{"title":"Recent innovations in clinical trial design for inflammatory bowel disease","authors":"Rocio Sedano , Christopher Ma , Vipul Jairath","doi":"10.1016/j.coph.2025.102551","DOIUrl":"10.1016/j.coph.2025.102551","url":null,"abstract":"<div><div>Clinical trial design in inflammatory bowel disease (IBD) is evolving to address challenges in drug development and approvals. For clinical development, notable innovations include Bayesian designs, adaptive designs, integrated-phase trials and master protocols (such as umbrella, basket, and platform trials). The inclusion of biomarker-driven strategies and precision medicine (PM) trials bring aim to enable patient stratification based on prognostic or predictive markers, leveraging molecular signatures to customize therapy. However, recent studies highlight both the promise and complexity of this approach. Patient-reported outcomes (PROs) have gained prominence as key endpoints, aligning trials with patient-centric measures and regulatory guidance that emphasize symptoms and quality-of-life metrics. Digital health tools and artificial intelligence (AI) are being integrated to streamline trial conduct, from remote monitoring and telemedicine visits to AI-assisted recruitment and data analysis. Pragmatic trials and the integration of real-world evidence (RWE) aim to complement traditional efficacy trials by evaluating treatments in routine care settings. Together, these innovations mark a new era in IBD clinical trial design, aiming to expedite therapeutic development and enhance the relevance of trials to patient care.</div></div>","PeriodicalId":50603,"journal":{"name":"Current Opinion in Pharmacology","volume":"84 ","pages":"Article 102551"},"PeriodicalIF":4.2,"publicationDate":"2025-07-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144738541","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}
Sachin S. Mali, Prakash D. Jadhav, Sameer J. Nadaf
{"title":"Smart solutions for tough infections: The rise of next-gen transdermal drug delivery","authors":"Sachin S. Mali, Prakash D. Jadhav, Sameer J. Nadaf","doi":"10.1016/j.coph.2025.102552","DOIUrl":"10.1016/j.coph.2025.102552","url":null,"abstract":"","PeriodicalId":50603,"journal":{"name":"Current Opinion in Pharmacology","volume":"84 ","pages":"Article 102552"},"PeriodicalIF":4.0,"publicationDate":"2025-07-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144695010","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":"Ionic liquid choline and geranic acid-mediated topical drug delivery in skin tissue regeneration and neutralization of potential pathogens: A review","authors":"Popat Mohite , Shubham Munde , Aarati Budar , Sudarshan Singh , Chuda Chittasupho","doi":"10.1016/j.coph.2025.102549","DOIUrl":"10.1016/j.coph.2025.102549","url":null,"abstract":"<div><div>Ionic liquids have emerged as promising vehicles for drug delivery, with choline and geranic acid (CAGE) demonstrating exceptional potential in topical formulation for skin tissue regeneration and antimicrobial properties. CAGE exhibits unique physicochemical properties such as viscosity, high ionic conductivity, and enhanced solubility that contribute to efficacy in enhanced drug permeation with controlled drug release. CAGE possesses the inherent antimicrobial properties, making it an ideal candidate for the management of dermal complications. The review discusses the recent advancements in CAGE-oriented formulations, emphasizing their role in wound healing, followed by formulation strategies and key process parameters.</div></div>","PeriodicalId":50603,"journal":{"name":"Current Opinion in Pharmacology","volume":"84 ","pages":"Article 102549"},"PeriodicalIF":4.0,"publicationDate":"2025-06-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144634175","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}
Swati Udugade , Babaso V. Udugade , Sanket R. Patil , Ashwini C. Utage , Shagun Swaroop
{"title":"Nanotechnology-enhanced transdermal systems for infectious diseases","authors":"Swati Udugade , Babaso V. Udugade , Sanket R. Patil , Ashwini C. Utage , Shagun Swaroop","doi":"10.1016/j.coph.2025.102547","DOIUrl":"10.1016/j.coph.2025.102547","url":null,"abstract":"<div><div>Nanotechnology-enhanced transdermal drug delivery systems (NETS) show great potential in treating infectious diseases by improving drug penetration, stability, and bioavailability. Unlike traditional methods, NETS overcome skin barrier limitations through the use of lipid-based, polymeric nanoparticles, and dendrimers, enabling efficient drug transport and controlled release. This results in enhanced therapeutic efficacy and reduced systemic side effects for bacterial, viral, and fungal infections. However, challenges related to toxicity, stability, and regulatory hurdles remain. This paper examines the mechanisms, advantages, and limitations of NETS, while highlighting promising future research opportunities and clinical applications in combating infectious diseases.