Massimo Imazio, Valentino Collini, Francesco Venturelli, Maria Cristina Tomat, Giulio Savonitto, Davide Stolfo
{"title":"Emerging therapies for pericarditis: from anti-IL-1 agents to novel therapeutic options.","authors":"Massimo Imazio, Valentino Collini, Francesco Venturelli, Maria Cristina Tomat, Giulio Savonitto, Davide Stolfo","doi":"10.1080/14728214.2026.2726141","DOIUrl":"10.1080/14728214.2026.2726141","url":null,"abstract":"<p><strong>Introduction: </strong>Although often self-limited, acute pericarditis recurs in up to 30% of patients. Recurrent pericarditis (RP) causes substantial morbidity (pain, fatigue, and impaired quality of life) and can lead to constriction. Traditional treatments have important limitations, including corticosteroid dependence, recurrent flares, and treatment-related adverse effects. Emerging targeted immunomodulators are therefore under active investigation.</p><p><strong>Areas covered: </strong>This review summarizes the burden of pericarditis across etiologies, current therapies, and the global market for pericarditis treatment. We then focus on novel agents in development with an emphasis on phase II/III studies. The pathobiology of pericardial inflammation (notably interleukin (IL)-1 and inflammasome pathways) is discussed as the rationale for targeted drugs. We review key trials of IL-1 inhibitors, NLRP3 inhibitors (VTX2735), and other innovations (e.g. cannabidiol-based CardiolRx). Potential obstacles to development are examined.</p><p><strong>Expert opinion: </strong>Randomized-withdrawal trials support a marked reduction in recurrences with IL-1 blockade in selected patients with inflammatory, colchicine-resistant and corticosteroid-dependent RP. However, open-label enrichment, small samples, short follow-up, uncertain durability after withdrawal, cost, and limited evidence outside idiopathic or post-cardiac injury disease restrict generalizability. New pipeline agents hold promise for broader use, however, remain investigational until controlled trials establish their efficacy and long-term safety.</p>","PeriodicalId":12292,"journal":{"name":"Expert Opinion on Emerging Drugs","volume":" ","pages":"1-8"},"PeriodicalIF":3.8,"publicationDate":"2026-10-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149079681","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Charles Zhang, Sinan Ersan, Abdullah Virk, Alexander E Higgins, Ingrid U Scott, Harry W Flynn
{"title":"Emerging drugs for diabetic macular edema: an update.","authors":"Charles Zhang, Sinan Ersan, Abdullah Virk, Alexander E Higgins, Ingrid U Scott, Harry W Flynn","doi":"10.1080/14728214.2026.2739626","DOIUrl":"https://doi.org/10.1080/14728214.2026.2739626","url":null,"abstract":"<p><strong>Introduction: </strong>Diabetic macular edema (DME) is a major cause of vision loss among working‑age adults in the United States. Currently, intravitreal anti-vascular endothelial growth factor (anti‑VEGF) injections are the first‑line pharmacological treatment for the management of center‑involving DME. However, real‑world outcomes with anti-VEGF injections are suboptimal due to limited durability, inconsistent follow‑up, and incomplete response.</p><p><strong>Areas covered: </strong>Novel therapeutic approaches include multi-target biologics combining VEGF inhibition with complementary pathways, non-VEGF barrier-restorative biologics, inflammation-modulating agents, small-molecule VEGF-pathway tyrosine kinase inhibitors, alternative corticosteroid delivery approaches, and ocular gene-therapy vectors.</p><p><strong>Expert opinion: </strong>Emerging therapies are likely to complement rather than immediately replace the current anti-VEGF paradigm. Durable therapies including sustained-release implants and gene therapy demonstrate promise in reducing treatment burden and integrate well into the current treatment paradigm. Combination strategies targeting VEGF alongside complementary inflammatory or vascular pathways may improve outcomes in patients with incomplete response, although prospective studies are still needed to identify the patients most likely to benefit from these approaches. Agents seeking to replace the current anti-VEGF regimens face the greatest challenges. Ultimately, the clinical adoption of these therapies will depend on demonstrating durable efficacy, an acceptable safety profile, procedural feasibility, and payer acceptance.