Drugs最新文献

{"title":"Use of Sedative-Hypnotic Drugs and the Risk of Developing Alzheimer's Disease: A Systematic Review, Meta-Analysis and Meta-Regression.","authors":"Anderson Matheus Pereira da Silva, Gabriel Caruso Novaes Tudella, Ocilio Ribeiro Gonçalves, Filipe Virgilio Ribeiro, Maria Antonia Oliveira Machado Pereira, Maria da Vitória Santos do Nascimento, Bernardo Vieira Nogueira, Diogo Haddad Santos, Fábio Henrique de Gobbi Porto, Poul F Høilund-Carlsen, Filipe Silveira Duarte, George Perry, Eryvelton de Souza Franco, Maria Bernadete de Sousa Maia","doi":"10.1007/s40265-026-02335-9","DOIUrl":"10.1007/s40265-026-02335-9","url":null,"abstract":"<p><strong>Background: </strong>Sedative-hypnotics, including benzodiazepines (BZDs) and non-benzodiazepine hypnotics (Z-drugs), are widely prescribed for insomnia and anxiety, particularly in older adults. Their long-term cognitive safety and potential association with Alzheimer's disease (AD) remain uncertain. We examined whether use of BZDs and Z-drugs is associated with incident AD and assessed variation by drug class, pharmacokinetics, and methodological factors.</p><p><strong>Methods: </strong>PubMed, Embase, and the Cochrane Central Register of Controlled Trials were searched from inception to 16 August 2025 without language restrictions. Reference lists of eligible articles and reviews were screened. We included observational cohort and nested case-control studies enrolling adults without dementia at baseline that compared BZD or Z-drug users with non-users and reported incident AD diagnosed using validated clinical or administrative criteria (e.g., ICD-9/10, NINCDS-ADRDA, or NIA-AA). We excluded reviews, case reports, conference abstracts, studies with overlapping populations, and studies without extractable effect estimates. Two reviewers independently screened studies, extracted data, and assessed risk of bias using ROBINS-E. Random-effects meta-analyses were performed separately for odds ratios (ORs) and hazard ratios (HRs). Heterogeneity was quantified with I<sup>2</sup>. Publication bias was evaluated with funnel plots and Egger test when applicable. Subgroup and meta-regression analyses assessed clinical and methodological modifiers. Certainty of evidence was rated using GRADE. The protocol was prospectively registered (PROSPERO CRD420251141623).</p><p><strong>Results: </strong>Thirteen studies (N = 721,354 subjects) were included. Overall sedative-hypnotic use was associated with higher odds of AD (OR 1.29; 95% CI, 1.10-1.53; I<sup>2</sup> = 86.5%). Estimates restricted to HRs were attenuated and not statistically significant (HR 1.17; 95% CI, 0.87-1.58; I<sup>2</sup> = 73.1%). In subgroup analyses, BZDs overall (OR 1.21; 95% CI 1.07-1.36), Z-drugs (OR 1.14; 95% CI 1.10-1.18; I<sup>2</sup> = 0%), and short-acting agents (OR 1.19; 95% CI 1.04-1.36) were associated with higher odds of AD, whereas broad-acting BZDs were not (OR 1.01; 95% CI 0.98-1.05). Long-acting agents showed a borderline estimate (OR 1.44; 95% CI 0.99-2.09). Age-stratified analyses showed higher odds in individuals aged <75 years (OR 1.36; 95% CI 1.24-1.49), but not in those aged ≥75 years (OR 1.14; 95% CI 0.61-2.11). Estimates were also higher in studies using ICD-based definitions (OR 1.47; 95% CI 1.16-1.86) than in those using clinical criteria (OR 1.13; 95% CI 0.84-1.52). Meta-regression identified drug class and publication year as significant moderators. Risk of bias was rated moderate to serious in several studies, mainly due to residual confounding and exposure misclassification. Certainty of evidence ranged from very low to moderate.</p><p><strong>Conclus","PeriodicalId":11482,"journal":{"name":"Drugs","volume":"86 7","pages":"1103-1119"},"PeriodicalIF":14.7,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148301303","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Efficacy and Safety of SPH3127 Tablet, a Novel Direct Renin Inhibitor, in Patients with Mild-to-Moderate Essential Hypertension: A Phase III Randomised Trial.","authors":"Qiang Lv, Changsheng Ma, Fang Wang, Lipeng Li, Gang Xiong, Zhanquan Li, Yanling Qu, Wenyue Pang, Wenliang Xiao, Hongyun Ruan, Liping Wei, Gang Liu, Jun Zhang, Qiong Liu, Ling Lin, Mingzhi Long, Huanming Li, Hong Yuan, Ling Liu, Yue Gao, Peijing Liu, Cuntai Zhang, Zhirong Wang, Jianhong Xie, Jiguang Wang, Xin Zhang, Yongyi Lu, Kai Huang, Min Liu, Jiyan Chen, Xiaohong Gao, Dongfang Wang, Xueping Ma, Xiaoping Chen, Yuhui Li, Yue Zhang, Xiangqing Kong, Fang Chen, Xiaowei Zhang, Jie Qi, Yuanyuan Cao, Yaohua Huang, Yue Zhang, Weiwei Cui","doi":"10.1007/s40265-026-02315-z","DOIUrl":"10.1007/s40265-026-02315-z","url":null,"abstract":"<p><strong>Objective: </strong>To evaluate the efficacy and safety of sitokiren (SPH3127) tablet in patients with mild-to-moderate essential hypertension in comparison to valsartan capsule.