Pharmaceuticals最新文献

{"title":"<i>M. avium Complex</i> Pulmonary Infections: Therapeutic Obstacles and Progress in Drug Development.","authors":"Elise Si Ahmed Charrier, Alexandra Dassonville-Klimpt, Claire Andréjak, Pascal Sonnet","doi":"10.3390/ph18060891","DOIUrl":"10.3390/ph18060891","url":null,"abstract":"<p><p>Worldwide, several million people are infected with mycobacteria such as <i>Mycobacterium tuberculosis</i> (<i>M. tb</i>) or non-tuberculous mycobacteria (NTM). In 2023, 10.8 million cases and 1.25 million deaths due to <i>M. tb</i> were recorded. In Europe and North America, the emergence of NTM is tending to outstrip that of <i>M. tb</i>. Among pulmonary NTM, <i>Mycobacterium avium complex</i> (MAC) is the most common, accounting for 80% of NTM infections. First-line treatment requires the combination of at least three antibiotics over a long period and with different mechanisms of action to limit cross-resistance. The challenge is to discover more effective new anti-MAC molecules to reduce the duration of treatment and to overcome resistant strains. The aim of this review is to present an overview of the challenges posed by MAC infection such as side effects, reinfections and resistance mechanisms. The latest therapeutic options such as the optimized combination therapy, drug repurposing and the development of new formulations, as well as new anti-MAC compounds currently in (pre)clinical trials will also be discussed.</p>","PeriodicalId":20198,"journal":{"name":"Pharmaceuticals","volume":"18 6","pages":""},"PeriodicalIF":4.3,"publicationDate":"2025-06-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12195860/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144507641","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Improving Ex Vivo Nasal Mucosa Experimental Design for Drug Permeability Assessments: Correcting Mucosal Thickness Interference and Reevaluating Fluorescein Sodium as an Integrity Marker for Chemically Induced Mucosal Injury.","authors":"Shengnan Zhao, Jieyu Zuo, Marlon C Mallillin, Ruikun Tang, Michael R Doschak, Neal M Davies, Raimar Löbenberg","doi":"10.3390/ph18060889","DOIUrl":"10.3390/ph18060889","url":null,"abstract":"<p><p><b>Objectives</b>: Ex vivo nasal mucosa models provide physiologically relevant platforms for evaluating nasal drug permeability; however, their application is often limited by high experimental variability and the absence of standardized methodologies. This study aimed to improve experimental design by addressing two major limitations: the confounding effects of mucosal thickness and the questionable reliability of fluorescein sodium (Flu-Na) as an integrity marker for chemically induced mucosal injury. <b>Methods</b>: Permeability experiments were conducted using porcine nasal tissues mounted in Franz diffusion cells, with melatonin and Flu-Na as model compounds. Tissues of varying thickness were collected from both intra- and inter-individual sources, and a numerical simulation-based method was employed to normalize apparent permeability coefficients (Papp) to a standardized mucosal thickness of 0.80 mm. The effects of thickness normalization and chemically induced damage were systematically evaluated. <b>Results</b>: Thickness normalization substantially reduced variability in melatonin Papp, particularly within same-animal comparisons, thereby improving statistical power and data reliability. In contrast, Flu-Na exhibited inconsistent correlations across different pigs and failed to reflect the expected increase in permeability following isopropyl alcohol (IPA)-induced epithelial damage. These results suggest that the relationship between epithelial injury and paracellular transport may be non-linear and not universally applicable under ex vivo conditions, limiting the suitability of Flu-Na as a standalone marker of mucosal integrity. <b>Conclusions</b>: The findings highlight the importance of integrating mucosal thickness correction into standardized experimental protocols and call for a critical reassessment of Flu-Na in nasal drug delivery research.