This study aims to compare the efficacy and safety of lumateperone and cariprazine as adjuncts in patients with depression associated with bipolar I using standardized efficacy assessment tools such as the Montgomery-Åsberg Depression Rating Scale (MADRS) and Clinical Global Impression bipolar severity scale (CGI-BP-S) and recording treatment emergent adverse effect.
Participants will undergo baseline assessment on day 0 using these scales. Follow-up assessments using MADRS and CGI scales will be conducted at Day 15, Day 30 and Day 45. Safety analysis will be performed for all participants who receive at least one dose of study medication. Vitals and treatment-emergent adverse events (TEAEs) will be recorded at every visit

Start Date01 Dec 2026

Sponsor / Collaborator-

NCT07747389

/ Not yet recruitingPhase 3

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of Fixed Doses of Lumateperone Administered as Monotherapy in Participants With Major Depressive Disorder and an Open-label Long-term Extension Treatment With Lumateperone

The purpose of the study is to assess how well each dose of lumateperone (Dose 1 and 2) works when given alone as compared to placebo in participants with major depressive disorder (MDD; a medical condition characterized by a persistent feeling of deep sadness, hopelessness, and a loss of interest in activities for a prolonged period of time and interfere with ability to function).

Start Date20 Oct 2026

Sponsor / Collaborator

Intra-Cellular Therapies, Inc.

NCT07623135

/ RecruitingPhase 3IIT

Lumateperone for Late-Life Depression

The purpose of this research study is to examine how well a medication called lumateperone (Caplyta) works to relieve depression in older adults with treatment-resistant depression. Lumateperone (Caplyta) is approved by the U.S. Food and Drug Administration to treat Major Depressive Disorder in adults who are also taking another antidepressant medication. This study will compare lumateperone (Caplyta) to placebo (a sugar pill without medication).

Start Date01 Aug 2026

Sponsor / Collaborator

Washington University School of Medicine

[+2]

100 Clinical Results associated with Lumateperone Tosylate

100 Translational Medicine associated with Lumateperone Tosylate

100 Patents (Medical) associated with Lumateperone Tosylate

145

Literatures (Medical) associated with Lumateperone Tosylate

01 Nov 2026·JOURNAL OF AFFECTIVE DISORDERS

Efficacy, acceptability, and related outcomes of pharmacological interventions for acute bipolar depression: A systematic review and dose-related network meta-analysis across different age groups

Review

Author: Vieta, Eduard ; Oliva, Vincenzo ; De Prisco, Michele ; Di Lorenzo, Chiara ; Fornaro, Michele

BACKGROUND:

Acute bipolar depression poses a significant burden and socioeconomic costs. We investigated the comparative efficacy/response/acceptability of pharmacological interventions for acute bipolar depression, considering dose effects across different age groups.

METHODS:

We conducted a network meta-analysis (NMA), searching for randomized controlled trials (RCTs) comparing pharmacological interventions against each other/or placebo in patients with acute bipolar depression (Type-I/Type-II/other), indexed in PubMed/MEDLINE, Embase, Web-of-Science/and Scopus (database inception up to 2025.11.25). Co-primary outcomes were change in depressive symptoms/response/and acceptability. Tolerability/remission/change in anxious symptoms/and risk-of-manic/hypomanic switches were secondary outcomes. Confidence-In-Network-Meta-Analysis was likewise appraised.

RESULTS:

103 RCTs, encompassing 71 distinct treatment combinations, included 20,941 participants. Sensitivity analysis including low-risk-of-bias studies only and excluding outliers for possible effect modifiers indicated that lamotrigine 50 mg/day or 200 mg/day, quetiapine extended-release 150 mg/day and 300 mg/day, and lumateperone 42 mg/day outperformed placebo for depressive symptoms, with estimates ranging from -1.53(95%C.I. = -2.13;-0.93) for lamotrigine 50 mg/day, to -0.36(95%C.I. = -0.68;-0.04) for lumateperone 42 mg/day. Several additional drugs might be efficacious, although they emerged as outliers for either mean age of participants/proportion of females/BD-II participants/psychotic features/rapid cycling/baseline severity of depression/and trial duration. No treatment outperformed placebo for response/remission/acceptability/tolerability/and manic/hypomanic switches.