</div></div>","PeriodicalId":50603,"journal":{"name":"Current Opinion in Pharmacology","volume":"84 ","pages":"Article 102547"},"PeriodicalIF":4.0,"publicationDate":"2025-06-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144604720","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":"Precision medicine and immunotherapeutic approaches for relapsed/refractory paediatric acute myeloid leukaemia","authors":"Caroline C. Smith , Sarah K. Tasian","doi":"10.1016/j.coph.2025.102546","DOIUrl":"10.1016/j.coph.2025.102546","url":null,"abstract":"<div><div>Despite improved clinical outcomes amongst children and adolescents/young adults with acute myeloid leukaemia (AML) treated with modern risk-adapted frontline therapies, approximately one third of patients will relapse. Significant advances in comprehensive cytomolecular genetic diagnostics and correlation with survival outcomes via clinical trial data have identified paediatric patients with AML at highest risk of primary chemoresistance and/or subsequent relapse for whom new treatment approaches are needed. This brief North American-based perspective highlights promising small molecule inhibitors and antibody-based and cellular immunotherapies with demonstrated or emerging activity in specific high-risk subtypes of paediatric AML and outlines potential treatment strategies for children and adolescents/young adults with relapsed AML.</div></div>","PeriodicalId":50603,"journal":{"name":"Current Opinion in Pharmacology","volume":"83 ","pages":"Article 102546"},"PeriodicalIF":4.0,"publicationDate":"2025-06-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144572759","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}
Shivraj Sangappa Shivpuje , Durgacharan A. Bhagwat , Pankaj Ashok Jadhav , Kimaya P. Joshi , Suraj N. Mali
{"title":"Transdermal delivery of antibacterial peptides in the management of methicillin-resistant Staphylococcus aureus","authors":"Shivraj Sangappa Shivpuje , Durgacharan A. Bhagwat , Pankaj Ashok Jadhav , Kimaya P. Joshi , Suraj N. Mali","doi":"10.1016/j.coph.2025.102548","DOIUrl":"10.1016/j.coph.2025.102548","url":null,"abstract":"<div><div>Bacterial antimicrobial resistance (AMR) is of major public concern around the globe that arises when bacteria which earlier responded to the antibiotic therapy no longer respond to the same therapy and become resistant. The AMR has emerged due to the antibiotic abuse resulting in the development of multidrug-resistant (MDR) bacteria including methicillin-resistant <em>Staphylococcus aureus</em> (MRSA). The conventional antibiotics including vancomycin have nowadays become ineffective due to the gradual evolution and adaptation of bacteria to the surrounding environment. Antimicrobial peptides (AMPs) have emerged as an effective therapeutic option for the treatment of MRSA-induced skin and soft tissue infections (SSTIs). They offer broad-spectrum antibacterial activity with lower probability of drug resistance development. However, these AMPs face limitations such as proteolytic degradation, poor bioavailability, and potential cytotoxicity limiting their efficacy in clinical settings. Transdermal drug delivery platforms, including microneedles (MNs) coupled with the nano-formulations, have been developed to improve the AMP stability, bioavailability, and targeted release to avoid off-target cytotoxicity. Innovative strategies including Janus-type antibacterial dressings, bioresponsive MNs, and metal–organic frameworks (MOFs)-based nanocarriers have shown favorable results against the MRSA-induced skin infection. Numerous naturally occurring and synthetic antibacterial biopeptides and a Food and Drug Administration–approved glycopeptide, vancomycin, exhibited improved biofilm penetration and therapeutic efficacy when combined with smart MNs and nanosystems. Despite these improvements, challenges associated with AMP stability, cytotoxicity, and manufacturing costs still remain that limit its clinical translation. This review discussed the various MN-assisted deliveries of AMPs and associated challenges for the treatment of MRSA infections.</div></div>","PeriodicalId":50603,"journal":{"name":"Current Opinion in Pharmacology","volume":"83 ","pages":"Article 102548"},"PeriodicalIF":4.0,"publicationDate":"2025-06-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144580365","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}
Sanjeevani R. Desai , Durgacharan A. Bhagwat , Anil Kumar Singh , Rupali Baban Kumbhar , Jiyauddin Khan
{"title":"Bioadhesive polymers in transdermal formulations for skin disorders","authors":"Sanjeevani R. Desai , Durgacharan A. Bhagwat , Anil Kumar Singh , Rupali Baban Kumbhar , Jiyauddin Khan","doi":"10.1016/j.coph.2025.102544","DOIUrl":"10.1016/j.coph.2025.102544","url":null,"abstract":"<div><div>Transdermal drug delivery (TDD) offer numerous advantages over conventional routes, including improved patient compliance and sustained drug release. Bioadhesive polymers play a crucial role in TDD, enhancing drug retention and controlled release. This review explores the applications of bioadhesive polymers in transdermal formulations for skin disorders, focusing on their adhesion mechanisms, structural modifications, and therapeutic potential. Natural bioadhesives like alginate and chitosan demonstrate anti-inflammatory, antimicrobial, and wound-healing properties, while synthetic polymers such as polyvinyl alcohol (PVA) and polyvinylpyrrolidone (PVP) offer controlled drug release and mechanical stability. Despite their advantages, challenges such as adhesion failure, moisture sensitivity, and limited macromolecular drug delivery persist. Recent innovations, including self-healing hydrogels, nanofiber-based transdermal systems, and enzymatic drug carriers, present new opportunities for dermatological applications.</div></div>","PeriodicalId":50603,"journal":{"name":"Current Opinion in Pharmacology","volume":"83 ","pages":"Article 102544"},"PeriodicalIF":4.0,"publicationDate":"2025-06-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144307973","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}