A Randomised, Controlled Trial to Investigate the Effect of an Intensified Pharmacological Treatment for Schizophrenia, Major Depressive Disorder and Bipolar Depression in Subjects Who Had a First-time Treatment Failure on Their First-line Treatment.

Schizophrenia, bipolar and major depressive disorders collectively affect over 10 million people across the EU and are associated with annual healthcare and societal costs in excess of 100 billion Euros. When diagnosed with one of these disorders, patients are prescribed psychotropic medication such as antidepressants, mood stabilisers or antipsychotics. It is unknown whether this first-line treatment will be successful. After this first-line treatment fails, usually a second-line treatment is initiated, and when this is not successful either a third-line treatment is initiated. Third-line treatments are quite successful, especially when compared to second-line treatments. The research question is whether the third-line treatments (early-intensified treatments) would be more efficacious than the current second-line treatments (treatment as usual) for schizophrenia, bipolar and major depressive disorders. If this is indeed the case, this could lead to the prevention of unnecessary trials of ineffective treatments and adaptations of worldwide guidelines as well as a reduction of healthcare and societal costs.

开始日期2025-04-27

申办/合作机构

Universität Leipzig

ChiCTR2500099510

/ SuspendedN/AIIT

A modeling predictive study of clinical factors associated with lithium on treatment responsiveness in patients with bipolar disorder

开始日期2025-04-01

申办/合作机构

中南大学湘雅医院

NCT05973786

/ Recruiting临床3期IIT

A Randomised, Controlled Trial to Investigate the Effect of a Six Week Intensified Pharmacological Treatment for Bipolar Depression Compared to Treatment as Usual in Subjects Who Had a First-time Treatment Failure on Their First-line Treatment.

Bipolar disorders affect approximately 4.5 million people across the European Union (EU) and are associated with high annual healthcare and societal costs. Bipolar disorder I and II represent disorders that cause extreme fluctuation in a person's mood, energy, and ability to function, in which symptoms of (hypo)mania and depression alternate. The depressive episodes of bipolar disorders are often referred to as bipolar depression (BD). In other words: it is a phase/state of the disorder. For many patients with BD, the depressive polarity is often more pervasive and more debilitating than manic states, with estimates that depressed mood accounts for up to two-thirds of the time spent unwell, even with treatment. The burden of not received an effective treatment for BD is high: more severe psychopathology, higher rates of unemployment, more hospitalisations, lower quality of life, lower cognitive functioning, risk of suicide, comorbidities and poorer social and occupational functioning and thus more carer burden. For BD, the treatment guidelines are very heterogeneous, amongst other reasons because the disease is heterogeneous and treatments should be tailored to the patients. There is no clear treatment algorithm and it cannot yet be predicted which treatment will be effective. Especially the place of adjunctive antidepressants is under debate. Usually, for psychiatric disorders (including bipolar disorder), a patient is considered to be treatment-resistant is two medicinal treatments have been tried (in sufficient duration and dosage) without sufficient success. For BD, there is no consensus on when to consider a patient as treatment-resistant, but the most common definition is after one prior treatment failure. This raises the research question whether adjunctive antidepressants to treat BD should be introduced earlier in the treatment. Additionally, The INTENSIFY trial is part of the larger Horizon 2021 project, with the central goal of paving the way for a shift towards a treatment decision-making process tailored for the individual at risk for treatment resistance. To that end, we aim to establish evidence-based criteria to make decisions of early intense treatment in individuals at risk for treatment resistance across the major psychiatric disorders of schizophrenia, bipolar disorder and major depression.

开始日期2025-02-11

申办/合作机构

Universität Leipzig

100 项与 Lithium succinate 相关的临床结果

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100 项与 Lithium succinate 相关的转化医学

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100 项与 Lithium succinate 相关的专利（医药）

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62,732

项与 Lithium succinate 相关的文献（医药）

2025-12-31·Bioengineered

Assessing the effect of temperature drop on a stable anaerobic fermentation for volatile fatty acids production

Article

作者: Afecto Gonçalves, Manuel Joao ; Greses, Silvia ; González-Fernández, Cristina

Anaerobic fermentation (AF) processes are sensitive to temperature fluctuations, which can influence the microbial activity and overall metabolic performances. Anaerobic reactors can face unforeseen temperature control failures, leading to instabilities in the process. The present study investigated the effect of two short-term temperature perturbations (down to 20°C and 15°C) on AF of food wastes (FWs). While 20°C did not exhibit a negative impact on AF performance maintaining the bioconversion yields over 40%, the reactor subjected to 15°C presented an acidogenic limitation, which decreased the bioconversion yields (36.4 ± 1.8%). As a result, 2.2 ± 0.5 g/L of succinic acid was accumulated in the reactor, being identified as a temperature failure indicator. Once the conditions were reestablished (operation temperature of 25ºC), the metabolic redundancies identified in the reactors allowed the AFs recovery to initial fermentation yields. 20°C was further tested as operational temperature resulting in stable bioconversion yield similar to the Control Reactor (43.2 ± 0.3%). These results showed the feasibility of conducting AF under low temperatures, indicating the potential of this technology to increase the cost-effectiveness of AF at psychrophilic conditions.