</p>","PeriodicalId":20198,"journal":{"name":"Pharmaceuticals","volume":"18 6","pages":""},"PeriodicalIF":4.3,"publicationDate":"2025-06-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12195738/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144507741","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Recent Preclinical Evidence on Phytocannabinoids in Neurodegenerative Disorders: A Focus on Parkinson's and Alzheimer's Disease.","authors":"Nicoleta-Mirela Blebea, Ciprian Pușcașu, Gabriel Hancu, Alina Mihaela Stăniguț, Cornel Chiriță","doi":"10.3390/ph18060890","DOIUrl":"10.3390/ph18060890","url":null,"abstract":"<p><p>The endocannabinoid system (ECS) is a vital biological network essential for maintaining homeostasis and supporting various physiological functions. It comprises cannabinoid receptors, endogenous lipid-based ligands, known as endocannabinoids, as well as metabolic enzymes and associated proteins responsible for regulating their levels within tissues. The ECS plays a central role in modulating processes involving the central nervous system (CNS). Recent studies have highlighted its antioxidant, anti-inflammatory, and neuroprotective properties. The therapeutic potential of cannabinoids, particularly phytocannabinoids derived from plants, has attracted significant attention in medical and pharmaceutical research. This interest has grown in parallel with the increasing availability of cannabinoid-based food supplements on the pharmaceutical market. Given the complexity of the ECS and its broad range of interactions, the discovery of this system has spurred extensive investigations into the use of cannabinoids for various health conditions. In this review, we examine recent preclinical evidence supporting the use of phytocannabinoids in the context of neurodegenerative diseases, particularly in Alzheimer's disease and Parkinson's disease. Targeting the ECS through phytocannabinoid-based pharmacological modulation offers a promising therapeutic strategy for these neurological disorders. Among these compounds, cannabidiol has emerged as a key focus of research due to its multifaceted effects and favorable safety profile. Nonetheless, continued investigation is necessary to clarify its mechanisms of action, and to develop effective, evidence-based clinical applications.</p>","PeriodicalId":20198,"journal":{"name":"Pharmaceuticals","volume":"18 6","pages":""},"PeriodicalIF":4.3,"publicationDate":"2025-06-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12196234/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144507777","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Exploring Plasma Proteome Thermal Stability in Peripheral Arterial Disease: Biophysical Findings Under Cilostazol Therapy.","authors":"Dorottya Szabó, László Benkő, Dénes Lőrinczy","doi":"10.3390/ph18060886","DOIUrl":"10.3390/ph18060886","url":null,"abstract":"<p><p><b>Introduction</b>: Intermittent claudication, an early symptom of peripheral artery disease, can be treated by cilostazol to alleviate symptoms and improve walking distance. Our previous investigation focused on cilostazol-induced alterations in the thermodynamic properties of plasma, utilizing differential scanning calorimetry (DSC) as a potential monitoring tool. The current proof-of-concept study aimed to enhance the interpretation of DSC data through deconvolution techniques, specifically examining protein transitions within the plasma proteome during cilostazol therapy. <b>Results</b>: Notable differences in thermal unfolding profiles were found between cilostazol-treated patients and healthy controls. The fibrinogen-associated transition exhibited a downward shift in denaturation temperature and decreased enthalpy by the third month. The albumin-related transition shifted to higher temperatures, accompanied by lower enthalpy. Transitions associated with globulins showed changes in thermal stability, while the transferrin-related peak demonstrated increased structural rigidity in treated patients compared to controls. <b>Discussion</b>: These observations suggest that cilostazol induces systemic changes in the thermodynamic behavior of plasma proteins. DSC, when combined with deconvolution methods, presents a promising approach for detecting subtle, therapy-related alterations in plasma protein stability. <b>Materials and methods</b>: Ten patients (median age: 58.6 years) received 100 milligrams of cilostazol twice daily. Blood samples were collected at the baseline and after 2 weeks, 1 month, 2 months, and 3 months of therapy. Walking distances were also assessed. The DSC curves were retrieved from the thermal analysis investigated by deconvolution mathematical methods. <b>Conclusions</b>: Although the exact functional consequences remain unclear, the observed biophysical changes may reflect broader molecular adaptations involving protein-protein interactions, post-translational modifications, or acute phase response elements.