Drugs[JOURNAL]
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200 papers
Current and Emerging Pharmacological Approaches to Agitation in Alzheimer's Disease: A Narrative Review of New and Repurposed Therapies.
Smoller C, Schiller E, Yamashita K … +2 more , Silverglate BD, Grossberg GT
Drugs · 2025 Nov · PMID 40913683 · Publisher ↗
This narrative review explores current pharmacological treatments for agitation in Alzheimer's disease (AD). Agitation, a common and difficult-to-manage symptom in AD, often requires targeted intervention. While nonpharm...
This narrative review explores current pharmacological treatments for agitation in Alzheimer's disease (AD). Agitation, a common and difficult-to-manage symptom in AD, often requires targeted intervention. While nonpharmacological methods, such as behavioral therapy and environmental modifications, are considered first line, they may not always be effective. In cases where these approaches fail, pharmacological treatment can become a necessary component of care. Historically, antipsychotics have been the mainstay of pharmacological treatment for agitation in AD; however, safety and efficacy concerns have prompted exploration into alternative treatments. The purpose of this narrative review is to synthesize current literature on pharmacological treatments for agitation in AD with a focus on new and repurposed drugs. It also examines agents that have failed to demonstrate clinical benefit, offering insights into the ongoing challenges of drug development in this area. This review synthesizes recent findings on various drug classes, including anticonvulsants, antipsychotics, selective serotonin reuptake inhibitors (SSRIs), atypical antidepressants, sedatives, anti-dementia drugs, dextromethorphan, and cannabinoids. Both brexpiprazole and risperidone have demonstrated efficacy and received approval from government agencies, including brexpiprazole in the USA and risperidone in parts of Europe. Despite these advances, concerns remain regarding their long-term use and safety profiles. As a result, multiple other therapies are currently being studied as possible alternative solutions. However, no other pharmacological agents are currently approved, underscoring the need for further research on safe and effective options for this vulnerable population.
Current Evidence on Celecoxib Safety in the Management of Chronic Musculoskeletal Conditions: An Umbrella Review.
Beaudart C, Brabant C, Alokail M … +2 more , Reginster JY, Bruyère O
Drugs · 2025 Oct · PMID 40911151 · Full text
OBJECTIVES: Our objective was to systematically synthesize and evaluate the existing evidence from meta-syntheses (systematic reviews and meta-analyses) reporting on the safety of celecoxib in adults with chronic musculo...
OBJECTIVES: Our objective was to systematically synthesize and evaluate the existing evidence from meta-syntheses (systematic reviews and meta-analyses) reporting on the safety of celecoxib in adults with chronic musculoskeletal disorders. METHODS: We conducted a comprehensive literature search in November 2024 across MEDLINE, Cochrane Central, and Scopus databases, following Preferred Reporting Items for Systematic Reviews and Meta-Analyses 2020 guidelines for umbrella reviews. Only systematic reviews and meta-analyses involving celecoxib safety in osteoarthritis, rheumatoid arthritis, or ankylosing spondylitis were included. We assessed the risk of bias using the AMSTAR-2 tool and graded the certainty of evidence using GRADE. RESULTS: Of 2294 retrieved records, 16 systematic reviews based on randomized controlled trials met the inclusion criteria (14 of 16 were rated as critically low quality). Celecoxib was consistently associated with a lower risk of gastroduodenal ulcers than were non-selective non-steroidal anti-inflammatory drugs (NSAIDs), and some studies also reported fewer gastrointestinal complaints and serious events with celecoxib than with non-selective NSAIDs. Cardiovascular safety outcomes were generally similar to those with non-selective NSAIDs, although one meta-analysis showed a lower risk of cardiovascular mortality with celecoxib. Compared with placebo or non-selective NSAIDs, celecoxib did not increase the risk of renal dysfunction or elevated creatinine and may be associated with fewer renal adverse events. Evidence on all-cause mortality was limited and inconsistent, but one study suggested a lower risk than with non-selective NSAIDs. CONCLUSIONS: Celecoxib appears to offer better gastrointestinal safety than non-selective NSAIDs. Although data on cardiovascular, renal, and mortality outcomes suggest possible advantages, the evidence remains limited and of low certainty. Moreover, some real-world evidence raises concerns in specific high-risk populations. Future research should integrate data from both randomized trials and observational studies to better inform long-term safety assessments and guide individualized treatment decisions.
