MOLRECORD
Compound record · Metabolic

Tirzepatide

A dual GIP and GLP-1 receptor agonist approved for type 2 diabetes and weight management.

  • EVIDENCE · APPROVED INDICATION
  • HUMAN RCTs · LARGE PROGRAMME
  • REGULATORY · 503B EXCLUSION PROPOSED APR 2026
ENTRIES
2
REVIEWED
5 Oct 2026
Specimen · reference label · hover to turn
The Tirzepatide reference label, laid flat
Specimen label · as wrapped on the vial aboveReference artwork · not packaging

WHERE THE EVIDENCE STANDS

Tirzepatide's pivotal programme reported weight reduction of about 22.5 % at 72 weeks in its first obesity trial, a benchmark the retatrutide programme is now compared against. A head-to-head Phase 3 trial of retatrutide versus tirzepatide (TRIUMPH-5) is active.

The 30 April 2026 FDA proposal to exclude tirzepatide from the 503B bulks list follows more than 320 adverse-event reports tied to compounded versions, according to reporting on the proposal.

ENTRIES ABOUT Tirzepatide · 2

Mar – Jun 2026
PAPER
What GLP-1 users do differently: activity, bone and persistence

Reports in 2026 describe falling physical activity among people on GLP-1 drugs, claims-data signals on bone and joint conditions with long-term use, and one-year persistence nearly doubling since 2021.

30 Apr 2026
REGULATION
FDA proposes to end 503B compounding of semaglutide, tirzepatide and liraglutide

A 30 April 2026 proposal would exclude the three GLP-1 drugs from the 503B bulks list, closing the outsourcing-facility route that opened during the shortage years.

SOURCES

  1. Drug Discovery News. GLP-1 agonist clinical pipeline 2026. 26 Jun 2026. News feature. https://www.drugdiscoverynews.com/glp-1-agonist-clinical-pipeline-2026-semaglutide-tirzepatide-and-what-s-in-phase-2-17286
  2. AJMC. Peptide regulation debate intensifies after FDA advisory panel's controversial vote. 25 Sep 2026. News feature. https://www.ajmc.com/view/peptide-regulation-debate-intensifies-after-fda-advisory-panel-s-controversial-vote

REVIEWED 5 Oct 2026 · NEXT REVIEW JAN 2027 · CORRECTIONS ARE LOGGED HERE