CONCLUSIONS:

Our findings are consistent with previous NMAs and current guidelines, thereby expanding knowledge by concurrently appraising different drugs, doses, and age groups.

01 Jul 2026·EUROPEAN NEUROPSYCHOPHARMACOLOGY

Long-term adjunctive lumateperone 42 mg treatment in major depressive disorder: Results from a 6-month open-label extension study

Article

Author: Cutler, Andrew J ; Kozauer, Susan G ; Lakkis, Hassan ; Earley, Willie R ; Durgam, Suresh ; Chen, Changzheng

This Phase 3 open-label extension study (NCT05061719) investigated long-term safety of lumateperone 42mg (simultaneous modulator of serotonin, dopamine, and glutamate neurotransmission) adjunctive to antidepressant therapy (ADT) in patients with major depressive disorder (MDD) with inadequate ADT response. Eligible adults (18-65years) completed 6-week double-blind treatment (NCT04985942; NCT05061706) and had DSM-5-defined MDD with inadequate response to 1-2 ADTs in the current depressive episode, Montgomery-Åsberg Depression Rating Scale (MADRS) Total score ≥24, and Clinical Global Impression-Severity (CGI-S) score ≥4 at lead-in study entry. Patients received 26-week, open-label, oral lumateperone 42mg+ADT once-daily. The primary endpoint was safety/tolerability, assessed by adverse events (AEs), vital signs, and laboratory parameters. The secondary endpoint was efficacy, assessed by MADRS Total score and CGI-S score changes from double-blind baseline to open-label Week 26. Of 809 patients treated, 84.5% completed open-label treatment; 67.7% experienced ≥1 treatment-emergent AE (TEAE). Most common TEAEs (≥5%) were headache (16.6%), dizziness (10.6%), dry mouth (8.0%), nausea (7.7%), somnolence (7.2%), diarrhea (6.2%), and nasopharyngitis (5.2%). The majority (98.9%) of TEAEs were mild-to-moderate severity. Rate of extrapyramidal symptom (EPS)-related TEAEs per broad standardized MedDRA query was low (3.8%). No notable changes in EPS scales, body morphology, or cardiometabolic parameters occurred from double-blind baseline to end of open-label treatment. No emergence of suicidal behavior occurred during treatment. Symptoms of depression improved with lumateperone+ADT from double-blind baseline to open-label Week 26 (mean change: MADRS Total score=-22.9, P<.0001; CGI-S score=-2.7, P<.0001). Overall, lumateperone 42mg+ADT was safe and effective during 26-week treatment in patients with MDD with inadequate ADT response.

01 Jul 2026·EUROPEAN NEUROPSYCHOPHARMACOLOGY

Treatment of bipolar depression: results from a comprehensive network meta-analysis and updated systematic review

Review

Author: Vieta, Eduard ; Yildiz, Ayşegül ; Leucht, Stefan ; Yalin, Nefize ; Siafis, Spyridon

Depressive episodes present a treatment challenge in bipolar disorder (BD), and an urgent need exists for novel treatment options. This review sought to revisit the results from a recent network meta-analysis (NMA) that examined treatment options for bipolar depression and to update those findings with a complementary systematic review (PROSPERO-ID: CRD42020171726). The NMA was based on the qualitative synthesis of 145 studies and the quantitative analysis of 101 studies investigating acute depression in adults with bipolar depression from inception to April 2023. A complementary systematic review was conducted using MEDLINE, OVID, EMBASE, PsychINFO, CINAHL, LILACS, Cochrane, Web of Science Core Collaboration, and Google Scholar databases from April 2023 to November 2024 to identify the most recent randomized controlled trials on the treatment of bipolar depression. Studies identified via systematic review were subjected to narrative synthesis and quality assessment was completed using revised Cochrane risk of bias tool. The original NMA showed that olanzapine plus fluoxetine, quetiapine, olanzapine, lurasidone, lumateperone, cariprazine, and lamotrigine were more efficacious than placebo in reducing depressive symptoms in BD with good confidence. Several other drugs might also be efficacious, but confidence in the evidence was very low to low. The complementary systematic review identified 24 clinical trials, seven of which had published results suitable for meta-analysis; the remaining 17 studies were either ongoing or completed with no available results. Collectively, the NMA and systematic review findings can inform evidence-based care and the development of international treatment guidelines for bipolar depression.

