ProRelix Research is also a leader in drug repurposing clinical trials—a strategic and efficient approach to bring existing compounds to new indications. By leveraging existing data and known safety profiles, we significantly reduce the time and cost associated with the development process.
What is Drug Repurposing?
Drug repurposing (also known as repositioning) identifies new therapeutic uses for already approved or investigational drugs. These drugs may have failed in their original indication or proven effective in new off-label settings.
Regulatory Pathway: 505(b)(2) : We specialize in 505(b)(2) regulatory submission services, which allow sponsors to reference previously submitted safety and efficacy data, bypassing redundant studies. This route expedites time-to-market while maintaining scientific and ethical standards.
Benefits of Drug Repurposing
- Lower development costs
Shorter timelines
Known manufacturing processes
Existing safety profiles
Potential for orphan drug or fast-track designation
A notable example of drug repurposing occurred during the COVID-19 pandemic, when COVID-19 drug repurposing example like remdesivir (originally for Ebola) was quickly adapted for SARS-CoV-2.
Our CRO Services for Repurposed Drugs
Regulatory and Scientific Strategy
We perform thorough literature reviews and data mining to build a strong case for new indications. Our team identifies what data can be referenced and where additional studies are required.
Bridging Study Development
If the drug is used in a new population or formulation, we help design bridging studies for repurposed drugs to demonstrate equivalence or new safety/efficacy profiles.
Clinical Trial Support
We provide support for clinical trial support for new indications through protocol development, site qualification, ethics submissions, and patient engagement plans.
Pharmacovigilance and Monitoring
We monitor ongoing safety and efficacy signals, reporting findings as per global standards. We ensure full compliance with pharmacovigilance requirements during and after trial phases.
Data Compilation and NDA Preparation
We consolidate new clinical data with historical studies and submit complete 505(b)(2) applications for market authorization.
Why ProRelix Research?
Extensive experience with repurposed drug trials
Familiarity with global regulatory expectations
Proven track record in expedited approvals
Advanced patient recruitment and monitoring systems
Transparent and cost-effective service delivery
We provide not just execution but also strategic consulting, helping you assess the viability of drug repurposing even before you commit to large investments.
Thinking of repurposing a drug for a new indication?
We can accelerate your drug repurposing clinical trials through our expert support and strategic solutions.