</p><p><strong>Methods: </strong>This multicentre, randomised, double-blind, parallel Phase III trial was designed in 2 stages. In the 1st stage, eligible patients were randomised to receive 50 mg, 100 mg or 200 mg of SPH3127 tablet or 80 mg of valsartan capsule once daily (QD) for 12 consecutive weeks. In the 2nd stage, eligible patients were randomised to receive assigned dose of SPH3127 tablet based on the results from the 1st stage or valsartan 80 mg QD for 12 consecutive weeks. Primary outcome was the change from baseline in mean sitting diastolic blood pressure (msDBP) at Week 12. Safety outcome measures included any adverse events. Exploratory outcomes included plasma concentration of SPH3127, as well as the assessment of the correlation between SPH3127 exposure with the level of renin inhibition, clinical efficacy and occurrence of adverse events.</p><p><strong>Results: </strong>The 1st stage enrolled 189 patients, of which 129 eligible patients were randomised. High plasma renin activity (PRA) inhibitory effect (83%) and the biggest reduction of msDBP at Week 12 from baseline (- 8.17 ± 5.90 mmHg) was detected in SPH3127 group at the dosage of 100 mg, which was determined for the subsequent stage 2 of this trial. The 2nd stage screened 1260 patients, of which 828 eligible patients were randomised to receive SPH3127 tablet 100 mg (N = 413) and valsartan capsule 80 mg (N = 415), QD. Main analysis based on the treatment policy strategy indicated 5.97 (0.41) mmHg [least-square mean (LSM) and standard error (SE)] of the msDBP changes at Week 12 from baseline in the SPH3127 and 6.32 (0.41) in valsartan groups, with inter-group difference of - 0.35 mmHg (95% CI: - 1.48, 0.78, p = 0.005). Main analysis based on hypothetical strategy showed 5.95 (0.41) mmHg of the msDBP changes at Week 12 from baseline in the SPH3127 and 6.31 (0.42) mmHg in valsartan groups, with inter-group difference of - 0.36 mmHg (95% CI: - 1.51, 0.78, p = 0.006). During the 12-week treatment period, 250 (61.1%) patients in SPH3127 group and 231 (56.2%) patients in valsartan group reported treatment emergent adverse events (TEAEs). Adverse drug reaction (ADR) was reported by 34 (8.3%) and 41 (10.0%) patients in SPH3127 and valsartan group, respectively. The serious adverse events (SAEs) reported by 10 patients were considered not related to the investigational drugs. Death was reported in 1 patient in the valsartan group due to myocardial infarction, which was considered not related to the study drug.</p><p><strong>Conclusions: </strong>Oral SPH3127 tablet 100 mg QD is effective and safe for adult patients with mild-to-moderate essential hypertension.</p><p><strong>Trial registration: </strong>Clinicaltrials.gov Identifier number NCT05359068.</p>","PeriodicalId":11482,"journal":{"name":"Drugs","volume":" ","pages":"1121-1132"},"PeriodicalIF":14.7,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13290787/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147981127","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"EGFR Exon 20 Insertion-Mutated Non-Small Cell Lung Cancer: Current Treatment Landscape and Future Directions.","authors":"Eunice L Y Lau, Noor Rashidha Binte Meera Sahib, Carina Ysha P Cangco, Aaron C Tan","doi":"10.1007/s40265-026-02329-7","DOIUrl":"10.1007/s40265-026-02329-7","url":null,"abstract":"<p><p>Epidermal growth factor receptor (EGFR) exon 20 insertions are the third most common EGFR mutation subtype in non-small cell lung cancer, occurring in up to ~4% of cases. Although the clinical profile overlaps with classical sensitizing EGFR mutations, most exon 20 insertions confer primary resistance to earlier generation epidermal growth factor receptor tyrosine kinase inhibitors, reflecting position- and variant-dependent steric constraints within the adenosine triphosphate-binding pocket. More than 100 distinct variants have been described, motivating structure- and variant-informed frameworks for diagnosis and treatment selection. Accurate detection is therefore essential: fixed-content polymerase chain reaction assays may miss clinically actionable variants, whereas next-generation sequencing improves variant capture and supports standardized reporting, including identification of co-alterations. Plasma cell-free DNA testing can complement tissue profiling when biopsy is not feasible, but low circulating tumour DNA shedding can yield false-negative results, supporting reflex tissue