163

News (Medical) associated with Lumateperone Tosylate

03 Aug 2026

·www.biospace.com

Helus Pharma Appoints Michael Halstead as Chief Executive Officer

Former President of Intra-Cellular Therapies, Inc. was instrumental in building and scaling the company, which was subsequently acquired by Johnson & Johnson Experienced executive with a proven track record of guiding pharmaceutical companies through late-stage clinical development and commercialization Appointed as Helus Pharma prepares for topline data readout from APPROACH, the first pivotal Phase 3 Study of HLP003 as an adjunctive treatment for Major Depressive Disorder (“MDD”), expected in Q4 2026 This news release constitutes a “designated news release” for the purpose of the Company’s prospectus supplement dated December 30, 2025, to its short form base shelf prospectus dated September 17, 2025, as amended on December 19, 2025. ezstandalone.cmd.push(function () { ezstandalone.showAds(131); }); NEW YORK and TORONTO, Aug. 03, 2026 (GLOBE NEWSWIRE) -- Helus Pharma (Nasdaq: HELP) (Cboe CA: HELP) (the “Company” or “Helus Pharma”), a clinical-stage pharmaceutical company committed to helping minds heal by developing novel serotonergic agonists (“NSAs”), today announced the appointment of Michael Halstead as Chief Executive Officer, effective immediately. Mr. Halstead’s appointment comes as Helus Pharma advances HLP003 through late-stage clinical development and prepares for potential commercialization. Enrollment is complete in APPROACH, with topline data expected in Q4 2026, while enrollment continues in EMBRACE, the second pivotal study in the Phase 3 PARADIGM program. Participant rollover is ongoing into EXTEND, the long-term extension study. Mr. Halstead brings 25 years of industry experience, most recently serving as President of Intra-Cellular Therapies, Inc. (“Intra-Cellular”). During his tenure at Intra-Cellular, he played a pivotal role in transforming the company from an early-stage clinical development organization into a fully integrated commercial biopharmaceutical enterprise. He was instrumental in the successful development, launch, and commercialization of CAPLYTA® (lumateperone), which has received approvals across multiple indications, including schizophrenia, bipolar depression and the adjunctive treatment of major depressive disorder. Mr. Halstead also supported the advancement of the company’s pipeline programs in generalized anxiety disorder and neuropsychiatric symptoms associated with Alzheimer’s disease. In addition, he managed multiple equity offerings and led the company’s US$14.6 billion sale to Johnson & Johnson in 2025. “Mr. Halstead’s leadership and operational experience guiding pharmaceutical companies through late-stage development, infrastructure buildout, and commercialization will be invaluable as we execute against our upcoming HLP003 and HLP004 clinical, regulatory, and commercial milestones,” said Eric So, Co-Founder and Executive Chairman. “I’m honored to join the Helus Pharma team at this crucial stage in the Company’s evolution,” said Mr. Halstead. “HLP003, a potential differentiated new option in the adjunctive treatment landscape for MDD, and HLP004, a compelling short-acting compound in development for generalized anxiety disorder, position Helus Pharma to pursue a unique approach focused on the outcomes that matter most to patients.” “The clinical results in the HLP003 program to date suggest the potential to transform the treatment paradigm for MDD. I am impressed with the program’s rigor and focus on providing the optimal solution for patients, providers, and payors. The Company’s intellectual property portfolio of more than 350 patent applications and more than 100 granted patents worldwide provide a solid foundation for continued growth,” concluded Mr. Halstead. Prior to his time at Intra-Cellular, Mr. Halstead held senior leadership roles at Warner Chilcott plc where he oversaw major strategic initiatives, including the US$3 billion acquisition of Procter & Gamble’s pharmaceutical business in 2009 and the integration of its approximately 2,000 employees across multinational operations and Warner Chilcott’s US$8.5 billion sale to Actavis in 2013. Mr. Halstead holds a J.D. from Villanova University Charles Widger School of Law and a B.A. in International Relations from Boston University. About Helus Pharma Helus Pharma™, the commercial operating name of Cybin Inc., is a clinical-stage pharmaceutical company committed to helping minds heal by developing proprietary NSAs, synthetic molecules designed to activate serotonin pathways that are believed to promote neuroplasticity. The Company’s proprietary NSAs are intended to address the large unmet need for people who suffer from depression, anxiety, and other mental health conditions. With class-leading data, Helus Pharma aims to improve the treatment landscape through the introduction of NSAs that aim to provide durable improvements in mental health. Helus Pharma is currently developing HLP003, a proprietary NSA, in Phase 3 clinical development for the adjunctive treatment of MDD that has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration and HLP004, also