DrugsPub Date : 2026-08-01Epub Date: 2026-05-29DOI: 10.1007/s40265-026-02326-w
Serge Yaacoub, Charles Bardawil, Ryan Yammine, Ali H Dakroub, Ali H Eid
{"title":"Sex-Biased Pharmacotherapeutic Disparities in Hypertension.","authors":"Serge Yaacoub, Charles Bardawil, Ryan Yammine, Ali H Dakroub, Ali H Eid","doi":"10.1007/s40265-026-02326-w","DOIUrl":"10.1007/s40265-026-02326-w","url":null,"abstract":"<p><p>Hypertension manifests with striking sex-based disparities in prevalence, pathophysiology, and therapeutic outcomes, necessitating the reappraisal of current management paradigms. For example, men exhibit higher blood pressure (BP) in early adulthood, while post-menopausal women suffer from accelerated cardiovascular risk owing to estrogen depletion, endothelial dysfunction, and distinct aging trajectories. Moreover, the renin-angiotensin-aldosterone system (RAAS) operates rather divergently: testosterone upregulates vasoconstrictive angiotensin II type 1 receptors in men, whereas estrogen enhances nitric oxide bioavailability and modulates angiotensin II type 2 receptor in premenopausal women. These hormonal influences extend to cardiovascular aging, as women develop greater arterial stiffness post-menopause, predisposing them to heart failure with preserved ejection fraction. Conversely, men demonstrate higher endothelial dysfunction and cardiomyocyte apoptosis. Furthermore, sex-specific pharmacokinetic profiles (e.g., renal clearance, hepatic metabolism) and pharmacodynamic responses to antihypertensives underscore the inadequacy of uniform treatment strategies. This is demonstrated in women by the observed reduced efficacy of angiotensin-converting enzymes inhibitors, but superior blood pressure control using diuretics. Men, however, respond more robustly to beta blockers. Emerging evidence highlights epigenetic modifiers, including X-chromosome-linked microRNAs (miRNAs) and sex-hormone-driven transcriptional regulators, as pivotal mediators of vascular tone and drug metabolism disparities. Despite these insights, clinical guidelines remain relatively inadequately stratified by sex, perpetuating suboptimal outcomes. This review synthesizes molecular, physiologic, and pharmacotherapeutic axes of sexual dimorphism in hypertension. It also advocates for precision medicine approaches that integrate hormonal status, aging-related vascular remodeling, and genetic polymorphisms. Addressing these physiological paradigms promises to bridge the translational gap between bench and bedside, ultimately mitigating the global burden of hypertensive disease, while mitigating shortcomings in sex-based antihypertensive management.</p>","PeriodicalId":11482,"journal":{"name":"Drugs","volume":" ","pages":"1261-1284"},"PeriodicalIF":14.7,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13375693/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148053318","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 : 2026-08-01Epub Date: 2026-06-11DOI: 10.1007/s40265-026-02348-4
Sha Li, Ying Gao, Cheng-Gang Zhu, Jian-Jun Li
{"title":"Recaticimab: The First Fc-Engineered PCSK9 Monoclonal Antibody for More Long-Lasting Effect in Lipid Lowering.","authors":"Sha Li, Ying Gao, Cheng-Gang Zhu, Jian-Jun Li","doi":"10.1007/s40265-026-02348-4","DOIUrl":"10.1007/s40265-026-02348-4","url":null,"abstract":"<p><p>Atherosclerotic cardiovascular disease (ASCVD) continues to be a leading cause of morbidity and mortality worldwide, with elevated low-density lipoprotein cholesterol (LDL-C) being a major modifiable risk factor. Despite the efficacy of proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors in LDL-C reduction, suboptimal adherence remains a significant challenge and may limit the cardiovascular benefits achievable with these therapies. Recaticimab, the first Fc-engineered anti-PCSK9 monoclonal antibody incorporating YTE mutation (M252Y/S254T/T256E), was specifically designed to prolong half-life through enhanced neonatal Fc receptor (FcRn) binding, thereby enabling ultra-long dosing intervals of up to 12 weeks. Results from three Phase III clinical trials demonstrated that recaticimab achieves potent and sustained LDL-C reductions, either as monotherapy or in combination with statins, with a favorable safety and tolerability profile. By integrating the YTE mutation-derived structural innovation with robust Phase III clinical evidence, recaticimab may help address some limitations of existing PCSK9 inhibitors, including frequent injections and suboptimal persistence in real-world use. However, whether these pharmacological advantages translate into improved cardiovascular outcomes remains to be established, particularly given that current clinical evidence is largely derived from studies conducted in Chinese populations, and thus requires further validation in broader populations. Future studies should evaluate its impact on real-world adherence, cardiovascular outcomes, and cost effectiveness.</p>","PeriodicalId":11482,"journal":{"name":"Drugs","volume":" ","pages":"1325-1338"},"PeriodicalIF":14.7,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13375700/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148216842","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 : 2026-08-01Epub Date: 2026-07-01DOI: 10.1007/s40265-026-02352-8
