Drugs最新文献

{"title":"Doravirine/Islatravir: First Approval.","authors":"Sheridan M Hoy","doi":"10.1007/s40265-026-02367-1","DOIUrl":"https://doi.org/10.1007/s40265-026-02367-1","url":null,"abstract":"<p><p>Doravirine/islatravir is an oral two-drug fixed-dose combination of doravirine [a non-nucleoside reverse transcriptase inhibitor (NNRTI)] and islatravir [a nucleoside reverse transcriptase translocation inhibitor (NRTTI)]. Developed by Merck & Co., Inc., Rahway, NJ, USA, doravirine/islatravir [IDVYNSO^® イドビンソ^® (Japan); IDVYNSO™ (USA); IDVYNSO^® (Canada)] was first approved on 6 March 2026 in Japan and subsequently approved on 21 April 2026 in the USA and 3 June 2026 in Canada for the treatment of HIV-1 infection in adults who are virologically suppressed (HIV-1 RNA < 50 copies/mL). Clinical development is underway in several other countries worldwide. This article summarizes the milestones in the development of doravirine/islatravir leading to these first approvals.</p>","PeriodicalId":11482,"journal":{"name":"Drugs","volume":" ","pages":""},"PeriodicalIF":14.7,"publicationDate":"2026-09-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148955065","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":"Atacicept: First Approval.","authors":"Hannah A Blair","doi":"10.1007/s40265-026-02384-0","DOIUrl":"https://doi.org/10.1007/s40265-026-02384-0","url":null,"abstract":"<p><p>Atacicept (atacicept-vymj; TRUTAKNA^™) is a human recombinant fusion glycoprotein targeting B lymphocyte stimulator [BLyS; also known as B cell-activating factor (BAFF)] and A proliferation-inducing ligand (APRIL) being developed by Vera Therapeutics, under a license from Merck Serono. On 7 July 2026, atacicept received accelerated approval in the USA to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk for disease progression. In patients with IgAN, atacicept produced sustained reductions in proteinuria across the ORIGIN clinical development program and stabilized estimated glomerular filtration rates through 96 weeks. This article summarizes the milestones in the development of atacicept leading to this first approval for IgAN.</p>","PeriodicalId":11482,"journal":{"name":"Drugs","volume":" ","pages":""},"PeriodicalIF":14.7,"publicationDate":"2026-09-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148918473","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":"Pivekimab Sunirine: First Approval.","authors":"Yahiya Y Syed","doi":"10.1007/s40265-026-02378-y","DOIUrl":"https://doi.org/10.1007/s40265-026-02378-y","url":null,"abstract":"<p><p>Pivekimab sunirine (pivekimab sunirine-pvzy; DECNUPAZ™) is first-in-class CD123-directed antibody-drug conjugate (ADC) developed by ImmunoGen for the treatment of haematological malignancies, including blastic plasmacytoid dendritic cell neoplasm (BPDCN) and acute myeloid leukaemia (AML). CD123 is an attractive therapeutic target because it is highly expressed on malignant cells and leukaemic stem cells, but has limited expression on normal haematopoietic stem cells. On 27 May 2026, pivekimab sunirine received its first approval in the USA for the treatment of adult patients with BPDCN. This article summarizes the milestones in the development of pivekimab sunirine leading to this first approval.</p>","PeriodicalId":11482,"journal":{"name":"Drugs","volume":" ","pages":""},"PeriodicalIF":14.7,"publicationDate":"2026-09-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148891296","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":"Relacorilant: First Approval.","authors":"Hannah A Blair","doi":"10.1007/s40265-026-02351-9","DOIUrl":"10.1007/s40265-026-02351-9","url":null,"abstract":"<p><p>Relacorilant (LIFYORLI^™) is a non-steroidal, selective glucocorticoid receptor II (GR II) antagonist being developed by Corcept Therapeutics for the treatment of various solid tumours (including ovarian cancer, fallopian tube cancer, peritoneal cancer, pancreatic cancer and prostate cancer) and Cushing syndrome. Relacorilant received its first approval in the USA on 25 March 2026 for use in combination with nab-paclitaxel for the treatment of adults with platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal cancer who have received 1-3 prior systemic treatment regimens, at least one of which included bevacizumab. This article summarizes the milestones in the development of relacorilant leading to this first approval for platinum-resistant ovarian, fallopian tube or peritoneal cancer.</p>","PeriodicalId":11482,"journal":{"name":"Drugs","volume":" ","pages":"1553-1561"},"PeriodicalIF":14.7,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148301134","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":"Biologics and Small Molecule Inhibitors: Novel Therapeutic Strategies for Cutaneous Adverse Drug Reactions.","authors":"Yue Yin, Yuanyuan Wang, Jing Zhou, Yifei Xu, Jiangluyi Cai, Nan Yang, Yuxiong Jiang, Xiaomin She, Yuanting Zhi, Zhengkai Qu, Bo Yu, Jun Gu, Yuling Shi, Xilin Zhang","doi":"10.1007/s40265-026-02354-6","DOIUrl":"10.1007/s40265-026-02354-6","url":null,"abstract":"<p><p>Cutaneous adverse drug reactions (cADRs) are unintended and harmful skin responses to medications that impose significant clinical and economic burdens worldwide. The increasing use of novel agents, particularly immune checkpoint inhibitors, has further compounded this