</p>","PeriodicalId":20198,"journal":{"name":"Pharmaceuticals","volume":"18 6","pages":""},"PeriodicalIF":4.3,"publicationDate":"2025-06-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12196216/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144507735","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Identification of Inhibitors with Potential Anti-Prostate Cancer Activity: A Chemoinformatics Approach.","authors":"Norberto S Costa, Lúcio R Lima, Jorddy N Cruz, Igor V F Santos, Rai C Silva, Alexandre A Maciel, Elcimar S Barros, Maracy L D S Andrade, Ryan S Ramos, Njogu M Kimani, Alberto Aragón-Muriel, Juan M Álvarez-Caballero, Joaquín M Campos, Cleydson B R Santos","doi":"10.3390/ph18060888","DOIUrl":"10.3390/ph18060888","url":null,"abstract":"<p><p><b>Background:</b> Prostate cancer is the most common cancer in men, especially after the age of 50. It is a malignant disease that is increasing due to the increased life expectancy of the world population. Its development and progression are dependent on androgenic stimulation. <b>Objectives:</b> This study aimed to identify potential inhibitors with anti-prostate cancer activity through the application of chemoinformatics tools, exploring the Princeton (~1.2 million compounds) and Zinc Drug (~175 million compounds) databases. <b>Methods:</b> The methodology used several computational techniques, such as ROCS (Rapid Chemical Structure Superposition) and EON (Electrostatic Potential Screening), predictions of pharmacokinetic and toxicological properties, molecular docking, synthetic accessibility, biological activity, and molecular dynamics. <b>Results:</b> At the end of all these virtual screening steps, the study resulted in four promising potential candidates for the treatment of prostate cancer: the molecules ZINC34176694, ZINC03876158, ZINC04097308, and ZINC03977981, which exhibited all the desirable pharmacokinetic parameters (ADME/Tox) for a potential drug. <b>Conclusions:</b> Docking and molecular dynamics studies demonstrate stability and interaction with the androgen receptor of the selected compounds, showing them to be promising candidates for the development of new drugs.</p>","PeriodicalId":20198,"journal":{"name":"Pharmaceuticals","volume":"18 6","pages":""},"PeriodicalIF":4.3,"publicationDate":"2025-06-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12196096/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144507666","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A Comprehensive Quality Evaluation System for Medicinal Leeches by Integrating Macromolecular Protein Analysis and Small-Molecule Marker Detection as Well as Quantitative Bioassays.","authors":"Wenduan Wang, Yufei Liu, Wenjiao Lou, Liangmian Chen, Tianze Xie, Zhimin Wang, Yue Ma, Huimin Gao","doi":"10.3390/ph18060887","DOIUrl":"10.3390/ph18060887","url":null,"abstract":"<p><p><b>Background/Objectives:</b> Medical leech (<i>Hirudo</i> in the Chinese Pharmacopoeia) is renowned in traditional medicine for its significant antithrombin activity. As an animal-derived medicine with complex and incompletely understood composition, its insufficient quality control measures are met with widespread counterfeiting caused by limited animal resources and rising demand. <b>Methods:</b> In this study, an integrated quality evaluation strategy guided by \"Totality of the Evidence\" (TOE) method is proposed. This strategy combines chemical characterization of small and macromolecular components with bioassays relevant to its clinical functions. A total of 28 batches of samples were analyzed, comprising 23 genuine and 5 counterfeit batches. Species origins were identified by morphology and DNA barcoding. Chemical characterization included TLC, HPLC and UPLC-QTOF-MS/MS for small molecules, and SDS-PAGE with HPLC-Orbitrap Fusion Lumos Tribrid-MS for macromolecules. Antithrombotic activity was assessed by thrombin titration and platelet aggregation assays. <b>Results:</b> Several characteristic components were discovered and identified as key quality control markers, including eight small molecules such as an unreported compound SZ-1, plus seven major differential proteins across species. Based on these markers, accurate and rapid authentication methods were established using SDS-PAGE for macromolecules, and both HPLC and TLC for small molecules. Furthermore, using bioassay methods we established for quality evaluation, <i>Hirudo nipponica</i> exhibits potent anti-thrombin activity and inhibits platelet aggregation, while <i>Whitmania pigra</i> shows weak anti-thrombin activity and promotes platelet aggregation. <b>Conclusions:</b> This quality evaluation strategy is not only applicable for the quality assessment of genuine <i>Hirudo</i> products of different origins, but also for distinguishing medical leeches from their counterfeits.