PeptideScanner

Setmelanotide official document review · version 1

This page preserves this version's findings, scope and source pins. Open the current profile →

Inside the official reviews

Reviewed 2026-09-19 · Preserved version 1

Small, genetically defined study populations

The 2020 FDA review reports at least 10% weight loss at one year in 8 of 10 participants with POMC/PCSK1 deficiency and 5 of 11 with LEPR deficiency. These small groups and their wide confidence intervals limit precision; the findings are not estimates for general obesity. FDA PDF pp. 20 ↗

More findings, study links and document coverage

Withdrawal evidence is not a year-long placebo comparison

The studies were mainly open-label. An initial-response requirement selected participants for a short blinded withdrawal period. FDA’s full-analysis estimates also included early nonresponders, avoiding the larger effects obtained from a responder-enriched subset. FDA PDF pp. 4, 20, 21 ↗

Hunger findings were less secure than weight findings

FDA considered the hunger results suggestive but insufficient to establish substantial evidence of an effect. The review cites subjective assessment, open-label expectations, missing data and limitations of the measurement instruments. FDA PDF pp. 5 ↗

Keep the original indication separate from later expansions

This reading covers the original POMC/PCSK1 and LEPR submission, not every subsequently approved population. Its small safety database also limits conclusions about uncommon or long-term harms. FDA PDF pp. 2, 5 ↗

Read the separate U.S. label account → Label version and indication scope are preserved there; these agency reviews describe their own dated evidence.

Document coverage

Selected sections read in 1 of 25 inventoried documents; 24 not yet reviewed. Reading selected sections does not establish complete appraisal of a document.

Selected English EMA PDFs from the retained September 15, 2026 title-matched document feed, plus independently retrieved FDA approval-package documents where listed. Candidate entries are not verified product/application matches. This is a bounded inventory, not a complete FDA, national or worldwide source search. EMA inventory source ↗

Inspect documents, application identities and source pins

Page references use one-based PDF file pages, which can differ from printed page numbers. Candidate feed associations are not verified application identities.

Remaining work

  • Appraise the later Bardet–Biedl syndrome and pediatric regulatory extensions separately.
  • Resolve the linked literature correction before treating the affected report as fully appraised.

Open versioned document coverage and study pins →

Public beta · Selective source coverageNot medical advice · No dosing or purchasing guidance