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# Peptide Clinical Pharmacology Guidance
- URL: https://www.fdaweb.com/peptide-clinical-pharmacology-guidance/
- Published: 2023-12-12T12:00:00.000Z
- Updated: 2026-09-14T14:18:23.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155974

FDA has published a draft guidance, *Clinical Pharmacology Considerations for Peptide Drug Products*, with recommendations to assist industry in developing peptide drug products. When finalized, the [document](https://downloads.regulations.gov/FDA-2023-D-3391-0028/attachment%5F1.pdf?ref=fdaweb.com) says, it will describe the agency’s current thinking about the impact of clinical pharmacology considerations, including hepatic impairment, drug-drug interactions, QTc prolongation risk, and immunogenicity risk on a peptide drug product’s pharmacokinetics, safety, and efficacy.

The guidance does not focus on the development of any particular peptide drug product, it says. Questions about regulatory requirements for a particular peptide drug product should be addressed to the appropriate review division, FDA says.