cagrilintide trial Scorecard: REDEFINE 1 and 2 In the REDEFINE 1 phase

We provide realistic expectations based on current understanding of peptide therapy

Sections 503A and 503B of the FD&C Act allow pharmacies and registered outsourcing facilities (facilities registered with the FDA under Section 503B that may compound larger volumes of drugs without individual patient prescriptions), respectively, to compound customized medications but not copies of commercially available drugs, unless those drugs are on the FDAs shortage list (a publicly available, regularly updated database identifying drugs whose national supply cannot meet current demand)

The prototype drug could not be detected 4 h after administration, and its elimination half-life was less than 30 min

Manufacturers sell them to individuals without requiring prescriptions