2025-12-31·Virulence

Immunogenicity and vaccine efficacy of Actinobacillus pleuropneumoniae -derived extracellular vesicles as a novel vaccine candidate

Article

作者: Seo, Byoung-Joo ; Kim, Chonghan ; Ryu, Young Bae ; Han, Jeong Moo ; Hyun Park, Su ; Park, Gyeong-Seo ; Kim, Yun Hye ; Lee, Hyeon Jin ; Kim, Woo Sik

Actinobacillus pleuropneumoniae (APP) is a significant pathogen in the swine industry, leading to substantial economic losses and highlighting the need for effective vaccines. This study evaluates the potential of APP-derived extracellular vesicles (APP-EVs) as a vaccine candidate compared to the commercial Coglapix vaccine. APP-EVs, isolated using tangential flow filtration (TFF) and cushioned ultracentrifugation, exhibited an average size of 105 nm and a zeta potential of -17.4 mV. These EVs demonstrated stability under external stressors, such as pH changes and enzymatic exposure and were found to contain 86 major metabolites. Additionally, APP-EVs induced dendritic cell (DC) maturation in a Toll-like receptor 4 (TLR4)-dependent manner without cytotoxicity. APP-EVs predominantly elicited Th1-mediated IgG responses in immunized mice without significant liver and kidney toxicity. Contrarily, unlike Coglapix, which induced stronger Th2-mediated responses and notable toxicity. In addition, APP-EVs triggered APP-specific Th1, Th17, and cytotoxic T lymphocyte (CTL) responses and promoted the activation of multifunctional T-cells. Notably, APP-EV immunization enhanced macrophage phagocytosis and improved survival rates in mice challenged with APP infection compared to those treated with Coglapix. These findings suggest that APP-EVs are promising vaccine candidates, capable of inducing potent APP-specific T-cell responses, particularly Th1, Th17, CTL, and multifunctional T-cells, thereby enhancing the protective immune response against APP infection.

2025-12-01·Rice

A Dual-localized Fructose Bisphosphate Aldolase is Essential for Chloroplast Development and Carbon Metabolism in Rice

Article

作者: Gao, Yingbo ; Yao, Youli ; Lin, Lingshang ; Tang, Siyuan ; Zhou, Yong ; Liu, Xin ; Dong, Guichun ; Huang, Jianye ; Zhang, Xiaoxiang ; Ben, Linli ; Zhou, Juan ; Yang, Zefeng

Fructose-1,6-bisphosphate aldolase (FBA) stands as a pivotal enzyme involved within the Calvin cycle and glycolytic pathways in bacteria and higher plants, but the specific function of OsFBA in rice is still unclear. Here, we identified a chloroplast and mitochondria dual-localized FBA protein, OsFBA1, in rice. Experimental evidence showed that the functionally deficient osfba1 mutants featured a notable decline in chlorophyll content, photosynthetic rate, and severe growth impediment by the three-leaf stage, leading to eventual plant demise. Up-regulation of photosynthetic-pathway genes in the osfba1 mutants indicated the essential role of OsFBA1 in chloroplast development and suggested a compensatory mechanism of other genes in the process. Furthermore, the absence of OsFBA1 impaired the carbon assimilation in young rice seedlings, and supplying exogenous glucose could partially sustain the survival of osfba1 mutant for a few more days. Pathway-specific metabolomics analysis revealed a systemic change of metabolites in the glycolytic pathway, and consequential carbohydrates accumulation due to OsFBA1 disruption. Transcriptomics profiling corroborated the expression changes of photosynthesis, and carbon metabolism pathway genes. We further demonstrated that OsFBA1 serves as the primary FBA enzyme governing energy generation, photosynthesis and carbon metabolism. These results prove that OsFBA1 is an essential core gene in supporting the life cycle of rice, its expression has to be tightly regulated.

