Drug Repurposing: Strengthening Outcomes of Existing Pharmaceuticals to Shift Emerging Health Challenges

A Special Issue of Pharmacy (ISSN 2226-4787) belonging to the section "Pharmacy Practice and Practice-Based Research".

Deadline for manuscript submissions: 20 January 2027 | Viewed by 5893

Editors


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Guest Editor
Department of Organization and Economics of Pharmacy, Faculty of Pharmacy, Medical University of Sofia, Sofia, Bulgaria
Interests: drug regulation; pharmacovigilance; clinical pharmacy; pharnmacoepidemiology; hospital pharmacy

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Guest Editor
Department of Pharmaceutical Sciences & Social Pharmacy, Faculty of Pharmacy, Medical University of Pleven, Pleven, Bulgaria
Interests: drug regulation; pharmacovigilance; clinical pharmacy; drug utilization research; pharmacoeconomics

Special Issue Information

Dear Colleagues,

Drug repurposing is an innovative and increasingly successful approach to identify new therapeutic uses for approved or investigational drugs. This strategy is supported by the shared biological mechanisms underlying many diseases and the concept of pleiotropic drug action. Among its key advantages are a reduced risk of failure—owing to established safety and efficacy in preclinical models and humans—and a significant shortening of the overall development timeline.

Drug repurposing plays a particularly important role during public health crises, where rapid access to effective treatments is critical. Moreover, the search for new indications often leads to the discovery of novel drug targets or signaling pathways, thereby advancing our understanding of disease biology.

This Special Issue aims to highlight both the innovative and practical dimensions of drug repurposing while also exploring its intersections with drug regulation and pharmacological research. We welcome original research articles, as well as comprehensive reviews, that contribute to advancing this dynamic field.

Prof. Dr. Ilko Getov
Prof. Dr. Hristina Lebanova
Guest Editors

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Keywords

  • repurposing
  • repositioning
  • drug utilization research
  • drug regulation
  • clinical trials
  • pharmacoeconomics
  • unmet medical needs
  • marketing authorization
  • drug rediscovery
  • extension of indications

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Published Papers (5 papers)

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Research

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9 pages, 217 KB  
Article
Drug-Induced Hyponatremia as a Cause of Emergency Department Attendance
by Joel Gené Grasa, Natalia Sanz López, Marta Docio Alfaya, Verónica Mate García, Alicia Serrano García-Calvo, Adrián Plaza Díaz and Jesús Ruiz Ramos
Pharmacy 2026, 14(2), 49; https://doi.org/10.3390/pharmacy14020049 - 17 Mar 2026
Viewed by 1690
Abstract
Background: Hyponatremia is one of the most common electrolyte disturbances in emergency departments. This study aimed to describe the characteristics of patients presenting with drug-induced hyponatremia and analyse factors associated with 30-day revisits. Methods: Retrospective observational study including adult patients who attended the [...] Read more.
Background: Hyponatremia is one of the most common electrolyte disturbances in emergency departments. This study aimed to describe the characteristics of patients presenting with drug-induced hyponatremia and analyse factors associated with 30-day revisits. Methods: Retrospective observational study including adult patients who attended the emergency department for drug-induced hyponatremia between 2020 and 2024. Results: 141 patients were analysed (mean age 80.5 years; 78% women). Thiazide diuretics were the most frequently implicated pharmacological class (50.3%). In univariable analyses, polypharmacy, dementia, and treatment changes at discharge were associated with a higher risk of revisit for hyponatremia. In the multivariable model, only polypharmacy remained significantly associated with 30-day revisits. Conclusions: Thiazide diuretics were the leading drug-related cause of hyponatremia in the emergency setting. Polypharmacy was identified as an independent factor associated with increased revisit risk, underscoring the need for systematic medication review and close clinical follow-up after hospital discharge. Full article
15 pages, 919 KB  
Article
Drug Repurposing for Inclusion of COVID-19-Related Indication: Field Study of the European Medicines Agency’s Response to the Pandemic
by Antonio Ivanov, Violeta Getova-Kolarova and Ines Hababa-Ivanova
Pharmacy 2025, 13(6), 179; https://doi.org/10.3390/pharmacy13060179 - 10 Dec 2025
Cited by 1 | Viewed by 1135
Abstract
As one of the biggest challenges for healthcare in the 21st century, COVID-19 placed a sustained and intense demand on the European Medicines Agency’s resources and required constant adaptation and mobilization of different regulatory processes. In this situation, drug repurposing appeared as a [...] Read more.
As one of the biggest challenges for healthcare in the 21st century, COVID-19 placed a sustained and intense demand on the European Medicines Agency’s resources and required constant adaptation and mobilization of different regulatory processes. In this situation, drug repurposing appeared as a promising potential approach in quickly emerging health crises due to its main advantage of reducing the time and cost for addition of new indications since it uses products proven to be of high quality, safe, and effective. We performed an analysis of European Public Assessment Reports for medicinal products authorized for the SARS-CoV-2 infection by the European Medicines Agency, showing a total of eight products with this indication, three (37.5%) of which used repurposing as a mechanism for development (remdesivir, tocilizumab, and anakinra). The application of this mechanism by these medicines highlights the importance of the life cycle stage at which repositioning is undertaken, which resulted in different volumes of data submitted in the respective European Public Assessment Reports. The participation of organizations other than the marketing authorization holder in key stages in the drug development process of repurposed products was once again confirmed, which emphasizes the need to regulate this interaction. Full article
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Review