a proprietary NSA in Phase 2 for GAD. Additionally, Helus Pharma has an extensive research portfolio of investigational NSAs. The Company operates in Canada, the United States, the United Kingdom, and Ireland. For Company updates and to learn more about Helus Pharma, visit or follow the team on X, LinkedIn, YouTube and Instagram. Helus Pharma™ is a trademark of Helus Pharma Corp. Cautionary Notes and Forward-Looking Statements Certain statements in this news release relating to the Company are forward-looking statements or forward-looking information within the meaning of applicable securities laws (collectively, “forward-looking statements”) and are prospective in nature. Forward-looking statements are not based on historical facts, but rather on current expectations and projections about future events and are therefore subject to risks and uncertainties which could cause actual results to differ materially from the future results expressed or implied by the forward-looking statements. These statements generally can be identified by the use of forward-looking words such as “may”, “should”, “could”, “potential”, “possible”, “intend”, “estimate”, “plan”, “anticipate”, “expect”, “believe” or “continue”, or the negative thereof or similar variations. Forward-looking statements in this news release include statements regarding the Company’s plan to readout HLP003 topline data in the fourth quarter of 2026; the Company’s expectation that HLP003 will be a differentiated new option in the adjunctive landscape for patients living with MDD; the potential of HLP003 to transform the treatment paradigm for MDD; the potential of HLP003 to meaningfully improve outcomes for patients living with MDD; the commercialization of HLP003; the Company’s continued growth; and plans to engineer proprietary drug discovery platforms, innovative drug delivery systems, novel formulation approaches and treatment regimens for mental health conditions. These forward-looking statements are based on reasonable assumptions and estimates of management of the Company at the time such statements were made. Actual future results may differ materially as forward-looking statements involve known and unknown risks, uncertainties, and other factors which may cause the actual results, performance, or achievements of the Company to materially differ from any future results, performance, or achievements expressed or implied by such forward-looking statements. Such factors, among other things, include: fluctuations in general macroeconomic conditions; fluctuations in securities markets; expectations regarding the size of the NSA market; the ability of the Company to successfully achieve its business objectives; plans for growth; political, social and environmental uncertainties; employee relations; the presence of laws and regulations that may impose restrictions in the markets where the Company operates; implications of disease outbreaks on the Company's operations; and the risk factors set out in each of the Company's management's discussion and analysis for the year ended March 31, 2026, and the Company’s annual information form for the year ended March 31, 2026, which are available under the Company's pro SEDAR+ at and with the U.S. Securities and Exchange Commission on EDGAR at Although the forward-looking statements contained in this news release are based upon what management of the Company believes, or believed at the time, to be reasonable assumptions, the Company cannot assure shareholders that actual results will be consistent with such forward-looking statements, as there may be other factors that cause results not to be as anticipated, estimated or intended. Readers should not place undue reliance on the forward-looking statements contained in this news release. The Company assumes no obligation to update the forward-looking statements of beliefs, opinions, projections, or other factors, should they change, except as required by law. The Company makes no medical, treatment or health benefit claims about the Company’s proposed products. The FDA, Health Canada or other similar regulatory authorities have not evaluated claims regarding NSAs or HLP003, HLP004 and other programs of the Company. The efficacy of such products has not been confirmed by approved research. There is no assurance that the use of NSAs, HLP003, HLP004 or other programs of the Company can diagnose, treat, cure or prevent any disease or condition. Rigorous scientific research and clinical trials are needed. If Helus Pharma cannot obtain the approvals or research necessary to commercialize its business, it may have a material adverse effect on the Company’s performance and operations. Neither Cboe Canada, nor the Nasdaq Global Market stock exchange, have approved or disapproved the contents of this news release and are not responsible for the adequacy and accuracy of the contents herein. Investor Contact: Matthew Beck astr partners Managing Partner (917) 415-1750 Matthew.beck@astrpartners.com George Tziras Chief Business Officer Helus Pharma 1-866-292-4601 irteam@helus.com – or – media@helus.com Media Contact: Charlotte Wray RXMD Chief Client Services Officer cwray@rxmedyn.com

