DrugsPub Date : 2025-10-01Epub Date: 2025-08-13DOI: 10.1007/s40265-025-02201-0
Athena Philis-Tsimikas, Jens Aberle, Harpreet Bajaj, Ildiko Lingvay, Yiming Mu, Shehla Shaikh, André Vianna, Hirotaka Watada, Stefano Del Prato
{"title":"Clinical Use of Once-Weekly Insulin Icodec: Translating Clinical Trial Data into Practical Guidance for Diabetes Management.","authors":"Athena Philis-Tsimikas, Jens Aberle, Harpreet Bajaj, Ildiko Lingvay, Yiming Mu, Shehla Shaikh, André Vianna, Hirotaka Watada, Stefano Del Prato","doi":"10.1007/s40265-025-02201-0","DOIUrl":"10.1007/s40265-025-02201-0","url":null,"abstract":"<p><p>Insulin icodec (icodec) is a first-in-class once-weekly basal insulin approved for the treatment of adults with type 1 diabetes (T1D) and type 2 diabetes (T2D). Healthcare professionals (HCPs) may benefit from clear and practical guidance on translating the use of icodec from a controlled clinical trial setting into real-world clinical practice to ensure its appropriate implementation. Here, we primarily review the available evidence for icodec in T2D to provide evidence-based clinical recommendations and expert opinions to guide the use of icodec in a clinical setting. The pharmacology of icodec is summarized, along with an overview of the results from the ONWARDS 1-6 clinical trials (NCT04460885, NCT04770532, NCT04795531, NCT04880850, NCT04760626, NCT04848480). Key guidance on the practical use of icodec, including treatment initiation, switching to icodec from a once- or twice-daily basal insulin, switching from icodec back to a daily basal insulin, and dose titration, is provided. Icodec usage in special populations and practical situations (e.g., elderly and pediatric individuals, hepatic and renal impairment, hospitalized individuals, and those who are pregnant or planning pregnancy) is discussed. Considerations for glucose monitoring and management, as well as co-administration of icodec with other non-insulin glucose-lowering medications, are provided. Finally, we also briefly summarize the available evidence on icodec use in individuals with T1D, although the primary focus of this review is on its use in T2D. This review provides a comprehensive information resource for HCPs regarding the use of icodec in clinical practice.</p>","PeriodicalId":11482,"journal":{"name":"Drugs","volume":" ","pages":"1253-1268"},"PeriodicalIF":14.4,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12484257/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144834509","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}
DrugsPub Date : 2025-10-01Epub Date: 2025-08-22DOI: 10.1007/s40265-025-02222-9
Yuye Jiang, Wenrui Huang, Yiyang Zhang, QiuHong Ji
{"title":"Tirofiban in Acute Ischemic Stroke: Mechanistic Rationale, Clinical Advances, and Emerging Therapeutic Strategies.","authors":"Yuye Jiang, Wenrui Huang, Yiyang Zhang, QiuHong Ji","doi":"10.1007/s40265-025-02222-9","DOIUrl":"10.1007/s40265-025-02222-9","url":null,"abstract":"<p><p>Tirofiban is a selective inhibitor of the glycoprotein IIb/IIIa receptor that reversibly prevents platelet aggregation and clot formation-processes central to the development and progression of ischemic stroke. Its use has been widely studied in both laboratory and clinical settings, particularly as an early intervention, a rescue option after failed mechanical thrombectomy, and in combination with clot-dissolving therapies. Emerging evidence supports tirofiban's role in preventing stroke progression, especially in high-risk groups such as older adults, women around menopause, patients with diabetes, liver or kidney dysfunction, and those who are pregnant. The drug has generally shown good safety and effectiveness in promoting blood flow restoration and improving long-term recovery. However, the most effective dosing, treatment scenarios, and patient profiles remain uncertain. Given its strong antiplatelet action and potential protective effects on brain tissue, tirofiban continues to gain interest as a treatment for acute ischemic stroke. This review summarizes key studies published since 2018, based on a structured literature search of PubMed, Embase, and Web of Science through May 2025, with the goal of guiding future research and improving clinical integration.</p>","PeriodicalId":11482,"journal":{"name":"Drugs","volume":" ","pages":"1269-1287"},"PeriodicalIF":14.4,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12484258/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144946790","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}
DrugsPub Date : 2025-10-01Epub Date: 2025-08-27DOI: 10.1007/s40265-025-02228-3
Stéphane Jouneau, Pierre Chauvin, Mathieu Lederlin, Benoît Painvin, Mallorie Kerjouan