180

项与 Lithium succinate 相关的新闻（医药）

2025-07-08

·investor.jnj.com

Supplemental new drug application submitted to U.S. FDA for CAPLYTA® (lumateperone) with data demonstrating significant schizophrenia relapse prevention compared to placebo

Submission is based on long-term Phase 3 data demonstrating 63 percent reduction in risk of relapse in adults with schizophrenia compared to placebo CAPLYTA® is FDA approved to treat schizophrenia and is the first and only approved treatment for bipolar I and II depression as an adjunctive and monotherapy With the addition of CAPLYTA® to Johnson & Johnson's robust portfolio of therapies, the Company now offers the broadest range of treatment options for adults with schizophrenia TITUSVILLE, N.J., July 8, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE:JNJ) announced today the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) based upon long-term data evaluating the safety and efficacy of CAPLYTA® (lumateperone) for the prevention of relapse in schizophrenia. CAPLYTA® is the newest addition to Johnson & Johnson's portfolio of schizophrenia therapies, which now offers the broadest range of oral and long-acting injectable treatment options to support each patient's individual treatment journey. "For people living with schizophrenia, relapses can be devastating as they disrupt lives, undo hard-earned treatment progress toward patients' goals, and increase the risk of hospitalization with each episode," said Christoph U. Correll, M.D., Clinical Professor of Psychiatry at the Zucker School of Medicine at Hofstra/Northwell, New York.a "CAPLYTA® substantially lowers the chance of relapse for patients compared to placebo, which is often a major source of anxiety and suffering for them and their families." The submission is supported by positive results from a Phase 3, double-blind, multicenter, placebo-controlled, randomized withdrawal trial, which on the primary endpoint found time to relapse during the 26-week double-blind treatment phase was significantly longer in patients receiving CAPLYTA® compared to those receiving placebo (p=0.0002). Treatment with CAPLYTA® was also associated with a 63 percent reduction in risk of relapse versus placebo (hazard ratio [95% CI] = 0.37, [0.22, 0.65]). The key secondary endpoint showed a significantly delayed time to all-cause discontinuation, including relapse, compared with placebo during the double-blind phase (p=0.0007). The safety profile of CAPLYTA® was consistent with the existing body of clinical data, and no new safety concerns were identified. The most commonly reported adverse event that was observed at a rate greater than or equal to 5% and twice the rate of placebo was headache.i Schizophrenia affects up to an estimated 2.8 million adults in the United States, yet it remains insufficiently treated, with approximately 40 percent of people not receiving care.ii When left untreated, this complex mental health disorder can lead to episodes of psychosis, hallucinations, or other disruptive behaviors, which can damage and interrupt the lives of those living with schizophrenia as well as their loved ones.iii Relapses, or a recurrence of symptoms, are associated with significant functional decline, increased caregiver burden, and a greater likelihood of hospitalization.iii On average, an adult with schizophrenia experiences nine relapses in less than six years.iv "Relapse prevention is a critical goal for the long-term care and management of this debilitating disorder," said Bill Martin, Ph.D., Global Therapeutic Area Head, Neuroscience, Johnson & Johnson Innovative Medicine. "These Phase 3 results provide compelling evidence of meaningful relapse prevention, which is critical in preserving long-term patient stability, breaking the cycle of hospitalization, and helping to control symptom progression. We're committed to building on the decade of research reinforcing the robust efficacy, proven safety, and favorable tolerability of CAPLYTA® and providing additional data to support the long-term use of this medicine in neuropsychiatric disorders." While its exact mechanism of action is unknown, CAPLYTA® is characterized by high serotonin 5-HT2A receptor occupancy and lower amounts of dopamine D2 receptor occupancy at therapeutic doses. In short-term clinical studies, CAPLYTA® was similar to placebo in weight change, metabolic effects, and extrapyramidal symptoms, which are often cited as reasons for treatment discontinuation. The most commonly reported adverse events were somnolence/sedation, dizziness, nausea, and dry mouth. CAPLYTA® can be taken at any time of day with or without food and does not require titration, allowing adult patients to start treatment at the effective dose. CAPLYTA® is FDA approved for the treatment of schizophrenia, as well as