Minimal Residual Disease Negativity as the Primary Goal of Multiple Myeloma Therapy.
Cooperrider JH, Derman BA
Drugs · 2025 Oct · PMID 40908381 · Full text
Measurable (or minimal) residual disease (MRD) testing offers critical prognostic insight in multiple myeloma (MM), surpassing conventional response criteria. While bone-marrow-based assays are most commonly performed, M...
Measurable (or minimal) residual disease (MRD) testing offers critical prognostic insight in multiple myeloma (MM), surpassing conventional response criteria. While bone-marrow-based assays are most commonly performed, MRD assessment in peripheral blood and advanced imaging may add complementary value. A comprehensive approach, integrating serial MRD testing across compartments, may offer the most accurate appraisal of disease burden. MRD has been validated as a surrogate endpoint for accelerated approval (AA) of MM therapies and is increasingly adopted as a key clinical trial endpoint. Ongoing phase 3 trials are using MRD status to tailor consolidation and maintenance strategies, and emerging evidence supports its role in guiding treatment de-escalation, including discontinuation of maintenance therapy. However, barriers remain to implementing MRD as a treatment goal, including cost, complexity of interpreting results, and uncertainty around the optimal timing for guiding decision-making. Moreover, there is a paucity of data on the use of MRD resurgence to prompt changes in therapy. While MRD negativity represents a compelling endpoint in both clinical practice and research, prospective randomized studies will help to better elucidate how best to incorporate MRD into the MM treatment paradigm.
Clesrovimab: First Approval.
Syed YY
Drugs · 2025 Nov · PMID 40906348 · Publisher ↗
Clesrovimab (ENFLONSIA™; clesrovimab-cfor) is a long-acting monoclonal antibody developed by Merck & Co., Inc. to prevent respiratory syncytial virus (RSV) disease in infants. It binds a highly conserved epitope at antig...
Clesrovimab (ENFLONSIA™; clesrovimab-cfor) is a long-acting monoclonal antibody developed by Merck & Co., Inc. to prevent respiratory syncytial virus (RSV) disease in infants. It binds a highly conserved epitope at antigenic site IV of the RSV fusion protein, blocking viral entry into host cells and conferring passive immunity. Incorporation of a YTE triple amino acid substitution in the Fc region enhances binding to the neonatal Fc receptor, extending serum half-life and allowing a single, body weight-independent dose. Clesrovimab received its first US approval on 9 June 2025 for preventing RSV lower respiratory tract disease in neonates and infants born during, or entering, their first RSV season. This article summarises the milestones leading to this first approval.
Aldosterone Synthase Inhibitors for Resistant Hypertension: Pharmacological Insights - A Systematic Review.
Cicero AFG, Tocci G, Avagimyan A … +5 more , Penson P, Nardoianni G, Perone F, Borghi C, Fogacci F
Drugs · 2025 Nov · PMID 40885884 · Full text
BACKGROUND: Resistant hypertension (RHT) is a challenging clinical condition characterized by persistently elevated blood pressure despite adherence to lifestyle modifications and the use of at least three antihypertensi...
