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Drug Development Process

Developing a new drug is a complicated and expensive process that can take many years. This process can be daunting for families who are counting every minute, but there are many drugs in development for Duchenne now that are pretty far along in this process already (see our Therapeutic Pipeline section)—we are not starting from scratch in every case.

The information in this section is designed to provide you with a framework by which to understand the different stages of drug development. This is not meant to be a comprehensive explanation, but rather a jumping off point. Additional references are provided at the end if you would like to learn more.

In this section

Basic Research
Proof-of-Concept
Preclinical Development
Phase I: The "Normal Human" Study
Phase II: Safety and Efficacy
Phase III: Efficacy
Post-marketing Surveillance
Expanded Access

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