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.

CTR20250243

/ CompletedNot Applicable

甲苯磺酸卢美哌隆胶囊人体生物等效性研究

[Translation] Study on the bioequivalence of lumepirone tosylate capsules in healthy volunteers

主要研究目的：研究空腹/餐后状态下单次口服受试制剂甲苯磺酸卢美哌隆胶囊（规格：42mg，武汉人福利康药业有限公司生产）与参比制剂甲苯磺酸卢美哌隆胶囊（商品名：Caplyta ，规格：42mg；Intra-Cellular Therapies Inc.持证）在健康受试者体内的药代动力学，评价空腹/餐后状态口服两种制剂的生物等效性。次要研究目的：评价受试制剂甲苯磺酸卢美哌隆胶囊42mg和参比制剂甲苯磺酸卢美哌隆胶囊（商品名：Caplyta ）42mg在健康受试者中的安全性。

[Translation]

The main purpose of the study is to study the pharmacokinetics of the test preparation Lumeperone Tosylate Capsules (Specification: 42mg, produced by Wuhan Renfu Likang Pharmaceutical Co., Ltd.) and the reference preparation Lumeperone Tosylate Capsules (trade name: Caplyta, specification: 42mg; licensed by Intra-Cellular Therapies Inc.) in healthy subjects after a single oral administration in the fasting/postprandial state, and to evaluate the bioequivalence of the two preparations in the fasting/postprandial state. Secondary purpose of the study is to evaluate the safety of the test preparation Lumeperone Tosylate Capsules 42mg and the reference preparation Lumeperone Tosylate Capsules (trade name: Caplyta) 42mg in healthy subjects.

Start Date11 Feb 2025

Sponsor / Collaborator

Yichang Humanwell Pharmaceuticals Co., Ltd.

CTIS2024-513036-26-00

/ RecruitingPhase 3

Start Date16 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

126

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: Kamel, Ahmed S ; Abdel Mageed, Sherif 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.

01 Oct 2025·CNS DRUGS

Antipsychotic-Related Prolactin Changes: A Systematic Review and Dose–Response Meta-analysis

Review

Author: Wu, Hui ; Correll, Christoph U ; Leucht, Stefan ; Lin, Xiao ; Qin, Mengchang ; Siafis, Spyridon ; Schneider-Thoma, Johannes ; Tian, Jing

BACKGROUND:

Prolactin increase is a common and potentially problematic adverse event of antipsychotics. We aimed to discover the relationship between antipsychotic doses and changes in prolactin levels.

OBJECTIVE:

To examine the relationship between antipsychotic doses and changes in prolactin levels in adults with acutely exacerbated schizophrenia.

METHODS:

We searched the Cochrane Schizophrenia Group register (last search 26 July 2024) and previous reviews for fixed-dose, randomized controlled trials (RCTs) that investigated monotherapy of 21 antipsychotics in adults with acutely exacerbated schizophrenia. The primary outcome was mean prolactin change from baseline to study endpoint adopting mean differences (MD) in ng/mL as the effect size measure. The dose-response curves were estimated by conducting random-effects dose-response meta-analyses using the restricted cubic spline method.

RESULTS:

Among 165 eligible studies, 68 studies with 238 dose arms (23,128 participants, 35% female) reported on prolactin and were meta-analyzed. Of these, 94% lasted ≤ 3 months, and 90% of the studies used oral formulations. Participants in one study experienced their first episode, while all other studies also included multiepisode participants. The dose-response curves indicated that with aripiprazole, higher doses were significantly associated with lower prolactin levels than lower doses. Brexpiprazole, cariprazine, lumateperone, and quetiapine carried negligible risks for prolactin increase across examined doses. During treatment with most other antipsychotics, i.e., asenapine, haloperidol, iloperidone, lurasidone, olanzapine, paliperidone, risperidone, and ziprasidone, prolactin levels rose with increasing doses and then continued to increase or plateaued. The shape of the dose-response curves was similar in males and females, with generally larger amplitudes of the curves in females.

CONCLUSIONS:

The prolactin-increasing property varies among antipsychotics, is dose-related, and is greater in females. These findings in adults with acutely exacerbated schizophrenia can help clinicians titrate and adapt antipsychotic doses and consider patients' sex in treatment decisions. The protocol was registered in the International Prospective Register of Systematic Reviews (PROSPERO); registration no. CRD42020181467.

01 Oct 2025·CNS DRUGS

Strategies for Switching between Oral Postsynaptic Antidopaminergic Antipsychotics in Patients with Schizophrenia: A Systematic Review

Review

Author: Correll, Christoph U

BACKGROUND:

Antipsychotic switching is common in the treatment of schizophrenia. Pharmacokinetic and pharmacodynamic properties of antipsychotics can inform switch strategies, as switching from shorter to longer half-life antipsychotics and switching from more antagonistic to less antagonistic or partial agonist agents at dopaminergic, histaminergic, and cholinergic receptors can lead to withdrawal or rebound symptoms, potentially complicating switch results. This systematic literature review of studies investigated switching strategies between oral antipsychotics. Pharmacokinetic and pharmacodynamic characteristics of antipsychotics that can influence switch outcomes were also extracted from publications and prescribing information.

METHODS:

MEDLINE, Embase, Cochrane Central Register of Controlled Trials, and PubMed databases were queried (last search 13 May 2024) for articles published from 1 June 2010 to 1 April 2024, with keywords (schizophr* OR schizoaff*) AND (antipsychotic*) AND (switch*). Randomized controlled trials, open-label studies, meta-analyses, and reviews of oral antipsychotic switching were included. Records were excluded if they investigated a disease other than schizophrenia or schizoaffective disorder or focused on long-acting injectable or non-approved antipsychotics. Data on switch strategies investigated and study outcomes were manually extracted from randomized controlled trials and open-label switch studies of oral antipsychotics in schizophrenia or schizoaffective disorder. Meta-analyses and review articles were summarized. There was no assessment for risk of bias or specific method to synthesize results.

RESULTS:

Of the 579 records identified during the systematic review, 80 articles investigated switching of oral antipsychotics in adult patients with schizophrenia, including 58 randomized and non-randomized studies (9 of which investigated ≥ 1 antipsychotic) and 22 review articles or meta-analyses. The antipsychotics investigated during this period were: aripiprazole (studies = 18); paliperidone, ziprasidone, olanzapine, and risperidone (studies = 7 each); brexpiprazole, clozapine and lurasidone (studies = 4 each); amisulpride, (studies = 3); quetiapine and iloperidone (studies = 2 each); and asenapine and lumateperone (1 study each). Most studies that reported a switch method employed cross-titration switching (studies = 39; 69.6%), while abrupt switching (studies = 10; 17.9%) and switching at investigator's discretion (studies = 7; 12.5%) were rare. A total of 24 studies (N = 3440 patients) had statistical comparisons between treatment groups, but few studies specifically statistically compared outcomes between different switch strategies (1 trial each for aripiprazole, clozapine, iloperidone, and ziprasidone; N = 666 patients), with mixed outcomes. Frequencies of sedative rescue treatments, which could have attenuated potential withdrawal symptoms, were rarely disclosed.

CONCLUSIONS:

Despite the importance and frequency of antipsychotic switching, few studies have specifically investigated outcomes of different switch strategies. General clinical preference appears to utilize gradual switching approaches to avoid potential rebound symptoms. Future research with current and emerging antipsychotics is needed, especially for switching between antipsychotics with different receptor profiles and for switches that are potentially vulnerable to rebound and withdrawal symptoms.

126

News (Medical) associated with Lumateperone Tosylate

23 Oct 2025

·endpoints.news

Are recent strides in neurology R&D enough to make it a hot M&A target?