BACKGROUND: Resistant hypertension (RHT) is a challenging clinical condition characterized by persistently elevated blood pressure despite adherence to lifestyle modifications and the use of at least three antihypertensive agents, including a high-dose diuretic. RHT is a heterogeneous condition, influenced by multiple pathophysiological mechanisms such as sodium retention, sympathetic overactivity, and vascular dysfunction. Among these, hyperaldosteronism plays a pivotal role in a subset of patients. METHODS: This systematic review examines in depth the pharmacokinetic properties of aldosterone synthase inhibitors (ASIs), with a focus on their therapeutic potential in patients with RHT. A comprehensive literature search was conducted to identify clinical trials and pharmacological studies investigating ASIs, including baxdrostat, dexfadrostat, lorundrostat, LY3045697, and osilodrostat (LCI699). RESULTS: ASIs have shown compelling efficacy in lowering both office-based and 24-h ambulatory blood pressure, particularly in patients with elevated aldosterone levels. These findings underscore the critical role of aldosterone-mediated mechanisms in the pathophysiology of RHT. The inhibitors differ substantially in their metabolic pathways, selectivity profiles, and pharmacokinetic characteristics. CONCLUSIONS: Emerging data support the potential of ASIs as a therapeutic option for RHT, particularly when treatment is individualized based on renal function, dietary sodium intake, and comorbidities. Personalized treatment strategies may enhance efficacy, improve tolerability, and support durable blood pressure control in this difficult-to-treat population. REGISTRATION: PROSPERO identifier number CRD42024522918 [Graphical abstract available].
Systemic Therapy for Advanced Thyroid Cancer-New Personalized Options.
Cheng L, Newbold K
Drugs · 2025 Nov · PMID 40880035 · Publisher ↗
Tyrosine kinase inhibitors (TKIs) have revolutionised systemic therapy for advanced thyroid cancers, including radioiodine-refractory differentiated thyroid cancer (RR-DTC), anaplastic thyroid cancer (ATC) and medullary...
Tyrosine kinase inhibitors (TKIs) have revolutionised systemic therapy for advanced thyroid cancers, including radioiodine-refractory differentiated thyroid cancer (RR-DTC), anaplastic thyroid cancer (ATC) and medullary thyroid cancer (MTC), which respond poorly to conventional cytotoxic chemotherapy. The treatment of advanced thyroid cancer is also increasingly personalised, with recent advances in genomic-driven, highly selective targeted therapies. This review summarises contemporary evidence regarding the efficacy, safety and clinical application of drug therapies in thyroid cancers, whilst exploring their evolving role in the age of personalised medicine. Multikinase inhibitors (MKIs) such as sorafenib, lenvatinib, vandetanib and cabozantinib have demonstrated significant improvements in progression-free survival and objective response rates in patients with RR-DTC and MTC. In ATC-a highly lethal tumour-BRAF-directed therapies have shown promising efficacy in patients harbouring the BRAF V600E mutation, yielding enhanced survival outcomes. Moreover, highly-selective inhibitors targeting RET, NTRK and other actionable alterations have refined treatment paradigms by increased integration of molecular testing via next-generation sequencing, ensuring treatments are tailored to the genetic profile of an individual tumour. Despite significant progress, management of advanced thyroid cancer remains challenged by drug resistance and toxicity, underscoring the need for ongoing research and innovation. Furthermore, vast improvements are still required to ensure universal access to molecular testing and targeted therapies.
Linvoseltamab: First Approval.
Lee A
Drugs · 2025 Oct · PMID 40880034 · Publisher ↗
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 b...
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.
'I crave not to feel uncomfortable' - investigating craving for opioids and cannabis among individuals with chronic pain.
Thrul J, Nordeck CD, Devkota J … +6 more , Mun CJ, Dunn KE, Bergeria CL, Zipunnikov V, Vandrey R, Finan PH
Drugs (Abingdon Engl) · 2025 Jun · PMID 40859985 · Full text
BACKGROUND: The assessment of drug craving is common in survey studies, including those using real-time data collection methods, such as Ecological Momentary Assessment (EMA). However, few studies investigate how partici...
