Accelerating Drug Development:

The Promise of Repurposing

Wajid Ahmad*, Riyaz Khan, Razia Pathan, Vishal Jain, Dipali Rajput

Department of Pharmacology, Campus Institute of Pharmacy, Chicholi, Betul - 460001.

*Corresponding Author E-mail: wajidahmad806@gmail.com

ABSTRACT:

Because it entails the use of de-risked compounds and may result in reduced total development costs and shorter development timeframes, repurposing "old" medications to treat common and uncommon diseases is increasingly becoming an appealing prospect given the high attrition rates, significant costs, and sluggish pace of new drug discovery and development. Finding repurposable medication candidates has been approached in a number of data-driven and experimental ways, but there are significant technological and regulatory obstacles that must be overcome. In order to rationally discover or identify new uses for pharmacological molecules, drug repositioning combines the efforts of activity-based or experimental and in silico-based or computational methodologies. Therefore, it is thought to be a new approach in which medications that have previously been shown safe for use in humans are redirected based on a legitimate target molecule to cure diseases, especially those that are uncommon, challenging to treat, or ignored. In this review, we outline strategies for medication repurposing, sometimes referred to as drug repositioning, talk about the difficulties the purposing community faces, and suggest creative solutions to these difficulties in order to help achieve the full potential of drug repurposing.

KEYWORDS: Approaches, Repurposed Drugs, Challenges, Expensive, Time Consuming.

INTRODUCTION:

One method for finding new applications for authorized or experimental medications that fall beyond the purview of their original medical indication is drug repurposing, also known as drug repositioning, reprofiling, or re-tasking. Drug repurposing is based on two key ideas. One is that a medicine can interact with more than one target, opening the door to finding additional target sites of action for the molecule.

The second idea is that targets linked to a disease are frequently related to several biological processes of pathogenesis, which opens the door to the identification of a new indication for the existing target^1-4.

Compared to creating a whole new medication for a previously undiscovered indication, this approach has a number of benefits. First and possibly most significantly, there is a decreased chance of failure because the intended medication has previously been shown to be adequately safe in preclinical models and humans if. After early-stage studies are finished, there is a lower chance of failure, at least from a safety perspective, in later effectiveness trials. Second, since the majority of preclinical testing, safety evaluation, and, in some situations, formulation development will already have been finished, the time period for drug development can be shortened.  Third, less money is required, albeit this may vary significantly based on the stage and development of the intended candidate^5-8. By reducing the significant financial and time-related costs and hazards associated with traditional drug development, the identification of novel indications for existing molecules through drug repurposing offers the potential to supplement it. Compounds that have a demonstrated safety and tolerability profile based on successful phase I or phase II clinical studies are referred to as existing compounds for the purposes of this study. A new discipline of drug repurposing has emerged as a result of successful repurposed medication examples, the ever-increasing high prices and failures of traditional drug research, and the introduction of new data and technology^9-11. Traditional drug development is a hard, costly, time-consuming, and risky procedure. With the added benefit of saving up to five to seven years in the usual drug development period, it offers a lower chance of failure, while a failure rate of about 45% is linked to safety or toxicity concerns in traditional drug discovery programs^12-15.

Methods for Repurposing drugs:

With the development of technologies like proteomics, metabolomics, transcriptomics, and genomics, as well as the availability of large databases and resources like drugomics and diseaseomics data, there are many chances to find new medications by drug repositioning in a collaborative and integrated effort to fall into the previously described methods/approaches^16-19. Researchers now have the most up-to-date, trustworthy tools and data to investigate previously unidentified mechanisms of action or pathways based on disease-specific target proteins, genes, and/or unique biomarkers linked to the disease's progression. Clinical data-based drug repurposing is covered in these two primary       topics ²⁰.

Table 1: Both Experimental and Computer Methods

Computational approaches

Experimental approaches

Computational techniques, such as signature matching and drug-centric repurposing, are data-driven methods that examine various data sources to develop hypotheses. These techniques focus on predicting novel indications for existing therapeutic compounds, often using polypharmacological agents that interact with multiple targets, despite their potential side effects.