</p>","PeriodicalId":20198,"journal":{"name":"Pharmaceuticals","volume":"18 6","pages":""},"PeriodicalIF":4.3,"publicationDate":"2025-06-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12195895/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144507598","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Immunomodulatory Effects of Pulmonarom^®: In Vitro Induction of TLR and Cytokine Expression in Human Dendritic Cells.","authors":"Juan A Hernández-Aceves, Sandra Georgina Solano-Gálvez, Arturo A Wilkins-Rodríguez, José Delgado-Domínguez, Alberto Garcia Lozano, Carlos Cabello-Gutierrez, Lidia Flor Estela Huerta, Gladis Fragoso, Laila Gutiérrez-Kobeh, Rosalino Vázquez-López","doi":"10.3390/ph18060885","DOIUrl":"10.3390/ph18060885","url":null,"abstract":"<p><p><b>Background:</b> Bacterial lysates are known to modulate the immune response against respiratory infections. However, the effects of the commercial bacterial lysate Pulmonarom^® on dendritic cells-particularly human monocyte-derived dendritic cells (moDCs)-have not been studied. Additionally, limited data are available on the expression of Toll-like receptors (TLRs) and cytokines following stimulation with bacterial lysates. <b>Methods:</b> Human monocytes were isolated from buffy coats and differentiated into moDCs. Pulmonarom^® was lyophilized, quantified, and used to stimulate moDCs. Ultrastructural changes were evaluated using transmission electron microscopy. The expression of TLRs and selected cytokines was analyzed by flow cytometry. <b>Results:</b> Pulmonarom^® stimulation induced morphological changes in moDCs, including an increased number of dendrites and lysosomes. It also led to the upregulation of MHC class II molecules and TLRs 2, 3, 6, and 7. Additionally, the production of IL-4, IL-6, IL-8, and MCP-1 was significantly increased. <b>Conclusions:</b> Pulmonarom^® promotes moDC maturation, characterized by enhanced antigen presentation capabilities and lysosomal activity, along with increased expression of specific TLRs and cytokines. These features suggest a trained immunity phenotype in moDCs, potentially improving their ability to initiate adaptive immune responses against respiratory pathogens. To our knowledge, this is the first study to investigate the immunomodulatory effects of Pulmonarom^® on human moDCs, providing novel insights into its potential as an immunotherapeutic adjuvant.</p>","PeriodicalId":20198,"journal":{"name":"Pharmaceuticals","volume":"18 6","pages":""},"PeriodicalIF":4.3,"publicationDate":"2025-06-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12196250/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144507667","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The Efficacy of Combined Use of Huaier Granules in the Treatment of Primary Liver Cancer: An Updated Systematic Review and Meta-Analysis.","authors":"Tianhui Zhou, Yingying Zhang, Yuqing Lu, Zhaodong Sun, Dehui Wang, Xiaolong Zhang, Yu Wang, Yinuo Wei, Tiange Zhang, Xin Zhang, Ruohan Wei, Po Hu, Guangming Yang, Xinzhu Wang, Yang Pan","doi":"10.3390/ph18060884","DOIUrl":"10.3390/ph18060884","url":null,"abstract":"<p><p><b>Objective:</b> Existing clinical data suggest that Huaier granules effectively improve the condition of PLC patients. However, their specific efficacy and safety in PLC patients remain unclear. This study aimed to investigate the effects of Huaier granules as an adjunctive therapy for PLC patients. <b>Methods:</b> This cohort study includes 4577 PLC patients, with data retrieved up to 2024. The patients were divided into the Huaier group (<i>n</i> = 2404) and a control group (<i>n</i> = 2173), and the treatment effects and safety between the two groups were compared. Review Manager 5.3 was used to analyze the clinical data. The fixed-effects and random-effects models were adopted. Stata 17.0 was used for sensitivity and bias analyses to evaluate publication bias. <b>Results:</b> Heterogeneity testing and analysis using a random-effects model showed that the combination of Huaier granules and conventional treatment significantly reduced the recurrence rate (OR = 0.65, 95% CI 0.50-0.85, <i>p</i> = 0.002) and improved the one-year survival rate (OR = 0.79, 95% CI 0.65-0.96, <i>p</i> = 0.02). Huaier granules also improved quality of life, reduced AFP levels (<i>p</i> < 0.00001), and significantly impacted immune function by altering the levels of the T lymphocyte subtypes CD³⁺, CD⁴⁺, CD⁸⁺ and the CD⁴⁺/CD⁸⁺ ratio. When Huaier granules were used in combination with other medications, no significant changes in side effects were observed. <b>Conclusions:</b> Huaier combination therapy shows good therapeutic efficacy and safety in PLC patients. However, this conclusion needs to be further validated through prospective clinical studies.