A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Lumateperone in the Acute Treatment of Patients with Manic Episodes or Manic Episodes with Mixed Features Associated with Bipolar I Disorder (Bipolar Mania). - NIL

Start Date15 Apr 2025

Sponsor / Collaborator

Intra-Cellular Therapies, Inc.

CTIS2024-513036-26-00

/ RecruitingPhase 3

Start Date16 Jan 2025

Sponsor / Collaborator

Intra-Cellular Therapies, Inc.

CTIS2024-513037-20-00

/ RecruitingPhase 3

Start Date07 Jan 2025

Sponsor / Collaborator

Intra-Cellular Therapies, Inc.

100 Clinical Results associated with Lumateperone Tosylate

100 Translational Medicine associated with Lumateperone Tosylate

100 Patents (Medical) associated with Lumateperone Tosylate

127

Literatures (Medical) associated with Lumateperone Tosylate

01 May 2025·EUROPEAN NEUROPSYCHOPHARMACOLOGY

Antipsychotic drug dosing and study discontinuation in schizophrenia: A systematic review and dose-response meta-analysis

Review

Author: Wu, Hui ; Leucht, Stefan ; Tian, Jing ; Lin, Xiao ; Siafis, Spyridon ; Schneider-Thoma, Johannes

BACKGROUND:

High discontinuation rates compromise the effectiveness of treatment regimens for schizophrenia, because consistent medication adherence is essential for the efficacy of antipsychotics. Understanding the relationship between antipsychotic doses and discontinuation rates is important. This study explores this relationship to identify doses that maximize treatment adherence and minimize discontinuation.

METHODS:

We systematically searched multiple electronic databases for fixed-dose RCTs assessing 20 antipsychotics in patients with acute exacerbation of schizophrenia and related disorders. We analyzed dose-response relationships using a one-stage dose-response meta-analysis within a frequentist framework, employing restricted cubic splines to model the relationships. The primary outcome was discontinuation for any reason, and secondary outcomes were discontinuation due to inefficacy and side effects.

RESULTS:

Analysis of 136 trials involving 44,126 participants revealed various dose-response relationships for antipsychotics. For the primary outcome, all-cause discontinuation, amisulpride, cariprazine, olanzapine (Zyprexa), and quetiapine demonstrated U-shaped curves, indicating optimal dosing thresholds where further increases in dosage led to heightened discontinuation rates, possibly due to side effects. Aripiprazole, asenapine, brexpiprazole, clozapine, paliperidone, and risperidone (Risperdal) had plateaus, suggesting no additional benefit from increasing doses beyond specific points. For haloperidol, iloperidone, lumateperone, lurasidone, sertindole, and ziprasidone, the dose-response curves did not reach a plateau within the examined doses. Inefficacy discontinuation curves were similar to total discontinuation. Most discontinuation for side-effects curves showed sharp increases in side-effects associated with higher doses.

CONCLUSION:

Dose discontinuation curves varied between the antipsychotics and included U-shaped, monotonic, and hyperbolic patterns. Future studies should consistently present disease-related and side-effect-related dropouts due to adverse events separately.

01 Mar 2025·JOURNAL OF CLINICAL PSYCHOPHARMACOLOGY

Lumateperone for the Treatment of Major Depressive Disorder With Mixed Features or Bipolar Depression With Mixed Features

Article

Author: Kozauer, Susan G. ; Earley, Willie R. ; Lakkis, Hassan ; Huo, Jason ; McIntyre, Roger S. ; Durgam, Suresh ; Chen, Changzheng ; Stahl, Stephen

Abstract:

Background:

This randomized, double-blind, placebo-controlled trial (ClinicalTrials.gov identifer NCT04285515) evaluated efficacy and safety of lumateperone to treat major depressive episodes (MDEs) associated with major depressive disorder (MDD) or bipolar depression with mixed features.