depressive episodes associated with bipolar I or II disorder in adults, as monotherapy, and as adjunctive therapy with lithium or valproate. An sNDA for CAPLYTA® as an adjunctive treatment for adults with major depressive disorder (MDD) is currently under FDA review. If approved, CAPLYTA® has the potential to become a new standard of care to treat some of today's most prevalent and debilitating mental health disorders. Editor's note: a. Christoph U. Correll, M.D., has provided consulting, advisory, and speaking services to Johnson & Johnson. He has not been paid for any media work. About Schizophrenia Schizophrenia is a complex, chronic brain disorder that affects how people think, feel, speak, and act. It affects up to an estimated 2.8 million adults in the United States yet remains widely misunderstood and insufficiently treated.ii Symptoms vary by person, but confusion and distortions in perceptions, emotions, and behavior are common. Evidence shows that the first three to five years after diagnosis – "the critical period" – from symptom onset are key for a patient's treatment, as this is when the condition progresses most rapidly.v,vi A comprehensive treatment plan, which may include medication, therapy, and psychosocial services, can be critical in delaying the time to relapse for adults with schizophrenia.iii About Study 304This study was a multicenter, multi-national, double-blind, placebo-controlled, randomized withdrawal study of lumateperone for the prevention of symptomatic relapse in adult patients with schizophrenia. The approximately 47-week study included an 18-week open-label phase where patients with schizophrenia were treated with lumateperone 42 mg per day. Patients who met the stabilization criteria during the open-label period progressed to the double-blind treatment phase. These patients were randomized to continue on lumateperone 42 mg (N=114) or switched to placebo (N=114) for up to 26 weeks or until the time to relapse occurred. The primary endpoint was time to first symptom relapse and the key secondary endpoint was time to all cause discontinuation during the double-blind phase. About CAPLYTA® (lumateperone) CAPLYTA® 42 mg is an oral, once daily atypical antipsychotic approved in adults for the treatment of schizophrenia and depressive episodes associated with bipolar I or II disorder (bipolar depression), as monotherapy, and as adjunctive therapy with lithium or valproate. While the mechanism of action of CAPLYTA® is unknown, the efficacy of CAPLYTA® could be mediated through a combination of antagonist activity at central serotonin 5-HT2A receptors and postsynaptic antagonist activity at central dopamine D2 receptors. CAPLYTA® is under FDA review for potential approval as an adjunctive treatment for adults with major depressive disorder and is being studied for other neuropsychiatric and neurological disorders. CAPLYTA® is not FDA-approved for these disorders. CAPLYTA® (lumateperone) is indicated in adults for the treatment of schizophrenia and depressive episodes associated with bipolar I or II disorder (bipolar depression) as monotherapy and as adjunctive therapy with lithium or valproate. Important Safety Information Boxed Warnings: Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. CAPLYTA is not approved for the treatment of patients with dementia-related psychosis. Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adults in short-term studies. All antidepressant-treated patients should be closely monitored for clinical worsening, and for emergence of suicidal thoughts and behaviors. The safety and effectiveness of CAPLYTA have not been established in pediatric patients. Contraindications: CAPLYTA is contraindicated in patients with known hypersensitivity to lumateperone or any components of CAPLYTA. Reactions have included pruritus, rash (e.g., allergic dermatitis, papular rash, and generalized rash), and urticaria. Warnings & Precautions: Antipsychotic drugs have been reported to cause: Cerebrovascular Adverse Reactions in Elderly Patients with Dementia-Related Psychosis, including stroke and transient ischemic attack. See Boxed Warning above. Neuroleptic Malignant Syndrome (NMS), which is a potentially fatal reaction. Signs and symptoms include: high fever, stiff muscles, confusion, changes in breathing, heart rate, and blood pressure, elevated creatinine phosphokinase, myoglobinuria (and/or rhabdomyolysis), and acute renal failure. Patients who experience signs and symptoms of NMS should immediately contact their doctor or go to the emergency room. Tardive Dyskinesia, a syndrome of uncontrolled body movements in the face, tongue, or other body parts, which may increase with duration of treatment and total cumulative dose. TD may not go away, even if CAPLYTA is discontinued. It can also occur