Giancarlo De la Torre Canales, Marie-Amélie Dureisseix, Thiago Germano Dos Santos, Pedro Miguel Teixeira Carvas Cebola, Glauce Crivelaro do Nascimento, Tatiana Foscaldo, Rodrigo Lorenzi Poluha, Justin Durham, Nikolaos Christidis
{"title":"Botulinum Toxin Type A for Trigeminal and Postherpetic Neuralgia: An Umbrella Review of Systematic Reviews.","authors":"Giancarlo De la Torre Canales, Marie-Amélie Dureisseix, Thiago Germano Dos Santos, Pedro Miguel Teixeira Carvas Cebola, Glauce Crivelaro do Nascimento, Tatiana Foscaldo, Rodrigo Lorenzi Poluha, Justin Durham, Nikolaos Christidis","doi":"10.1007/s40265-026-02352-8","DOIUrl":"10.1007/s40265-026-02352-8","url":null,"abstract":"<p><p>BACKGROUND AND OBJECTIVE: Trigeminal neuralgia (TN) and postherpetic neuralgia (PHN) are severe peripheral neuropathic pain conditions associated with substantial functional impairment. Although pharmacological treatments are available, many patients experience insufficient efficacy or poor tolerability. Botulinum toxin type A (BoNT-A) has emerged as a potential treatment, but uncertainties remain regarding its efficacy, safety, and clinical positioning. This umbrella review aimed to synthesise evidence from systematic reviews evaluating BoNT-A in TN and PHN.</p><p><strong>Methods: </strong>A systematic search was conducted in MEDLINE, Embase, Cochrane Library, Web of Science, and CINAHL from inception to November 2025. Systematic reviews with or without meta-analysis evaluating BoNT-A in adults with TN or PHN were included. Methodological quality was assessed using AMSTAR-2, and only moderate- or high-quality reviews were included. Primary outcomes were pain intensity reduction and responder rates (≥ 50% pain reduction). Secondary outcomes included quality of life and adverse events.</p><p><strong>Results: </strong>Ten systematic reviews (2015-2024) met the inclusion criteria. Botulinum toxin type A was consistently associated with reductions in pain intensity and higher responder rates than placebo, particularly in TN. In PHN, evidence was more limited but supported short-term (1-3 months) improvements in pain intensity. Evidence on quality of life was scarce and inconclusive. Botulinum toxin type A was well tolerated, with mostly mild and transient adverse events.</p><p><strong>Conclusions: </strong>Botulinum toxin type A appears to provide short-term pain relief in selected patients with TN and PHN and is generally well tolerated. Current evidence supports its role as an adjunctive third-line option for focal peripheral neuropathic pain, although heterogeneity and limited long-term data warrant cautious interpretation.</p>","PeriodicalId":11482,"journal":{"name":"Drugs","volume":" ","pages":"1339-1364"},"PeriodicalIF":14.7,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13375694/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148359853","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 : 2026-08-01Epub Date: 2026-05-21DOI: 10.1007/s40265-026-02327-9
Simon Leiter, Philipp Mahlknecht, Werner Poewe
{"title":"Recent Developments in the Drug Treatment of Parkinson's Disease.","authors":"Simon Leiter, Philipp Mahlknecht, Werner Poewe","doi":"10.1007/s40265-026-02327-9","DOIUrl":"10.1007/s40265-026-02327-9","url":null,"abstract":"<p><p>Parkinson's disease (PD) is a common neurodegenerative disorder caused by a spread of misfolded α-synuclein and ascending neuronal degeneration mainly in dopaminergic neurons, leading to progressive nigrostriatal dysfunction and disruption of other pathways. It is clinically defined by its cardinal motor features of bradykinesia, rest tremor and rigidity, which are usually accompanied by a variety of non-motor symptoms. Here we provide a review on recent developments in the pharmacological treatment of PD with a focus on recently approved drugs, new modes of delivery and agents that are in advanced stages of clinical development. Pharmacological dopamine substitution remains the mainstay of symptomatic treatment approaches to control PD motor symptoms. While levodopa