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16 pages, 1205 KB  
Review
Automated Processes and Artificial Intelligence in Generating Candidates for Oncology Drug Repurposing: Three-Year Scoping Review of Data
by Antonio Ivanov, Ines Hababa-Ivanova, Savina Elitova, Svetoslav Stoev and Violeta Getova-Kolarova
Pharmacy 2026, 14(4), 96; https://doi.org/10.3390/pharmacy14040096 - 1 Jul 2026
Viewed by 453
Abstract
Oncology conditions are increasingly defined by their molecular profiles, and drug repurposing exploits this new evidence to identify new therapeutic uses of authorized/investigational medicinal products outside their original indication(s). This scoping review mapped original research published between January 2022 and December 2024 to [...] Read more.
Oncology conditions are increasingly defined by their molecular profiles, and drug repurposing exploits this new evidence to identify new therapeutic uses of authorized/investigational medicinal products outside their original indication(s). This scoping review mapped original research published between January 2022 and December 2024 to determine the impact of automated processes and artificial intelligence in generating oncology candidates for drug repositioning, and 42 individual projects met the eligibility criteria and were analyzed. The included studies demonstrate extensive use of computational approaches for candidate prioritization, large-scale data integration, and hypothesis generation in oncology drug repurposing, creating opportunities for positive impact on efficiency. The included projects most commonly were target-oriented and disease-oriented and used multiple databases and computational validation procedures, while experimental and clinical validation were less frequently reported. The available open-access literature suggests substantial activity in China and India, which can support the notion that digitalization represents an important instrument in healthcare systems of low- and middle-income countries but should be interpreted cautiously. While the search was limited to PubMed and open-access English-language publications, we identified a relatively small number of drug-oriented projects, the importance of providing publicly accessible source code to reduce development costs, and the predominant role of academic institutions. Full article
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17 pages, 3677 KB  
Review
From Laboratory to Patient Access: A Scoping Review of the Multi-Dimensional Challenges in Drug Repurposing
by Antonio Ivanov, Veselina Ruseva, Ines Hababa-Ivanova, Violeta Getova-Kolarova, Hristina Lebanova and Ilko Getov
Pharmacy 2026, 14(3), 85; https://doi.org/10.3390/pharmacy14030085 - 11 Jun 2026
Viewed by 895
Abstract
Drug repurposing is often promoted as a faster, lower-risk alternative to de novo discovery, yet substantial barriers continue to limit successful implementation. We performed a scoping review of articles included in PubMed and ScienceDirect with the aim to identify and categorize challenges and [...] Read more.
Drug repurposing is often promoted as a faster, lower-risk alternative to de novo discovery, yet substantial barriers continue to limit successful implementation. We performed a scoping review of articles included in PubMed and ScienceDirect with the aim to identify and categorize challenges and analyze the intersections between them. Our review included 73 articles which revealed scientific, clinical, regulatory, economic, and implementation barriers, with the principal being the clinical translation of generated candidates. Scientific challenges include the necessity for new Phase II/III trials to validate efficacy, safety, and optimal dosing in new therapeutic contexts. Across disease areas, domain-specific barriers include subgroup-dependent responses in oncology, resistance and penetration challenges in anti-infectives, and data scarcity in rare diseases. Computational and AI-assisted approaches face fragmented data, model robustness, and insufficient validation. In addition, off-patent drugs face evidence requirements as rigorous as those for de novo entities, yet lack the market exclusivity incentives required to attract private investment. Additionally, an “institutional bottleneck” hinders academic researchers from bringing findings “on-label” due to a lack of regulatory infrastructure and collaborative frameworks. We conclude that drug repurposing requires a distinct translational paradigm involving multi-stakeholder collaboration and early regulatory engagement to bridge the gap between laboratory discovery and patient access. Full article
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Other

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14 pages, 1270 KB  
Perspective
Integrating Drug Repurposing into EU Health Crisis Preparedness: The Strategic Role of Health Emergency Preparedness and Response Authority (HERA)
by Atanas Toshev, Stanislav Gueorguiev, Anna Mihaylova, Violeta Getova-Kolarova, Vasil Madzharov, Dimitar Mirchev and Elina Petkova-Gueorguieva
Pharmacy 2026, 14(3), 72; https://doi.org/10.3390/pharmacy14030072 - 12 May 2026
Viewed by 741
Abstract
The COVID-19 pandemic exposed significant vulnerabilities in the European Union’s health security architecture and highlighted the need for stronger coordination mechanisms for managing cross-border health threats. In response, the European Union established the Health Emergency Preparedness and Response Authority (HERA) as a central [...] Read more.
The COVID-19 pandemic exposed significant vulnerabilities in the European Union’s health security architecture and highlighted the need for stronger coordination mechanisms for managing cross-border health threats. In response, the European Union established the Health Emergency Preparedness and Response Authority (HERA) as a central body responsible for strengthening preparedness, coordinating procurement, and supporting the development and availability of medical countermeasures. This study examines the potential role of drug repurposing as a strategic tool within the evolving EU health crisis preparedness framework. A narrative literature review and policy analysis were conducted using scientific publications indexed in PubMed and Scopus, as well as institutional and regulatory documents from the European Commission, the European Medicines Agency (EMA), and other relevant organisations. The findings indicate that drug repurposing offers important advantages during health emergencies, including shorter development timelines, lower research costs, and the possibility of leveraging existing manufacturing and regulatory infrastructures. At the same time, several challenges remain, particularly regarding regulatory coordination, intellectual property considerations, and the scalability of pharmaceutical production during periods of increased demand. The analysis suggests that drug repurposing could evolve from an ad hoc response mechanism into a more institutionalised component of EU health crisis preparedness. Integrating repurposing strategies into HERA’s threat prioritisation, regulatory coordination, and industrial preparedness mechanisms may significantly enhance the European Union’s ability to respond rapidly and effectively to future health emergencies. Full article
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