after CAPLYTA is discontinued. Metabolic Changes, including hyperglycemia, diabetes mellitus, dyslipidemia, and weight gain. Hyperglycemia, in some cases extreme and associated with ketoacidosis, hyperosmolar coma or death, has been reported in patients treated with antipsychotics. Measure weight and assess fasting plasma glucose and lipids when initiating CAPLYTA and monitor periodically during long-term treatment. Leukopenia, Neutropenia, and Agranulocytosis (including fatal cases). Complete blood counts should be performed in patients with pre-existing low white blood cell count (WBC) or history of leukopenia or neutropenia. CAPLYTA should be discontinued if clinically significant decline in WBC occurs in absence of other causative factors. Decreased Blood Pressure & Dizziness. Patients may feel lightheaded, dizzy or faint when they rise too quickly from a sitting or lying position (orthostatic hypotension). Heart rate and blood pressure should be monitored and patients should be warned with known cardiovascular or cerebrovascular disease. Orthostatic vital signs should be monitored in patients who are vulnerable to hypotension. Falls. CAPLYTA may cause sleepiness or dizziness and can slow thinking and motor skills, which may lead to falls and, consequently, fractures and other injuries. Patients should be assessed for risk when using CAPLYTA. Seizures. CAPLYTA should be used cautiously in patients with a history of seizures or with conditions that lower seizure threshold. Potential for Cognitive and Motor Impairment. Patients should use caution when operating machinery or motor vehicles until they know how CAPLYTA affects them. Body Temperature Dysregulation. CAPLYTA should be used with caution in patients who may experience conditions that may increase core body temperature such as strenuous exercise, extreme heat, dehydration, or concomitant anticholinergics. Dysphagia. CAPLYTA should be used with caution in patients at risk for aspiration. Drug Interactions: CAPLYTA should not be used with CYP3A4 inducers. Dose reduction is recommended for concomitant use with strong CYP3A4 inhibitors or moderate CYP3A4 inhibitors. Special Populations: Newborn infants exposed to antipsychotic drugs during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery. Dose reduction is recommended for patients with moderate or severe hepatic impairment. Adverse Reactions: The most common adverse reactions in clinical trials with CAPLYTA vs. placebo were somnolence/sedation, dizziness, nausea, and dry mouth. CAPLYTA is available in 10.5 mg, 21 mg, and 42 mg capsules. Please click here to see full Prescribing Information including Boxed Warnings. 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 https://www.jnj.com/ or at www.innovativemedicine.jnj.com. Follow us at @JNJInnovMed. © Johnson & Johnson and its affiliates 2025. All rights reserved. Cautions Concerning Forward-Looking Statements This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of CAPLYTA®. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's most recent Annual Report on Form 10-K, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments. Footnotes i Intra-Cellular Therapies Announces Positive Topline Results in Phase 3 Trial Evaluating CAPLYTA for the Prevention of Relapse in Patients with Schizophrenia. GlobeNewswire, 05 Nov. 2024, https://www.globenewswire.com/news-release/2024/11/05/2974784/30597/en/Intra-Cellular-Therapies-Announces-Positive-Topline-Results-in-Phase-3-Trial-Evaluating-CAPLYTA-for-the-Prevention-of-Relapse-in-Patients-with-Schizophrenia.html. ii "Schizophrenia Fact Sheet." Treatment Advocacy Center, 10 Mar. 2025, www.tac.org/reports_publications/schizophrenia-fact-sheet/. iii Alphs L, et al. Factors associated with relapse in schizophrenia despite adherence to long-acting injectable therapy. Int Clin Psychopharmacol. 2016;31(4)202-209. doi:10.1097/YIC.0000000000000125 iv Lafeuille MH, Gravel J, Lefebvre P, et al. Patterns of relapse and associated cost burden in schizophrenia patients receiving atypical antipsychotics. J Med Econ. 2013;16(11):1290-1299. doi: 10.3111/13696998.2013.841705 v Birchwood, M. "Early intervention and sustaining the management of vulnerability." The Australian and New Zealand journal of psychiatry vol. 34 Suppl (2000): S181-4. doi:10.1080/000486700241 vi Tandon, Rajiv et al. "The schizophrenia syndrome, circa 2024: What we know and how that informs its nature." Schizophrenia research vol. 264 (2024): 1-28. doi:10.1016/j.schres.2023.11.015 View original content to download multimedia:https://www.prnewswire.com/news-releases/supplemental-new-drug-application-submitted-to-us-fda-for-caplyta-lumateperone-with-data-demonstrating-significant-schizophrenia-relapse-prevention-compared-to-placebo-302499436.html SOURCE Johnson & Johnson