</p>","PeriodicalId":12292,"journal":{"name":"Expert Opinion on Emerging Drugs","volume":" ","pages":"1-17"},"PeriodicalIF":3.8,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149106246","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Emerging drugs for the treatment of gastrointestinal stromal tumors: a spotlight on bezuclastinib and the evolving treatment landscape.","authors":"Javier Pozas, Andrea Napolitano, Robin L Jones","doi":"10.1080/14728214.2026.2739621","DOIUrl":"10.1080/14728214.2026.2739621","url":null,"abstract":"","PeriodicalId":12292,"journal":{"name":"Expert Opinion on Emerging Drugs","volume":" ","pages":"1-5"},"PeriodicalIF":3.8,"publicationDate":"2026-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149037348","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Camila R Marquez, Aditya Joshi, Lauren Gawey, Stacey N Giuffre, Crystal Khem, Jennifer L Hsiao, Vivian Y Shi
{"title":"Recent advances in hidradenitis suppurativa therapeutics: a focus on existing and future medical therapeutics.","authors":"Camila R Marquez, Aditya Joshi, Lauren Gawey, Stacey N Giuffre, Crystal Khem, Jennifer L Hsiao, Vivian Y Shi","doi":"10.1080/14728214.2026.2731005","DOIUrl":"10.1080/14728214.2026.2731005","url":null,"abstract":"<p><strong>Introduction: </strong>HS is an inflammatory skin condition that causes abscesses, nodules, and tunnels in intertriginous areas. Treatment consists of multimodal therapy such as topical and systemic antibiotics, washes and ointments, hormonal modulation, retinoids, surgery, and recently biologic therapy. The FDA approved three biologics for HS in the last 10 years, although novel options are needed for recalcitrant disease.</p><p><strong>Areas covered: </strong>A comprehensive search of the National Institutes of Health (NIH) Clinical Trials database was performed in April 2025, with an updated search in October 2025. Trials were limited to hidradenitis suppurativa, phase II or III, and a status of not yet recruiting, recruiting, active, completed, or terminated. Data were supplemented with a PubMed query and an internet search for data and press releases from companies. Results include 52 phase 2 and 16 phase 3 studies.</p><p><strong>Expert opinion: </strong>Biologics serve as a steppingstone to a new age of therapy for HS. Investigations are needed for recalcitrant disease, to minimize adverse events, and provide personalized treatment. Compounds with promise include JAK inhibitors, while other compounds await results, and others limited by small sample sizes and non-randomized study designs. Future trials should focus on comparative drug designs and ensuring fair access for all, particularly patients with the highest disease burden.</p>","PeriodicalId":12292,"journal":{"name":"Expert Opinion on Emerging Drugs","volume":" ","pages":"1-19"},"PeriodicalIF":3.8,"publicationDate":"2026-09-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148896941","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"σ<sub>1</sub> receptor agonists: the new trend or an emerging therapeutic option?","authors":"Tangui Maurice","doi":"10.1080/14728214.2026.2696872","DOIUrl":"10.1080/14728214.2026.2696872","url":null,"abstract":"","PeriodicalId":12292,"journal":{"name":"Expert Opinion on Emerging Drugs","volume":" ","pages":"79-82"},"PeriodicalIF":3.8,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148344329","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Daniel Neureiter, Dino Bekric, Christian Mayr, Tobias Kiesslich, Matthias Ocker
{"title":"Emerging claudin-18.2 antagonists in the treatment of biliary tract cancer.","authors":"Daniel Neureiter, Dino Bekric, Christian Mayr, Tobias Kiesslich, Matthias Ocker","doi":"10.1080/14728214.2026.2681745","DOIUrl":"10.1080/14728214.2026.2681745","url":null,"abstract":"<p><strong>Introduction: </strong>The tight junction protein Claudin-18.2 (CLDN-18.2) has been identified as a novel drug target for various solid tumors, including biliary tract cancers (BTC). Antibody-based approaches to target CLDN-18.2 have shown promising results in early clinical trials and several novel modalities like antibody-drug conjugates, bispecific T-cell engagers or CAR T-cells are currently also explored.