicidal thoughts and actions in some people 24 years of age and younger, especially within the first few months of treatment or when the dose is changed. SPRAVATO ® is not for use in children. Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. Some people may have a higher risk of having suicidal thoughts or actions. These include people who have (or have a family history of) depression or a history of suicidal thoughts or actions. How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member? Pay close attention to any changes, especially sudden changes, in mood, behavior, thoughts, or feelings, or if you develop suicidal thoughts or actions. Tell your healthcare provider right away if you have any new or sudden changes in mood, behavior, thoughts, or feelings, or if you develop suicidal thoughts or actions. Keep all follow-up visits with your healthcare provider as scheduled. Call your healthcare provider between visits as needed, especially if you have concerns about symptoms. Tell your healthcare provider or get emergency help right away if you or your family member have any of the following symptoms, especially if they are new, worse, or worry you: Do not take SPRAVATO ® if you: have blood vessel (aneurysmal vascular) disease (including in the brain, chest, abdominal aorta, arms and legs) have an abnormal connection between your veins and arteries (arteriovenous malformation) have a history of bleeding in the brain are allergic to esketamine, ketamine, or any of the other ingredients in SPRAVATO®. If you are not sure if you have any of the above conditions, talk to your healthcare provider before taking SPRAVATO®. Before you take SPRAVATO ® , tell your healthcare provider about all of your medical conditions, including if you: have heart or brain problems, including: high blood pressure (hypertension) slow or fast heartbeats that cause shortness of breath, chest pain, lightheadedness, or fainting history of heart attack history of stroke heart valve disease or heart failure history of brain injury or any condition where there is increased pressure in the brain have liver problems have ever had a condition called "psychosis" (see, feel, or hear things that are not there, or believe in things that are not true). are pregnant or plan to become pregnant. SPRAVATO® may harm your unborn baby. You should not take SPRAVATO® if you are pregnant. Tell your healthcare provider right away if you become pregnant during treatment with SPRAVATO®. If you are able to become pregnant, talk to your healthcare provider about methods to prevent pregnancy during treatment with SPRAVATO®. There is a pregnancy registry for women who are exposed to SPRAVATO® during pregnancy. The purpose of the registry is to collect information about the health of women exposed to SPRAVATO® and their baby. If you become pregnant during treatment with SPRAVATO®, talk to your healthcare provider about registering with the National Pregnancy Registry for Antidepressants at 1-844-405-6185 or online at programs/pregnancyregistry/antidepressants/. are breastfeeding or plan to breastfeed. SPRAVATO® passes into your breast milk. You should not breastfeed during treatment with SPRAVATO®. Tell your healthcare provider about all the medicines that you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Taking SPRAVATO® with certain medicine may cause side effects. Especially tell your healthcare provider if you take central nervous system (CNS) depressants, psychostimulants, or monoamine oxidase inhibitors (MAOIs) medicines. Keep a list of them to show to your healthcare provider and pharmacist when you get a new medicine. How will I take SPRAVATO ® ? You will take SPRAVATO® nasal spray yourself, under the supervision of a healthcare provider in a healthcare setting. Your healthcare provider will show you how to use the SPRAVATO® nasal spray device. Your healthcare provider will tell you how much SPRAVATO® you will take and when you will take it. Follow your SPRAVATO® treatment schedule exactly as your healthcare provider tells you to. During and after each use of the SPRAVATO® nasal spray device, you will be checked by a healthcare provider who will decide when you are ready to leave the healthcare setting. You will need to plan for a caregiver or family member to drive you home after taking SPRAVATO®. If you miss a SPRAVATO® treatment, your healthcare provider may change your dose and treatment schedule. Some people taking SPRAVATO® get nausea and vomiting. You should not eat for at least 2 hours before taking SPRAVATO® and not drink liquids at least 30 minutes before taking SPRAVATO®. If you take a nasal corticosteroid or nasal decongestant medicine take these medicines at least 1 hour before taking SPRAVATO®. What should I avoid while taking SPRAVATO ® ? Do not drive, operate machinery, or do anything where you need to be completely alert after taking SPRAVATO®. Do not take part in these activities until the next day following a restful sleep. See "What is the most important information I should know about SPRAVATO ® ?" What are the possible side effects of SPRAVATO ® ? SPRAVATO ® may cause serious side effects including: See "What is the most important information I should know about SPRAVATO ® ?" Increased blood pressure. SPRAVATO® can cause a temporary increase in your blood pressure that may last for about 4 hours after taking a dose. Your healthcare provider will check your blood pressure before taking SPRAVATO® and for at least 2 hours after you take SPRAVATO®. Tell your healthcare provider right away if you get chest pain, shortness of breath, sudden severe headache, change in vision, or seizures after taking SPRAVATO®. Problems with thinking clearly. Tell your healthcare provider if you have problems thinking or remembering. Bladder problems. Tell your healthcare provider if you develop trouble