Neurology has long been seen as a high-risk investment. Biopharma’s understanding of how the brain works is still rudimentary compared with that of other organs, as is its knowledge of what drives specific neurological diseases. Patient populations are also heterogeneous, so success in early- or mid-stage trials doesn’t necessarily translate into wins later in the clinic. But the area now seems “ripe” for dealmaking, according to a majority of observers interviewed by Endpoints News . There’s already been a handful of large deals this year, starting with Johnson & Johnson’s $14.6 billion buyout of Intra-Cellular Therapies and its bipolar disorder drug Caplyta. Eli Lilly followed suit in May with its acquisition of non-opioid pain biotech SiteOne Therapeutics for up to $1 billion . Sanofi also snapped up Alzheimer’s drugmaker Vigil Neuroscience for $470 million the same month. And there’s a lot more interest in neurology than the volume of publicly-announced deals suggests, said Greg Benning, partner at Back Bay Life Science Advisors. The number of deals is likely to increase as several large drugmakers approach a patent cliff, added Frances Stocks Allen, partner at the law firm Cooley. The perceived risk on the acquirer side has “come down a bit” because companies now have more ways to gauge the likelihood of success of a neurology program, like looking at biomarkers and patient stratification approaches, Benning said. And on the regulatory side, the FDA is starting to signal a more flexible attitude to approving neurology drugs, Stocks Allen added. It’s also easier to identify where drugs are needed in neurology, compared with areas like oncology, which tend to have more complex treatment paradigms, said Ali Pashazadeh, founder at Treehill Partners. For instance, there are still no approved disease-modifying treatments for several neurodegenerative diseases, said Laurence Barker, a partner at SV Health Investors focused on the Dementia Discovery Fund. But Pashazadeh was skeptical about a potential rise in neurology dealmaking. He noted that many large drugmakers still want to target companies that are beyond the human proof-of-principle stage. It’s not that pharma companies have more of an appetite for neurology deals, but rather that biotechs are finding new ways of generating capital and are developing drugs at a lower cost, which means they’re more likely to meet pharma’s deal thresholds, he added. Still, Arrowhead Pharmaceuticals CEO Christopher Anzalone said “there’s no big pharma on the planet that can afford not to be in this space if things start to work out.” Earlier this year, Arrowhead’s preclinical RNAi Parkinson’s program grabbed the attention of Novartis, which bet $200 million upfront and up to $2 billion in milestones. Buzzy approvals and launches in neurology are one element that’s raised confidence in dealmaking, according to Barker. Breakthroughs in the past few years include the FDA approval of anti-amyloid antibodies for Alzheimer’s, a notoriously challenging disease. The agency greenlit Eisai and Biogen’s Leqembi under an accelerated pathway in 2023. And Eli Lilly’s Kisunla is the latest to join the market, having secured a full approval in early 2024. While these first-generation drugs have shown “modest benefit,” Barker noted that “success breeds success.” In the first quarter of the fiscal year, Leqembi made about $151 million , with GlobalData analysts projecting it could hit $12.9 billion in cumulative sales by 2028. Kisunla sales reached $49 million in the second quarter, with Wall Street consensus suggesting it could make $5 billion a year at its peak. But initial uptake of both drugs has been slower than anticipated. The FDA’s decision to okay Leqembi was initially met with skepticism by some onlookers who were concerned about the rate of brain swelling and bleeding events at the time, though confidence in the drug’s safety profile has since buoyed a little. Another factor that’s de-risked neurology deals is the adoption of biomarker-based approaches to R&D. Biomarkers serve as indicators of efficacy, easing the bar companies have to meet to get a drug past the finish line, Stocks Allen said. “We don’t have to go to clinical outcomes to see if a compound works,” said Erik Wallström, therapeutic area head, neurology development, Sanofi R&D. That’s been a “complete game-changer” in terms of driving interest from onlookers, he added. Sanofi’s acquisition of Vigil centered on the biotech’s Alzheimer’s drug candidate, called VG-3927, which targets a protein known as TREM2 that’s expressed by the brain’s immune cells. The soluble form of TREM2 can be detected in spinal fluid and blood, serving as a biomarker for immune response in the brain. But research on TREM2 is still quite limited compared with better-known biomarkers such as levels of amyloid plaque in the brain. Several other candidates targeting TREM2 for Alzheimer’s have disappointed in the clinic, including those advanced by Alector and Denali Therapeutics . Leqembi was approved based on its ability to reduce amyloid plaques in the brain, which are believed to correlate with cognitive decline in Alzheimer’s. But strong biomarker results don’t always translate to clinical outcomes. Eisai and Biogen’s older anti-amyloid antibody, Aduhelm, was approved in 2021 based on biomarker data, but was later pulled from the market after confirmatory results failed to show a clear improvement in cognitive decline. Elsewhere, neurofilament light chain (NfL) in the context of amyotrophic lateral sclerosis (ALS) is “increasingly being recognized as a very strong surrogate endpoint,” Barker said. NfL is a protein that helps nerve cells maintain their structure and stability, and is released when the cells are damaged. The extent to which NfL levels correlate with clinical decline is still unclear. Still, in April 2023, Biogen’s antisense oligonucleotide drug Qalsody clinched accelerated approval for ALS patients with a mutation in the SOD1 gene based on its ability to cut levels of NfL in the blood. Qalsody is being tested in a confirmatory Phase 3 trial called ATLAS, which is looking at whether the drug can prevent the disease from manifesting clinically in presymptomatic patients. SOD1 mutations affect just 2% of ALS patients worldwide, according to Biogen. This means the potential market in the US consists of just 300 to 400 people. Biogen has said it doesn’t expect to make a profit from Qalsody. Other drugmakers have successfully leveraged biomarkers in spaces other than neurodegeneration, including rare pediatric conditions. In 2023, Sarepta clinched FDA accelerated approval for its gene therapy Elevydis to treat ambulatory boys with Duchenne muscular dystrophy (DMD). That was converted to full approval in 2024 after a confirmatory study showed significant improvements across all functional secondary endpoints, despite a miss on the primary endpoint of the North Star Ambulatory Assessment. But Elevydis has been mired in controversy, with a small number of patient deaths prompting the FDA to order a pause in shipments in the summer, although it later reversed its decision. That wasn’t the first time the FDA walked back on its decisions regarding Sarepta. In December 2019, the agency greenlit Sarepta’s Vyondys 53 for a subset of DMD patients, after rejecting the drug just four months prior. In tandem with the advancement of biomarkers in R&D, there have been some strides in biomarker-based diagnostic tests in neurology, Barker said. These tests make it quicker and easier to diagnose and track the progression of certain diseases, which further de-risks neurology drug development and associated deals, he added. In May, the FDA cleared the first test to diagnose Alzheimer’s based on levels of tau and amyloid protein in the blood. Fujirebio Diagnostics’ Lumipulse is intended for use in adult patients aged 55 and older who are showing signs and symptoms of the disease, including cognitive decline. The test could help reduce the need for expensive PET scans or invasive spinal taps. This month, Roche and Eli Lilly said their tau-based Alzheimer’s test was greenlit for use in a primary care setting in the same type of patients. But many biomarker-based diagnostics are still in the early stages of development and demonstrate varying levels of accuracy. Developers often struggle to achieve the right levels of sensitivity and specificity for their assays, as well as reproducibility of results. Even so, the uptick in biomarker-based strategies shows that neuroscience is starting to learn from fields like oncology, which have wielded precision medicine to their advantage. Precision medicine involves targeting subgroups within a broader patient population who share the same underlying biology, such as the same genetic driver of a disease, Barker explained. The broader adoption of AI and machine learning technologies, early as they may be, means it’s also becoming faster to identify which neurology candidates are likely to succeed, Citeline analyst Emma Wille told Endpoints in an email. For instance, Dallas-based Lantern Pharma has developed an AI-powered platform that helps predict how well small molecules can penetrate the blood-brain barrier. With all these factors coming together, neurology is “ripe with opportunities for success,” Wille said. “Yes, there’s risk and uncertainty in this therapeutic area — but the payoff could be substantial.”