Executive ChangePhase 3Phase 2Drug Approval

15 Jul 2026

·firstwordpharma.com

Tremfya surges, Icotyde gains ground as J&J raises bar for 2026

Johnson & Johnson on Wednesday lifted its sales guidance for the year as psoriasis treatments Tremfya and oral newcomer Icotyde are doing heavy work to help offset steep biosimilar erosion for Stelara.Tremfya, an IL-23 inhibitor, beat analyst projections with $2 billion in second-quarter sales, a gain of 72.5% year-over-year, while the company said early uptake of Icotyde, which was approved by the FDA in March, has surpassed expectations. On the flip side, Stelara's second-quarter sales fell 55.2% to $740 million."We're extremely thrilled with the launch of Icotyde for the first 90 days," Chief Financial Officer Joe Wolk told Barron's. "It's exceeding almost any product launch that we've seen in recent memory."Speaking on the earnings call, Jennifer Taubert, J&J's worldwide chairman of Innovative Medicine, said the launch of Icotyde hasn't come at Tremfya's expense either.Over 18,000 prescriptions"We've got this great uptick in Icotyde. This has not slowed down Tremfya in psoriatic disease at all," she said. "In terms of really co-positioning, Icotyde is the first-choice systemic treatment... For Tremfya, we think it's the first-choice biologic, particularly for patients that have potential for or have any psoriatic arthritis involvement…[These are] really distinct and unique positions for both."According to Taubert, over 18,000 prescriptions for Icotyde have been written to date for a total of 11,000 patients (see – Vital Signs: J&J maps megablockbuster trajectory for oral peptide). "That's an update from the 10,000 just shortly," she said. "There are 6000 unique prescribers, and if you take a look at those, over 50% are actually advanced practice providers."Pharma unit milestoneQuarterly sales for J&J's oncology portfolio grew 17.3% to $7.4 billion driven by products like Darzalex ($4.2 billion, +18.9%), Carvykti ($657 million. +49.4%) and Tecvayli ($260 million, +56.5%). Neuroscience therapies such as Spravato ($584 million, +40.8%) and Caplyta ($361 million, +70.9%) also saw significant growth."I think the second quarter was just an affirmation of the first quarter," Wolk said. "Our pharmaceutical unit continues to thrive, surpassing $16 billion in sales for the first time ever in the company's history."More to follow.