testing after negative plasma findings when clinical suspicion remains high. Therapeutically, the landscape has shifted rapidly since 2021, with the introduction of exon 20 insertion-directed strategies including bispecific antibodies and next-generation tyrosine kinase inhibitors, alongside an expanding pipeline of mutant-selective agents and rational combinations. Despite these advances, response durability remains limited for many patients, and both intrinsic and acquired resistance via on-target changes, bypass signalling and tumour evolution continues to drive unmet need. Future progress will likely depend on central nervous system-active strategies, adaptive sequencing guided by longitudinal molecular profiling and combination approaches that address pathway bypass and tumour heterogeneity.</p>","PeriodicalId":11482,"journal":{"name":"Drugs","volume":" ","pages":"1075-1090"},"PeriodicalIF":14.7,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13290872/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147971238","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Pixavir Marboxil: First Approval.","authors":"Connie Kang","doi":"10.1007/s40265-026-02320-2","DOIUrl":"10.1007/s40265-026-02320-2","url":null,"abstract":"<p><p>Pixavir marboxil (Yilikang^®; ^®) is an oral cap-snatching endonuclease inhibitor being developed by TaiGen Biotechnology for the treatment of influenza virus infections. Pixavir marboxil recently received approval in China for the treatment of uncomplicated influenza A and B in previously healthy adults and adolescents aged ≥ 12 years. This article summarizes the milestones in the development of pixavir marboxil leading to this first approval for uncomplicated influenza A and B infections.</p>","PeriodicalId":11482,"journal":{"name":"Drugs","volume":" ","pages":"1141-1145"},"PeriodicalIF":14.7,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13364818/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147765796","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Narsoplimab: First Approval.","authors":"Matt Shirley","doi":"10.1007/s40265-026-02328-8","DOIUrl":"10.1007/s40265-026-02328-8","url":null,"abstract":"<p><p>Narsoplimab (narsoplimab-wuug; YARTEMLEA^®) is a recombinant human immunoglobulin G4 monoclonal antibody targeted against mannan-binding lectin-associated serine protease 2 (MASP-2) being developed by Omeros Corporation initially for the treatment of haematopoietic stem cell transplantation (HCT)-associated thrombotic microangiopathy (TA-TMA). MASP-2 inhibition by narsoplimab is thought to provide benefit in patients with TA-TMA by decreasing or preventing lectin complement pathway-mediated cellular injury. In December 2025, narsoplimab received its first approval, in the USA, for the treatment of adult and paediatric patients aged ≥ 2 years with TA-TMA. Additionally, a Marketing Authorisation Application for narsoplimab for the treatment of TA-TMA is currently under regulatory review in the EU. This article summarises the milestones in the development of narsoplimab leading to this first approval for TA-TMA.</p>","PeriodicalId":11482,"journal":{"name":"Drugs","volume":" ","pages":"1165-1170"},"PeriodicalIF":14.7,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147962619","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Etripamil: First Approval.","authors":"Michael B Brown","doi":"10.1007/s40265-026-02321-1","DOIUrl":"10.1007/s40265-026-02321-1","url":null,"abstract":"<p><p>Etripamil (CARDAMYST^TM) is an intranasal L-type calcium channel blocker (CCB) developed by Milestone Pharmaceuticals for the treatment of symptomatic paroxysmal supraventricular tachycardia (PSVT) and is under investigation for atrial fibrillation with rapid ventricular rate (AF-RVR). It received its first approval on the 12 December 2025 in the USA for the conversion of acute symptomatic PSVT episodes to sinus rhythm in adults. Additional global regulatory filings of etripamil for PSVT in adults, a phase II trial of etripamil in pediatrics, and a phase III trial for AF-RVR are in progress. This article summarizes the milestones in the development of etripamil leading to this first approval for PSVT.