临床结果临床3期上市批准细胞疗法

2025-06-24

·PRNewswire

A New Chapter in the Story of Chlorthalidone: Low-Dose HEMICLOR® Now Available in Pharmacies Nationwide

Preferred diuretic option now accessible in guideline-recommended 12.5 mg dose for U.S. patients. WEST CONSHOHOCKEN, Pa., June 24, 2025 /PRNewswire/ -- PRM Pharma, LLC today announced that HEMICLOR® (12.5 mg chlorthalidone tablets) — the first FDA-approved low-dose formulation of chlorthalidone — for the treatment of hypertension in adults — is now available in pharmacies across the United States and third party discount coupon programs are available to assist with patient access ( see below). Chlorthalidone, a thiazide-like diuretic, has played a central role in hypertension management for decades, with extensive data supporting its cardiovascular outcome benefits. Until now, however, U.S. clinicians and patients lacked access to an approved 12.5 mg formulation — the starting dose consistently used in landmark hypertension trials such as ALLHAT and SHEP and recommended in current guidelines.1-4 "The evidence for the benefit of low-dose chlorthalidone spans over 30 years, but unfortunately we've lacked a commercially available product that enabled widespread use of the drug effectively in practice," said Michael Ernst, PharmD, AHSCP-CHC, Clinical Professor, Department of Pharmacy Practice and Science, College of Pharmacy; and Department of Family and Community Medicine, Carver College of Medicine, The University of Iowa, Iowa City, IA. "The availability of a low dose formulation aligns with our contemporary understanding of how to optimize the benefit-risk when using the drug, and I'm excited for this new chapter in chlorthalidone's storied history." The 2017 ACC/AHA Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults recognizes chlorthalidone as the preferred diuretic based on its long half-life and extensive outcome evidence.1 However, until the approval of HEMICLOR, only 25 mg and 50 mg chlorthalidone tablets were available in the U.S. The availability of an FDA-approved 12.5 mg tablet now enables guideline-consistent dosing and may help reduce the risk of dose-related side effects.5 "Chlorthalidone has played a key role in hypertension treatment strategies for decades," said William B. White, MD, Professor Emeritus at the University of Connecticut School of Medicine and past president of the American Society of Hypertension. "Having access to a 12.5 mg dose in the U.S. may offer clinicians additional flexibility when initiating therapy and aligns with current treatment recommendations for many adult patients with stage 1 or stage 2 hypertension." Joseph T. McDevitt, President and CEO of PRM Pharma, LLC, added, "We are proud to introduce HEMICLOR as a new treatment option for adults with hypertension. Our mission is to address unmet clinical needs by developing low-dose pharmaceutical products that support evidence-based care. Lower effective doses may offer a more individualized approach to initiating therapies, particularly for elderly patients who are more susceptible to dose-related adverse effects." HEMICLOR (chlorthalidone) 12.5 mg tablets is now available in pharmacies nationwide, and third party pharmacy HemiClor coupon programs are available to assist in patient access. VISIT: SaveHealth Links to all outside sites are provided as a resource and do not imply an endorsement or recommendation by PRM Pharma, LLC of any provider, including a pharmacy. Indication and Usage5 HEMICLOR (chlorthalidone) is indicated for the treatment of hypertension to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been demonstrated in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including chlorthalidone. Important Safety Information Contraindications: HEMICLOR is contraindicated in patients with anuria or known hypersensitivity to chlorthalidone or sulfonamide-derived drugs. Adverse Reactions: The most common adverse reactions observed with chlorthalidone include electrolyte imbalance (particularly hypokalemia), dizziness, and gastrointestinal discomfort. Monitoring: Periodic monitoring of serum electrolytes is recommended. Chlorthalidone may increase blood sugar levels, affect diabetes control, and cause changes in the need for diabetes medication. Drug Interactions: Chlorthalidone may potentiate the effects of other antihypertensive agents and may interact with lithium, antidiabetics, or NSAIDs. These are not all the possible side effects of chlorthalidone. Please see the Full Prescribing Information, available at , for complete efficacy and important safety information.5 About PRM Pharma, LLC PRM Pharma, LLC is a privately held specialty pharmaceutical company based in Pennsylvania, focused on developing low-dose therapies to support clinical practice guidelines and improve patient care. Media Inquiries: PRM Pharma, LLC – Media Relations Email: [email protected] To report suspected adverse reactions, contact PRM Pharma at 1-877-748-1970 or the FDA at or 1-800-FDA-1088. References 1. Whelton PK, Carey RM, Aronow WS, et al. 2017 ACC/AHA Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults: Executive Summary. Hypertension. 2018;71(6):1269-1324. 2. ALLHAT Collaborative Research Group. Major outcomes in high-risk hypertensive patients randomized to ACE inhibitor or calcium channel blocker vs diuretic. JAMA. 2002;288(23):2981-2997. doi:10.1001/jama.288.23.2981 3. SHEP Cooperative Research Group. Prevention of Stroke by Antihypertensive Drug Treatment in Older Patients with Isolated Systolic Hypertension. JAMA. 1991;265(24):3255-3264. 4. James PA, Oparil S, Carter BL, et al. 2014 Evidence-Based Guideline for the Management of High Blood Pressure in Adults. JAMA. 2014;311(5):507-520. doi:10.1001/jama.2013.284427 5. HEMICLOR™ Prescribing Information. PRM Pharma, LLC. 2025. SOURCE PRM Pharma, LLC WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

上市批准

2025-06-16

·EINPresswire

Osmol Therapeutics E.U. Patent Allowance for Novel Therapy Targeting Chemotherapy-induced Neuropathy