Binding assays and proteomic methods like mass spectrometry and affinity chromatography are used to find target interactions in pharmaceuticals. The Cellular Thermo-Stability Assay (CETSA) maps target engagement in cells. Phenotypic drug screening strategies help identify new medications by accident, involving changes in in vitro-in vivo models or clinical observations. These methods help determine the disease state and mechanism of action.

Researchers from a wide range of scientific domains have been paying more attention to medication repurposing strategies because they expedite the drug development process. Larger expenditures are also required, and repurposed medications have been shown to be safe in preclinical models, which further lowers attrition rates. Therefore, the primary benefits of therapeutic repurposing are linked to the known candidate compounds' proven safety as well as significantly shortened development timelines and expenses related to moving a candidate into clinical trials ^21-23.

Methods for in-Silicore Purposing:

Using advanced analytical techniques on data that already exists, in-silicore purposing methodologies find new possible drug-disease connections^24-26. Approaches can be roughly classified into two groups:

1. Molecular methods

2. Real-World Data (RWD) methodologies

Table 2: Molecular approaches and Real-World-Data (RWD)approaches

Molecular approaches:

Real-World-Data (RWD) approaches:

The core of molecular methods to medication repurposing is comprehending the molecular basis of a treatment and connecting it with a clinical indication that differs from the one for which it was first approved or produced. Understanding drug action and disease pathophysiology is the foundation of molecular techniques, which are frequently driven by extensive molecular data (also known as "omic data"), including genetic, transcriptomic, or proteomic data, as well as information on drug targets and chemical structure. Because data sets on pharmaceuticals and disorders are readily available, and because the data is robust and reproducible, transcriptomics and genomes are the two forms of omic data that are most frequently utilized to promote drug repurposing.

Based on RWD—data about an individual's health, habits, and behavior that is recorded without interference from the environment or biases imposed by data collecting methodologies—it focuses on identifying undiscovered, often surprising, correlations between medications and illnesses or their symptoms. Large, complicated, elaborately organized datasets that frequently contain years' worth of data on millions of patients are what define RWD, or non-interventional data on people's behaviors and health.

Recent case studies of inclined trials using recycled drugs: The likelihood of failure is significantly decreased when discovering new indications because many of the compounds selected for repurposing are already authorized. Repurposing offers a chance for rare illness treatment in addition to reducing the expenses associated with medication development. Numerous studies have used repurposing techniques to reveal new indications for medications that are previously licensed. Amyloid-β, for instance, is essential to the pathophysiology of Alzheimer's disease. Recently, it was shown that the dual kinase inhibitor saracatinib, a cancer medication from AstraZeneca, targets amyloid-β signaling in the brain and restores synaptic loss ^27-29.

Table 3: Successful drug repurposing examples and the repurposing approach employed:

Drug name	Original indication	New indication	Repurposing approach used
Zidovudine	Cancer	HIV/AIDS	Screening of chemical libraries in vitro
Minoxidil	Hypertension	Hairloss	Clinical studies conducted in the past (identifying hair growth as a negative consequence)
Sildenafil	Angina	Erectile dysfunction	Retrospective clinical analysis
Thalidomide	Morning sickness	Multiple myeloma, erythema nodosum, and leprosum	Pharmacological analysis and off-label use
Celecoxib	Pain and inflammation	Polyps with familiar ladenomatous	Pharmacological analysis
Aspirin	Analgesia	Colorectal cancer	Clinical and pharmacological retrospective analysis
Ketoconazole	Fungal infections	Cushing syndrome	Pharmacologic alanalysis

Delivery issues for repurposed medications and opportunities for pharmaceutical-driven repurposing initiatives:

· Only by using appropriate drug delivery systems and the best possible distribution route may the benefits of repurposed drugs be realized. Success in medication repurposing is therefore made more difficult by the requirement that not only do a number of fundamental and clinical disciplines come together, but also formulation and delivery channel considerations^30-32.

· In some situations, repurposed medications may need to be administered via routes and delivery systems that differ from authorized dose regimens, necessitating their reformulation^30-32.

· Therefore, while creating appropriate formulations, it may be necessary to address issues like reformulation or the requirement to combine the formulation with the appropriate drug delivery system^30-32.

· In addition to the scientific difficulties in finding promising and strong candidate compounds, financial strategies are required to enable the use of current molecules as treatments for novel indications^30-32.