is still considered the gold-standard of symptomatic efficacy, its chronic use is associated with the development of response oscillations and drug-induced dyskinesias in a majority of patients. Thus, much effort has been put into developing more continuous ways of levodopa delivery. Novel formulations and modes of application include extended-release (ER) oral levodopa (IPX203), levodopa powder for inhalation, and levodopa infusion therapies through subcutaneous (foslevodopa/foscarbidopa, ND0612) or intrajejunal pumps (levodopa [entacapone] carbidopa intestinal gel). Additionally, different preparations for subcutaneous and sublingual administration of apomorphine, a dopamine agonist with equivalent efficacy to levodopa, are available for the treatment of PD motor fluctuations. Novel dopamine agonists have been developed and tavapadon, a selective dopamine D1/D5 receptor partial agonist, was shown to be efficacious as monotherapy in early PD and adjunct to levodopa in patients with motor fluctuations. In addition, new data on the early use of the COMT-inhibitor opicapone have emerged. This expanding drug armamentarium is complemented by an increasing number of drugs targeting non-dopaminergic pathways with increasing evidence for amantadine's symptomatic efficacy in treating levodopa-induced dyskinesia and motor fluctuations. Beyond the approval of different botulinum toxin preparations for the treatment of sialorrhea, efforts to address the plethora of non-motor symptoms of the disease have not translated to novel PD-specific approvals over the last few years. PD symptoms can usually be satisfactorily controlled in the early to mid-stages, but the progressive course of the disease inevitably leads to increasing functional disability underlining the yet unmet need for disease-modifying therapies. While there is currently no conclusive evidence for disease-modifying efficacy on any of the numerous efforts, we summarize recent late-stage clinical trial evidence focusing on glucagon-like peptide 1 (GLP1) agonists, approaches targeting the glucocerebrosidase (GBA) pathway and inhibition of the leucine-rich repeat kinase 2 (LRRK2), as well as α-synuclein based treatments.</p>","PeriodicalId":11482,"journal":{"name":"Drugs","volume":" ","pages":"1231-1260"},"PeriodicalIF":14.7,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13375751/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147981105","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 : 2026-08-01Epub Date: 2026-06-03DOI: 10.1007/s40265-026-02342-w
Kirk E Evoy, Daija Drain, Justin Pedigo, Jordan R Covvey, Olivia Ramey
{"title":"Misuse of Pregabalin and Gabapentin: A Second Systematic Review Update.","authors":"Kirk E Evoy, Daija Drain, Justin Pedigo, Jordan R Covvey, Olivia Ramey","doi":"10.1007/s40265-026-02342-w","DOIUrl":"10.1007/s40265-026-02342-w","url":null,"abstract":"<p><strong>Background: </strong>A 2017 systematic review and 2021 update identified 114 studies regarding gabapentinoid (gabapentin and pregabalin) misuse, dependence, or overdose.</p><p><strong>Objective: </strong>We aimed to update previous systematic reviews and describe new insights regarding gabapentinoid misuse.</p><p><strong>Methods: </strong>PubMed was searched from 1 September, 2020 to 24 January, 2025 using the following four searches: \"gabapentin [MeSH] OR pregabalin [MeSH] OR gabapentinoid AND\" one of the following four substance misuse-related terms: \"substance-related disorders [MeSH],\" \"overdose,\" \"abuse,\" or \"misuse.\" Additional research was identified by reviewing papers cited by included studies. Studies presenting novel data regarding gabapentinoid misuse, dependence, or overdose were included. Non-English articles, review articles, and animal studies were excluded.</p><p><strong>Results: </strong>One hundred studies (87 observational, 13 case reports/series) were included, from North America (33), Europe (39), Asia (20), Australia (7), and Africa (1). Sixteen studied gabapentin, 20 pregabalin, and 51 both medications. These studies corroborated previous findings that gabapentinoids are misused both for therapeutic and non-therapeutic purposes, often in conjunction with opioids or other substances, and commonly in people with substance use disorders and psychiatric conditions. Recent research built on the previous systematic review, providing more robust evidence that concomitant use with opioids or benzodiazepines increases overdose risks. New studies also highlight a growing body of evidence regarding misuse within the Middle East and North Africa, among adolescents, and in patients with chronic pain.</p><p><strong>Conclusions: </strong>Newly published evidence demonstrated that gabapentinoid misuse remains a significant concern, including in several populations not often highlighted in previous research. It provides more compelling evidence that gabapentinoids increase overdose risk, particularly when used with opioids or benzodiazepines.</p>","PeriodicalId":11482,"journal":{"name":"Drugs","volume":" ","pages":"1365-1378"},"PeriodicalIF":14.7,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13375660/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148155862","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 : 2026-08-01Epub Date: 2026-06-04DOI: 10.1007/s40265-026-02339-5