{"title":"Pharmacotherapy for Autoimmune Pulmonary Alveolar Proteinosis.","authors":"Stéphane Jouneau, Pierre Chauvin, Mathieu Lederlin, Benoît Painvin, Mallorie Kerjouan","doi":"10.1007/s40265-025-02228-3","DOIUrl":"10.1007/s40265-025-02228-3","url":null,"abstract":"<p><p>Pulmonary alveolar proteinosis is suspected when a \"crazy paving\" pattern is observed on a chest CT scan. This diagnosis is confirmed by the presence of eosinophilic extracellular material that shows positive staining with Periodic Acid Schiff on bronchoalveolar lavage samples. The autoimmune form of pulmonary alveolar proteinosis is confirmed by detecting anti-granulocyte-macrophage colony-stimulating factor antibodies in the patient's serum. The historical first-line treatment for autoimmune pulmonary alveolar proteinosis is whole lung lavage, which should only be performed in expert centers. It remains the preferred treatment for patients experiencing respiratory failure, especially at the time of diagnosis. Inhaled granulocyte-macrophage colony-stimulating factor supplementation with molgramostim or sargramostim is now considered a first-line treatment in the international guidelines for autoimmune pulmonary alveolar proteinosis, following the positive results of recent randomized placebo-controlled studies. Rituximab and plasmapheresis can be prescribed as third- and fourth-line treatments, respectively. Lung transplantation may be considered for eligible patients experiencing terminal respiratory failure. A deeper understanding of the pathogenesis of autoimmune pulmonary alveolar proteinosis has opened up new therapeutic avenues, such as the use of PPARγ agonists or statins.</p>","PeriodicalId":11482,"journal":{"name":"Drugs","volume":" ","pages":"1193-1206"},"PeriodicalIF":14.4,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12484331/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144946815","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}
DrugsPub Date : 2025-10-01Epub Date: 2025-08-04DOI: 10.1007/s40265-025-02208-7
Susan J Keam
{"title":"Atrasentan: First Approval.","authors":"Susan J Keam","doi":"10.1007/s40265-025-02208-7","DOIUrl":"10.1007/s40265-025-02208-7","url":null,"abstract":"<p><p>Atrasentan (VANRAFIA<sup>®</sup>), a potent, highly selective, orally administered endothelin type A (ET<sub>A</sub>) receptor antagonist, is in development by Novartis for the treatment of glomerular disease. In April 2025, atrasentan was approved in the USA (under accelerated approval based on a reduction in proteinuria) to reduce proteinuria in adults with primary IgA nephropathy (IgAN) at risk of rapid disease progression, generally a urine protein-to-creatinine ratio (UPCR) ≥ 1.5 g/g. It has not been established whether atrasentan slows kidney function decline in patients with IgAN. This article summarizes the milestones in the development of atrasentan leading to this first approval for the reduction of proteinuria in adults with primary IgAN at risk of rapid disease progression.</p>","PeriodicalId":11482,"journal":{"name":"Drugs","volume":" ","pages":"1311-1317"},"PeriodicalIF":14.4,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144783821","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}
DrugsPub Date : 2025-10-01Epub Date: 2025-08-29DOI: 10.1007/s40265-025-02207-8
Arnold Lee
{"title":"Linvoseltamab: First Approval.","authors":"Arnold Lee","doi":"10.1007/s40265-025-02207-8","DOIUrl":"10.1007/s40265-025-02207-8","url":null,"abstract":"<p><p>Linvoseltamab (Lynozyfic™) is a human B cell maturation antigen (BCMA)×cluster of differentiation (CD) 3 bispecific antibody that binds to both BCMA and CD3 to direct T cells against malignant B cells. Linvoseltamab is being developed by Regeneron Pharmaceuticals, Inc. for multiple indications including multiple myeloma and received its first approval on 28 Apr 2025 in the EU. This article summarises the milestones in the development of linvoseltamab leading to this first approval in the EU as monotherapy for the treatment of adult patients with relapsed/refractory multiple myeloma who have received ≥ 3 prior therapies, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody, and have demonstrated disease progression on the last therapy.</p>","PeriodicalId":11482,"journal":{"name":"Drugs","volume":" ","pages":"1329-1333"},"PeriodicalIF":14.4,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144946817","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}
DrugsPub Date : 2025-09-30DOI: 10.1007/s40265-025-02231-8
Stephanie Young Moss, Angie Lee, James A Simon
{"title":"Advances in Pharmacotherapy for Menopausal Vasomotor Symptoms.","authors":"Stephanie Young Moss, Angie Lee, James A Simon","doi":"10.1007/s40265-025-02231-8","DOIUrl":"https://doi.org/10.1007/s40265-025-02231-8","url":null,"abstract":"<p><p>Vasomotor symptoms (VMS) are considered the cardinal symptoms of menopause, affecting up to 80% of American women at some point during the menopausal transition. VMS, particularly if they are moderate to severe, frequent, or cause sleep disturbances, can have a negative impact on a woman's quality of life, physical and mental health, and professional life. Furthermore, VMS have been associated with negative health outcomes, including an increased risk of coronary heart disease and cognitive impairment. Menopausal hormonal therapy (MHT) is supported by level 1 evidence and can address many of the negative impacts associated with menopause, including VMS. However, not all women can take MHT (owing to having contraindications to their use) or choose not to take MHT. In addition to MHT, non-hormonal therapy options, which include neurokinin (NK)-targeted therapies, are also available. Fezolinetant (NK3 receptor antagonist) and the newly approved elinzanetant (NK1 and NK3 receptor antagonist) are non-hormonal treatment options approved for the treatment of VMS associated with menopause. These approvals expand the treatment options for women. A number of investigational agents are currently in phase 2 trials for potential future use for VMS; these include Q-122, PhytoSERM, NOE-115, GS1-144, and HS-10384. In this review, we highlight the recent advancements in our understanding of the pathophysiology of VMS and consider the current, new, and investigational treatment options for the treatment of VMS.</p>","PeriodicalId":11482,"journal":{"name":"Drugs","volume":" ","pages":""},"PeriodicalIF":14.4,"publicationDate":"2025-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145198819","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}