</p>","PeriodicalId":11482,"journal":{"name":"Drugs","volume":" ","pages":"1147-1152"},"PeriodicalIF":14.7,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147812370","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Bruton's Tyrosine Kinase Inhibitors in Multiple Sclerosis.","authors":"Jeffrey Lambe, Robert J Fox","doi":"10.1007/s40265-026-02324-y","DOIUrl":"10.1007/s40265-026-02324-y","url":null,"abstract":"<p><p>Multiple sclerosis (MS) is a chronic, inflammatory disorder of the central nervous system (CNS) characterized by overlapping relapsing and progressive pathologies. Although they exist along a continuum, pathology in relapsing MS (RMS) is primarily driven by the peripheral adaptive immune system, while progressive MS (PMS) pathology is underpinned by innate immune activity and other pathologic processes compartmentalized within the CNS. While currently approved therapies are highly effective in targeting aspects underpinning relapsing pathology, they have limited efficacy in PMS due to either inability to cross the blood brain barrier (BBB) or inability to modulate pathologies driving PMS. Bruton's tyrosine kinase (BTK) inhibitors are an emerging class of oral agents that represent a novel approach to MS treatment. These agents target BTK, an enzyme which plays a pivotal role in both adaptive and innate immune signaling. As small molecules, some BTK inhibitors can cross the BBB at biologically relevant concentrations. Therefore, BTK inhibitors may potentially modulate both relapsing and progressive MS pathology. Data from Phase 2 and Phase 3 trials have been promising in this regard. The unique pharmacological profile of each BTK inhibitor may underpin observed differences in efficacy and safety outcomes to date. In particular, tolebrutinib has demonstrated efficacy against disability progression in non-relapsing secondary progressive MS, while fenebrutinib has recently shown promise in both relapsing and primary progressive MS. However, adverse events include elevated liver enzymes, which can reach life-threatening levels. This review highlights the role of BTK in immune signaling and the rationale for BTK inhibition in MS, discusses the evolution of BTK inhibitors for MS and other indications, summarizes findings from Phase 2 and Phase 3 trials in RMS and PMS, and explores practical questions around the potential use of BTK inhibitors in real-world practice.</p>","PeriodicalId":11482,"journal":{"name":"Drugs","volume":" ","pages":"989-1012"},"PeriodicalIF":14.7,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13290806/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147927748","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Incretin-Based Anti-obesity Medications in Polycystic Ovary Syndrome: The Evidence Map.","authors":"Mojca Jensterle, Andrej Janez","doi":"10.1007/s40265-026-02325-x","DOIUrl":"10.1007/s40265-026-02325-x","url":null,"abstract":"<p><p>Polycystic ovary syndrome (PCOS) is a common, heterogeneous condition that is tightly linked to obesity, visceral adiposity and insulin resistance. Lifestyle intervention and off-label use of metformin provide only modest and unsustained weight loss, insufficient to reverse obesity-driven pathophysiology in most women with PCOS and obesity. Incretin-based anti-obesity medications, including glucagon-like peptide-1 receptor agonists (GLP-1RAs) and dual glucose-dependent insulinotropic polypeptide/glucagon-like peptide-1 receptor agonists (dual GIP/GLP-1RAs), offer a biologically plausible way to target adipose dysfunction, hyperinsulinemia and chronic inflammation that drive PCOS in a large subset of patients. In this narrative, product-segmented review, we map the evidence for liraglutide, semaglutide and tirzepatide in PCOS across mechanistic, clinical, and safety domains, and highlight key evidence gaps that limit current practice. Liraglutide has the densest PCOS-specific evidence, demonstrating reproducible weight loss across small and heterogeneous cohorts, reductions in visceral adiposity and hepatic fat, improved glycemia and inflammatory markers, and early signals for androgen and fertility benefits in selected phenotypes. Semaglutide data remain sparse but conceptually rich, demonstrating weight-loss efficacy and mechanistic insights, alongside preliminary signals of increased likelihood of natural conception. Tirzepatide currently has no PCOS-specific evidence and cannot be recommended beyond extrapolation from obesity and diabetes trials. Across all agents, reproductive outcomes, periconceptional and pregnancy safety, adolescent use, long-term cardiovascular-kidney-metabolic trajectories, obstructive sleep apnea, musculoskeletal health and phenotype-stratified response remain major evidence gaps. We propose a multidimensional, metabolic high-risk PCOS phenotype as the most rational current target for incretin therapy, while emphasizing that well-designed, PCOS-specific trials are essential before these drugs can be viewed as PCOS-modifying therapies rather than powerful, but still adjunctive, weight-loss agents.