· Pharmaceuticals confront a difficulty in attempting to recover the investment required to bring a repurposed medication to market, and despite the possible shortened clinical development path for repurposed therapies, there is still a considerable commitment in the requirement to establish the efficacy of the molecule in stone applications ^30-32.

Obstacles to drug reuse:

· Regulatory issues

· Oganizational obstacles

· Patent considerations.

Regulatory Issues:

Drug repurposing is hampered by several legal and intellectual property issues. The main obstacles to encouraging medication repurposing are the challenges of patenting a new repurposed indication and upholding patent rights, which significantly affect the possible profit anticipated from the repurposed product. In the majority of the main pharmaceutical markets, a new medical application of a known therapeutic molecule can be protected as long as it is novel and creative (i.e., not immediately apparent)^33-35.

Drug repurposing is hampered by several legal and intellectual property issues. The main obstacles to encouraging medication repurposing are the challenges of patenting a new repurposed indication and upholding patent rights, which significantly affect the possible profit anticipated from the repurposed product1. In the majority of the main pharmaceutical markets, a new medical application of a known therapeutic molecule can be protected as long as it is novel and creative (i.e., not immediately apparent).

Oganizational Obstacles:

The improvement of repurposed pharmaceuticals is heavily influenced by regulatory factors.According to a research by Murteira and colleagues 100 assessing the regulatory path related to repurposed and reformulated medications, the centralized approach was the most crucial avenue for the submission of repurposed drugs for approval within the EU (the UK, France, and Germany were examined).NDA type 1 (new molecular entity), NDA type 6 (new indication), and supplementary new drug application (sNDA) (new indication) were only utilized for drug-repurposing submissions in the United States, according to the categorization of Murteira and colleagues 100. In contrast, NDA type 3 (new dosage form) and NDA type 4 (new combination) were used for either medication reformulation or drug repurposing. The survey also discovered that most repurposing instances were allowed prior to the patent expiration of the original product in the US (69.6%) and the EU (France: 83.3%; Germany: 88.9% and UK: 93.8%)^33-35.

Patent Considerations:

Pharmaceutical corporations are collaborating with smaller biotech startups and academic institutions after understanding the possibility of repurposing drugs outside of their main illness area of emphasis. One such example is the AstraZeneca Open Innovation Platform, which encourages outside partnerships to enhance therapeutic repurposing research by providing access to well-characterized molecules appropriate for repurposing through translational, preclinical, and clinical phase II studies. However, there may be organizational obstacles to repurposing in the pharmaceutical business, especially if the chemical has been terminated in development or the proposed indication is not within the organization's designated disease area, in which case the R&D division no longer has a "live" project to offer committed support for the new indication^33-35.

Advantages:

Focus on Translation: Translational research in academia provides incentives by encouraging innovative partnerships and connecting fundamental scientists with clinicians from other disciplines, which is in line with and advantageous from academic freedom. Instant access to medical facilities and professionals is a huge benefit that frequently bridges the communication gap between two (otherwise disparate) cultures.

In accordance with and advantageous to academic freedom, translational research in academia provides incentives through the development of innovative partnerships and the partnering of fundamental scientists with clinicians from other fields. One huge benefit is having instant access to hospitals and medical professionals, which frequently bridges the communication gap between two (otherwise disparate) cultures^36-37.

Translational research in academia provides incentives by encouraging innovative partnerships and connecting fundamental scientists with clinicians from other disciplines, which is in line with and advantageous from academic freedom. Instant access to medical facilities and professionals is a huge benefit that frequently bridges the communication gap between two (otherwise disparate) cultures^36-37.

Focus on Disease:

Clinical education and clinical research-specific activities provide in-depth knowledge in specific disease areas, lowering "activation obstacles" and allowing projects to quickly go beyond the early (basic science) phases. On the other hand, research at the cellular and molecular level and direct route linkages might result from clinical data. In this way, drug-purposing efforts may quickly be applied to disorders for which there are no viable treatments.

By lowering "activation obstacles" and providing in-depth knowledge in specific disease areas, activities related to clinical education and clinical research allow projects to quickly progress beyond the early (basic science) phases. On the other hand, clinical findings may result in cellular and molecular investigations and direct route linkages. This allows for the quick application of drug-purposing efforts to illnesses for which there are no viable treatments.