urinating, such as a frequent or urgent need to urinate, pain when urinating, or urinating frequently at night. The most common side effects of SPRAVATO ® include: If these common side effects occur, they usually happen right after taking SPRAVATO ® and go away the same day. These are not all the possible side effects of SPRAVATO®. Call your doctor for medical advice about side effects. You may report side effects to Johnson & Johnson at 1-800-526-7736, or to the FDA at 1-800-FDA-1088. Please see full Prescribing Information , including Boxed WARNINGS, and Medication Guide for SPRAVATO ® and discuss any questions you may have with your healthcare provider. cp-170363v4 About Johnson & Johnson At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity. Learn more at or at . Follow us at @JNJInnovMed. © Johnson & Johnson and its affiliates 2026. All rights reserved. Cautions Concerning Forward-Looking Statements This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 related to product development and the potential benefits and treatment impact of CAPLYTA® (lumateperone), SPRAVATO® (esketamine) CIII nasal spray, and seltorexant. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's most recent Annual Report on Form 10-K, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at , , or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments. References: Bhagwagar Z, Chen C, Durgam S et al. Remission With Lumateperone 42 mg Adjunctive to Antidepressant Therapy in Patients With Major Depressive Disorder: Analysis of Short-Term and Long-Term Trials. 2026 ACNP Annual Meeting; January 12-15, 2026. Poster TH66. Canuso C, Drevets W.C., Flossbach Y et al. Metabolic Profiles of Participants With Major Depressive Disorder With Insomnia Symptoms in a Phase 3 Trial of Seltorexant Versus Quetiapine Extended Release as Adjunctive Therapy. 2026 ACNP Annual Meeting; January 12-15, 2026. Poster TH67. Bossie C, Cutler A.J., Drevets W.C. et al. Short- and Long-Term Effects of Esketamine Nasal Spray on Anhedonia in Treatment-Resistant Depression: Post-Hoc Analyses From Two Phase 3 Studies. 2026 ACNP Annual Meeting; January 12-15, 2026. Poster W123. Anticevic A, Demsar J, Helmer M et al. NAIO (Neuroscience and AI-Optimized Platform): A Multi-Modal Computational Platform for Informing Target and Indication Selection, Biomarker Readout, and Patient Stratification in CNS Drug Development. 2026 ACNP Annual Meeting; January 12-15, 2026. Poster W117. Triana-Baltzer G et al. Complement and Synaptic Protein Profiling in Schizophrenia CSF and Plasma: Analysis of the Psychiatric Biomarkers Network Cohort. 2026 ACNP Annual Meeting; January 12-15, 2026. Poster TU30. Ahnaou A, Almenar J, Balana B et al. Selective GluN2D Inhibition Recapitulates Non-Selective NMDAR Antagonists Effects on Synaptic Plasticity in Rodents. 2026 ACNP Annual Meeting; January 12-15, 2026. Poster TH202. World Health Organization. Mental disorders. Accessed January 2026. National Alliance on Mental Health. Mental health by the numbers. Accessed January 2026. Key substance use and mental health indicators in the United States: results from the 2023 national survey on drug use and health. Center for Behavioral Health Statistics and Quality, Substance Abuse and Mental Health Services Administration. Published July 2024. Accessed January 2026. Su YA and Si T. Progress and challenges in research of the mechanisms of anhedonia in major depressive disorder. Gen Psychiatr. 2022;35:e100724. doi: 10.1136/gpsych-2021-10072 Pandya M, et al. Where in the Brain Is Depression? Curr Psychiatry Rep. 2012;14:634–642. doi: 10.1007/s11920-012-0322-7 Rush AJ, Trivedi MH, Wisniewski SR, et al. Acute and longer-term outcomes in depressed outpatients requiring one or several treatment steps: a STAR*D report. Am J Psychiatry. 2006 Nov;163(11):1905-17. doi: 10.1176/ajp.2006.163. Arnaud AM, Brister TS, Duckworth K, et al. Impact of major depressive disorder on comorbidities: a systematic literature review. J Clin Psychiatry. 2022;83(6):21r14328. Ohayon MM, Roth T. Place of chronic insomnia in the course of depressive and anxiety disorders. J Psychiatr Res. 2003;37(1):9-15. doi:10.1016/S0022-3956(02)00052-3 Taddei-Allen P. Economic Burden and Managed Care Considerations for the Treatment of Insomnia. AJMC. Updated April 12, 2020. Accessed January 2026. Ağargün MY, Kara H, Solmaz M. Sleep disturbances and suicidal behavior in patients with major depression. J Clin Psychiatry. 1997;58(6):249-51. National Institute of Mental Health. Major Depression. Accessed January 2026. Zhdanava M, Pilon D, Ghelerter I, et al. The prevalence and national burden of treatment-resistant depression and major depressive disorder in the United States. J Clin Psychiatry. 2021;82(2):20m13699. doi: 10.4088/JCP.20m13699 Sanacora G, Zarate C, Krystal J, et al. Targeting the glutamatergic system to develop novel, improved therapeutics for mood disorders. Nat Rev Drug Discov. 2008;7(5):426-437. doi:10.1038/nrd2462 Recourt K, de Boer P, Zuiker R, et al. The selective orexin-2 antagonist seltorexant (JNJ-42847922/MIN-202) shows antidepressant and sleep-promoting effects in patients with major depressive disorder [published correction appears in Transl Psychiatry. 2019 Oct 2;9(1):240. doi: 10.1038/s41398-019-0585-4]. Nollet M, Leman S. Role of orexin in the pathophysiology of depression: potential for pharmacological intervention. CNS Drugs. 2013;27(6):411-422. doi:10.1007/s40263-013-0064-z Brooks S, Jacobs GE, de Boer P, et al. The selective orexin-2 receptor antagonist seltorexant improves sleep: An exploratory double-blind, placebo controlled, crossover study in antidepressant-treated major depressive disorder patients with persistent insomnia. J Psychopharmacol. 2019;33(2):202-209. doi:10.1177/0269881118822258 SOURCE Johnson & Johnson 21% more press release views with Request a Demo