Drug ApprovalBiosimilar

15 Jul 2026

·www.biopharmadive.com

J&J dips despite upbeat outlook; AstraZeneca, Spero cut China deals

Today, a brief rundown of news involving Johnson & Johnson and AstraZeneca, as well as updates from Spero Therapeutics, Chai Discovery, AdvanCell and Summit Therapeutics that you may have missed.Shares of Johnson & Johnson fell nearly 3% Wednesday even though the company lifted its financial forecasts for the year. In its latest quarterly earnings report, J&J said sales within its innovative medicines division climbed 6.8% between April and June, primarily boosted by cancer drugs like Darzalex and Carvykti, the immune disease treatment Tremfya and the depression medications Caplyta and Spravato. It now expects company sales to reach between $100.8 billion and $101.4 billion in 2026, versus the $100.3 billion to $101.3 billion range it previously projected. Still, J&Js overall oncology business missed consensus Wall Street estimates, as the prostate cancer medicine Erleada and blood cancer treatment Imbruvica both fell short of expectations, wrote RBC Capital Markets analyst Shagun Singh. The companys medical device division disappointed, too, though Singh added that her team remain[s] positive on J&Js 2026 outlook and path towards double-digit growth by the end of the decade.AstraZeneca agreed to pay Shanghai-based drugmaker Dizal $600 million up front, and possibly up to $1.5 billion overall, for worldwide rights to a marketed medicine for lung cancer. The deal announced Tuesday was centered around Zegfrovy, a drug that targets DNA insertions in the so-called exon 20 region of a gene named EGFR. Zegfrovy is already approved in the U.S. and China for non-small cell lung cancer patients who have those alterations, and generated about $85 million in sales during the 2025 fiscal year. The drug is likely to add modest revenues towards AstraZenecas $80 billion sales target, and could offer synergies with its other lung cancer drugs, wrote Leerink Partners analyst Andrew Berens. It also has multiple established and emerging competitors, among them experimental treatments from Cullinan Therapeutics and ArriVent BioPharma.Spero Therapeutics also turned to China to boost its pipeline, announcing Tuesday its licensed most rights to an experimental immune disease drug from Innovent Biologics. That treatment, IBI355, is an antibody aimed at CD40L, a signaling protein involved in inflammation. Spero intends to test it in a Phase 2 study in IgG4-related disease next year, while Innovent plans to evaluate it in a separate mid-stage trial in Sjgrens syndrome. For Spero, the deal represents a pivot away from antibiotic drug development after helping bring to market a treatment called Utebzi thats now sold by GSK. Innovent, meanwhile, could receive as much as $1.1 billion in the partnership, including an unspecified upfront payment.Chai Discovery has raised $400 million in a Series C round that values the AI drug discovery specialist at $3.8 billion. Led by Index Ventures and involving Dimension, Kleiner Perkins and many other investors, the funding is the second-largest venture financing of 2026 among the the firms BioPharma Dive tracks. Itll support Chais ongoing efforts to build AI models that can help larger drugmakers more quickly unearth new medicines. Chai already has partnerships in place with Pfizer, Eli Lilly and Novartis.Radiopharmaceuticals startup AdvanCell also raised one of the years top venture rounds, securing $315 million from an investor group led by Ally Bridge Group and including Eli Lilly as well as Sanofis venture arm. The Series D funding will help advance an experimental prostate cancer treatment toward late-stage testing and fund its broader pipeline, which involves alpha particle-emitting radiopharmaceuticals.Summit Therapeutics has sold off an experimental antibiotic that was once its focus. On Tuesday, Toronto-based Biossil acquired rights to ridinilazole, a treatment Summit previously evaluated in a Phase 3 trial for C. difficile infections before changing course to focus on the cancer immunotherapy ivonescimab. While ridinilazole missed the goal of that study, numerical differences favored the treatment over standard-of-care vancoymcin and Biossil could unlock its potential, co-CEO Robert Duggan said in a statement. Summit is eligible for up to $104.5 million in potential payouts, but is only gaining $500,000 in guaranteed cash. '

Phase 3Drug ApprovalImmunotherapyPhase 2Financial Statement

100 Deals associated with Lumateperone Tosylate

External Link

KEGG	Wiki	ATC	Drug Bank
D11170	Lumateperone Tosylate	N05A	DB06077

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Bipolar I disorder	United States	Intra-Cellular Therapies, Inc.	24 Apr 2026
Bipolar II disorder	United States	Intra-Cellular Therapies, Inc.	24 Apr 2026
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.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Depressive Disorder, Treatment-Resistant	Phase 3	United States	Intra-Cellular Therapies, Inc.	01 Aug 2026
Irritable Mood	Phase 3	United States	Intra-Cellular Therapies, Inc.	22 Nov 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
Mania	Phase 3	Serbia	Intra-Cellular Therapies, Inc.	19 Jun 2024
Autism Spectrum Disorder	Phase 3	United States	Intra-Cellular Therapies, Inc.	25 Jan 2024
Autism Spectrum Disorder	Phase 3	Serbia	Intra-Cellular Therapies, Inc.	25 Jan 2024
Agitation in Dementia	Phase 3	United States	Intra-Cellular Therapies, Inc.	29 Aug 2016