BACKGROUND: The assessment of drug craving is common in survey studies, including those using real-time data collection methods, such as Ecological Momentary Assessment (EMA). However, few studies investigate how participants with chronic pain interpret the word 'craving' and how interpretations impact survey responses. METHODS: We conducted a mixed-methods study among 12 individuals with chronic pain who were using prescription opioids and cannabis. Participants completed baseline surveys, cognitive interviews, and 14-day smartphone-based EMA data collection. Analyses included deductive and inductive coding of interviews and t-tests of EMA self-reports of opioid and cannabis craving. RESULTS: Four participants had negative reactions to the word 'craving', including mentions that these questions offended them. The remaining eight participants mentioned no negative connotation. EMA data showed that participants without negative reactions reported a greater range (opioids), higher standard deviation (opioids), and higher maximum (opioids, cannabis) on Likert-type EMA craving items, compared to those with a negative reaction. CONCLUSIONS: Some individuals with chronic pain may have a negative reaction to the word 'craving' related to opioid and cannabis use and this reaction may impact survey responses. Alternative wording of survey items is recommended, for example focused on 'wanting' or 'needing'.
Pharmacotherapy for Autoimmune Pulmonary Alveolar Proteinosis.
Jouneau S, Chauvin P, Lederlin M … +2 more , Painvin B, Kerjouan M
Drugs · 2025 Oct · PMID 40866780 · Full text
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 wi...
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.
Tirofiban in Acute Ischemic Stroke: Mechanistic Rationale, Clinical Advances, and Emerging Therapeutic Strategies.
Jiang Y, Huang W, Zhang Y … +1 more , Ji Q
Drugs · 2025 Oct · PMID 40847265 · Full text
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 h...
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.
Retraction Note: Progesterone Treatment to Prevent Preterm Birth.
Meis PJ, Aleman A
Drugs · 2025 Oct · PMID 40844665 · Publisher ↗
Abstract loading — click title to view on PubMed.
Managing Burning Mouth Syndrome: Current and Future Directions.
Sangalli L, Mirfarsi S, Kramer JM … +2 more , Eisa E, Miller CS
Drugs · 2025 Sep · PMID 40815383 · Publisher ↗
Burning mouth syndrome (BMS) is a chronic pain condition characterized by a persistent burning sensation in the oral mucosa in the absence of visible clinical signs. Its management remains a significant clinical challeng...
Burning mouth syndrome (BMS) is a chronic pain condition characterized by a persistent burning sensation in the oral mucosa in the absence of visible clinical signs. Its management remains a significant clinical challenge due to the unclear and multifactorial nature of its etiopathogenesis. Differentiating between primary (idiopathic) and secondary (associated with identifiable underlying conditions) BMS is critical for guiding treatment. Current management strategies range from addressing underlying systemic or local factors to utilizing established systemic or topical pharmacologic options (such as benzodiazepines, capsaicin, anticonvulsants, antidepressants), new off-label treatments (including low-dose naltrexone), supplements (such as alpha lipoic acid and phytotherapeutics), alongside non-pharmacological approaches aimed at addressing pain symptoms and enhancing pain-coping skills (such as nerve blocks, cognitive behavioral therapy, and transcranial magnetic stimulation). This review synthesizes the current evidence supporting both established and newly investigated therapies and discusses future research directions to improve outcomes for individuals affected by this chronic pain condition. Ultimately, the best management approach should be based on the most robust evidence-based findings, tailored to the underlying etiopathogenetic mechanisms, and individualized to address patient contributing factors.
PCSK9 Inhibitors: A Potential Priority Choice for Lipid Management in Patients with Diabetic Kidney Disease.
Bao L, Shi X, Shao Y
Drugs · 2025 Sep · PMID 40804212 · Publisher ↗
Diabetic kidney disease (DKD), a severe microvascular complication of diabetes mellitus (DM), is the predominant cause of end-stage renal disease. Patients with DM frequently experience dyslipidemia, which can exacerbate...