Phase 3Drug ApprovalClinical Result

12 Jan 2026

·www.fiercepharma.com

The top 10 biopharma M&A deals of 2025

None Following a mercurial couple of years for biopharma M&A activity, 2025 saw a marked return to form, with a bevy of looming patent expirations and a thawing of the biotech investment scene prompting drug developers of all stripes to pull out their checkbooks in 2025.Still, the scope and scale of the deals tallied in 2025—which one leader at L.E.K. Consulting’s global health practices estimated to be the “strongest M&A year since 2019”—wasn’t a sure thing for much of the first half of 2025, as the industry grappled with major policy uncertainties in the U.S.But by the back half of the year, as the biopharma realm came to grips with the new normal, a spate of deals kicked off.While none of those transactions approached the heights of historic major outlays like Takeda’s $64 billion Shire takeover, AbbVie’s $63 billion Allergan buyout or Bristol Myers Squibb’s $74 billion play for Celgene, the acceleration of mergers and acquisitions in the final months of 2025 is likely to keep pace in the new year, Bart Van de Vyer, an M&A consultant with McKinsey, told Fierce in a recent interview.Leading the pack of biopharma M&A transactions in 2025 was Johnson & Johnson’s $14.6 billion outlay for central nervous system disease specialist Intra-Cellular Therapies. The crown jewel of that transaction was Intra-Cellular’s Caplyta, a schizophrenia and bipolar disorder drug that also won an FDA nod in the lucrative yet tough-to-crack indication of major depressive disorder in November. The drug will now complement J&J’s ketamine-based nasal spray Spravato in the field.Multiple other deals landed in the $10-billion-plus range last year, including Novartis’ move to acquire neuroscience specialist Avidity Biosciences, Pfizer’s buyout of obesity biotech Metsera and Merck & Co.’s deal for Verona Pharma and its blockbuster-to-be in chronic obstructive pulmonary disease (COPD).Pfizer’s play for Metsera, which followed a clear-out of its internal obesity pipeline earlier in 2025, marked one of the year’s most attention-grabbing deals, thanks in no small part to a surprise bid for Metsera from GLP-1 heavyweight Novo Nordisk.While Novo ultimately failed to prevail in that bidding contest, another deal from the Danish Drugmaker ranked on the 2025 leaderboard, with Novo’s $5.2 billion buyout of Akero Therapeutics and its metabolic dysfunction-associated steatohepatitis (MASH) candidate efruxifermin landing in the no. 8 spot on this year’s list.“With $300 [billion] in drug revenue set to lose exclusivity by 2030 and pharma companies holding up to $1.2 [trillion] in acquisition capacity, pressure to rebuild pipelines is intensifying,” Pierre Jacquet, the Boston-based Vice Chair of L.E.K. Consulting’s global healthcare practice, said in a late 2025 statement to Fierce. “Supported by significant patent-cliff risk, strong balance sheets, and improving biotech sentiment, 2026 is likely to see a major acceleration in dealmaking, including 20+ acquisitions over $1 [billion].” Aside from industry watchers at L.E.K. and McKinsey, Gabrielle Witt, an M&A Partner at law firm Hogan Lovells, also pointed to the likelihood that M&A momentum will persist in 2026.Still, mammoth deals like those for Shire, Allergan or Celgene may be off the table for the foreseeable future as drugmakers increasingly seek out selective and strategic acquisitions, especially in fields like rare disease, next-generation biologics and cancer, Impiricus’ chief strategy officer Sandy Donaldson told Fierce last year.“The pipeline gaps, the need for innovation and the more innovation around de-risked models is really kind of driving this M&A growth that we’re seeing,” he added.For comparison, in 2024, the industry charted just one acquisition above the $10 billion threshold, marked by Novo’s $16.5 billion purchase of CDMO giant Catalent. In fact, the majority of deals that ranked on Fierce’s M&A list last year came in below the $5 billion range.At the time, analysts at PwC and Leerink Partners noted that while the overall volume of M&A activity was largely healthy in 2024, total deal value was on the decline.