Drug ApprovalAcquisitionPhase 3Oligonucleotide

22 Oct 2025

·www.biospace.com

How J&J Kept Growing Amid the Erosion of Cornerstone Drug Stelara

iStock, Denis_prof The company cut back in areas while investing in internal and external opportunities to offset the loss of exclusivity on a product that, until recently, accounted for 20% of innovative medicine sales. Johnson & Johnson has made a molehill out of a mountain. Facing the loss of exclusivity on a drug that accounted for 20% of innovative medicine sales in 2023, J&J has reshaped its business around other products and programs to leave analysts predicting a new era of growth for the company. The anticipated arrival of biosimilar versions of Stelara, J&J’s blockbuster autoimmune disease drug, has occupied analysts for years. J&J executives have fielded questions about their preparations since at least 2021, reflecting how important the anti-IL-12 and IL-23 antibody became to the company after sales of chronic inflammatory disease drug Remicade began to erode in the face of off-patent rivals. Stelara sales peaked at $10.9 billion in 2023. Biosimilar competition, first overseas and later in the U.S., caused sales to slip in 2024 and tumble further in 2025. Yet while sales of the drug fell 40% over the first nine months of 2025, J&J still grew global innovative medicine revenue by 5%. BioSpace , Annalee Armstrong Cutting and Investing The growth reflects J&J’s multi-year effort to adapt its business for a post-Stelara future. Some parts of the business have been sacrificed to enable investment in the most promising programs. In 2023, J&J axed clinical-phase programs targeting hepatitis B, HIV and respiratory syncytial virus and ended R&D at an infectious disease and vaccine site in the Netherlands. J&J CFO Joseph Wolk framed the infectious disease and vaccine changes in the context of Stelara at a Bernstein event in May; The company “probably had to cut some investment” to prepare for the entry of Stelara biosimilars, he said. J&J’s medtech business provides sales to offset slowdowns at the medicines unit but the company nonetheless had to pull back from some areas. “We still make choices. You saw last year we exited infectious diseases and vaccines. We still prioritize, but it gives us a lot more flexibility to manage for that long term and have the robust pipeline and the growth outlook we have for the balance of this decade,” Wolk said. As J&J pulled back from infectious diseases and vaccines, it invested in other areas to ensure new growth drivers were in place to ease the Stelara transition. At J&J’s immunology unit, rising sales of Tremfya and Simponi are partly offsetting the decline of Stelara and the development of icotrokinra , JNJ-4804 and nipocalimab are laying the groundwork for a potential new-look portfolio. All three assets are in development for multiple indications, from plaque psoriasis to ulcerative colitis to psoriatic arthritis. The emergence of oncology as J&J’s tentpole business has allowed the company to weather a period of falling immunology sales. Five years ago, J&J reported nine-month oncology revenue of $8.9 billion. Oncology sales for the first nine months of 2025 were $18.5 billion. The growth reflects the blossoming of multiple myeloma drug Darzalex, plus product launches. Darzalex was a blockbuster in 2020, generating sales of $2.9 billion in just the first nine months of the year. It has grown significantly since then. The growth covers a period in which J&J launched a subcutaneous version of Darzalex and expanded the label. Sales hit $10.4 billion over the first nine months of 2025. J&J has also turned its prostate cancer drug Erleada, which was approved in 2019, into a multi-billion dollar a year product. The CAR T cell therapy Carvykti became J&J’s latest cancer blockbuster in the third quarter of 2025, when total sales for the year reached $1.3 billion. With sales of the bispecific antibodies Tecvayli, Talvey and Rybrevant still rising, and the bladder cancer drug Inlexzo new to the market, J&J is aiming to grow oncology revenues to $50 billion by 2030. The forecast was at least three times above the 2028 analyst consensus estimate when the company made the prediction in July, partly reflecting J&J’s belief that annual Inlexzo sales will exceed $5 billion. Guggenheim Securities analysts recently discussed Inlexzo’s prospects with a community urologist. J&J could face competition from CG Oncology’s oncolytic immunotherapy cretostimogene grenadenorepvec. The urologist told the analysts that the ability to keep Inlexzo at room temperature, the lack of biohazard requirements and the option to administer the drug at the office give J&J an advantage. “The speaker emphasized that in his community practice setting, practical convenience and logistical advantages would be the main determinants in choosing between the two products,” the analysts wrote in a note to investors. “As such, he envisions using Inlexzo in the large majority of his patients when both products are available in the future.” Deals Drive Growth Speaking on an earnings call in October, J&J CEO Joaquin Duato called Inlexzo an example of the company’s “outstanding business development model.” J&J acquired the asset through its 2019 takeover of Taris Biomedical. Wolk said on the earnings call that the company paid “a couple of hundred million dollars” for Taris, which was then in early clinical development. Duato said J&J has completed “more than 60 deals of this kind” in the past 18 months. J&J has struck the early-stage deals alongside bigger bets such as its $14.6 billion takeover of Intra-Cellular Therapies. The deal added the schizophrenia and bipolar depression drug Caplyta to J&J’s neuroscience portfolio. Caplyta generated $240 million in the third quarter, helping J&J grow neuroscience revenues despite sales of Concerta and Invega falling. Spravato is the other key product in J&J’s neuroscience portfolio. Sales grew more than 50% to near $1.2 billion over the first nine months of 2025. The drugs have established neuroscience as J&J’s third biggest innovative medicine unit after oncology and immunology. J&J’s pulmonary hypertension and cardiovascular units also have blockbuster drugs, giving the company a broad base to offset future challenges. The nature of the pharma industry means new challenges are inevitable. J&J is now receiving questions about potential price negotiations and patent expirations for Darzalex. Guggenheim analysts said they believe investors are “underappreciating Darzalex’s increased longevity and potentially improved economics,” but at some point J&J will need to adapt to pressure on its latest star drug. Having navigated the launches of Remicade and Stelara biosimilars over the past decade, the company has established a track record of managing such pressures and continuing to grow.

