PeptideAmerica

GLP-1 receptor agonists

Tirzepatide

Mounjaro; Zepbound

US status
FDA-approved
Class
GLP-1 receptor agonists
Approved product
Mounjaro, Zepbound
Route
Subcutaneous injection

Regulatory record

April 2026
FDA proposes excluding tirzepatide from the 503B bulks list; the lawful remainder is patient-specific 503A compounding with documented clinical need.

Status verified for this index · August 2026

Definition

Tirzepatide is a 39-amino-acid synthetic peptide that activates both the GIP and GLP-1 receptors, the first dual incretin agonist approved in the United States; it is marketed for type 2 diabetes and for chronic weight management.

Engaging two incretin receptors rather than one produces larger average weight reductions than GLP-1 agonism alone, at the cost of a similar gastrointestinal tolerability profile.

Evidence

In SURMOUNT-1, 2,539 adults with obesity received weekly tirzepatide or placebo for 72 weeks; mean weight change was −15.0 percent at 5 mg, −19.5 percent at 10 mg, and −20.9 percent at 15 mg, against −3.1 percent with placebo [1].

As with semaglutide, the open questions are durability and long-term safety in broad use; efficacy against placebo is settled.

Lawful access

The approved products are the lawful supply route. The FDA declared the tirzepatide shortage resolved in October 2024, ending shortage-based compounding; the April 2026 proposal to exclude it from the 503B bulks list closes the outsourcing route, and patient-specific 503A compounding requires documented clinical need [2].

Telehealth programs in the supply panel provide prescriber-led GLP-1 treatment; molecule and formulation vary by provider and should be confirmed on the provider's own site.

References

  1. Jastreboff AM, Aronne LJ, Ahmad NN, et al. Tirzepatide once weekly for the treatment of obesity. N Engl J Med. 2022;387(3):205–216. PMID 35658024
  2. Orrick. FDA moves to shut the door on large-scale compounding of GLP-1 drugs. May 2026. Source