</p><p><strong>Areas covered: </strong>This review discusses the translational knowledge and gaps related to the underrepresentation of BTC in early clinical (basket) studies. We outline the current status of early clinical trials of drugs targeting CLDN-18.2 in BTC and discuss the need to determine prevalence and cutoff data in larger cohorts to overcome limitations related to clinical and molecular heterogeneity of BTC.</p><p><strong>Expert opinion: </strong>Targeting CLDN-18.2 is a promising novel approach to treat solid tumors, including BTC. To confirm encouraging first clinical data, larger studies specific for BTC are needed to address tumor heterogeneity and to determine cutoff levels of CLDN-18.2 expression. Such studies are also needed to understand combination options and sequencing of therapies and to further validate novel approaches to fully exploit the potential of targeting CLDN-18.2 in BTC.</p>","PeriodicalId":12292,"journal":{"name":"Expert Opinion on Emerging Drugs","volume":" ","pages":"83-93"},"PeriodicalIF":3.8,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148149245","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Madia Lozupone, Vittorio Dibello, Rodolfo Sardone, Roberta Zupo, Fabio Castellana, Ilaria Bortone, Luisa Lampignano, Michela Di Matteo, Giuseppe Moramarco, Flora Dellegrazie, Antonio Daniele, Vincenzo Solfrizzi, Francesco Panza
{"title":"Evaluating emerging amyloid-β centric drugs for the treatment of Alzheimer's disease.","authors":"Madia Lozupone, Vittorio Dibello, Rodolfo Sardone, Roberta Zupo, Fabio Castellana, Ilaria Bortone, Luisa Lampignano, Michela Di Matteo, Giuseppe Moramarco, Flora Dellegrazie, Antonio Daniele, Vincenzo Solfrizzi, Francesco Panza","doi":"10.1080/14728214.2026.2693701","DOIUrl":"10.1080/14728214.2026.2693701","url":null,"abstract":"<p><strong>Introduction: </strong>The amyloid cascade hypothesis provided a compelling rationale for Alzheimer's disease (AD) drug development, but many amyloid-β (Aβ)-targeted agents failed to show benefit. The present review article evaluated emerging Aβ-directed therapies, focusing on mechanisms, clinical efficacy, safety, and regulatory progress.</p><p><strong>Areas covered: </strong>The recent approvals of lecanemab and donanemab offered the first convincing evidence that reducing Aβ burden can modestly slow cognitive decline in early AD. Beyond these first-generation monoclonal antibodies, the pipeline includes next-generation antibodies with enhanced brain penetration (trontinemab), therapies designed also for presymptomatic intervention (remternetug tested for secondary prevention), and novel approaches targeting galectin-3 to disrupt Aβ aggregation and neuroinflammation. Active immunotherapies like UB-311 and small molecules such as ALZ-801, avoiding amyloid-related imaging abnormalities (ARIA), broaden the therapeutic horizon with potentially safer and more accessible options, but with no proven efficacy.</p><p><strong>Expert opinion: </strong>Clinical benefits for Aβ-centric therapies are modest, ARIA poses ongoing safety concerns, and high costs coupled with intensive monitoring limit accessibility. Regulators have begun to restrict approval to genetically defined subgroups according to apolipoprotein E genotype, underscoring the need for precision medicine. Therefore, while Aβ-centric therapies are incremental, they represent essential steps toward combination and precision strategies in the treatment of AD.</p>","PeriodicalId":12292,"journal":{"name":"Expert Opinion on Emerging Drugs","volume":" ","pages":"107-121"},"PeriodicalIF":3.8,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148283645","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Sailish Honap, Axel Dignass, Vipul Jairath, Fernando Magro, Silvio Danese, Laurent Peyrin-Biroulet
{"title":"Obefazimod (ABX464) for moderate-to-severe Crohn's disease: clinical development of a novel oral therapeutic approach.","authors":"Sailish Honap, Axel Dignass, Vipul Jairath, Fernando Magro, Silvio Danese, Laurent Peyrin-Biroulet","doi":"10.1080/14728214.2026.2693032","DOIUrl":"10.1080/14728214.2026.2693032","url":null,"abstract":"","PeriodicalId":12292,"journal":{"name":"Expert Opinion on Emerging Drugs","volume":" ","pages":"73-77"},"PeriodicalIF":3.8,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148293963","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}