Caplyta (lumateperone) / J&J - LARVOL DELTA

Lumateperone Added to Antidepressant Therapy in Adults With Major Depressive Disorder Experiencing Emotional Blunting (clinicaltrials.gov) - P4 | N=30 | Not yet recruiting | Sponsor: Future Options Research, LLC

New P4 trial • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

Lumateperone as Adjunctive Therapy in Patients With Major Depressive Disorder and Anxious Distress: Post Hoc Analysis of a Phase 3, Randomized, Double-Blind Trial. (PubMed, J Clin Psychiatry) - P3 | " Adjunctive lumateperone 42 mg significantly improved depression and anxiety symptoms in patients with MDD with inadequate ADT response and anxious distress. Trial Registration: ClinicalTrials.gov identifier: NCT04985942."

Clinical • Journal • P3 data • Retrospective data • CNS Disorders • Depression • General Anxiety Disorder • Major Depressive Disorder • Mood Disorders • Psychiatry

Caplyta Versus Placebo for Adults With Social Anxiety Disorder (clinicaltrials.gov) - P4 | N=40 | Recruiting | Sponsor: Jason Careri | Not yet recruiting ➔ Recruiting

Enrollment open • CNS Disorders • Mood Disorders • Psychiatry • Social Anxiety Disorder

The Effects of Lumateperone on Obesity and Physiologic Aging and Their Association With Antidepressant Response in Bipolar Depression (clinicaltrials.gov) - P4 | N=25 | Recruiting | Sponsor: Massachusetts General Hospital | Not yet recruiting ➔ Recruiting

Enrollment open • Bipolar Disorder • CNS Disorders • Depression • Genetic Disorders • Mood Disorders • Obesity • Psychiatry

Lumateperone-induced mania: A case series. (PubMed, Indian J Psychiatry) - "Alternative causes were excluded, symptoms resolved after discontinuing lumateperone and optimizing mood stabilizers, and Naranjo scores (7-8) indicated a probable drug association. Lumateperone may precipitate mania in susceptible individuals, highlighting the need for close monitoring during the early treatment period."

Journal • Bipolar Disorder • CNS Disorders • Depression • Mood Disorders • Psychiatry

Long-term safety and tolerability of lumateperone 42 mg in patients with stable symptoms of schizophrenia: Results from a 1-year open-label study. (PubMed, Schizophr Res) - "Lumateperone 42 mg demonstrated a favorable safety profile with improvements in cardiometabolic and prolactin parameters and a low EPS risk and maintenance of stable symptoms of schizophrenia over 1-year treatment."

Journal • CNS Disorders • Depression • Dyslipidemia • Pain • Psychiatry • Schizophrenia • Xerostomia

Evaluation of Sexual Function With Adjunctive Lumateperone in Patients With Major Depressive Disorder. (PubMed, J Clin Psychiatry) - P3 | " Adjunctive lumateperone 42 mg did not worsen sexual functioning and was not associated with treatment-related sexual dysfunction in patients with MDD with inadequate response to ADT. Trial Registration: ClinicalTrials.gov identifier: NCT05061706."

Clinical • Journal • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry • Schizophrenia • Sexual Disorders

Caplyta Versus Placebo for Adults With Social Anxiety Disorder (clinicaltrials.gov) - P4 | N=40 | Not yet recruiting | Sponsor: Jason Careri

New P4 trial • CNS Disorders • Mood Disorders • Psychiatry • Social Anxiety Disorder

Evidence based interventions for bipolar disorder across phases and age groups: living umbrella review, evaluation, analysis, and communication hub (U-REACH) project. (PubMed, BMJ) - "The EBI-BD tool can help clinicians make evidence based, personalised treatment decisions for bipolar disorder. This resource can inform clinical guidelines and provides a foundation for continuously improving bipolar disorder care as new evidence emerges."

Journal • Review • Bipolar Disorder • CNS Disorders • Depression • Mood Disorders • Psychiatry

CANDLE: A Study of Lumateperone Versus Placebo in Participants With Major Depressive Disorder (clinicaltrials.gov) - P3 | N=585 | Not yet recruiting | Sponsor: Intra-Cellular Therapies, Inc.