Diabetic kidney disease (DKD), a severe microvascular complication of diabetes mellitus (DM), is the predominant cause of end-stage renal disease. Patients with DM frequently experience dyslipidemia, which can exacerbate DKD progression. Consequently, initiating aggressive lipid-lowering therapy in the early stages of DKD is as important as controlling blood glucose and reducing urinary protein. Statins have been the cornerstone of lipid management, but their use is often limited by adverse effects and potential risks of accelerating DKD progression with prolonged administration. As such, identifying optimal lipid management agents for patients with DKD remains an urgent clinical priority. As a pivotal enzyme in lipid metabolism, proprotein convertase subtilisin/kexin type 9 (PCSK9) plays a role in lipid regulation and is intricately linked to various biological processes, including inflammation, programmed cell death (apoptosis, autophagy, pyroptosis, and ferroptosis), and tumor immunity. Emerging evidence suggests that PCSK9 is involved in the occurrence and development of DKD. This article reviews the possible pathways through which PCSK9 is involved in DKD from the aspects of inflammation, oxidative stress, and programmed cell death and how PCSK9 inhibitors may have the potential to improve DKD while reducing cholesterol levels. Therefore, we propose that PCSK9 inhibitors can be a potential priority choice for lipid-lowering in patients with DKD.
Clinical Use of Once-Weekly Insulin Icodec: Translating Clinical Trial Data into Practical Guidance for Diabetes Management.
Philis-Tsimikas A, Aberle J, Bajaj H … +6 more , Lingvay I, Mu Y, Shaikh S, Vianna A, Watada H, Del Prato S
Drugs · 2025 Oct · PMID 40802020 · Full text
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...
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.
Nipocalimab: First Approval.
Fung S
Drugs · 2025 Sep · PMID 40779124 · Publisher ↗
Nipocalimab (nipocalimab-aahu; IMAAVY™) is a fully human monoclonal antibody that binds to and blocks the neonatal fragment crystallizable (Fc) receptor (FcRn) resulting in the reduction of circulating IgG levels. It is...
Nipocalimab (nipocalimab-aahu; IMAAVY™) is a fully human monoclonal antibody that binds to and blocks the neonatal fragment crystallizable (Fc) receptor (FcRn) resulting in the reduction of circulating IgG levels. It is being developed by Johnson & Johnson for the treatment of a number of autoimmune disorders. On 29 April 2025, nipocalimab received its first approval in the USA for the treatment of generalized myasthenia gravis in adult and pediatric patients ≥ 12 years of age who are anti-acetylcholine receptor or anti-muscle specific tyrosine kinase antibody positive. Regulatory review of nipocalimab is underway for generalized myasthenia gravis in Japan and the European Union. This article summarizes the milestones in the development of nipocalimab leading to this first approval for generalized myasthenia gravis.
Avutometinib and Defactinib: First Approval.
Blair HA
Drugs · 2025 Oct · PMID 40762779 · Publisher ↗
Avutometinib and defactinib (AVMAPKI FAKZYNJA CO-PACK) is a co-packaged rapidly accelerating fibrosarcoma (RAF)/mitogen-activated protein kinase kinase (MEK) inhibitor (avutometinib) and focal adhesion kinase (FAK)/proli...
Avutometinib and defactinib (AVMAPKI FAKZYNJA CO-PACK) is a co-packaged rapidly accelerating fibrosarcoma (RAF)/mitogen-activated protein kinase kinase (MEK) inhibitor (avutometinib) and focal adhesion kinase (FAK)/proline-rich tyrosine kinase-2 (Pyk2) inhibitor (defactinib) being developed by Verastem Oncology for the treatment of RAS/MAPK pathway-driven cancers. In May 2025, avutometinib and defactinib was approved in the USA for the treatment of adult patients with KRAS-mutated recurrent low-grade serous ovarian cancer (LGSOC) who have received prior systemic therapy. This article summarizes the milestones in the development of avutometinib and defactinib leading to this first approval for KRAS-mutated recurrent LGSOC.