AcquisitionCell TherapyImmunotherapy

02 Jan 2026

·www.biospace.com

Five Biggest Biopharma Takeovers of 2025

iStock, SvetaZi Four of this year’s biggest acquisitions topped 11-figure figures. One was 2025’s messiest bidding war. After a post-pandemic correction—marked by a nosedive in dealmaking activity , a spike in bankruptcies and dried-up financing —M&A activity finally seemed to pick back up for biopharma in 2025. The year opened with the largest deal that would come: Johnson & Johnson’s $14.6 billion play for Intra-Cellular Therapeutics, putting the pharma in a commanding position in the neuroscience space. This deal also icked off a trend we would see throughout the year. In an industry with an underrepresented by women, many of the big ticket transactions this year invilved companies with a woman CEO. Besides Intra-Cellular, there was plenty of other exciting activity, especially later in the year, which witnessed two big-ticket bidding wars. One, between Novo Nordisk and Pfizer over obesity star Metsera, landed itself in this list by driving Pfizer to double its initial offer. The ordeal was also among the most dramatic public spats between two pharma powerhouses. The other bidding war was between Alkermes and Lundbeck over Avadel . While it got messy and hectic times, the dealmaking activity last year suggests that Big Pharmas have the money to fund hefty purchases—and are willing to spend it. Indeed, as of October 2025, the industry had hit an aggregate takeover value of $70 billion , according to a report from Oppenheimer at the time. This sum already eclipsed the total M&A spend in 2024, 2022 and 2021. Here, BioSpace looks back at the biggest acquisition deals of 2025. J&J Strikes Year’s Largest Deal in January Target: Intra-Cellular Therapies Acquisition date: January 13 Final bid: $14.6 billion 2025 got off to an explosive start when J&J announced in January the acquisition of neurology specialist Intra-Cellular Therapies for an eye-watering $14.6 billion . The deal, which formally closed in April , gave the healthcare giant Caplyta, a daily antipsychotic pill approved for the treatment of schizophrenia and depressive episodes in patients with bipolar I or bipolar II disorder. In November, the FDA approved an expansion for Caplyta as an adjunctive therapy with antidepressants for adults with major depressive disorder (MDD). M&A 5 Women Biotech Leaders Bagging Billions in M&A Dollars Some of the most high-pro in recent years have involved women-fronted biotechs. BioSpace reviews five of the most notable here. July 16, 2025 · 8 min read · Tristan Manalac Aside from Caplyta, J&J also got Intra-Cellular’s clinical pipeline, including the mid-stage ITI-1284, a deuterated form of Caplyta being tested for generalized anxiety disorder, as well as Alzheimer’s disease agitation and psychosis. These assets will complement J&J’s own neuro portfolio, led by the antidepressant nasal spray Spravato and the antipsychotic franchise Invega. Reacting to J&J’s takeover of Intra-Cellular, Stifel analysts wrote in a Jan. 15 note that the pharma’s $14.6-billion vote of confidence “is a much-needed win for the neuroscience space,” breathing life into a field that has notoriously been difficult to succeed in . The deal also set the tone for women-led biotechs securing exits in the double-digit billions, with CEO Sharon Mates, who co-founded Intra-Cellular back in 2002 and served as its chair, president and CEO. Months of Negotiations Land RNA Pipeline for Novartis Target: Avidity Biosciences Acquisition date: October 25 Final bid: $12 billion Joining J&J in giving neuro a nudge is Novartis, which in October put $12 billion on the line to swallow Avidity Biosciences and its portfolio of investigational RNA therapies, landing the second spot on this list. Novartis’ proposal wasn’t always that hefty, however. Regulatory documents released a month later showed that the pharma’s initial offer was $7.4 billion —way too low for the biotech’s CEO Sarah Boyce. Months of negotiation followed, with Novartis upping its bid to $8.5 billion then $10 billion and, lastly, to