DrugsPub Date : 2025-09-30DOI: 10.1007/s40265-025-02243-4
Preethy E Abraham, Douglas B Johnson
{"title":"Long-Term Toxicities of Immune Checkpoint Inhibitors.","authors":"Preethy E Abraham, Douglas B Johnson","doi":"10.1007/s40265-025-02243-4","DOIUrl":"https://doi.org/10.1007/s40265-025-02243-4","url":null,"abstract":"<p><p>Immune checkpoint inhibitors (ICIs) produce often durable responses in many cancer types but are associated with autoimmune-like toxicities. These immune-related adverse events (irAEs) occur in multiple organ systems and often improve with steroids or therapy cessation. However, many irAEs have either partial or no improvement, leading to residual sequelae even after ICI discontinuation. Chronic irAEs, often defined as irAEs lasting > 3 months, may occur in up to 40-50% of patients treated with ICI therapy and have a wide range of manifestations, severity, and duration. These chronic events likely stem from either ongoing inflammation or sequalae of prior inflammatory-mediated damage. IrAEs impacting the endocrine glands and joints have particularly high rates of chronicity, while chronic events impacting the gastrointestinal (GI) tract, liver, and lungs are less common. In this review, we discuss updated studies surrounding chronic irAEs, providing an overview, followed by organ-specific considerations and consideration of future directions. Key challenges for the field include characterizing the chronic impact of irAEs, developing better treatment or prevention strategies (one possible solution being anti-cytokine therapy), and identifying which patients have active inflammation.</p>","PeriodicalId":11482,"journal":{"name":"Drugs","volume":" ","pages":""},"PeriodicalIF":14.4,"publicationDate":"2025-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145198859","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}
DrugsPub Date : 2025-09-30DOI: 10.1007/s40265-025-02249-y
Matt Shirley
{"title":"Mazdutide: First Approval.","authors":"Matt Shirley","doi":"10.1007/s40265-025-02249-y","DOIUrl":"https://doi.org/10.1007/s40265-025-02249-y","url":null,"abstract":"<p><p>Mazdutide (Xinermei<sup>®</sup>) is a dual glucagon receptor (GcgR) and glucagon-like peptide-1 receptor (GLP-1R) agonist being developed by Eli Lilly and Company along with Innovent Biologics for use in weight management in adults with obesity or overweight and for the treatment of type 2 diabetes (T2D). In June 2025, mazdutide received its first approval, in China, for use (in combination with diet control and increased physical activity) in long-term body weight management in adults with a body-mass index (BMI) of ≥ 28 kg/m<sup>2</sup> or with a BMI ≥ 24 kg/m<sup>2</sup> together with one or more weight-related comorbidity. Subsequently, in September 2025, mazdutide also received approval in China for use in glycaemic control in adults with T2D. Additionally, mazdutide is under clinical evaluation for use in the treatment of metabolic dysfunction-associated fatty liver disease, obstructive sleep apnoea and alcohol use disorder. This article summarises the milestones in the development of mazdutide leading to this first approval for long-term body weight management in adults with obesity or overweight.</p>","PeriodicalId":11482,"journal":{"name":"Drugs","volume":" ","pages":""},"PeriodicalIF":14.4,"publicationDate":"2025-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145198847","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}
DrugsPub Date : 2025-09-30DOI: 10.1007/s40265-025-02248-z
Simon Fung
{"title":"Ifupinostat: First Approval.","authors":"Simon Fung","doi":"10.1007/s40265-025-02248-z","DOIUrl":"https://doi.org/10.1007/s40265-025-02248-z","url":null,"abstract":"<p><p>Ifupinostat (; Betlin) is a first-in-class dual phosphoinositide 3-kinase α (PI3Kα)/histone deacetylase (HDAC) inhibitor being developed by BeBetter Med for the treatment of relapsed or refractory diffuse large B-cell lymphoma. On the 30th June 2025, ifupinostat received its first approval in China as a monotherapy for adults with relapsed or refractory diffuse large B-cell lymphoma who have received at least two lines of systemic therapy. Continued approval is dependent on the results of a confirmatory, randomized, controlled phase 3 trial. This article summarizes the milestones in the development of ifupinostat leading to this first approval as a monotherapy for adults with relapsed or refractory diffuse large B-cell lymphoma who have received at least two lines of systemic therapy.</p>","PeriodicalId":11482,"journal":{"name":"Drugs","volume":" ","pages":""},"PeriodicalIF":14.4,"publicationDate":"2025-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145198778","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}