Monotherapy • New P3 trial • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

IRL Grey-C: Lumateperone for Late-Life Depression (clinicaltrials.gov) - P3 | N=100 | Recruiting | Sponsor: Eric Lenze | Not yet recruiting ➔ Recruiting

Enrollment open • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

Systematic review and network meta-analysis of the efficacy, safety and tolerability of xanomeline plus trospium chloride compared with eight oral antipsychotics for the acute treatment of schizophrenia. (PubMed, J Comp Eff Res) - "KarXT was associated with greater odds of clinical response (≥30% improvement in PANSS total score) than aripiprazole (odds ratio [OR]: 1.85; 95% credible interval [CrI]: 1.11, 3.11), brexpiprazole (OR: 2.23; 95% CrI: 1.34, 3.83) and cariprazine (OR: 2.05; 95% CrI: 1.19, 3.57); improved change from baseline (CFB) PANSS positive symptoms score versus brexpiprazole; improved CFB CGI-S score against aripiprazole, brexpiprazole, cariprazine and olanzapine; reduced odds of clinically significant (≥7%) weight gain over all comparators except clozapine (no data); improved CFB weight against brexpiprazole, clozapine, olanzapine, quetiapine and risperidone; and greater odds of all-cause discontinuation than aripiprazole, brexpiprazole, clozapine, lumateperone, olanzapine, quetiapine and risperidone. In this NMA, for patients receiving acute treatment for schizophrenia, KarXT compared favorably with second-generation antipsychotics on key efficacy endpoints and in terms of..."

Journal • Retrospective data • Anesthesia • CNS Disorders • Psychiatry • Schizophrenia

Lumateperone in the Treatment of Stuttering, Childhood Onset Fluency Disorder (clinicaltrials.gov) - P2 | N=24 | Recruiting | Sponsor: CSTrials Inc.

New P2 trial

Study of Lumateperone in the Treatment of Patients With Bipolar Mania (clinicaltrials.gov) - P3 | N=351 | Completed | Sponsor: Intra-Cellular Therapies, Inc. | Recruiting ➔ Completed

Trial completion • Bipolar Disorder • CNS Disorders • Mood Disorders • Psychiatry

Safety, Tolerability and Pharmacokinetics of Lumateperone in Pediatric Patients With Autism Spectrum Disorder (clinicaltrials.gov) - P1 | N=33 | Completed | Sponsor: Intra-Cellular Therapies, Inc. | Recruiting ➔ Completed | Trial completion date: Jul 2026 ➔ Nov 2025 | Trial primary completion date: Jul 2026 ➔ Nov 2025

Trial completion • Trial completion date • Trial primary completion date • Autism Spectrum Disorder • Genetic Disorders • Pediatrics

Study of Lumateperone in the Acute Treatment of Patients With Bipolar Mania (clinicaltrials.gov) - P3 | N=354 | Completed | Sponsor: Intra-Cellular Therapies, Inc. | Recruiting ➔ Completed

Trial completion • Bipolar Disorder • CNS Disorders • Mood Disorders • Psychiatry

A high-throughput lC-MS/mS method for simultaneous determination of lumateperone and its four metabolites in human plasma: application to a clinical trial. (PubMed, Xenobiotica) - P=N/A | "Lumateperone is an antipsychotic metabolised to four active metabolites IC200131, IC200161, IC200565 and IC201308, which are closely related to its clinical efficacy and safety.2. This study reports the first comprehensive pharmacokinetic profiles of lumateperone and its four active metabolites in Chinese subjects. The validated method provides a robust foundation for pharmacokinetic research of lumateperone in humans."

Journal • CNS Disorders

Safety and Tolerability of Adjunctive Lumateperone for the Treatment of Major Depressive Disorder: A Pooled Analysis of Two Randomized Placebo-Controlled Trials. (PubMed, CNS Drugs) - P3 | "Lumateperone 42 mg + ADT had a good safety profile and was generally well tolerated in this pooled analysis, with low risks of weight gain, cardiometabolic abnormalities, and EPS with short-term treatment but with higher discontinuation rates because of adverse events (8.7%) versus placebo + ADT, in patients with major depressive disorder with inadequate ADT response."