the final price of $12 billion. Avidity’s pipeline is led by three antibody-oligonucleotide conjugates (AOCs), all of which are in registrational development . These include del-zota for Duchenne muscular dystrophy (DMD), del-desiran for myotonic dystrophy type 1 and del-brax for facioscapulohumeral muscular dystrophy. AOCs consist of a monoclonal antibody to target a specific disease-related protein attached to a short string of nucleotides that produces therapeutic effects. Leveraging this mechanism, del-zota elicited a 25% increase in dystrophin expression in DMD patients, according to a Phase I/II readout in August last year. A week before being acquired by Novartis, Avidity announced that it expects to submit a biologics license application (BLA) for del-zota in the first quarter of 2026. Similarly, del-desiran and del-brax are moving steadily toward registration. The former is in Phase III development with first enrollment in July , while the company opened an accelerated pathway for the latter in June. Aside from del-zota, del-desiran and del-brax, Novartis also picked up other preclinical DMD and rare neuromuscular programs from the acquisition. Avidity also has two early precision cardiology programs that will spin out into a new public company. Mergers & acquisitions Avidity Played Hardball To Land Favorable Terms in $12B Novartis Deal At one point in merger negotiations with Novartis, Avidity CEO Sarah Boyce and her team walked, cutting off access to a data room and moving on to a capital raise. November 25, 2025 · 3 min read · Annalee Armstrong Merck Nabs Approved COPD Drug With $5B Potential Target: Verona Pharma Acquisition date: July 9 Final bid: $10 billion Also breaking the 11-figure mark this year is Verona Pharma, which in July commanded a $10 billion buyout offer from Merck. The centerpiece of the acquisition was Ohtuvayre, which won the FDA’s approval in June 2024 for chronic obstructive pulmonary disease (COPD), opening up a new mechanism of action for the indication for the first time in more than two decades. In the first quarter of this year, before Merck’s takeover, Verona reported around 25,000 prescriptions for Ohtuvayre, bringing in $71.3 million in sales. Jefferies has previously forecasted peak annual sales for Ohtuvayre between $3 billion and $5 billion. Regulatory documents released in August 2025 revealed that Merck was the sole bidder for Verona—despite the biotech starting its search for suitors in 2023. Still, during the duration of its courtship with Merck, which began in February, a handful of other unidentified companies approached Verona to explore the possibility of Ohtuvayre-centered agreements, though none of these worked out. The Merck transaction officially closed in October 2025 . At the time the acquisition was announced, analysts at BMO Capital Markets said that Merck’s $10-billion bet is part of its effort to “to replace commercial revenues now,” before mega-blockbuster cancer drug Keytruda loses patent protections in 2028 . Indeed, the pharma in recent years has gone on a shopping spree, buying Prometheus Biosciences for $10.8 billion in April 2023. M&A Merck Makes Big Respiratory Play With $10B Acquisition of Verona In the second biggest acquisition of the year, Merck gains the commercial COPD drug Ohtuvayre, which could help offset the loss of revenue when Keytruda’s patent expires later this decade. July 9, 2025 · 2 min read · Tristan Manalac Pfizer Battles Novo for the Hottest Obesity Biotech Target: Metsera Acquisition date: November 7 Final bid: $10 billion In November, Pfizer acquired one of the brightest rising stars in the weight-loss game with a $10 billion play for Metsera . The takeover represented Pfizer’s comeback in the obesity arena after scrapping a string of disappointing assets over the years, and the pharma had to work extra hard for its prize. Pfizer’s first bid for Metsera was a relatively modest $4.9 billion, which the biotech accepted in September. A month later, however, Novo Nordisk filed an unsolicited rival bid of $8.5 billion to snatch Metsera out from under Pfizer. Metsera