</p>","PeriodicalId":11482,"journal":{"name":"Drugs","volume":" ","pages":"1013-1032"},"PeriodicalIF":14.7,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147863642","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Diagnosis and Medication Treatment of Schizophrenia in Adolescents.","authors":"Robert L Findling, Dimal Shah, Parna Prajapati, Evan Cordrey, Manuel Nichols, Ekaterina Stepanova","doi":"10.1007/s40265-026-02332-y","DOIUrl":"10.1007/s40265-026-02332-y","url":null,"abstract":"<p><p>Schizophrenia is a chronic mental health condition that most commonly develops in the third decade of life, but may emerge during adolescence, although in rare cases it can also present in childhood. Pre-adult onset is associated with substantial morbidity, functional impairment, and long-term disability. Accurately diagnosing schizophrenia in youth is particularly challenging, as its symptoms frequently overlap with or are misattributed to other psychiatric or developmental conditions. Conversely, misdiagnosis can also occur when psychotic symptoms are present in patients suffering from other conditions. Establishing an accurate and timely diagnosis is therefore critical to prevent errors in treatment and to optimize prognosis and functional outcomes. Antipsychotic medications are first-line interventions for schizophrenia in youth, with second-generation antipsychotics (SGAs) having the strongest evidence base in this population. Randomized controlled trials and open-label studies support the efficacy of risperidone, aripiprazole, olanzapine, quetiapine, paliperidone, lurasidone, and brexpiprazole in reducing psychotic symptoms in adolescents. In contrast, ziprasidone and asenapine have not demonstrated clear benefit in treatment of schizophrenia in youth. Similar to studies in adults, evidence from pediatric clinical trials suggests that clozapine remains the most effective option for treatment-resistant adolescent schizophrenia, although its use requires close monitoring for hematologic and other adverse effects. While SGAs are generally favored over first-generation antipsychotics (FGAs) in youth because of their reduced propensity for causing extrapyramidal side effects as well as a stronger evidence base to support their use, their safety profiles require careful consideration. Weight gain, metabolic syndrome, sedation, extrapyramidal symptoms, and endocrine effects have been reported in youth with schizophrenia. Such side effects can significantly impact adherence and long-term physical health, necessitating the need for ongoing monitoring and thoughtful agent selection tailored to each patient's individual clinical profile and risk factors. Overall, current evidence supports SGAs as the foundation of psychopharmacologic treatment for schizophrenia in pediatric-aged patients, with clozapine reserved for refractory cases. However, the relative paucity of pediatric-specific data compared with adult populations underscores the importance of continued research to guide clinical practice. In the meantime, accurate diagnosis, early intervention, and vigilant monitoring of both therapeutic response and side effects remain essential to optimizing outcomes for youth with schizophrenia.</p>","PeriodicalId":11482,"journal":{"name":"Drugs","volume":" ","pages":"1033-1044"},"PeriodicalIF":14.7,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13290802/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147927761","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Lerodalcibep: First Approval.","authors":"Amy Zhuang-Yan, Hannah A Blair","doi":"10.1007/s40265-026-02317-x","DOIUrl":"10.1007/s40265-026-02317-x","url":null,"abstract":"<p><p>Lerodalcibep (lerodalcibep-liga; LEROCHOL^®), a subcutaneously administered third-generation proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor, is being developed by LIB Therapeutics for the treatment of hypercholesterolaemia. Lerodalcibep received its first approval on 12 December 2025 in the USA, as an adjunct to diet and exercise, to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolaemia, including heterozygous familial hypercholesterolaemia. Lerodalcibep is in preregistration for hypercholesterolaemia in the EU. Lerodalcibep is administered as a once-monthly subcutaneous injection. This article summarizes the milestones in the development of lerodalcibep leading to this first approval for the treatment of adults with hypercholesterolaemia.</p>","PeriodicalId":11482,"journal":{"name":"Drugs","volume":" ","pages":"1133-1139"},"PeriodicalIF":14.7,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147627333","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}