challenge. While most cADRs are mild and resolve upon drug discontinuation, approximately 2-6.7% progress to severe, potentially fatal conditions. The most common severe forms include acute generalized exanthematous pustulosis, Stevens-Johnson syndrome/toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms/drug-induced hypersensitivity syndrome, and drug-associated bullous pemphigoid. Current therapeutic options for refractory cADRs remain limited, primarily relying on systemic corticosteroids, conventional immunosuppressants, and intravenous immunoglobulin. Growing insights into disease pathogenesis and the subsequent repurposing of novel targeted therapies offer promising solutions to the persistent challenges of cADRs. Emerging agents, such as biologics targeting tumor necrosis factor-α, interleukins (IL-4/IL-13, IL-5, IL-6, IL-17, IL-36), immunoglobulin E, and CD20, along with small molecule inhibitors of Janus kinases and phosphodiesterase 4, hold the potential to revolutionize management paradigms, though their long-term efficacy and safety profiles await robust clinical validation.</p>","PeriodicalId":11482,"journal":{"name":"Drugs","volume":" ","pages":"1435-1452"},"PeriodicalIF":14.7,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148307623","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":"Balancing Act: The Dual Roles of BAFF in Systemic Lupus Erythematosus.","authors":"Jhonatan Antonio Álvarez-Gómez, Daniel Appelgren, Tomas Walhelm, Ioannis Parodis, Christopher Sjöwall","doi":"10.1007/s40265-026-02360-8","DOIUrl":"10.1007/s40265-026-02360-8","url":null,"abstract":"<p><p>In systemic lupus erythematosus (SLE) and other autoimmune diseases, B-cell activating factor (BAFF) and a proliferation-inducing ligand (APRIL) play critical roles through three receptors, i.e., BAFF-Receptor (BAFF-R), transmembrane activator and calcium-modulator and cyclophilin ligand (CAML) interactor (TACI), and B-cell maturation antigen (BCMA), promoting the survival of self-reactive B cells and supporting their differentiation into antibody-producing cells. Several biologic therapies with anti-BAFF and anti-BAFF/APRIL agents induce profound suppression of immunoglobulin production and B-cell survival with variable safety profiles. While belimumab has demonstrated significant improvement of overall disease activity in clinical trials, some cases of de novo lupus nephritis have been reported suggesting a potential lack of protection in certain cases. The sustained reduction in B cell populations expressing regulatory markers, alongside a rapid decline in IL-10 levels following belimumab initiation, suggests that BAFF may have a previously underappreciated role in supporting the development or function of regulatory B cells (Bregs). Given the complex receptor interactions of BAFF and APRIL, as well as the heterogeneous phenotype of regulatory B cells and their different mechanisms for regulating the immune response, the involvement of BAFF in regulatory immune responses remains difficult to fully elucidate. This review explores the current evidence on the anti-BAFF/APRIL therapies and examines the unresolved question of whether BAFF exerts a context-dependent role in supporting regulatory B cell function.</p>","PeriodicalId":11482,"journal":{"name":"Drugs","volume":" ","pages":"1453-1469"},"PeriodicalIF":14.7,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13529903/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148535568","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":"Long-Acting Lipoglycopeptide Treatment of Invasive Gram-Positive Infections.","authors":"Madison E Salam, Daniel B Chastain, Douglas Fish, Andrés F Henao-Martínez, Michal Krsak, Matthew Miller, Taylor Morrisette, Scott Mueller, Martin Krsak","doi":"10.1007/s40265-026-02357-3","DOIUrl":"10.1007/s40265-026-02357-3","url":null,"abstract":"<p><p>Gram-positive infections continue to pose a therapeutic challenge owing to their invasive nature (e.g., Staphylococcus aureus and Streptococcus pyogenes) and eradication difficulties (e.g., methicillin-resistant Staphylococcus aureus [MRSA] and vancomycin-resistant enterococci [VRE]). Long-acting lipoglycopeptides (laLGPs) present an effective and conveniently dosed option for the treatment of most invasive Gram-positive pathogens. Improved compliance monitoring associated with their infrequent intravenous dosing, that is not available to such degree with more frequently dosed antimicrobials outside of inpatient settings, is another benefit of laLGPs over more frequently dosed antimicrobials. In this article, we provide a narrative review, including the pharmacological characteristics of dalbavancin (DAL) and oritavancin (ORI), the only currently available laLGPs, as well as their approved and \"off-label\" use reported in the literature to date. We discuss their respective mechanism of action, caveats in compartments where they do not achieve sufficient concentrations (i.e., central nervous system [CNS]; potentially pneumonias with ORI), as well as their reported efficacy in individual organ systems as reported in literature. Lastly, we summarize insights about laLGP use in special populations and discuss the benefits of therapeutic drug monitoring of these agents, mainly in conditions requiring prolonged therapy (e.g., hardware-associated orthopedic infections).