dubbed the proposal “superior” to Pfizer’s offer and set off a clock for negotiations. Pfizer bristled at these developments and called Novo’s rival proposal “reckless and unprecedented.” Later, the pharma also claimed that Metsera’s controlling stockholders—including the investors ARCH Venture Fund and Validae Health—“conspired” with Metsera and Novo to promote “anti-competitive activities.” Pfizer sued both Novo and Metsera to stop what it called the “tortious interference” from Novo “to suppress competition.” At one point, the U.S. Federal Trade Commission, joined the fray and wrote to both Novo and Metsera, warning them that the proposed deal structure may be in violation of U.S. merger guidelines. All the while, Novo stood by its decision to try to steal Metsera away—no matter how unpopular it was—upping the bid to $10 billion. Novo’s new CEO, Maziar Mike Doustdar , even goaded Pfizer from the White House. “Our message to Pfizer is that if they would like to buy the company, then put your hand in the pocket and bid higher,” Doustdar said during an event for a drug pricing deal with the government for its GLP-1 drugs. Ultimately, that’s what Pfizer did. The pharma eventually matched Novo’s offer, finally convincing its rival to back down and Metsera to accept the proposal. Obesity Is Metsera Worth the Fuss? Pfizer and Novo Nordisk seem to want Metsera bad. Analysts are wondering, though: Is the obesity biotech really worth this much effort? November 5, 2025 · 4 min read · Annalee Armstrong Sanofi Takes Over Rising Cancer Star Target: Blueprint Medicines Acquisition date: June 2 Final bid: $9.5 billion Closing out this list is the mid-year merger between Sanofi and rare disease specialist Blueprint Medicines, led by CEO Kate Haviland, the third female leader on this list. The companies in June agreed to a $9.5 billion acquisition deal , giving Sanofi the FDA-approved systemic mastocytosis drug Ayvakit and a pipeline of investigational immunology and cancer therapies. In 2024, Ayvakit made $479 million . Because of the Sanofi takeover, Blueprint hasn’t reported sales figures for Ayvakit for the latter half of the year, but the pharma in its Q3 business report credited the drug as being partly responsible for a 57.1% increase in sales. Speaking to analysts in a call after the acquisition, Sanofi’s head of specialty care Brian Foard said that Ayvakit’s launch was “just getting started” and that the pharma sees a lot of long-term potential for the drug. Beyond Ayvakit, Sanofi also got elenestinib, a KIT blocker for systemic mastocytosis. Blueprint’s pipeline also includes BLU-808, in early-stage development for chronic urticaria, allergic rhinoconjunctivities, allergic asthma and mast cell activation syndrome. Blueprint is also bringing to the Sanofi fold several discovery-phase assets for various cancers, including breast cancer and other solid tumors. All told, Leerink analysts in a June 2 note estimated that Blueprint’s revenues could hit $2.1 billion by 2030—though to hit this bar, Sanofi “will need to deliver on its plans to find and treat more patients.” And, for the acquisition to pay off, “it is critical, in our view, that BPMC’s pipeline delivers blockbuster revenue over the long term,” Leerink added. Sanofi closed the Blueprint deal in July, a month after it was announced. .responsive-container { display: flex; flex-wrap: wrap; border: 1px solid #ededed; font-family: Helvetica, Arial, Sans-Serif; padding: 20px 20px 10px 20px; } .column-left { flex: 1; max-width: 45%; padding: 20px 20px 10px 20px; } .column-right { flex: 2; padding: 20px 20px 10px 20px; } @media (max-width: 768px) { .column-left, .column-right { max-width: 100%; flex: 100%; padding: 10px 0; } } Subscribe to BioPharm Executive! Market insights, trending business and policy stories for biopharma leaders hbspt.forms.create({ region: "na1", portalId: "4413123", formId: "7c139b3c-ff0b-44e0-bffe-f449801dca59", onFormSubmitted: function($form, data) { window.dataLayer = window.dataLayer || []; window.dataLayer.push({ 'event': 'GTMevent', 'event_name': 'newsletter_sign_up' }); } });