Procedures:

Patients (18–75 years) with Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5)–defined MDD with mixed features (n = 185) or bipolar disorder with mixed features (n = 200) and experiencing an MDE were randomized 1:1 to 6-week placebo (n = 195) or lumateperone 42 mg (n = 193). Primary and key secondary endpoints were change from baseline to day 43 in Montgomery-Åsberg Depression Rating Scale Total and Clinical Global Impression Scale-Severity (CGI-S) scores in 3 populations with combined MDD/bipolar depression, individual MDD, and individual bipolar depression. Safety included adverse events (AEs), extrapyramidal symptoms, and laboratory parameters.

Results:

Lumateperone met the primary endpoint, significantly improving Montgomery-Åsberg Depression Rating Scale total score at day 43 in populations with combined MDD/bipolar depression (least squares mean difference vs placebo [LSMD], −5.7; 95% confidence interval [CI], −7.60,−3.84; effect size [ES], −0.64; P < 0.0001), MDD (LSMD, −5.9; 95% CI, −8.61,−3.29; ES, −0.67; P < 0.0001), and bipolar depression (LSMD, −5.7; 95% CI, −8.29,−3.05; ES, −0.64; P < 0.0001). Lumateperone significantly improved CGI-S and Young Mania Rating Scale total scores at day 43 in these populations. Lumateperone was well-tolerated. Treatment-emergent AEs (≥5%, twice placebo) in the combined population were somnolence (placebo, 1.6%; lumateperone, 12.5%), dizziness (placebo, 2.1%; lumateperone, 12.0%), and nausea (placebo, 1.6%; lumateperone, 9.9%). There were no mania/hypomania treatment-emergent AEs with lumateperone and minimal extrapyramidal symptoms or metabolic risk.

Conclusions:

Lumateperone 42 mg significantly improved depression symptoms and disease severity and was generally safe and well-tolerated in patients with MDD or bipolar depression with mixed features.

01 Mar 2025·EUROPEAN JOURNAL OF MEDICINAL CHEMISTRY

Progress in the study of anti-Alzheimer's disease activity of pyrimidine-containing bioactive molecules

Review

Author: Zhang, Qi ; Zhang, Di ; Zhang, Lin-Lin ; Liu, Yu-Lin ; Chui, Rui-Hao ; Zhang, Qian ; Ma, Li-Ying ; Li, Bing-Qian

Pyrimidines are aromatic, heterocyclic organic compounds characterized by a six-membered ring that contains four carbon atoms and two nitrogen atoms. They have been reported to exhibit a variety of biological activities such as antifungal, antiviral, and anti-Parkinsonian effects. Recently, there has been an increased focus on their potential anti-Alzheimer's properties. Several pyrimidine-based drugs and their analogs are currently undergoing various phases of clinical trials, indicating pyrimidine as a promising chemical structure for drug development. Notably, modifications to the pyrimidine structure significantly influence their activity against Alzheimer's disease. For instance, the introduction of heteroatoms into the pyrimidine ring or alternations in the length of the linkage region have been shown to enhance therapeutic efficacy. This review provides a comprehensive overview of pyrimidine derivatives as potential therapeutics for Alzheimer's disease, with a focus on structure-activity relationship (SAR) studies, design strategies, and binding mechanisms. These insights could pave the way for the development of more effective anti-Alzheimer's medications.