AcquisitionDrug ApprovalImmunotherapyBiosimilar

14 Oct 2025

·www.businesswire.com

Johnson & Johnson Reports Q3 2025 Results; Raises 2025 Sales Outlook

NEW BRUNSWICK, N.J.--(BUSINESS WIRE)--Johnson & Johnson (NYSE: JNJ) today announced results for third-quarter 2025. “Johnson & Johnson delivered another strong performance in the third quarter fueled by the depth and strength of our portfolio and significant progress across our pipeline,” said Joaquin Duato, Chairman and Chief Executive Officer, Johnson & Johnson. “With a sharpened focus on the six priority areas of Oncology, Immunology, Neuroscience, Cardiovascular, Surgery and Vision, Johnson & Johnson is in a new era of accelerated growth and innovation, with pioneering treatments that will continue to transform lives.” Overall financial results Q3 ($ in Millions, except EPS) 2025 2024 % Change Reported Sales $23,993 $22,471 6.8% Net Earnings $5,152 $2,694 91.2% EPS (diluted) $2.12 $1.11 91.0% Q3 Non-GAAP* ($ in Millions, except EPS) 2025 2024 % Change Operational Sales1,2 5.4% Adjusted Operational Sales1,3 4.4% Adjusted Net Earnings1,4 $6,801 $5,876 15.7% Adjusted EPS (diluted)1,4 $2.80 $2.42 15.7% Free Cash Flow6,7 ~$14,200 $14,471 1 Non-GAAP financial measure; refer to reconciliations of non-GAAP financial measures included in accompanying schedules 2 Excludes the impact of translational currency 3 Excludes the net impact of acquisitions and divestitures and translational currency 4 Excludes intangible amortization expense and special items 5 Excludes COVID-19 Vaccine 6 Non-GAAP measure; defined as cash flow from operating activities, less additions to property, plant and equipment. Cash flow from operations, the most directly comparable GAAP financial measure, will be included in subsequent SEC filings. 7 Third-quarter YTD 2025 is estimated as of October 14, 2025 Regional sales results Q3 % Change ($ in Millions) 2025 2024 Reported Operational1,2 Currency Adjusted Operational1,3 U.S. $13,708 $12,909 6.2% 6.2 - 4.4 International 10,285 9,562 7.6 4.4 3.2 4.4 Worldwide $23,993 $22,471 6.8% 5.4 1.4 4.4 1 Non-GAAP financial measure; refer to reconciliations of non-GAAP financial measures included in accompanying schedules 2 Excludes the impact of translational currency 3 Excludes the net impact of acquisitions and divestitures and translational currency Segment sales results Q3 % Change ($ in Millions) 2025 2024 Reported Operational1,2 Currency Adjusted Operational1,3 Innovative Medicine $15,563 $14,580 6.8% 5.3 1.5 3.7 MedTech 8,430 7,891 6.8 5.6 1.2 5.7 Worldwide $23,993 $22,471 6.8% 5.4 1.4 4.4 1 Non-GAAP financial measure; refer to reconciliations of non-GAAP financial measures included in accompanying schedules 2 Excludes the impact of translational currency 3 Excludes the net impact of acquisitions and divestitures and translational currency Third-Quarter 2025 segment commentary: Operational sales* reflected below excludes the impact of translational currency. Innovative Medicine Innovative Medicine worldwide operational sales grew 5.3%*, with net acquisitions and divestitures positively impacting growth by 1.6% due to CAPLYTA. Growth was primarily driven by DARZALEX, CARVYKTI, ERLEADA and RYBREVANT/LAZCLUZE in Oncology, TREMFYA and SIMPONI/SIMPONI ARIA in Immunology, and SPRAVATO in Neuroscience. Growth was partially offset by an approximate (1,070) basis points impact from STELARA in Immunology, as well as IMBRUVICA in Oncology. MedTech MedTech worldwide operational sales grew 5.6%*, with net acquisitions and divestitures negatively impacting growth by 0.1%. Growth was primarily driven by electrophysiology products, Abiomed and Shockwave in Cardiovascular, wound closure products in General Surgery, as well as Surgical Vision. Full-year 2025 guidance: Johnson & Johnson does not provide GAAP financial measures on a forward-looking basis because the company is unable to predict with reasonable certainty the ultimate outcome of legal proceedings, unusual gains and losses, acquisition-related expenses, and purchase accounting fair value adjustments without unreasonable effort. These items are uncertain, depend on various factors, and could be material to Johnson & Johnson's results computed in accordance with GAAP. ($ in Billions, except EPS) October 2025 July 2025 Adjusted Operational Sales1,2,5 Change vs. Prior Year / Mid-point 3.5% – 4.0% / 3.8% 3.2% – 3.7% / 3.5% Operational Sales2,5 / Mid-point Change vs. Prior Year / Mid-point $93.0B – $93.4B / $93.2B 4.8% – 5.3% / 5.1% $92.7B – $93.1B / $92.9B 4.5% – 5.0% / 4.8% Estimated Reported Sales3,5/ Mid-point Change vs. Prior Year / Mid-point $93.5B – $93.9B / $93.7B 5.4% – 5.9% / 5.7% $93.2B – $93.6B / $93.4B 5.1% – 5.6% / 5.4% Adjusted Operational EPS (Diluted)2,4 / Mid-point Change vs. Prior Year / Mid-point $10.63 – $10.73 / $10.68 6.5% – 7.5% / 7.0% $10.63 – $10.73 / $10.68 6.5% – 7.5% / 7.0% Adjusted EPS (Diluted)3,4 / Mid-point Change vs. Prior Year / Mid-point $10.80 – $10.90 / $10.85 8.2% – 9.2% / 8.7% $10.80 – $10.90 / $10.85 8.2% – 9.2% / 8.7% 1 Non-GAAP financial measure; excludes the net impact of acquisitions and divestitures 2 Non-GAAP financial measure; excludes the impact of translational currency 3 Calculated using Euro Average Rate: Oct 2025 = $1.13 and July 2025 = $1.13 (Illustrative purposes only) 4 Non-GAAP financial measure; excludes intangible amortization expense and special items 5 Excludes COVID-19 Vaccine Other modeling considerations will be provided on the webcast. Notable announcements in the quarter: The information contained in this section should be read together with Johnson & Johnson’s other disclosures filed with the Securities and Exchange Commission, including its Current Reports on Form 8-K, Quarterly Reports on Form 10-Q and Annual Reports on Form 10-K. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. The reader is also encouraged to review all other news releases and information available in the Investor Relations section of the company’s website at Investor News, as well as Innovative Medicine Newsroom, MedTech News & Events, and www.factsabouttalc.com. Regulatory U.S. FDA approves TREMFYA (guselkumab) for the treatment of pediatric plaque psoriasis and active psoriatic arthritis, marking a first and only approval for an IL-23 inhibitor1 Press Release TREMFYA (guselkumab) achieves U.S. approval for subcutaneous induction in adults with ulcerative colitis, now the first and only IL-23 inhibitor with a fully subcutaneous regimen Press Release Johnson & Johnson receives positive CHMP opinion of nipocalimab to treat a broad population of antibody-positive patients living with generalised myasthenia gravis (gMG) Press Release Johnson & Johnson files with U.S. FDA to include new evidence in TREMFYA (guselkumab) label as the only IL-23 inhibitor to demonstrate significant inhibition of joint structural damage in active psoriatic arthritis Press Release European Commission approves DARZALEX (daratumumab) as the first licensed treatment for patients with high-risk smouldering multiple myeloma Press Release European Commission approves IMBRUVICA (ibrutinib) as the first targeted therapy for patients with previously untreated mantle cell lymphoma who would be eligible for autologous stem cell transplant Press Release Johnson & Johnson seeks first icotrokinra U.S. FDA approval aiming to revolutionize treatment paradigm for adults and adolescents with