Kevin F Boehnke, Niloufar Pouyan, Jacob S Aday
{"title":"Classic Psychedelics for Chronic Pain: A Critical Review of the Literature and Practical Advice for Clinicians.","authors":"Kevin F Boehnke, Niloufar Pouyan, Jacob S Aday","doi":"10.1007/s40265-026-02339-5","DOIUrl":"10.1007/s40265-026-02339-5","url":null,"abstract":"<p><p>Chronic pain is common, costly, and for many, remains inadequately treated by existing pharmacologic and non-pharmacologic approaches. In parallel with growing dissatisfaction with conventional therapies, classic serotonergic psychedelics, such as psilocybin, lysergic acid diethylamide (LSD), ayahuasca, N,N-dimethyltryptamine (DMT), and mescaline, administered alone or within psychedelic-assisted therapy models, have re-emerged as potential therapeutic tools for a range of health conditions, including chronic pain. In this review, we examine putative mechanisms of action relevant to pain, including effects on neuroplasticity, inflammation, large-scale brain network dynamics, and higher-order psychological processes, such as pain acceptance and cognitive flexibility. We also briefly overview findings from relevant preclinical models for pain. We then summarize recent observational studies and early-phase clinical trials that highlight preliminary signals of benefit across multiple pain conditions, including fibromyalgia, migraine, cluster headache, and other chronic pain syndromes. In addition, we critically evaluate safety considerations, contraindications, drug-drug interactions, and key regulatory challenges that will shape both research and clinical implementation of psychedelics for chronic pain. Finally, we offer pragmatic guidance for clinicians to work more skillfully with patients choosing to use these substances on their own. Although the existing literature suggests mechanistic plausibility and promising preliminary outcomes, the field is limited by small sample sizes, functional unblinding, and a lack of large, well-controlled randomized trials. We conclude by outlining critical methodological priorities and future research directions needed to rigorously evaluate the potential role of psychedelic compounds in the treatment of chronic pain.</p>","PeriodicalId":11482,"journal":{"name":"Drugs","volume":" ","pages":"1307-1324"},"PeriodicalIF":14.7,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13375812/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148162007","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 : 2026-08-01Epub Date: 2026-06-05DOI: 10.1007/s40265-026-02340-y
Susan J Keam
{"title":"Icotrokinra: First Approval.","authors":"Susan J Keam","doi":"10.1007/s40265-026-02340-y","DOIUrl":"10.1007/s40265-026-02340-y","url":null,"abstract":"<p><p>Icotrokinra (ICOTYDE™) is a targeted oral peptide interleukin (IL)-23 receptor (IL-23R) antagonist being developed by Johnson & Johnson, and Protagonist Therapeutics, Inc., for the treatment of immune-mediated inflammatory diseases. In March 2026, the US FDA approved icotrokinra for the treatment of moderate-to-severe plaque psoriasis (PsO) in adults and paediatric patients ≥ 12 years of age and who weigh ≥ 40 kg who are candidates for systemic therapy or phototherapy. Icotrokinra is also under review for this indication in the EU and in Canada. This article summarizes the milestones in the development of icotrokinra leading to this first approval for moderate-to-severe plaque PsO.</p>","PeriodicalId":11482,"journal":{"name":"Drugs","volume":" ","pages":"1401-1407"},"PeriodicalIF":14.7,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13586047/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148162064","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 : 2026-08-01Epub Date: 2026-06-10DOI: 10.1007/s40265-026-02343-9
Jonghoon Chang, Alex Hattenhauer, Luisa Saccaro, Ferida Mamatkazina, Elizabeth Felix, Lindsey De Lott, Anat Galor