</p>","PeriodicalId":11482,"journal":{"name":"Drugs","volume":" ","pages":"1421-1434"},"PeriodicalIF":14.7,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148430077","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":"Comparative Efficacy of Non-opioid Analgesic Drugs for Chronic Cancer Pain: A Bayesian Network Meta-analysis.","authors":"Sebastiano Mercadante, Giovanbattista Vizzini, Alessio Lo Cascio","doi":"10.1007/s40265-026-02356-4","DOIUrl":"10.1007/s40265-026-02356-4","url":null,"abstract":"<p><strong>Purpose: </strong>While opioids remain the primary pharmacological intervention for cancer pain management, their clinical utility is frequently compromised by dose-limiting toxicities. This study aimed to determine the comparative efficacy, opioid-sparing potential, and clinical hierarchy of non-opioid adjuvant drug classes. The study was structured around the PICO framework to evaluate the pharmacological strategies currently utilized in multimodal clinical oncology.</p><p><strong>Methods: </strong>A systematic search of electronic databases (PubMed, Embase, Cochrane) was conducted for randomized controlled trials (RCTs) published between 2000 and 2025. The primary outcome was global analgesic efficacy (standardized mean difference [SMD]), while secondary outcomes included the opioid-sparing effect, defined as the percentage reduction in morphine equivalent daily dose (MEDD) and the incidence of treatment-emergent adverse events (Harms). A Bayesian network meta-analysis (NMA) was performed to rank treatments using SUCRA values. The methodological quality was assessed using the Cochrane Risk of Bias (RoB 2.0) tool.</p><p><strong>Results: </strong>Twenty-three RCTs (n = 1845) met the inclusion criteria. Nonsteroidal anti-inflammatory drugs (NSAIDs) (-1.10) and anticonvulsants (-1.06) demonstrated the most robust analgesic effects. The SUCRA ranking confirmed a clear hierarchy, with the combination of anticonvulsants and antidepressants showing the highest probability of efficacy. A significant opioid-sparing effect was observed for gabapentinoids and ketamine, facilitating MEDD reduction. While serious adverse events were rare, minor harms (somnolence, dizziness) were more frequent in the most effective classes.</p><p><strong>Conclusion: </strong>Our NMA provides a robust evidence base for a \"Clinical Tier\" system, ranking adjuvants by their balance of efficacy and safety. These findings support the early integration of Tier I agents (anticonvulsants and NSAIDs) to optimize pain control and reduce opioid-related toxicities in chronic cancer pain management.</p>","PeriodicalId":11482,"journal":{"name":"Drugs","volume":" ","pages":"1535-1544"},"PeriodicalIF":14.7,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148410815","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":"Acoziborole: First Approval.","authors":"Aisling McGuigan","doi":"10.1007/s40265-026-02358-2","DOIUrl":"10.1007/s40265-026-02358-2","url":null,"abstract":"<p><p>Acoziborole (Acoziborole Winthrop), a single-dose, oral antiprotozoal agent, has been developed by Drugs for Neglected Diseases initiative (DNDi), Sanofi and partners for the treatment of human African trypanosomiasis due to Trypanosoma brucei gambiense (g-HAT). In February 2026, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for acoziborole for the treatment of first- and second-stage (including severe second-stage) g-HAT in adolescents aged ≥ 12 years and weighing ≥ 40 kg and in adults. Acoziborole was assessed via the EU-M4all procedure for medicines intended for use outside of the EU, and the positive opinion will facilitate the registration of acoziborole in sub-Saharan African countries where g-HAT is endemic. This article summarizes the milestones in the development of acoziborole leading to this positive opinion for the treatment of first- and second-stage g-HAT.</p>","PeriodicalId":11482,"journal":{"name":"Drugs","volume":" ","pages":"1571-1576"},"PeriodicalIF":14.7,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148618851","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":"Linerixibat: First Approval.","authors":"Sheridan M Hoy","doi":"10.1007/s40265-026-02349-3","DOIUrl":"10.1007/s40265-026-02349-3","url":null,"abstract":"<p><p>Linerixibat (LYNAVOY^®) is an orally administered reversible ileal bile acid transporter (IBAT) inhibitor developed by GSK for the treatment of cholestatic pruritus. In March 2026, linerixibat received its first approval for the treatment of cholestatic pruritus associated with primary biliary cholangitis (PBC) in adult patients in the USA. It is the first US FDA-approved therapy for this indication. Subsequently, linerixibat was approved in May 2026 in the UK for the treatment of cholestatic pruritus in adult patients with PBC. A regulatory review of linerixibat is currently underway in Canada, China and the EU for the treatment of cholestatic pruritus associated with PBC. This article summarizes the milestones in the development of linerixibat leading to these first approvals.</p>","PeriodicalId":11482,"journal":{"name":"Drugs","volume":" ","pages":"1545-1551"},"PeriodicalIF":14.7,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13658302/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148257798","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}