</p>","PeriodicalId":20198,"journal":{"name":"Pharmaceuticals","volume":"18 6","pages":""},"PeriodicalIF":4.3,"publicationDate":"2025-06-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12196447/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144507795","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"XMU-MP-1, Inhibitor of STE20-like MST1/2 Kinases of the Hippo Signaling Pathway, Suppresses the Cell Cycle, Activates Apoptosis and Autophagy, and Induces Death of Hematopoietic Tumor Cells.","authors":"Alexander G Stepchenko, Sofia G Georgieva, Elizaveta V Pankratova","doi":"10.3390/ph18060874","DOIUrl":"10.3390/ph18060874","url":null,"abstract":"<p><p><b>Background/Objectives</b>: Currently, there is limited knowledge on the molecular mechanisms of the \"non-canonical\" Hippo signaling pathway in hematopoietic tumor cells. We have shown that targeting the MST1/2 kinases, which are the key molecules in this signaling pathway, may be an effective approach to the treatment of hematologic tumors. <b>Methods</b>: The methods used in this study include cell growth assays, caspase assays, Western blot hybridizations, flow cytometry, and whole-transcriptome analyses. These methods allowed us to better understand the molecular pathways at play. <b>Results</b>: Our results showed that XMU-MP-1, an inhibitor of MST1/2 kinase, specifically reduces the viability of hematopoietic cancer cells but not breast cancer cells. It effectively inhibits the growth of the tumor B- and T-cell lines by blocking cell cycle progression, mainly during the G2/M phase, inducing apoptosis and autophagy. XMU-MP-1 treatment led to increased caspase 3/7 activity and increased levels of the cleaved PARP protein. Levels of the LC3-II protein were also shown to be increased, while the level of p62 decreased. These changes are associated with apoptosis and autophagy, respectively. RNA-seq analysis has demonstrated that XMU-MP-1 suppressed the expression of cell cycle regulators, such as E2F, and cell division cycle genes CDC6,7,20,25,45; cyclins A2,B1,B2, and cyclin-dependent kinases. At the same time, it increased the expression of genes involved in apoptosis, autophagy, and necroptosis. <b>Conclusions</b>: Combinations of growth assays, caspase assays, Western blotting, and RNA-seq have shown that the dramatic reduction in the number of hematopoietic tumor cells after treatment with XMU-MP-1 is due to both cytostatic and cytotoxic effects. The use of MST1/2 kinase inhibitors could be highly promising for complex therapy of hematological tumors.</p>","PeriodicalId":20198,"journal":{"name":"Pharmaceuticals","volume":"18 6","pages":""},"PeriodicalIF":4.3,"publicationDate":"2025-06-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12196308/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144507825","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Advancing Regulatory Oversight of Medical Device Trials to Align with Clinical Drug Standards in the European Union.","authors":"Ádám Pannonhalmi, Bence Sipos, Róbert Imre Kurucz, Gábor Katona, Lajos Kemény, Ildikó Csóka","doi":"10.3390/ph18060876","DOIUrl":"10.3390/ph18060876","url":null,"abstract":"<p><p>The regulation of clinical trials for medicinal products and medical devices has undergone numerous changes in recent years in the European Union, challenging manufacturers and national regulatory agencies as well. With the introduction of combined drug-device products, the regulatory landscape has been drastically changed to adapt to novel technological advancements and innovations. A comparative analysis has not yet been published highlighting the main differences and common elements of these two medicinal products, which took up almost all of the market in the pharmaceutical sector. Due to stricter regulations in the field of medical devices, the process from application up until post-market surveillance became more difficult, but a correlation between the regulation of drug trials can also be found. The main differences lie in the risk management systems, where, regardless of the background knowledge of a drug, it is always strict and mandatory structured progress, while in the case of medical devices, it is more flexible based on the risk category of the product. Generally, the utilization of e-health opportunities, transparency, and data accessibility have been improved in both fields. Via the adaptation of the mentioned regulation in the EU, the safety of patients and the efficacy of trials have been greatly increased. This manuscript aims to compare the specific regulations of these two types of medicinal products with a brief outlook on the non-EU sector as well.</p>","PeriodicalId":20198,"journal":{"name":"Pharmaceuticals","volume":"18 6","pages":""},"PeriodicalIF":4.3,"publicationDate":"2025-06-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12195702/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144507645","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}