Clinical • Journal • Retrospective data • CNS Disorders • Depression • Fatigue • Major Depressive Disorder • Mental Retardation • Mood Disorders • Movement Disorders • Psychiatry • Suicidal Ideation • Xerostomia

Johnson & Johnson reports Q2 2026 results, raises 2026 outlook (Businesswire) - "2026 Second-Quarter reported sales growth of 6.6% to $25.3 Billion with operational growth of 5.6% and adjusted operational growth of 5.7%...Advancing significant innovation for patients with approvals of TREMFYA to inhibit the progression of structural joint damage in adults with active psoriatic arthritis, CAPLYTA for the prevention of relapse in schizophrenia...fortifying future with data from RYBREVANT FASPRO in advanced head and neck cancer, TALVEY plus DARZALEX FASPRO in earlier-line relapsed or refractory multiple myeloma..."

Commercial • Multiple Myeloma • Psoriatic Arthritis • Schizophrenia • Squamous Cell Carcinoma of Head and Neck

The Effects of Lumateperone on Obesity and Physiologic Aging and Their Association With Antidepressant Response in Bipolar Depression (clinicaltrials.gov) - P4 | N=25 | Not yet recruiting | Sponsor: Massachusetts General Hospital

New P4 trial • Bipolar Disorder • CNS Disorders • Depression • Genetic Disorders • Mood Disorders • Obesity • Psychiatry

Study of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder (clinicaltrials.gov) - P3 | N=470 | Recruiting | Sponsor: Intra-Cellular Therapies, Inc. | Trial completion date: Oct 2026 ➔ Apr 2027 | Trial primary completion date: Sep 2026 ➔ Apr 2027

Trial completion date • Trial primary completion date • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

Safety and Tolerability Trial of Lumateperone in Pediatric Patients With Schizophrenia, Bipolar Disorder or Autism Spectrum Disorder (clinicaltrials.gov) - P3 | N=300 | Recruiting | Sponsor: Intra-Cellular Therapies, Inc. | N=500 ➔ 300 | Trial completion date: Dec 2027 ➔ Apr 2032 | Trial primary completion date: Dec 2027 ➔ Apr 2032

Enrollment change • Trial completion date • Trial primary completion date • Autism Spectrum Disorder • Bipolar Disorder • CNS Disorders • Genetic Disorders • Mood Disorders • Pediatrics • Psychiatry • Schizophrenia

ITI-007-602: Multicenter Study of Lumateperone for the Treatment of Irritability Associated With Autism Spectrum Disorder (ASD) in Pediatric Patients (clinicaltrials.gov) - P3 | N=160 | Recruiting | Sponsor: Intra-Cellular Therapies, Inc. | Trial primary completion date: Mar 2027 ➔ Jun 2027

Trial primary completion date • Autism Spectrum Disorder • Genetic Disorders • Pediatrics

ITI-007-601: Multicenter Study of Lumateperone for the Treatment of Irritability Associated With Autism Spectrum Disorder in Pediatric Patients (clinicaltrials.gov) - P3 | N=160 | Recruiting | Sponsor: Intra-Cellular Therapies, Inc. | Trial completion date: Apr 2027 ➔ Jul 2027 | Trial primary completion date: Mar 2027 ➔ Jun 2027

Trial completion date • Trial primary completion date • Autism Spectrum Disorder • Genetic Disorders • Pediatrics

Multicenter Study of Lumateperone for the Treatment of Bipolar Depression in Pediatric Patients (clinicaltrials.gov) - P3 | N=384 | Recruiting | Sponsor: Intra-Cellular Therapies, Inc. | Trial completion date: May 2027 ➔ Oct 2031 | Trial primary completion date: Apr 2027 ➔ Oct 2031

Trial completion date • Trial primary completion date • Bipolar Disorder • CNS Disorders • Depression • Mood Disorders • Pediatrics • Psychiatry