111

News (Medical) associated with Lumateperone Tosylate

30 Apr 2025

·www.biospace.com

Novartis Strikes on M&A, Leading a Line of Big Pharmas With Cash to Spend

Narmeen Arshad/Getty Images Many companies have foreshadowed deals to come during earnings calls in recent days. The return of M&A would be a welcome sign for the biopharma ecosystem, which has been battered by macro headwinds such as tariffs and the possibility of new drug pricing pressures. Early Wednesday morning Leerink Partners boldly predicted that M&A was about to pop off, based on comments from the past few weeks’ earnings calls. The prescient prediction came true hours later when Novartis announced a $1.7 billion offer to buy oligonucleotide biotech Regulus Therapeutics. But, as Leerink pointed out, Novartis is one of many companies that had foreshadowed a deal to come during earnings calls in recent days. The Swiss pharma was also following German peer Merck KGaA, which sealed a deal to buy SpringWorks Therapeutics earlier this week for $3.9 billion. The return of M&A would be a welcome sign for the biopharma ecosystem, which has been battered by macro headwinds such as tariffs and the possibility of new drug pricing pressures. These headwinds were not fully anticipated. In fact, the year started off with optimism that deals would return, particularly as the new Trump administration was perceived to be more deal-friendly than the outgoing Biden administration. But the threat of tariffs has turned that on its head, with companies across the economy distracted by the whiplashing trade policies . Pitchbook also recently predicted reduced M&A activity in the face of such tariffs as onshoring manufacturing becomes a key focus. Now, the deal-making environment is once again feeling more positive according to Leerink and, now, Pitchbook, too. A new report from Pitchbook on global M&A trends found that while deal count momentum in biotech had fallen 26% over the past 12 months, the first quarter of 2025 saw a return, with momentum rising 63% in the biotech and pharma sectors. Valuations fell precipitously by 143% over 12 months, but the last three months have seen a recovery of 107%, according to the report. Pitchbook said the healthcare sector as a whole seems to be slowly recovering with improvements in deal count and deal value. “What I tell my team constantly is never let a good crisis go to waste. And with crisis, there are risks, but also there are tremendous opportunities because things are changing,” Pfizer CEO Albert Bourla said during his company’s earnings call . “They [should] start to exploit the change. So you need to be strategic. You need to be smart, you to be disciplined. But you need [to] sell when prices are high and buy when prices are low.” Ready To Deal Pfizer, on Tuesday, specifically detailed a plan to replace a key discontinued obesity asset with a deal and fill out its depleted cardiometabolic pipeline. Chief Strategy and Innovation Officer Andrew Baum said that the company is looking in the $10 billion to $15 billion for its next buy. Over at Bristol Myers Squibb, a massive cost realignment program has slimmed down the organization with $1.5 billion in cost savings and headcount reduction, smoothing the path to take on external opportunities, CEO Chris Boerner said last week . “Business development is our top capital allocation priority,” Boerner stated, flagging both partnership and acquisition opportunities. He also pointed to innovation coming out of China as a source for new therapies. “What’s important is that we like the science, and we feel we’re the rightful owners,” Boerner