NEW HAVEN, Conn., June 16, 2025 (GLOBE NEWSWIRE) -- Osmol Therapeutics, a privately held clinical-stage biopharmaceutical company focused on developing preventative treatments for chemotherapy-induced peripheral neuropathy (CIPN) and chemotherapy-induced cognitive impairment (CICI), today announced that the European Patent Office (EPO) has allowed its European Union (EU) patent (exclusively licensed from Yale University) for Osmol’s lead program, OSM-0205. Osmol is completing a financing to initiate a Phase 1 study to advance OSM-0205 into clinical development for the treatment of CIPN and CICI, and plans to initiate Phase 2 studies the second half of 2026. The patent, which is granted in the United States and China for the development and commercialization of any form of lithium (IV, oral or other forms) used to treat CIPN and CICI, has now been allowed in the EU. In addition, a provisional patent has been filed to expand OSM-0205’s potential beyond taxanes, including neuropathy and cognitive impairment caused by emerging antibody drug conjugates (ADC’s) with potent microtubule-based payloads (MMAE’s). These ADC’s are known to cause significant neuropathy in patients and in many cases limit the dose and/or duration of the ADC treatment. “This allowance builds on the strong foundation for the development and commercialization established for OSM-0205 with the potential to address some of the most challenging and debilitating effects of chemotherapy that impact cancer patients worldwide,” said Bob Linke, MBA, President and CEO of Osmol Therapeutics. “Patients undergoing chemotherapy deserve therapies that not only fight cancer but also protect them from the toxicities that impact daily life,” said Barbara Ehrlich, PhD, Professor of Pharmacology at Yale University and Osmol’s Scientific Founder. “Securing this patent represents a significant milestone that validates our science and strengthens our ability to deliver meaningful innovation to cancer patients.” About OSM-0205 Osmol’s lead therapeutic candidate, OSM-0205, is based on the research of Barbara Ehrlich, PhD, in neuronal calcium sensor-1 (NCS1) at Yale School of Medicine, which is designed to prevent the off-target calcium surge caused by taxanes and potentially other chemotherapy treatments and ADC’s associated with peripheral nerve damage. Data from non-clinical studies conducted by Osmol show that pre-treatment with OSM-0205 prevents the pathologic damage caused by these chemotherapy agents. About Osmol Therapeutics Osmol Therapeutics is a privately held, clinical stage biopharma company focused on developing a treatment to prevent neuropathy and cognitive impairment caused by many chemotherapy and ADC treatments. The technology is based on the ground-breaking work of Barbara Ehrlich, PhD, Professor of Pharmacology, Yale School of Medicine, and Chief Scientific Advisor, Osmol Therapeutics. The company’s lead indication will be for the prevention of CIPN related to taxane treatment. As an example of the extent of this condition, up to 80% of taxane-treated patients with breast cancer have been reported to experience CIPN. Up to 50% of these patients have their taxane dose modified potentially impacting their cancer treatment. For more information, please visit https://osmoltherapeutics.com/. Contact : Gina Nugent gina@nugentcommunications.com Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

临床1期抗体药物偶联物

100 项与 Lithium succinate 相关的药物交易

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KEGG	Wiki	ATC	Drug Bank
-	Lithium succinate	D11AX04	DB14508

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适应症	国家/地区	公司	日期
脂溢性皮炎	英国	-	1990-01-01
特应性皮炎	英国	Scotia Holdings Plc	-

未上市

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适应症	最高研发状态	国家/地区	公司	日期
乳头状瘤病毒感染	临床2期	英国	Scotia Holdings Plc	-