AcquisitionDrug ApprovalPhase 3OligonucleotideImmunotherapy

100 Deals associated with Lumateperone Tosylate

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KEGG	Wiki	ATC	Drug Bank
D11170	Lumateperone Tosylate	N05A	DB06077

R&D Status

Approved

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Indication	Country/Location	Organization	Date
Depressive Disorder	United States	Johnson & Johnson	07 Nov 2025
Depressive Disorder, Major	United States	Intra-Cellular Therapies, Inc.	05 Nov 2025
Bipolar Disorder	United States	Intra-Cellular Therapies, Inc.	17 Dec 2021
Schizophrenia	United States	Intra-Cellular Therapies, Inc.	20 Dec 2019

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Irritable Mood	Phase 3	United States	Intra-Cellular Therapies, Inc.	22 Nov 2024
Bipolar I disorder	Phase 3	United States	Intra-Cellular Therapies, Inc.	19 Jun 2024
Bipolar I disorder	Phase 3	Bulgaria	Intra-Cellular Therapies, Inc.	19 Jun 2024
Bipolar I disorder	Phase 3	Croatia	Intra-Cellular Therapies, Inc.	19 Jun 2024
Bipolar I disorder	Phase 3	India	Intra-Cellular Therapies, Inc.	19 Jun 2024
Bipolar I disorder	Phase 3	Serbia	Intra-Cellular Therapies, Inc.	19 Jun 2024
Mania	Phase 3	United States	Intra-Cellular Therapies, Inc.	19 Jun 2024
Mania	Phase 3	Bulgaria	Intra-Cellular Therapies, Inc.	19 Jun 2024
Mania	Phase 3	Croatia	Intra-Cellular Therapies, Inc.	19 Jun 2024
Mania	Phase 3	India	Intra-Cellular Therapies, Inc.	19 Jun 2024