plaque psoriasis Press Release Data Releases Johnson & Johnson to highlight breadth of its major depressive disorder portfolio at 2025 ECNP Congress1 Press Release Icotrokinra data in ulcerative colitis show potential for a standout combination of therapeutic benefit and a favorable safety profile in once-daily pill1 Press Release TREMFYA (guselkumab) is first and only IL-23 inhibitor to demonstrate sustained clinical and endoscopic outcomes with a fully subcutaneous regimen through 48 weeks in ulcerative colitis1 Press Release Johnson & Johnson Unveils New Data Demonstrating Superior Clarity of Vision and Comfort of ACUVUE OASYS MAX 1-Day for ASTIGMATISM, and MULTIFOCAL for ASTIGMATISM Contact Lenses1 Press Release Johnson & Johnson’s investigational seltorexant shows numerically higher response in patients with depression with insomnia symptoms, with fewer side effects compared to quetiapine XR Press Release TECVAYLI plus DARZALEX FASPRO treatment demonstrates 100 percent overall response rate in transplant-eligible patients newly diagnosed with multiple myeloma Press Release Icotrokinra shows superiority to deucravacitinib in first reported head-to-head trials reinforcing promise of novel targeted oral peptide for treatment of plaque psoriasis Press Release Johnson & Johnson to showcase industry-leading neuropsychiatry innovations at the 2025 Psych Congress Annual Meeting Press Release Data published in The New England Journal of Medicine demonstrate RYBREVANT (amivantamab-vmjw) plus LAZCLUZE (lazertinib) is re-setting survival expectations in first-line EGFR-mutated lung cancer Press Release RYBREVANT (amivantamab-vmjw) plus LAZCLUZE (lazertinib) prevents acquired resistance versus osimertinib in first-line EGFR-mutated non-small cell lung cancer Press Release New real-world data elevating patient perspectives highlight the need for scientific advancement in maternal fetal immunology at ISUOG 2025 Press Release Johnson & Johnson Unveils Results from the VARIPURE Substudy of SECURE, a Real-World Study on VARIPULSE Platform, at 2025 European Society of Cardiology (ESC) Congress Press Release New Data from the DanGer Shock Randomized Control Trial, Published in The New England Journal of Medicine, Confirms the Long-Term Survival Benefit of the Impella CP Heart Pump Press Release Johnson & Johnson showcases latest advancements in Alzheimer's research at AAIC 2025 Press Release Product Launch U.S. FDA approval of INLEXZO (gemcitabine intravesical system) set to transform how certain bladder cancers are treated Press Release Johnson & Johnson Launches VIRTUGUIDE AI-Powered Patient-Matched Lapidus System in U.S. to Reduce Complexity in Bunion Surgery for Millions Press Release Other Johnson & Johnson Elects John Morikis, Retired Chairman, President and Chief Executive Officer of The Sherwin-Williams Company, to its Board of Directors Press Release 1 Subsequent to the quarter Webcast information: Johnson & Johnson will conduct a conference call with investors to discuss this earnings release today at 8:30 a.m., Eastern Time. A simultaneous webcast of the call for investors and other interested parties may be accessed by visiting the Johnson & Johnson website. A replay and podcast will be available approximately two hours after the live webcast in the Investor Relations section of the company's website at events-and-presentations. 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 www.jnj.com. Non-GAAP financial measures: * “Operational sales growth” excluding the impact of translational currency, “adjusted operational sales growth” excluding the net impact of acquisitions and divestitures and translational currency, as well as “adjusted net earnings”, “adjusted diluted earnings per share” and “adjusted operational diluted earnings per share” excluding after-tax intangible amortization expense and special items, are non-GAAP financial measures and should not be considered replacements for, and should be read together with, the most comparable GAAP financial measures. Except for guidance measures, reconciliations of these non-GAAP financial measures to the most directly comparable GAAP financial measures can be found in the accompanying financial schedules of the earnings release and the Investor Relations section of the company's website at quarterly results. Copies of the financial schedules accompanying this earnings release are available on the company’s website at quarterly results. These schedules include supplementary sales data, a condensed consolidated statement of earnings, reconciliations of non-GAAP financial measures, and sales of key products/franchises. Additional information on Johnson & Johnson, including adjusted income before tax by segment, an Innovative Medicine pipeline of selected compounds in late stage development and a copy of today’s earnings call presentation can also be found in the Investor Relations section of the company's website at quarterly results. Note to investors concerning forward-looking statements: This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding, among other things: future operating and financial performance, product development, and market position and business strategy. 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: economic factors, such as interest rate and currency exchange rate fluctuations or changes to applicable laws and regulations; competition, including technological advances, new products and patents attained by competitors; challenges inherent in new product research and development, including uncertainty of clinical success and obtaining regulatory approvals; uncertainty of commercial success for new and existing products; challenges to patents; the impact of patent expirations; the ability of the Company to successfully execute strategic plans, including restructuring plans; the impact of business combinations and divestitures; manufacturing difficulties or delays, internally or within the supply chain; product efficacy or safety concerns resulting in product recalls or regulatory action; significant adverse litigation or government action, including related to product liability claims; changes to applicable laws and regulations, including tax laws and global health care reforms; trends toward health care cost containment; changes in behavior and spending patterns of purchasers of health care products and services; financial instability of international economies and legal systems and sovereign risk; and increased scrutiny of the health care industry by government agencies. 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 www.sec.gov, www.jnj.com, investor.jnj.com, or on request from Johnson & Johnson. Any forward-looking statement made in this release speaks only as of the date of this release. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments. THIRD QUARTER NINE MONTHS Percent Change Percent Change 2025 2024 Total Operations Currency 2025 2024 Total Operations Currency $ 9,402 8,871 6.0 % 6.0 - $ 26,655 24,993 6.7 % 6.7 - 6,161 5,709 7.9 4.3 3.6 17,983 17,639 1.9 1.3 0.6 15,563 14,580 6.8 5.3 1.5 44,638 42,632 4.7 4.5 0.2 4,306 4,038 6.6 6.6 - 12,902 12,105 6.6 6.6 - 4,124 3,853 7.0 4.5 2.5 12,089 11,564 4.5 3.9 0.6 8,430 7,891 6.8 5.6 1.2 24,991 23,669 5.6 5.3 0.3 13,708 12,909 6.2 6.2 - 39,557 37,098 6.6 6.6 - 10,285 9,562 7.6 4.4 3.2 30,072 29,203 3.0 2.3 0.7 $ 23,993 22,471 6.8 % 5.4 1.4 $ 69,629 66,301 5.0 % 4.7 0.3 THIRD QUARTER NINE MONTHS Percent Change Percent Change 2025 2024 Total Operations Currency 2025 2024 Total Operations Currency $ 13,708 12,909 6.2 % 6.2 - $ 39,557 37,098 6.6 % 6.6 - 5,440 4,914 10.7 4.4 6.3 15,937 15,291 4.2 1.5 2.7 1,231 1,173 4.9 7.3 (2.4 ) 3,604 3,579 0.7 7.6 (6.9 ) 3,614 3,475 4.0 3.4 0.6 10,531 10,333 1.9 1.8 0.1 10,285 9,562 7.6 4.4 3.2 30,072 29,203 3.0 2.3 0.7 $ 23,993 22,471 6.8 % 5.4 1.4 $ 69,629 66,301 5.0 % 4.7 0.3 2025 2024 Percent Percent Percent Increase Amount to Sales Amount to Sales (Decrease) $ 23,993 100.0 $ 22,471 100.0 6.8 7,303 30.4 6,963 31.0 4.9 16,690 69.6 15,508 69.0 7.6 5,922 24.7 5,478 24.3 8.1 3,672 15.3 4,952 22.0 (25.8 ) 18 0.1 (99 ) (0.4 ) (478 ) (2.0 ) 1,798 8.0 63 0.3 41 0.2 7,493 31.2 3,338 14.9 124.5 2,341 9.7 644 2.9 263.5 $ 5,152 21.5 $ 2,694 12.0 91.2 $ 2.12 $ 1.11 91.0 2,428.6 2,427.9 31.2 % 19.3 % $ 8,436 35.2 $ 7,277 32.4 15.9 $ 6,801 28.3 $ 5,876 26.1 15.7 $ 2.80 $ 2.42 15.7 19.4 % 19.3 % 2025 2024 Percent Percent Percent Increase Amount to Sales Amount to Sales (Decrease) $ 69,629 100.0 $ 66,301 100.0 5.0 22,288 32.0 20,343 30.7 9.6 47,341 68.0 45,958 69.3 3.0 16,923 24.3 16,416 24.8 3.1 10,413 15.0 11,934 18.0 (12.7 ) - - 194 0.3 (62 ) (0.1 ) (433 ) (0.7 ) (7,692 ) (11.1 ) 4,855 7.3 144 0.2 192 0.3 27,615 39.7 12,800 19.3 115.7 5,927 8.6 2,165 3.3 173.8 $ 21,688 31.1 $ 10,635 16.0 103.9 $ 8.94 $ 4.38 104.1 2,424.8 2,429.5 21.5 % 16.9 % $ 24,635 35.4 $ 23,558 35.5 4.6 $ 20,206 29.0 $ 19,296 29.1 4.7 $ 8.33 $ 7.94 4.9 18.0 % 18.1 % Third Quarter Nine Months Ended 2025 2024 2025 2024 $5,152 $2,694 $21,688 $10,635 15 2,388 (6,894 ) 5,466 1,048 1,171 3,435 3,355 - 4 - 77 168 47 302 207 - 38 - 157 97 328 475 928 (387 ) (37 ) (327 ) 374 - - - 194 2 - 29 - (168 ) (762 ) 826 (2,055 ) 874 5 672 (42 ) $6,801 $5,876 $20,206 $19,296 2,428.6 2,427.9 2,424.8 2,429.5 $2.80 $2.42 $8.33 $7.94 $2.72 $8.24 1 2 6.8% 6.8% 6.8% 6.0% 6.6% 6.2% 7.9% 7.0% 7.6% 1.5 1.2 1.4 - - - 3.6 2.5 3.2 5.3% 5.6% 5.4% 6.0% 6.6% 6.2% 4.3% 4.5% 4.4% (1.6) (1.1) (2.7) (1.9) 0.0 0.0 0.0 0.1 0.1 0.0 0.2 0.1 0.0 0.1 0.0 3.7% 5.7% 4.4% 3.3% 6.8% 4.4% 4.3% 4.6% 4.4% 4.7% 5.6% 5.0% 6.7% 6.6% 6.6% 1.9% 4.5% 3.0% 0.2 0.3 0.3 - - - 0.6 0.6 0.7 4.5% 5.3% 4.7% 6.7% 6.6% 6.6% 1.3% 3.9% 2.3% (1.9) (0.6) (2.9) (0.9) (0.8) (0.2) (1.1) (0.7) (1.8) (1.2) 0.0 0.0 0.0 0.3 0.1 0.0 0.4 0.1 0.1 0.2 0.1 3.4% 3.7% 3.5% 4.9% 4.1% 4.6% 1.4% 3.3% 2.2% REPORTED SALES vs. PRIOR PERIOD ($MM) REPORTED SALES vs. PRIOR PERIOD ($MM) % Change % Change 2025 2024 Reported Operational (1) Currency 2025 2024 Reported Operational (1) Currency $ 3,468 2,816 23.2 % 23.2 % - $ 9,866 7,835 25.9 % 25.9 % - 3,060 2,565 19.3 % 14.8 % 4.5 % 8,652 7,450 16.1 % 15.0 % 1.1 % 6,529 5,380 21.3 % 19.2 % 2.1 % 18,519 15,284 21.2 % 20.6 % 0.6 % 396 258 53.3 % 53.3 % - 1,072 565 89.6 % 89.6 % - 128 27 * * * 260 63 * * * 524 286 83.5 % 81.4 % 2.1 % 1,332 629 * * * 2,088 1,684 24.0 % 24.0 % - 5,934 4,789 23.9 % 23.9 % - 1,584 1,332 18.9 % 14.7 % 4.2 % 4,514 3,797 18.9 % 17.9 % 1.0 % 3,672 3,016 21.7 % 19.9 % 1.8 % 10,448 8,586 21.7 % 21.3 % 0.4 % 378 337 12.3 % 12.3 % - 1,048 940 11.5 % 11.5 % - 558 453 23.0 % 17.6 % 5.4 % 1,567 1,275 22.9 % 21.1 % 1.8 % 936 790 18.4 % 15.3 % 3.1 % 2,615 2,215 18.0 % 17.0 % 1.0 % 211 259 (18.3 )% (18.3 )% - 685 770 (11.0 )% (11.0 )% - 483 494 (2.3 )% (6.6 )% 4.3 % 1,453 1,537 (5.4 )% (6.4 )% 1.0 % 695 753 (7.8 )% (10.6 )% 2.8 % 2,139 2,307 (7.3 )% (7.9 )% 0.6 % 136 68 99.7 % 99.7 % - 388 156 * * - 61 21 * * * 130 49 * * * 198 89 * * * 518 205 * * * 85 64 34.2 % 34.2 % - 235 173 35.8 % 35.8 % - 37 12 * * * 79 29 * * * 122 75 60.8 % 59.1 % 1.7 % 314 202 55.3 % 54.9 % 0.4 % 115 105 9.3 % 9.3 % - 334 310 7.5 % 7.5 % - 62 30 * * * 160 93 73.0 % 72.6 % 0.4 % 177 135 31.3 % 29.9 % 1.4 % 494 403 22.6 % 22.5 % 0.1 % 5 5 (25.0 )% (25.0 )% - 18 25 (30.4 )% (30.4 )% - 108 144 (25.1 )% (26.8 )% 1.7 % 365 470 (22.3 )% (23.0 )% 0.7 % 113 150 (25.1 )% (26.8 )% 1.7 % 383 496 (22.8 )% (23.4 )% 0.6 % 56 36 54.6 % 54.6 % - 153 106 44.8 % 44.8 % - 39 50 (22.2 )% (25.6 )% 3.4 % 123 136 (9.7 )% (10.6 )% 0.9 % 94 86 9.7 % 7.7 % 2.0 % 276 242 14.0 % 13.6 % 0.4 % REPORTED SALES vs. PRIOR PERIOD ($MM) REPORTED SALES vs. PRIOR PERIOD ($MM) THIRD QUARTER NINE MONTHS % Change % Change 2025 2024 Reported Operational (1) Currency 2025 2024 Reported Operational (1) Currency $ 2,676 3,068 (12.8 )% (12.8 )% - $ 7,377 8,499 (13.2 )% (13.2 )% - 1,493 1,552 (3.9 )% (6.3 )% 2.4 % 4,492 5,090 (11.8 )% (11.5 )% (0.3 )% 4,168 4,621 (9.8 )% (10.6 )% 0.8 % 11,868 13,590 (12.7 )% (12.6 )% (0.1 )% 326 281 16.2 % 16.2 % - 923 778 18.7 % 18.7 % - 19 27 (30.9 )% (30.9 )% - 63 89 (29.6 )% (29.6 )% - 132 112 17.7 % 16.7 % 1.0 % 413 380 8.6 % 10.4 % (1.8 )% 476 419 13.6 % 13.3 % 0.3 % 1,398 1,246 12.2 % 12.7 % (0.5 )% 309 299 3.6 % 3.6 % - 906 820 10.5 % 10.5 % - 377 218 73.0 % 69.8 % 3.2 % 1,130 787 43.5 % 44.6 % (1.1 )% 687 516 32.9 % 31.5 % 1.4 % 2,036 1,607 26.7 % 27.2 % (0.5 )% 1,022 1,770 (42.3 )% (42.3 )% - 3,081 5,021 (38.6 )% (38.6 )% - 549 906 (39.4 )% (41.4 )% 2.0 % 1,768 2,991 (40.9 )% (40.8 )% (0.1 )% 1,570 2,676 (41.3 )% (42.0 )% 0.7 % 4,848 8,012 (39.5 )% (39.5 )% 0.0 % 989 691 43.1 % 43.1 % - 2,384 1,789 33.3 % 33.3 % - 434 316 37.4 % 33.4 % 4.0 % 1,181 932 26.7 % 26.1 % 0.6 % 1,424 1,007 41.3 % 40.1 % 1.2 % 3,566 2,721 31.0 % 30.8 % 0.2 % 12 1 * * - 21 3 * * - 0 0 - - - 0 0 - - - 12 1 * * - 21 3 * * - 1,367 1,094 25.0 % 25.0 % - 3,712 3,250 14.2 % 14.2 % - 658 662 (0.7 )% (2.6 )% 1.9 % 2,011 2,090 (3.8 )% (3.7 )% (0.1 )% 2,024 1,755 15.3 % 14.6 % 0.7 % 5,722 5,340 7.2 % 7.2 % 0.0 % 240 - * * - 451 - * * - - - - - - - - - - - 240 - * * - 451 - * * - 14 26 (49.2 )% (49.2 )% - 76 101 (24.9 )% (24.9 )% - 127 117 9.0 % 8.5 % 0.5 % 376 382 (1.4 )% (0.4 )% (1.0 )% 140 142 (1.4 )% (1.8 )% 0.4 % 452 482 (6.3 )% (5.5 )% (0.8 )% 664 780 (14.9 )% (14.9 )% - 2,021 2,329 (13.2 )% (13.2 )% - 267 269 (0.9 )% (3.0 )% 2.1 % 804 830 (3.1 )% (3.0 )% (0.1 )% 929 1,049 (11.3 )% (11.9 )% 0.6 % 2,824 3,159 (10.6 )% (10.5 )% (0.1 )% 405 243 67.1 % 67.1 % - 1,047 660 58.7 % 58.7 % - 53 42 28.9 % 23.8 % 5.1 % 146 120 21.9 % 21.4 % 0.5 % 459 284 61.5 % 60.8 % 0.7 % 1,193 780 53.0 % 52.9 % 0.1 % 46 46 0.4 % 0.4 % - 119 161 (26.4 )% (26.4 )% - 210 235 (10.7 )% (12.3 )% 1.6 % 684 759 (9.8 )% (9.9 )% 0.1 % 256 281 (8.9 )% (10.2 )% 1.3 % 803 920 (12.7 )% (12.8 )% 0.1 % REPORTED SALES vs. PRIOR PERIOD ($MM) REPORTED SALES vs. PRIOR PERIOD ($MM) THIRD QUARTER NINE MONTHS % Change % Change 2025 2024 Reported Operational (1) Currency 2025 2024 Reported Operational (1) Currency $ 815 815 (0.1 )% (0.1 )% - $ 2,358 2,324 1.5 % 1.5 % - 300 287 4.8 % 2.0 % 2.8 % 895 866 3.4 % 2.6 % 0.8 % 1,115 1,102 1.1 % 0.4 % 0.7 % 3,253 3,190 2.0 % 1.8 % 0.2 % 409 417 (1.6 )% (1.6 )% - 1,175 1,149 2.3 % 2.3 % - 168 166 1.1 % (1.8 )% 2.9 % 507 506 0.2 % (0.7 )% 0.9 % 578 583 (0.8 )% (1.7 )% 0.9 % 1,682 1,655 1.7 % 1.4 % 0.3 % 392 379 3.5 % 3.5 % - 1,139 1,120 1.7 % 1.7 % - 92 80 15.2 % 12.0 % 3.2 % 272 232 17.0 % 16.4 % 0.6 % 484 458 5.6 % 5.0 % 0.6 % 1,411 1,352 4.3 % 4.2 % 0.1 % 13 21 (36.5 )% (36.5 )% - 44 56 (21.5 )% (21.5 )% - 39 39 (1.0 )% (2.5 )% 1.5 % 116 127 (8.9 )% (9.1 )% 0.2 % 53 60 (13.1 )% (14.1 )% 1.0 % 160 183 (12.7 )% (12.9 )% 0.2 % 326 365 (10.5 )% (10.5 )% - 961 1,023 (6.0 )% (6.0 )% - 501 471 6.4 % 0.5 % 5.9 % 1,472 1,599 (7.9 )% (9.8 )% 1.9 % 829 836 (0.9 )% (4.3 )% 3.4 % 2,434 2,622 (7.2 )% (8.3 )% 1.1 % 7 8 (7.9 )% (7.9 )% - 21 24 (11.8 )% (11.8 )% - 378 323 16.9 % 9.9 % 7.0 % 1,082 926 16.8 % 13.6 % 3.2 % 385 330 16.4 % 9.5 % 6.9 % 1,103 950 16.1 % 13.0 % 3.1 % 315 355 (11.0 )% (11.0 )% - 932 990 (5.8 )% (5.8 )% - 81 94 (13.6 )% (18.5 )% 4.9 % 264 315 (16.1 )% (16.6 )% 0.5 % 397 449 (11.6 )% (12.6 )% 1.0 % 1,196 1,305 (8.3 )% (8.4 )% 0.1 % 4 3 57.3 % 57.3 % - 8 10 (11.0 )% (11.0 )% - 42 54 (21.2 )% (22.3 )% 1.1 % 126 358 (64.7 )% (64.6 )% (0.1 )% 47 56 (17.5 )% (18.5 )% 1.0 % 135 367 (63.3 )% (63.2 )% (0.1 )% 750 713 5.3 % 5.3 % - 2,381 2,061 15.5 % 15.5 % - 149 170 (13.1 )% (15.6 )% 2.5 % 461 543 (15.2 )% (14.7 )% (0.5 )% 899 884 1.7 % 1.2 % 0.5 % 2,842 2,605 9.1 % 9.2 % (0.1 )% 635 592 7.4 % 7.4 % - 1,946 1,697 14.7 % 14.7 % - - - - - - - - - - - 635 592 7.4 % 7.4 % - 1,946 1,697 14.7 % 14.7 % - 115 121 (5.2 )% (5.2 )% - 435 364 19.4 % 19.4 % - 149 170 (13.1 )% (15.6 )% 2.5 % 461 543 (15.2 )% (14.7 )% (0.5 )% 264 292 (9.8 )% (11.3 )% 1.5 % 896 908 (1.3 )% (1.0 )% (0.3 )% 9,402 8,871 6.0 % 6.0 % - 26,655 24,993 6.7 % 6.7 % - 6,161 5,709 7.9 % 4.3 % 3.6 % 17,983 17,639 1.9 % 1.3 % 0.6 % $ 15,563 14,580 6.8 % 5.3 % 1.5 % $ 44,638 42,632 4.7 % 4.5 % 0.2 % REPORTED SALES vs. PRIOR PERIOD ($MM) REPORTED SALES vs. PRIOR PERIOD ($MM) THIRD QUARTER NINE MONTHS % Change % Change 2025 2024 Reported Operational (1) Currency 2025 2024 Reported Operational (1) Currency $ 1,306 1,148 13.8 % 13.8 % - $ 3,931 3,292 19.4 % 19.4 % - 908 819 10.8 % 8.4 % 2.4 % 2,698 2,353 14.6 % 13.8 % 0.8 % 2,213 1,966 12.6 % 11.6 % 1.0 % 6,629 5,645 17.4 % 17.1 % 0.3 % 720 660 9.1 % 9.1 % - 2,145 2,057 4.3 % 4.3 % - 698 619 12.6 % 10.4 % 2.2 % 2,064 1,889 9.2 % 8.6 % 0.6 % 1,418 1,279 10.8 % 9.7 % 1.1 % 4,209 3,946 6.7 % 6.4 % 0.3 % 336 293 14.5 % 14.5 % - 1,035 905 14.3 % 14.3 % - 86 68 26.8 % 20.2 % 6.6 % 256 207 23.9 % 20.7 % 3.2 % 423 362 16.8 % 15.6 % 1.2 % 1,291 1,112 16.1 % 15.5 % 0.6 % 220 163 34.4 % 34.4 % - 659 240 * * - 59 66 (11.2 )% (12.4 )% 1.2 % 169 66 * * * 278 229 21.2 % 20.9 % 0.3 % 828 306 * * * 30 30 0.0 % 0.0 % - 93 89 4.2 % 4.2 % - 65 66 (1.0 )% (2.5 )% 1.5 % 209 192 9.0 % 8.7 % 0.3 % 95 96 (0.7 )% (1.7 )% 1.0 % 302 281 7.5 % 7.2 % 0.3 % 1,396 1,359 2.7 % 2.7 % - 4,200 4,229 (0.7 )% (0.7 )% - 878 832 5.6 % 1.9 % 3.7 % 2,620 2,614 0.3 % (1.1 )% 1.4 % 2,274 2,191 3.8 % 2.4 % 1.4 % 6,820 6,843 (0.3 )% (0.8 )% 0.5 % 262 250 4.7 % 4.7 % - 796 785 1.3 % 1.3 % - 144 131 9.7 % 5.9 % 3.8 % 440 435 1.2 % 0.0 % 1.2 % 405 381 6.4 % 5.1 % 1.3 % 1,235 1,220 1.3 % 0.9 % 0.4 % 216 212 2.1 % 2.1 % - 673 684 (1.5 )% (1.5 )% - 160 140 14.3 % 10.9 % 3.4 % 482 463 4.0 % 3.0 % 1.0 % 377 352 7.0 % 5.6 % 1.4 % 1,155 1,147 0.7 % 0.3 % 0.4 % 512 497 3.0 % 3.0 % - 1,515 1,499 1.1 % 1.1 % - 281 265 6.4 % 2.5 % 3.9 % 818 786 4.1 % 2.7 % 1.4 % 793 761 4.2 % 2.9 % 1.3 % 2,333 2,285 2.1 % 1.6 % 0.5 % 406 400 1.3 % 1.3 % - 1,216 1,262 (3.7 )% (3.7 )% - 293 296 (1.1 )% (4.8 )% 3.7 % 881 930 (5.3 )% (6.8 )% 1.5 % 698 696 0.3 % (1.3 )% 1.6 % 2,096 2,191 (4.3 )% (5.0 )% 0.7 % REPORTED SALES vs. PRIOR PERIOD ($MM) REPORTED SALES vs. PRIOR PERIOD ($MM) THIRD QUARTER NINE MONTHS % Change % Change 2025 2024 Reported Operational (1) Currency 2025 2024 Reported Operational (1) Currency $ 1,031 983 4.9 % 4.9 % - $ 3,076 2,965 3.8 % 3.8 % - 1,511 1,451 4.1 % 2.2 % 1.9 % 4,417 4,373 1.0 % 0.9 % 0.1 % 2,542 2,434 4.4 % 3.3 % 1.1 % 7,493 7,338 2.1 % 2.1 % 0.0 % 477 448 6.2 % 6.2 % - 1,411 1,360 3.7 % 3.7 % - 688 661 4.2 % 2.1 % 2.1 % 1,991 1,977 0.7 % 0.5 % 0.2 % 1,165 1,109 5.0 % 3.8 % 1.2 % 3,402 3,337 1.9 % 1.8 % 0.1 % 555 535 3.8 % 3.8 % - 1,666 1,605 3.8 % 3.8 % - 823 791 4.0 % 2.2 % 1.8 % 2,426 2,397 1.2 % 1.3 % (0.1 )% 1,378 1,325 3.9 % 2.9 % 1.0 % 4,092 4,001 2.3 % 2.3 % 0.0 % 571 549 4.2 % 4.2 % - 1,694 1,619 4.7 % 4.7 % - 828 751 10.2 % 7.5 % 2.7 % 2,354 2,224 5.8 % 5.0 % 0.8 % 1,400 1,300 7.7 % 6.1 % 1.6 % 4,048 3,843 5.3 % 4.8 % 0.5 % 456 441 3.5 % 3.5 % - 1,337 1,288 3.8 % 3.8 % - 562 527 6.6 % 3.4 % 3.2 % 1,565 1,508 3.8 % 2.4 % 1.4 % 1,018 968 5.2 % 3.5 % 1.7 % 2,902 2,796 3.8 % 3.1 % 0.7 % 116 108 7.0 % 7.0 % - 358 331 8.0 % 8.0 % - 266 225 18.7 % 17.1 % 1.6 % 789 717 10.1 % 10.3 % (0.2 )% 383 333 14.9 % 13.8 % 1.1 % 1,147 1,048 9.4 % 9.6 % (0.2 )% 4,306 4,038 6.6 % 6.6 % - 12,902 12,105 6.6 % 6.6 % - 4,124 3,853 7.0 % 4.5 % 2.5 % 12,089 11,564 4.5 % 3.9 % 0.6 % $ 8,430 7,891 6.8 % 5.6 % 1.2 % $ 24,991 23,669 5.6 % 5.3 % 0.3 % GAAP to Non-GAAP Reconciliation $ in Millions Third Quarter Sept 28, 2025 GAAP Intangible asset amortization Litigation related Restructuring related Acquisition, integration and divestiture related (Loss)/gain on securities Tax legislation and other tax related Other Third Quarter Sept 28, 2025 Non-GAAP $ 3,672 (568 ) (11 ) 3,093 2,869 2,869 2,944 2,944 (368 ) 5 (48 ) 174 (1 ) (238 ) 6,446 568 (5 ) - 59 (174 ) - 1 6,895 $ 3,612 (480 ) (12 ) (1 ) 3,119 2,801 2,801 728 728 2 5 (156 ) (48 ) 213 (1 ) 15 1,287 480 (5 ) 168 49 (213 ) - 1 1,767 $ 19 19 252 252 - - (31 ) (25 ) 11 (45 ) (240 ) - 25 - (11 ) - - - (226 ) $ 7,303 (1,048 ) (12 ) (12 ) 6,231 5,922 5,922 3,672 3,672 (478 ) (15 ) (93 ) (85 ) 387 (2 ) (286 ) - - 18 18 63 (63 ) - 7,493 1,048 15 168 97 (387 ) - 2 8,436 2,341 193 3 34 16 (87 ) (874 ) 9 1,635 5,152 855 12 134 81 (300 ) 874 (7 ) 6,801 GAAP to Non-GAAP Reconciliation $ in Millions $ 3,549 (695 ) (2 ) 2,852 2,491 2,491 4,213 (2 ) 4,211 (155 ) (356 ) (19 ) (6 ) 41 (495 ) 4,482 695 356 19 6 (41 ) - 4 - 5,521 $ 3,381 (476 ) (6 ) (156 ) (16 ) 2,727 2,723 (3 ) 2,720 739 (36 ) (19 ) 684 (11 ) (19 ) (22 ) (85 ) (4 ) (141 ) 1,059 476 19 28 277 4 38 - - 1,901 $ 33 33 264 264 - - 1,906 (2,013 ) (45 ) (152 ) (2,203 ) - 2,013 - 45 - - - - (145 ) $ 6,963 (1,171 ) (6 ) (156 ) (16 ) (2 ) 5,612 5,478 (3 ) 5,475 4,952 (36 ) (19 ) (2 ) 4,895 1,798 (2,388 ) (136 ) 37 (689 ) - - (99 ) (99 ) 41 (41 ) - 3,338 1,171 2,388 47 328 (37 ) 38 4 - 7,277 644 169 527 9 59 (9 ) 6 1 (5 ) 1,401 2,694 1,002 1,861 38 269 (28 ) 32 3 5 5,876 Johnson & Johnson and Subsidiaries GAAP to Non-GAAP Reconciliation $ in Millions $ 11,670 (2,002 ) (24 ) 9,644 7,919 7,919 8,361 8,361 (520 ) 74 (275 ) 164 (14 ) (571 ) 17,208 2,002 (74 ) - 299 (164 ) - 14 19,285 $ 10,576 (1,433 ) (35 ) (52 ) 9,056 8,319 8,319 2,052 37 2,089 132 (78 ) (267 ) (155 ) 163 (15 ) (220 ) 3,912 1,433 78 302 170 (163 ) - 15 5,747 $ 42 42 685 685 - - (7,222 ) 6,898 (6 ) (330 ) 6,495 - (6,898 ) - 6 - - - (397 ) $ 22,288 (3,435 ) (35 ) (76 ) 18,742 16,923 16,923 10,413 37 10,450 (7,692 ) 6,894 (123 ) (436 ) 327 (29 ) (1,059 ) - - (62 ) (62 ) 144 (144 ) - 27,615 3,435 (6,894 ) 302 475 (327 ) - 29 24,635 5,927 603 (1,541 ) 58 118 (73 ) (672 ) 9 4,429 21,688 2,832 (5,353 ) 244 357 (254 ) 672 20 20,206 Johnson & Johnson and Subsidiaries GAAP to Non-GAAP Reconciliation $ in Millions $ 10,522 (2,087 ) (8 ) 8,427 7,594 7,594 9,831 (19 ) 9,812 (225 ) (399 ) (194 ) (100 ) (54 ) 26 (50 ) (996 ) 14,910 2,087 399 194 100 54 (26 ) - 77 - 17,795 $ 9,749 (1,268 ) (15 ) (206 ) (66 ) 8,194 7,976 (12 ) 7,964 2,103 (69 ) (79 ) 1,955 173 (15 ) (92 ) (472 ) (48 ) (454 ) 3,668 1,268 15 - 107 747 48 157 - - 6,010 $ 72 72 846 846 - - 4,860 (5,052 ) (127 ) (352 ) (671 ) (5,778 ) - 5,052 - - 127 352 - - - (247 ) $ 20,343 (3,355 ) (15 ) (206 ) (66 ) (8 ) 16,693 16,416 (12 ) 16,404 11,934 (69 ) (79 ) (19 ) 11,767 4,855 (5,466 ) (653 ) (374 ) (50 ) (1,688 ) 194 (194 ) - (433 ) (433 ) 192 (192 ) - 12,800 3,355 5,466 194 207 928 374 157 77 - 23,558 2,165 473 1,224 43 42 222 5 29 17 42 4,262 10,635 2,882 4,242 151 165 706 369 128 60 (42 ) 19,296