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


ATS2025	N/A	甲状腺危象	-	Methimazole 20 mg	糧膚築願簾衊餘鬱製獵(鏇糧鬱築鏇獵鬱膚憲鏇) = 簾鑰構積構齋襯窪鹹衊遞願繭鹹鏇蓋蓋觸膚壓 (觸襯壓鏇獵膚範醖衊廠 ) 更多	-	2025-05-16
				Hydrocortisone 50 mg	糧膚築願簾衊餘鬱製獵(鏇糧鬱築鏇獵鬱膚憲鏇) = 膚鹽糧網網製糧簾觸製遞願繭鹹鏇蓋蓋觸膚壓 (觸襯壓鏇獵膚範醖衊廠 ) 更多
ENDO2024	N/A	甲状腺功能亢进症 \| 粒细胞减少症 TSH receptor antibodies (TRAb)	-	Lithium	襯構觸齋簾夢觸糧觸襯(積鏇鑰窪鬱獵窪醖壓簾) = Carbimazole-induced agranulocytosis 觸選膚窪餘窪遞網構夢 (鏇選窪膚範淵觸窪廠繭 ) 更多	-	2024-06-01
				Carbimazole
ATS2024	N/A	气肿	-	Lithium users	願壓夢窪選鬱範壓顧築(鑰選糧糧淵遞蓋齋醖餘) = 夢遞窪鹹獵鹹積鬱鏇積襯簾壓憲積鑰網顧壓選 (鬱廠糧膚築醖顧顧憲網 )	-	2024-05-19
ATS2023	N/A	气肿	-	Lithium users	艱窪夢鑰襯夢醖壓艱觸(範壓膚鹹鹹廠簾艱鬱鬱) = 網選糧築構窪糧網築鏇築選淵鑰網餘衊製鏇醖 (膚醖鑰醖艱鹽艱淵觸鏇 ) 更多	-	2023-05-21
				Non-users	艱窪夢鑰襯夢醖壓艱觸(範壓膚鹹鹹廠簾艱鬱鬱) = 顧鑰製淵夢襯鑰構築顧築選淵鑰網餘衊製鏇醖 (膚醖鑰醖艱鹽艱淵觸鏇, 0.4 ~ 0.9) 更多
ASGCT2023	N/A	-	-	Lithium	獵廠蓋壓積觸選糧膚餘(構鏇觸簾構選構衊齋顧) = 蓋選築餘夢願積齋鏇鏇願繭選鹹夢簾遞窪蓋鬱 (顧觸遞憲積醖範繭鬱遞 ) 更多	积极	2023-05-01
ASN2022	N/A	肾性尿崩症	-	Lithium Carbonate 300 mg	顧築製醖夢醖夢鏇廠鹽(夢範製觸積獵顧鹽遞夢) = 築鏇鹽餘鏇蓋獵築衊願網簾鬱繭願網願顧蓋襯 (願繭壓網積廠積衊窪觸 )	-	2022-11-06
				Thiazide diuretic	顧築製醖夢醖夢鏇廠鹽(夢範製觸積獵顧鹽遞夢) = 衊築夢壓齋膚遞繭膚廠網簾鬱繭願網願顧蓋襯 (願繭壓網積廠積衊窪觸 )
ASN2022	N/A	肾性尿崩症	-	Lithium	艱範觸鬱鑰積鬱糧構願(遞鹽蓋網艱顧築襯齋簾) = 憲選獵願艱鏇蓋繭範鹹廠齋醖襯餘醖鏇繭鑰鏇 (憲築糧願鏇鏇壓襯醖觸 ) 更多	-	2022-11-06
				Desmopressin	觸窪壓選蓋願糧鏇膚積(觸願艱築夢選齋鬱窪簾) = 糧壓鏇餘積壓觸艱夢遞遞鏇壓鏇範襯製憲簾鹹 (糧艱繭夢鑰鏇蓋襯選蓋 )
ASN2022	N/A	急性肾损伤	2,682	Lithium-treated group	襯襯積襯範構積選構獵(網襯糧築夢鹽襯齋構製) = 糧繭餘窪廠遞夢構襯襯鏇衊願鏇選簾構選鹹廠 (選醖廠鬱選醖醖鑰襯鹽 )	积极	2022-11-04
				Lithium (Control group)	襯襯積襯範構積選構獵(網襯糧築夢鹽襯齋構製) = 齋築鏇餘鑰願齋窪鬱鹹鏇衊願鏇選簾構選鹹廠 (選醖廠鬱選醖醖鑰襯鹽 )
MDS2022	N/A	帕金森病 Nurr1 \| SOD1	16	High-dose lithium therapy	鹽顧窪糧鬱積齋鏇築積(顧遞壓鏇鏇積遞顧範襯) = 顧夢衊鏇窪蓋廠簾夢鏇鏇壓鑰壓糧襯顧窪範顧 (積鏇繭餘憲餘壓襯糧齋 )	-	2022-09-15
				Medium-dose lithium therapy	鹽顧窪糧鬱積齋鏇築積(顧遞壓鏇鏇積遞顧範襯) = 網簾範壓選艱憲夢衊淵鏇壓鑰壓糧襯顧窪範顧 (積鏇繭餘憲餘壓襯糧齋 )
ISN WCN2022	N/A	中毒 \| 间质性肾炎	-	Lithium carbonate 900 mg/day	願鏇憲築蓋積繭廠餘觸(膚膚繭簾選淵蓋遞簾憲) = The diagnosis of chronic interstitial nephritis was made based on suggestive clinical and biological signs 衊夢顧衊淵憲壓範範蓋 (構願醖鹹網鹽簾獵顧築 )	-	2022-02-01
				No lithium therapy