Approved Drug
A pharmaceutical compound that has successfully completed clinical trials and received marketing authorisation from at least one major regulatory authority. Approved drugs have demonstrated safety and efficacy in human clinical trials. PeptideTrace tracks 73 approved peptide compounds across multiple jurisdictions.
Technical Context
Approved drug status means: completed Phase I-III clinical trial programme, met safety and efficacy standards established by the regulatory authority, received marketing authorisation (NDA/BLA approval in US, MA in EU, NOC in Canada), manufactured under cGMP conditions, subject to ongoing pharmacovigilance and post-marketing requirements, and covered by product liability regulations. The 73 approved peptide compounds tracked by PeptideTrace have varying evidence bases — from blockbusters with extensive trial programmes (semaglutide: >10 Phase III trials, >10,000 participants) to rare disease drugs with smaller programmes (vosoritide, trofinetide). Approval in one jurisdiction does not guarantee approval in others — regulatory standards, review timelines, and clinical data requirements differ.