DRUG REPOSITIONING

INTRODUCTION

Drug repositioning can be defined as a process of identification of new pharmacological indications

from old/existing/failed investigational/already marketed FDA approved drug/pro-drug and the
application of the newly developed drugs to the treatment of disease other than the drug’s original
intended therapeutic use.
SYNONYM TERM OF DRUG REPOSITIONING

• Drug repositioning: finding new uses outside the scope of the original medical indication for
existing drug or developing new indications for existing drug or biologics
• Drug repurposing: identification, developing and commercializing new uses for existing or
abandoned drugs.
• Drug reprofiling: reducing the risk and associated with drug development with the advantage
that the drug has already undergone preclinical and clinical testing.
• Drug reformulating: finding ways to modify a formulation to allow a drug to enter a new market.
• Drug rediscovery: investigating new uses for currently prescribe drugs.
 NEED OF DRUG REPOSITIONING
• Saving time: The duration of the discovery phase for a repurposed drug is shorter as safety and
toxicology studies have already been assessed in the original indication.
• Saving cost: It costs approximately US$300 Million to bring a repurposed drug to market
representing a saving of about 85% compared to the US$2.6 Billion for a new drug if the cost of
failed projects is taken into account.
• Other reasons:
• Significant number of drugs are repurposed for rare diseases which attracts many developers due
to the incentives.
• FDA and EMA offend provide incentives in such situations.
• In addition to a lower cost of clinical trials and a shorter development time, drug repurposing is
associated with a higher success rate from Phase I to launch.
 DRUG REPURPOSING STARTS WITH:

• 1.Collection of raw data related to disease-drug-targets

• 2.Establishment of drug-target-disease relationship
• 3.Support of potential evidence
• 4.in silico screening techniques
• 5.Generation of proof of concept
• 6.Generation of experimental evidence
• 7.Further the shortlisted compounds pass through clinical trials
• 8.FDA approval
• 9.Successful repositioning of drug
CHALLENGES AND OPPORTUNITIES

• Optimization of inclusion and exclusion criteria in selection of target population

• Achievement within timeline
• Requirement for robust evidence
• Lack of funding to commercialize the product
• Clinical trial feasibility for rare diseases
• Technical challenges to repurposing drugs
• Novelty in repurposing
FEW LATEST DRUG REPOSITIONING
EXAMPLES:
 CONCLUSION

• Drug discovery and development is a costly, complex, and time-consuming process, often taking
14 to 20 years and $ 1 billion-plus in Research and Development costs, with no guarantee of
success. The use of drug repurposing such time- consuming and costly process that can be easy
to overcome.
• Apart from saving time this technique of drug use also favours the development of research for
academics, development of an academic institute-industry relationship.
• The most important advantage would be to the patient as the drug availability for new disease
would be quicker, relieving him of disease- related suffering
THANK YOU