EMA Approved Drug Library

EMA Approved Drug Library

New drug discovery is a highly resource-intensive, high-risk, and time-consuming endeavor. On average, it takes 10–15 years and costs several billion dollars to bring a novel therapeutic from target identification through lead optimization, preclinical studies, and multi-phase clinical trials. Moreover, the overall clinical failure rate exceeds 90%. Failures are particularly common in Phase II/III trials due to insufficient efficacy, safety concerns, or unfavorable pharmacokinetic properties—significantly limiting patient access to innovative therapies.
Against this backdrop, drug repurposing (also known as drug repositioning)—the strategy of identifying new therapeutic applications for already approved drugs beyond their original indications—has emerged as a key approach in modern drug development. Since these drugs have already undergone rigorous regulatory review, they possess well-established human safety profiles, favorable pharmacokinetic characteristics, and proven scalability in manufacturing. Repurposing them thus circumvents much of the uncertainty inherent in early-stage development and substantially accelerates translational success.
The EMA-Approved Drug Library contains 680 small-molecule compounds approved by the European Medicines Agency (EMA), spanning multiple therapeutic areas including oncology, cardiovascular diseases, neurological disorders, anti-infectives, immunomodulation, and endocrine/metabolic conditions. All compounds in the library have been clinically validated, with well-defined molecular targets, strong safety records, and good bioavailability—making them ideal candidates for drug repurposing. Leveraging this collection not only significantly enhances the likelihood of successful drug development but also shortens timelines and reduces overall R&D costs.

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