{"title":"Chronic Ocular Surface Pain: A Missing Member of the Chronic Overlapping Pain Conditions?","authors":"Jonghoon Chang, Alex Hattenhauer, Luisa Saccaro, Ferida Mamatkazina, Elizabeth Felix, Lindsey De Lott, Anat Galor","doi":"10.1007/s40265-026-02343-9","DOIUrl":"10.1007/s40265-026-02343-9","url":null,"abstract":"<p><p>Chronic overlapping pain conditions (COPCs) comprise a cluster of ten chronic pain disorders that frequently co-occur and are conceptualized as sharing centrally mediated or nociplastic mechanisms. Chronic ocular surface pain (COSP), defined as ocular surface pain lasting more than three months, has traditionally been classified under \"dry eye disease.\" However, emerging evidence suggests that in a subset of individuals, COSP shares important clinical and mechanistic features with COPCs, supporting the need for an updated synthesis as increasing data implicate central contributions to pain. This narrative review examines COSP within the broader COPC framework across epidemiology, risk factors, pathophysiology, diagnosis, and treatment, and proposes that in select cases, COSP may warrant conceptual consideration as an additional COPC. Across the literature, COSP shares several similarities with COPCs, including high prevalence, female predominance, and increasing frequency with age. Chronic ocular surface pain also commonly clusters with COPCs and, when nociplastic features are present, is associated with psychosocial comorbidity. Mechanistically, COSP in some individuals demonstrates characteristics of nociplastic pain, including symptom-sign discordance, persistent pain despite topical anesthesia, multisite hyperalgesia, and altered functional connectivity within central pain and sensory processing networks. Collectively, current evidence supports substantial overlap between COSP and COPCs within a nociplastic framework, suggesting that COSP may be best understood, in part, within this broader construct. Recognizing COSP in the context of COPCs has important implications for mechanism-based approaches to diagnosis, treatment, and future research aimed at improving outcomes.</p>","PeriodicalId":11482,"journal":{"name":"Drugs","volume":" ","pages":"1285-1306"},"PeriodicalIF":14.7,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13375826/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148216854","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 : 2026-08-01Epub Date: 2026-06-05DOI: 10.1007/s40265-026-02344-8
Hannah A Blair
{"title":"Rovadicitinib: First Approval.","authors":"Hannah A Blair","doi":"10.1007/s40265-026-02344-8","DOIUrl":"10.1007/s40265-026-02344-8","url":null,"abstract":"<p><p>Rovadicitinib (Anxu<sup>®</sup>) is a small molecule Janus kinase (JAK)/Rho-associated coiled-coil-containing protein kinase (ROCK) inhibitor being developed by Chia Tai Tianqing Pharmaceutical Group (a subsidiary of Sino Biopharmaceutical) for the treatment of primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis (PPV-MF), post-essential thrombocythemia myelofibrosis (PET-MF), graft-versus-host disease (GVHD) and haemophagocytic lymphohistiocytosis (HLH). On 25 February 2026, rovadicitinib received its first approval in China as first-line treatment for adult patients with intermediate-2 or higher-risk PMF, PPV-MF or PET-MF. This article summarizes the milestones in the development of rovadicitinib leading to this first approval for myelofibrosis.</p>","PeriodicalId":11482,"journal":{"name":"Drugs","volume":" ","pages":"1393-1399"},"PeriodicalIF":14.7,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13506543/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148162047","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 : 2026-08-01Epub Date: 2026-05-25DOI: 10.1007/s40265-026-02333-x
Yahiya Y Syed
{"title":"Culmerciclib: First Approval.","authors":"Yahiya Y Syed","doi":"10.1007/s40265-026-02333-x","DOIUrl":"10.1007/s40265-026-02333-x","url":null,"abstract":"<p><p>Culmerciclib (<sup>®</sup>) is an oral, small molecule CDK2/4/6 inhibitor developed by Chia Tai Tianqing Pharmaceutical for the treatment of breast cancer. By simultaneously inhibiting CDK2, CDK4 and CDK6, culmerciclib may help overcome resistance mechanisms in HR+/HER2- breast cancer. The drug received its first approval in China on 9 December 2025 for use in combination with fulvestrant in adults with HR+/HER2- advanced or metastatic breast cancer whose disease has progressed after endocrine therapy. This article summarizes the milestones in the development of culmerciclib leading to this first approval.</p>","PeriodicalId":11482,"journal":{"name":"Drugs","volume":" ","pages":"1379-1384"},"PeriodicalIF":14.7,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148013659","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}