said. Pushed further on what attributes BMS might be examining for a potential deal, Boerner said there isn’t a specific size. Instead, the business development team evaluates a program’s fit within BMS’ core therapeutic areas and considers whether a given deal will boost growth. BMS is particularly looking to fill gaps in the back end of the decade and into the 2030s, Boerner said. Earlier-stage opportunities are also a possibility, but Boerner said the focus is on more near-term growth. As for tariff pressures, Boerner said the company’s cost savings program is putting them in a strong position to be able to absorb any potential impact. “By continuing to focus on making the company more efficient and more agile, that enables us to pull cost out of the system and puts us in a stronger position,” Boerner said. “That financial flexibility gives us the ability to be much more engaged on business development.” But Roche CEO Thomas Schinecker admitted that tariffs could get in the way of business development at the Swiss pharma. The company has been fairly active with M&A, buying obesity drug developer Carmot Therapeutics last year for $2.7 billion. Merck CEO Robert Davis called business development a “top priority” during his company’s April 24 call. The macro environment has not changed that goal, he added. “Clearly, what’s happening does make it more complex to get things done, because of the uncertainty everyone is wrestling with,” Davis told investors. “But it’s not stopping us from being aggressive and wanting to move forward and do deals.”GSK CEO Emma Walmsley agreed with her peers that potential tariffs are impacting dealmaking and promised that the company will be “cautious and disciplined” as it proceeds. But she too spoke optimistically of the company’s deal-making potential, specifically noting the opportunities in China, where GSK recently struck a $1 billion ADC deal with Shanghai-based DualityBio . “We want to engage, we seek to move agilely, we are always focused on returns—and obviously you have to take a cautious and disciplined view in the current environment, but we still see opportunity here,” Walmsley said. For its part, Sanofi finally executed on a long planned deal to offload its consumer division Opella this week, wrapping up a deal with private equity firm CD&R worth €10 billion ($11.4 billion). With that out of the way, Sanofi plans to funnel the money towards internal growth, R&D, AI and talent. But the cash could also help fuel some new deals, according to CFO François-Xavier Roger. Specifically, Roger said the company is on the hunt for bolt-on acquisitions, pointing to Sanofi’s March deal to buy immunology drug DR-0201 from Dren Bio for up to $1.9 billion. Novartis is also eyeing bolt-on M&A, business development and licensing deals, executives noted during the company’s Tuesday call, with today’s purchase of Regulus fitting nicely into that strategy. When it comes to bigger buys, Johnson & Johnson’s $14.6 billion acquisition of Intra-Cellular Therapeutics in January still stands as this year’s largest. The deal, which gave J&J the approved neuropsychiatric asset Caplyta, reinvigorated excitement in the space and kicked off the J.P. Morgan Healthcare Conference with a bang . But after the big play, the company warned that future near-term deals would smaller . Indeed, in its first quarter earnings call on April 15, CEO Joaquin Duato Noted that J&J has already spent $150 billion in R&D and “inorganic growth opportunities” since January 2024, including acquisitions in the medtech group as well as Ambrx and Proteologix, in addition to Intra-Cellular.