Gepotidacin: First Approval.
Keam SJ
Drugs · 2025 Nov · PMID 40762778 · Publisher ↗
Gepotidacin (BLUJEPA), a small molecule triazaacenaphthylene bacterial type II topoisomerase inhibitor (BTI) antibacterial, has been developed by GSK for the treatment of uncomplicated urinary tract infections (uUTIs) an...
Gepotidacin (BLUJEPA), a small molecule triazaacenaphthylene bacterial type II topoisomerase inhibitor (BTI) antibacterial, has been developed by GSK for the treatment of uncomplicated urinary tract infections (uUTIs) and uncomplicated urogenital gonorrhoea (uUGC). In March 2025, gepotidacin was approved for the treatment of uUTIs caused by susceptible isolates of Escherichia coli, Klebsiella pneumoniae, Citrobacter freundii complex, Staphylococcus saprophyticus and Enterococcus faecalis in female adult and paediatric patients aged ≥ 12 years and weighing ≥ 40 kg in the USA. This article summarizes the milestones in the development of gepotidacin leading to this first approval for the treatment of bacterial uUTIs.
Atrasentan: First Approval.
Keam SJ
Drugs · 2025 Oct · PMID 40760295 · Publisher ↗
Atrasentan (VANRAFIA), a potent, highly selective, orally administered endothelin type A (ET) receptor antagonist, is in development by Novartis for the treatment of glomerular disease. In April 2025, atrasentan was appr...
Atrasentan (VANRAFIA), a potent, highly selective, orally administered endothelin type A (ET) 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.
Luvometinib: First Approval.
Keam SJ
Drugs · 2025 Sep · PMID 40751881 · Publisher ↗
Luvometinib (), a highly selective orally administered mitogen-activated protein kinase kinase 1/2 (MEK1/2) inhibitor, is being developed by Shanghai Fosun Pharmaceutical (Group) Co., Ltd (Fosun Pharma) for the treatment...
Luvometinib (), a highly selective orally administered mitogen-activated protein kinase kinase 1/2 (MEK1/2) inhibitor, is being developed by Shanghai Fosun Pharmaceutical (Group) Co., Ltd (Fosun Pharma) for the treatment of rare malignancies and other rare diseases associated with abnormal mitogen-activated protein kinase (MAPK) activation. In May 2025, luvometinib was approved in china for the treatment of adult patients with Langerhans cell histiocytosis (LCH) and histiocytic neoplasms and for the treatment of paediatric patients aged ≥ 2 years with neurofibromatosis type 1 (NF1) who have symptomatic plexiform neurofibromas (PN) not amenable to complete resection. This article summarizes the milestones in the development of luvometinib leading to this first approval for the treatment of adult patients with LCH/histiocytic tumours and children and adolescents aged ≥ 2 years with NF1 with symptomatic, inoperable PN.
Telisotuzumab Vedotin: First Approval.
Blair HA
Drugs · 2025 Sep · PMID 40736649 · Publisher ↗
Telisotuzumab vedotin (telisotuzumab vedotin-tllv; EMRELIS), an antibody-drug conjugate (ADC) directed against c-mesenchymal-epithelial transition factor (c-MET) protein, is being developed by AbbVie for the treatment of...
Telisotuzumab vedotin (telisotuzumab vedotin-tllv; EMRELIS), an antibody-drug conjugate (ADC) directed against c-mesenchymal-epithelial transition factor (c-MET) protein, is being developed by AbbVie for the treatment of solid tumours. On 14 May 2025, telisotuzumab vedotin received accelerated approval in the USA for the treatment of adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) with high c-Met protein overexpression, as determined by an FDA-approved test, who have received a prior systemic therapy. This article summarizes the milestones in the development of telisotuzumab vedotin leading to this first approval for NSCLC.
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