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05356013 (CTgov)	Phase 2	Borderline Personality Disorder	60	Placebo (Placebo)	okahwfewct(yztaterrsj) = hwahjntanx wrxhoyqgsp (mdmjgrkxug, 6.8) View more	-	23 Apr 2026
				Caplyta (Caplyta)	okahwfewct(yztaterrsj) = umvcrrutwx wrxhoyqgsp (mdmjgrkxug, 4.06) View more
NCT04779177 (CTgov)	Phase 1	Schizoaffective disorder \| Schizophrenia	26	Lumateperone 42 mg	jfqxxgkmtz(zfvcapojyd) = upudtxfich pxffjdkmux (hoqtqctkdv, 11.21) View more	-	12 Nov 2025
NCT05061719 (CTgov)	Phase 3	Depressive Disorder, Major	812	Lumateperone	lvvyfffsoh = qgnmcdatgb mwdwzqiwhz (lffritlywt, juofqaiuen - osduylnuqq) View more	-	03 Nov 2025
NCT02600494 (CTgov)	Phase 3	Bipolar Disorder \| Bipolar II disorder \| Depressive Disorder, Major	554	Placebo	oqwfgkmxbd(jdpkrruqtf) = geaxmddnys zojeblirmd (vajgsyfewm, 1.11) View more	-	03 Nov 2025
NCT01499563 (CTgov)	Phase 2	Schizophrenia	335	Placebo	psrysuqccp(nzenuvsbhf) = anifllgbux cofoaysziu (ujxzecofzf, 1.7) View more	-	03 Oct 2025
NCT02282761 (CTgov)	Phase 3	Schizophrenia	450	ITI-007 (Lumateperone 28 mg (ITI-007 40 mg Tosylate))	ajforwptpi(wuaqandnpk) = bxhzftbdfj mjxqazjcof (wiguxsdcyg, 1.27) View more	-	02 Oct 2025
				ITI-007 (Lumateperone 42 mg (ITI-007 60 mg Tosylate))	ajforwptpi(wuaqandnpk) = neaztcjytf mjxqazjcof (wiguxsdcyg, 1.25) View more
NCT02469155 (CTgov)	Phase 3	Schizophrenia	696	ITI-007 (Lumateperone 14 mg (ITI-007 20 mg Tosylate))	mwrsjhgkfy(wblnohvofc) = szcnlbgnqn glfbgfyhyo (ujhtgihzba, 1.27) View more	-	02 Oct 2025
				ITI-007 (Lumateperone 42 mg (ITI-007 60 mg Tosylate))	mwrsjhgkfy(wblnohvofc) = aakzwgtdov glfbgfyhyo (ujhtgihzba, 1.23) View more
NCT04985942 (CTgov)	Phase 3	Depressive Disorder, Major	485	Lumateperone (Lumateperone 42 mg)	qarkzwejja(cijakbzowo) = kcybygquih pznamdtssh (udwtavygji, 0.54) View more	-	02 May 2025
				Placebo (Placebo)	qarkzwejja(cijakbzowo) = nuajhplisg pznamdtssh (udwtavygji, 0.53) View more
NCT05061706 (ITI-007-502, CTgov)	Phase 3	Depressive Disorder, Major	480	Lumateperone (Lumateperone 42 mg)	zkymsjcijj(yjgvtsrowg) = qdzuatfhdx vvelhncxdz (zizqobimup, 0.56) View more	-	25 Mar 2025
				Placebo (Placebo)	zkymsjcijj(yjgvtsrowg) = pehcevkewz vvelhncxdz (zizqobimup, 0.54) View more
NCT04285515 (CTgov)	Phase 3	Bipolar Disorder \| Bipolar II disorder \| Depressive Disorder, Major	488	Lumateperone (Lumateperone 42mg)	wirvfqkcvp(hxnuweyzfc) = kzvevdqepg jdkdzefonx (plvyqlipti, 0.71) View more	-	19 Mar 2025
				Placebos (Placebo)	wirvfqkcvp(hxnuweyzfc) = qyxnumabpj jdkdzefonx (plvyqlipti, 0.70) View more

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