Drug ApprovalFinancial 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 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
Depressive Disorder, Major	NDA/BLA	United States	Intra-Cellular Therapies, Inc.	03 Dec 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
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

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05061719 (CTgov)	Phase 3	Depressive Disorder, Major	812	Lumateperone	pwunwtgoub = cgapsxjglu rnstflaqkl (howknlkjyo, hxqqficknb - nddtafqvyw) View more	-	03 Nov 2025
NCT01499563 (CTgov)	Phase 2	Schizophrenia	335	Placebo	kfdrfvoxqb(tiwgihosow) = gqyxjmixvc snkyuwhdvt (tvivbhkzqo, 1.7) View more	-	03 Oct 2025
NCT02282761 (CTgov)	Phase 3	Schizophrenia	450	ITI-007 (Lumateperone 28 mg (ITI-007 40 mg Tosylate))	evppltabby(kmvobgyzvn) = hxezpmikdm qaffdrazea (dzuonfzqoy, 1.27) View more	-	02 Oct 2025
				ITI-007 (Lumateperone 42 mg (ITI-007 60 mg Tosylate))	evppltabby(kmvobgyzvn) = hbmdsulzvc qaffdrazea (dzuonfzqoy, 1.25) View more
NCT02469155 (CTgov)	Phase 3	Schizophrenia	696	ITI-007 (Lumateperone 14 mg (ITI-007 20 mg Tosylate))	bcbasuqiqv(nvgulrpcnf) = yazkuztakp oavlauoeab (grvxieqbsl, 1.27) View more	-	02 Oct 2025
				ITI-007 (Lumateperone 42 mg (ITI-007 60 mg Tosylate))	bcbasuqiqv(nvgulrpcnf) = judczwwkwg oavlauoeab (grvxieqbsl, 1.23) View more
NCT04985942 (CTgov)	Phase 3	Depressive Disorder, Major	485	Lumateperone (Lumateperone 42 mg)	aolgewjgni(iqehehlyqd) = mhrjahxxuw fihtoqmzfq (kbgwogdpnq, 0.54) View more	-	02 May 2025
				Placebo (Placebo)	aolgewjgni(iqehehlyqd) = gcbudhaqno fihtoqmzfq (kbgwogdpnq, 0.53) View more
NCT05061706 (ITI-007-502, CTgov)	Phase 3	Depressive Disorder, Major	480	Lumateperone (Lumateperone 42 mg)	ypinrlirhk(xwudyzndvy) = mhbzvcxjwj tymdsuabso (xzhrdwltzb, 0.56) View more	-	25 Mar 2025
				Placebo (Placebo)	ypinrlirhk(xwudyzndvy) = thofkdipaz tymdsuabso (xzhrdwltzb, 0.54) View more
NCT04285515 (CTgov)	Phase 3	Bipolar Disorder \| Bipolar II disorder \| Depressive Disorder, Major	488	Lumateperone (Lumateperone 42mg)	sexscifhlj(ykfdgakyjb) = qorybmcogd ckznjodabd (bwueyrnmsq, 0.71) View more	-	19 Mar 2025
				Placebos (Placebo)	sexscifhlj(ykfdgakyjb) = ytmmopeqxl ckznjodabd (bwueyrnmsq, 0.70) View more
NCT04959032 (Company_Website) Manual	Phase 3	Schizophrenia	228	Lumateperone 42 mg	symknybgjs(gmyurntnmi) = qxrirdkfxt uziqliagec (fwasmcrmzg ) Met	Positive	05 Nov 2024
				Placebo	symknybgjs(gmyurntnmi) = wjxmznkqnd uziqliagec (fwasmcrmzg ) Met
NCT05061706 (ITI-007-502, Company_Website) Manual	Phase 3	Depressive Disorder, Major Neoadjuvant	480	Lumateperone 42 mg	ibfayrcuev(vjwzuhjqab) = bicgfzgtyv umtujpyvnf (beupzbxqtv ) Met	Positive	18 Jun 2024
				Placebo	ibfayrcuev(vjwzuhjqab) = gbefraveih umtujpyvnf (beupzbxqtv ) Met
NCT04985942 (Corporate Publications) Manual	Phase 3	Depressive Disorder, Major	485	Lumateperone 42 mg	ecctodwenl(xiskoyfibu) = ujswckyjzs wxpcnrmwmy (xetxideeqh ) Met	Positive	16 Apr 2024

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