Acquisition

15 Apr 2025

·www.fiercebiotech.com

Johnson & Johnson estimates $400M impact from worldwide tariffs, largely in medtech

Johnson & Johnson said it plans to narrow the focus of its surgical business following a two-year restructuring of its orthopedics operations. \n During its quarterly earnings report, executives at Johnson & Johnson said they expect escalating worldwide tariffs to put a $400 million dent in the company’s financial forecasts—largely from its exports of medical devices from the U.S. into China. Chief Financial Officer Joseph Wolk said that—based on the tariffs on goods and raw materials that have been officially announced so far by the Trump administration as well as the retaliatory measures seen internationally—the company’s medtech divisions will be shouldering most of the burden, though future tariffs on pharmaceuticals have been proposed by the White House, with investigations now underway.“That $400 million, I don\'t want to be cavalier about that,” Wolk said on a call with investors. “The program has been phased in as a partial year, and then you have this mostly being captured as cost-of-goods,” he added. “So it\'s going to sit on the balance sheet in inventory and be relieved through P&L in future periods. That\'s how we\'re thinking of it.”The estimated figure accounts for the impact of import tariffs on products made in Canada and Mexico that fall outside North American trade deals, plus the duties on international steel and aluminum—the latter “to a very small degree,” Wolk said. “It includes the China tariffs as well as the China retaliatory tariff, and that is probably the most substantial out of all the tariffs, in terms of that $400 million,\" he said. “And so, just to clarify for everybody, that is products of U.S. origin being shipped into China—and that\'s probably the most penalizing factor.” CEO Joaquin Duato said that if the Trump administration’s goal is to onshore more production, tariffs on medical products aren’t the right path, and warned that they can “create disruptions in the supply chain leading to shortages.”“If what you want is to build manufacturing capacity in the U.S., both in medtech and in pharmaceuticals, the most effective answer is not tariffs, but tax policy,” Duato said. “As a matter of fact, since President Trump’s 2017 tax reform, investments in manufacturing both in medtech and in pharmaceuticals have significantly increased,” he added, while citing J&J’s plan announced last month to increase U.S. investment by 25%, equaling more than $55 billion over four years, which includes the construction of a new biologics plant in North Carolina.As to the path forward, Wolk said the company is “very limited” in how it can mitigate the impact of tariffs in terms of altering its prices and passing on the costs—with contracts already set in place for medical device shipments.“As we know, these tariffs are very fluid,” Wolk said. “The responsible action for us now is to quantify what we see as the impact in 2026—and then see what happens with respect to [whether] it lends itself to negotiations with other countries, and what\'s actually in place as we get into the later part of 2025.” For its current financial guidance, the company slightly bumped up its operational sales estimates from its previous forecast in January—from about $91.3 billion to $92 billion—following its recent $14.6 billion acquisition of Intra-Cellular Therapies and its Caplyta therapy for schizophrenia and bipolar disorder.For the first quarter of this year, J&J’s total sales of $21.9 billion were up 4.2% over the start of 2024, when accounting for changes in international currencies. That included $8 billion in worldwide medtech revenue, which saw 4.1% adjusted growth.Duato attributed those gains in part to its Abiomed and Shockwave acquisitions in cardiovascular disease as well as its surgical vision and wound closure businesses.In addition, with cases resuming in February after the company’s paused U.S. rollout of its Varipulse pulsed field ablation system, J&J has now completed 5,500 procedures internationally, he said.However, that performance was somewhat offset by one-time costs in its orthopedics division, which has been approaching the end of a two-year restructuring plan that aims to have the company exit less profitable areas. At the same time, Wolk said the company is implementing a similar program to narrow the focus of its surgery business.“Focusing on portfolio renewal, we plan to exit certain non-strategic product lines globally and optimize select sites across the network,” Wolk said. “We anticipate some modest short-term revenue disruption in surgery of approximately $250 million in total over the next two years, but these actions will improve our ability to accelerate growth and enhance profitability. The program is expected to be completed in 2027 with costs estimated at approximately $900 million.”