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04779177 (CTgov)	Phase 1	Schizoaffective disorder \| Schizophrenia	26	Lumateperone 42 mg	qiijaigvcb(etuvqcsasa) = vthtvbzaom fydljzfbbk (wjcgvpgfvx, 11.21) View more	-	12 Nov 2025
NCT02600494 (CTgov)	Phase 3	Bipolar Disorder \| Bipolar II disorder \| Depressive Disorder, Major	554	Placebo	zbrjtfrfor(dxxndgyusv) = tezvnbnumq hgmnjfzcuy (ovhajcaeze, 1.11) View more	-	03 Nov 2025
NCT05061719 (CTgov)	Phase 3	Depressive Disorder, Major	812	Lumateperone	imkneiohro = rtpwecpdac ejndlibqfn (mybrjkzjli, nzvdrrujxc - oelzgfxfrv) View more	-	03 Nov 2025
NCT01499563 (CTgov)	Phase 2	Schizophrenia	335	Placebo	gklnhsjivc(tmjlfqrehi) = gqhuxqraef hbxjjlebxj (auvnlmoatz, 1.7) View more	-	03 Oct 2025
NCT02469155 (CTgov)	Phase 3	Schizophrenia	696	ITI-007 (Lumateperone 14 mg (ITI-007 20 mg Tosylate))	ibvlmwpbns(wvdyudoyre) = hvgajyucua ympvidjmsw (guyqsjmdaj, 1.27) View more	-	02 Oct 2025
				ITI-007 (Lumateperone 42 mg (ITI-007 60 mg Tosylate))	ibvlmwpbns(wvdyudoyre) = fyaycedrzt ympvidjmsw (guyqsjmdaj, 1.23) View more
NCT02282761 (CTgov)	Phase 3	Schizophrenia	450	ITI-007 (Lumateperone 28 mg (ITI-007 40 mg Tosylate))	yhffviqyxu(hikhmpnsdv) = pzghsqolei gpciefxhcd (ikcwotzspj, 1.27) View more	-	02 Oct 2025
				ITI-007 (Lumateperone 42 mg (ITI-007 60 mg Tosylate))	yhffviqyxu(hikhmpnsdv) = urxnybfzig gpciefxhcd (ikcwotzspj, 1.25) View more
NCT04985942 (CTgov)	Phase 3	Depressive Disorder, Major	485	Lumateperone (Lumateperone 42 mg)	nrclfypkwv(bjgsewgare) = tgornorgrs cksvnygbbf (vrgpxprsut, 0.54) View more	-	02 May 2025
				Placebo (Placebo)	nrclfypkwv(bjgsewgare) = yrtckywvsn cksvnygbbf (vrgpxprsut, 0.53) View more
NCT05061706 (ITI-007-502, CTgov)	Phase 3	Depressive Disorder, Major	480	Lumateperone (Lumateperone 42 mg)	ewdabazdnm(kmeikdpkcz) = lxuvsjnmjm hyeugehylp (ypgvrptdrs, 0.56) View more	-	25 Mar 2025
				Placebo (Placebo)	ewdabazdnm(kmeikdpkcz) = avqptkumaz hyeugehylp (ypgvrptdrs, 0.54) View more
NCT04285515 (CTgov)	Phase 3	Bipolar Disorder \| Bipolar II disorder \| Depressive Disorder, Major	488	Lumateperone (Lumateperone 42mg)	ptjwhkmkbb(gapvlcfwyc) = zrfcwfkijw ppxnaddavy (jztlwrbtki, 0.71) View more	-	19 Mar 2025
				Placebos (Placebo)	ptjwhkmkbb(gapvlcfwyc) = csfauegqxq ppxnaddavy (jztlwrbtki, 0.70) View more
NCT04959032 (Company_Website) Manual	Phase 3	Schizophrenia	228	Lumateperone 42 mg	vhysssurju(stkxkmrhrl) = efhucridjd ivqahhlwts (zvmphxemvp ) Met	Positive	05 Nov 2024
				Placebo	vhysssurju(stkxkmrhrl) = aluxqscnua ivqahhlwts (zvmphxemvp ) Met

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