Activities unique to clinical education and clinical research remove "activation barriers," provide in-depth knowledge in specific disease areas, and allow projects to quickly progress beyond the early (basic science) phases. On the other hand, clinical findings may result in cellular and molecular research and direct route connections. Diseases without effective treatments might thus be quickly exposed to drug-purposing         initiatives ^38-41.

The Target Focus:

Targets that are nodalpoints in general systems, such as cell division, autophagy, apoptosis, and metabolism, can be therapeutically manipulated for a range of sometimes clinically diverse results. Understanding pathway interdependencies and shunts, as well as the clinical implications of modulated therapeutic perturbations for such targets, requires close, effective collaboration between basic scientists, clinicians, and pharmaceutical scientists. Strict requirements must be met before a new medication may be put on the market ⁴².

Suggestions for Repurposing Drugs:

We close by offering six suggestions to assist achieve the full potential of medication repurposing, keeping in mind the opportunities and difficulties for this process that were previously mentioned.  First, improved data analysis integrative platforms are required. It is evident how big data might help identify prospects for repurposing. Data integration and access, especially for clinical data (such as physician notes in patient case records), continue to be a barrier. Advanced technology solutions are required to lessen the requirement for formal curation and to assist integrate various forms of genomic data (BOX 5) so that more "non-experts" may do more detailed and user-friendly analysis of subsequent data.

Second, there has to be better access to preclinical and clinical chemicals produced by the industry. Although the MRC and NIH-NCATS programs are a positive start, more chemicals should be made available to university researchers, preferably in well-stocked libraries. Simplifying the procedures is also necessary, particularly when it comes to material transfer agreements, signatures, and compound dissemination.

Third, more information from phase II–IV clinical studies financed by the industry has to be made available. This might enable other researchers to go through the data for fresh insights that might lead to prospects for repurposing, especially for programs that have been stopped⁴².

Fourth, more recent safety risks associated with repurposed medications should be investigated. The search for any additional safety issues related to repurposed medications is still ongoing. These might occur from changes in the dose pattern (e.g., chronic instead of intermittent dosing), usage in new populations, or novel interactions between the medicine and the condition for which it is repurposed⁴³. 

Fifth, more funding options are needed for medication repurposing projects in general, such as financing suitable technologies, facilitating compound access, and exchanging drug repurposing libraries. Innovative financing sources, such crowd-sourcing and parent entrepreneurs, are also required for medication repurposing activities, particularly in uncommon illnesses^44-45.

CONCLUSION:

Early periodenthusiasm in academic drug development is increasingly giving way to the informed reality of therapeutically useful treatments practice in the burgeoning field. The benefits of doing research in an integrated setting are substantial. The results of such undertakings are also hampered by risks related to inexperience with, for instance, dosage and IP. More ambitious adjustments may help create international drug approval methods, databases, and systems that facilitate the sharing of precompetitive information to lower failure risk. Drug repurposing is emerging as a possible alternative to traditional drug research because of its greater failure rates and high cost and time requirements. Patients and the healthcare system as a whole eventually gain from drug repurposing since it makes it easier to find new uses for existing medications in shorter amounts of time, while also being cost-effective and lowering attrition rates. The development of treatments must be done in parallel with the growing number of viral illnesses that are being discovered every day.

Repurposing FDA-approved medications is a crucial strategy to combat the coronavirus outbreak, using safe medications with established safety profiles. The right delivery mechanism and route must be chosen to reduce dosage and distribute repurposed medications locally. To address dosage and safety concerns, toxicology and pharmaceutical sciences must be integrated. Cooperation between researchers on medication repurposing, drug delivery methods, and inhaler devices is crucial for treating illnesses caused by viruses like SARS-CoV-2. Strategic drug repositioning has led to innovation, as it reduces R&D costs, increases success rates, shortens research time, and reduces investment risk. This approach benefits discovery scientists, drug researchers, consumers, and pharmaceutical corporations by enabling the adoption of innovative repositioning strategies for various human illnesses.

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Received on 10.09.2025      Revised on 14.10.2025

Accepted on 12.11.2025   Published on 12.02.2026

Available online from February 14, 2026

Res.J. Pharmacology and Pharmacodynamics.2026;18(1):59-64.

DOI: 10.52711/2321-5836.2026.00007

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