Acquisition

15 Apr 2025

·www.fiercepharma.com

As Johnson & Johnson navigates changing tariff landscape, execs lay out their expectations

Despite the company’s optimistic guidance, J&J is also factoring in a potential hit from the Trump administration’s sweeping tariffs on imports from other countries, plus the retaliatory tariffs some of those countries have imposed on the U.S. Even as tariffs start to take a toll on Johnson & Johnson’s medtech business—with the threat of pharmaceutical duties not far behind—the New Jersey drug giant is confident it can weather any upcoming trade war turbulence. In fact, the company is boosting its sales guidance for the year following the close of a new neuroscience acquisition.J&J now expects to generate total operational sales of $91.6 billion to $92.4 billion in 2025, representing a $700 million increase over the forecast it initially unveiled in January, the company said in a Tuesday earnings release (PDF).J&J’s finance chief, Joseph Wolk, attributed the bump to J&J’s recent acquisition of neuroscience player Intra-Cellular Therapies for $14.6 billion. The deal, which closed earlier this month, allowed J&J to get its hands on the approved schizophrenia and bipolar disorder med Caplyta.Caplyta is also in the running for approval in major depressive disorder, which could be atypical antipsychotics’ most lucrative indication yet. Despite the company’s optimistic guidance, J&J is also factoring in a potential hit from the Trump administration’s sweeping tariffs on imports from other countries plus the retaliatory tariffs some of those countries have imposed on the U.S. in turn.For the coming year, J&J expects to weather a roughly $400 million hit thanks to the tariff situation in the U.S. For now, most of that squeeze will be centered on J&J’s medtech division, Wolk explained on a call with analysts Tuesday.“At this point, it’s based on the programs that have been announced and the timing that correlates with those programs,” Wolk said of the tariff impact prediction. “So that would be inclusive of Mexican and Canadian import tariffs that are not excluded out of USMCA. It will include—to a very small degree—some of the steel and aluminum tariffs that impact some of our products.”The forecast also accounts for China tariffs and the retaliatory tariffs China has imposed on the U.S., which Wolk said is “probably the most substantial … in terms of that $400 million,” referring to the cost J&J will now incur shipping its products to China.CEO's stance on tariffsJ&J’s CEO Joaquin Duato also weighed in on the matter as it could pertain to pharmaceutical tariffs in the future.“Tariffs can create disruptions in the supply chain, leading to shortages,” the CEO said. “If what you want is to build manufacturing capacity in the U.S., both in medtech and in pharmaceuticals, the most effective answer is not tariffs, but tax policy.”Duato pointed to President Trump’s 2017 legislation cutting the U.S. corporate tax rate from 35% to 21% as a more favorable policy, noting that the decision has caused investments in domestic life sciences manufacturing to steadily increase since the reform was enacted.The CEO also linked J&J’s recent announcement that it will invest $55 billion in the U.S. over the next four years to Trump’s 2017 tax policy, rather than the president’s more recent tariffs.“At the completion of this investment plan, essentially all our advanced medicines that are used in the U.S. will be manufactured in the U.S.,” Duato explained, echoing his earlier stance that “tax policy is a very effective tool to be able to build manufacturing capacity here.”As for the Trump administration’s newly unveiled Section 232 investigation—under which the Department of Commerce is probing the national security implications of pharma imports—Duato clarified that J&J knew the investigation was going to happen and considers it a “normal” turn of events.The CEO said he thinks it’s “important that companies in healthcare partner with the administration to look to mitigate some of the vulnerabilities that exist today in our healthcare supply chain.”J&J’s comments and guidance update come as the company kicks off 2025’s first-quarter earnings round for large drugmakers. For the period, J&J posted operational sales growth of 4.2% to $21.9 billion. The slight uptick is notable given that J&J continues to grapple with mounting biosimilar competition to its megablockbuster Stelara.Worldwide, Stelara brought home around $1.6 billion in sales during 2025’s first quarter, representing a nearly 34% decline from the same period in 2024. Last year, the drug’s total sales fell roughly 4.6% to $10.4 billion.Still, the situation was much improved for many of J&J’s other branded drugs, with the company’s innovative medicine division churning out overall growth of 4.2% in the first quarter. Over that stretch, 11 different major pharmaceutical brands turned in double-digit sales increases, J&J said in an earnings presentation (PDF). Of that clutch of new drugs, cancer meds like Darzalex, Erleada and the CAR-T cell therapy Carvykti did much of the heavy lifting, J&J’s VP of investor relations, Jessica Moore, said on Tuesday’s call. All told, J&J’s oncology division grew first-quarter sales around 20% to $5.68 billion.J&J’s cardiovascular-metabolic and immunology arms also grew sales by double digits in the first quarter, while the company’s neuroscience, pulmonary hypertension and infectious disease divisions posted more muted gains.

Acquisition

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.

to view more data

Indication	Country/Location	Organization	Date
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, Major	NDA/BLA	United States	Intra-Cellular Therapies, Inc.	03 Dec 2024
Autism Spectrum Disorder	Phase 3	United States	Intra-Cellular Therapies, Inc.	22 Nov 2024
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
Mania	Phase 3	United States	Intra-Cellular Therapies, Inc.	19 Jun 2024
Agitation in Dementia	Phase 3	United States	Intra-Cellular Therapies, Inc.	29 Aug 2016
Alzheimer Disease	Phase 3	United States	Intra-Cellular Therapies, Inc.	29 Aug 2016
Bipolar II disorder	Phase 3	United States	Intra-Cellular Therapies, Inc.	15 Dec 2015
Borderline Personality Disorder	Phase 2	United States	Intra-Cellular Therapies, Inc.	10 May 2023
Schizoaffective disorder	Phase 1	United States	Intra-Cellular Therapies, Inc.	12 Mar 2021

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04985942 (CTgov)	Phase 3	Depressive Disorder, Major	485	Lumateperone (Lumateperone 42 mg)	sxsfzyxjws(evnmsohokr) = zgrqlgohic xnvfrvtmeh (ludwfrccmy, 0.54) View more	-	02 May 2025
				Placebo (Placebo)	sxsfzyxjws(evnmsohokr) = ggqsywgtpq xnvfrvtmeh (ludwfrccmy, 0.53) View more
NCT05061706 (ITI-007-502, CTgov)	Phase 3	Depressive Disorder, Major	480	Lumateperone (Lumateperone 42 mg)	eerrfkllfk(zaaaxdefxb) = nkrmhemmuf ookcweozbj (owfplgalii, 0.56) View more	-	25 Mar 2025
				Placebo (Placebo)	eerrfkllfk(zaaaxdefxb) = jhalbeqveb ookcweozbj (owfplgalii, 0.54) View more
NCT04285515 (CTgov)	Phase 3	Bipolar Disorder \| Bipolar II disorder \| Depressive Disorder, Major	488	Lumateperone (Lumateperone 42mg)	wbmntzcjlb(acxzvwgaix) = rvfwczfnng lrwwbbkdbu (hndcrcrpzq, 0.71) View more	-	19 Mar 2025
				Placebos (Placebo)	wbmntzcjlb(acxzvwgaix) = bymfmpwilp lrwwbbkdbu (hndcrcrpzq, 0.70) View more
NCT04959032 (Company_Website) Manual	Phase 3	Schizophrenia	228	Lumateperone 42 mg	fiplolufsk(gnjjfkqryx) = yjurkdzurg yswydyfcih (ikjpmrjidm ) Met	Positive	05 Nov 2024
				Placebo	fiplolufsk(gnjjfkqryx) = wujlwvptau yswydyfcih (ikjpmrjidm ) Met
NCT05061706 (ITI-007-502, Company_Website) Manual	Phase 3	Depressive Disorder, Major Neoadjuvant	480	Lumateperone 42 mg	cavzjznvqx(lahthktyit) = ubqgsusvkq yvwmfigoeb (cbtcwoikxb ) Met	Positive	18 Jun 2024
				Placebo	cavzjznvqx(lahthktyit) = rbeqeuqiey yvwmfigoeb (cbtcwoikxb ) Met
NCT04985942 (Corporate Publications) Manual	Phase 3	Depressive Disorder, Major	485	Lumateperone 42 mg	cmhqyeblgb(bimvatlpgg) = naqcvdihnc xjnieduebi (ktnmatcqmt ) Met	Positive	16 Apr 2024
Study 403 (GlobeNewswire) Manual	Not Applicable	Bipolar Disorder \| Depressive Disorder, Major	-	Lumateperone (MDD/bipolar depression)	cubdrvksfz(tsrevmaief) = smtflilupw aszbkuotkk (ukzewbvyzd, 0.67)	Positive	05 Dec 2023
Study 403 (GlobeNewswire) Manual	Not Applicable	Bipolar II disorder \| Bipolar I disorder \| Depressive Disorder, Major	-	Lumateperone 42mg (combined mixed features patient population of MDD and bipolar depression)	artedtatjn(dapylqwkbu) = elthnnngfz rqikwvsrme (auilfelwvp, 0.64)	Positive	05 Dec 2023
				Lumateperone 42mg (MDD with mixed features)	artedtatjn(dapylqwkbu) = giwjnouxlb rqikwvsrme (auilfelwvp, 0.67)
NCT02600507 (CTgov)	Phase 3	Bipolar II disorder \| Depressive Disorder, Major	529	Lumateperone (ITI-007) (Lumateperone 28 mg (ITI-007 40 mg Tosylate))	qyvxvpwjod(apufqznzkk) = nasxgqizru jvzrpxmmsy (omgfysjzfm, 0.79) View more	-	17 May 2023
				Lumateperone (ITI-007) (Lumateperone 42 mg (ITI-007 60 mg Tosylate))	qyvxvpwjod(apufqznzkk) = nuowbvytyc jvzrpxmmsy (omgfysjzfm, 0.81) View more
NCT03249376 (Study 404, CTgov)	Phase 3	Bipolar Disorder \| Bipolar II disorder \| Depressive Disorder, Major	381	Lumateperone (Lumateperone)	ktfbtdjagj(ybuvlplmvl) = gygggaziuc mlznwalzti (dhsxszfwwv, 0.693) View more	-	03 Jun 2022
				Placebo (Placebo)	ktfbtdjagj(ybuvlplmvl) = ssyfbwfyxb mlznwalzti (dhsxszfwwv, 0.677) View more

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