GLP-1ApprovedEvidence tier: Human RCT

Tirzepatide

Last updated October 21, 2026. Approval line checked October 21, 2026. No compounding source date is assigned.

Quick answer

Tirzepatide (Zepbound) is approved for chronic weight management. On December 20, 2024, the FDA also approved it for moderate to severe obstructive sleep apnea in adults with obesity.

FDA status: Zepbound approved November 8, 2023, for chronic weight management. Source: FDA .

Last reviewed November 1, 2026 by the PeptideX team. Educational info, not medical advice. PeptideX doesn't give dosing advice. Talk to a licensed clinician.

FDA status

Approved

Approved. FDA-approved drug products containing tirzepatide include Zepbound (chronic weight management; obstructive sleep apnea with obesity) and Mounjaro (type 2 diabetes). Approval is specific to the product, indication, and route.

Drugs@FDA: Zepbound (NDA 217806)

Evidence tier

Human RCT. The tier is the highest indexed study type. It is not a safety rating and it is not an FDA approval. Confidence score 5/5. 2,100 PubMed citations indexed.

Products sold as "research use only" are not approved for human use. FDA warning.

Tirzepatide in the literature

Dual GLP-1 and GIP receptor agonist producing superior weight loss to single GLP-1 agonists; GIP activation adds complementary metabolic and adipose tissue effects.

What the literature studies

Dual GLP-1/GIP Agonist

Evidence tier

Human RCT

Compounding record

Status not verified

Confidence
5/5

Regulatory record

Status not verified. No product-specific FDA primary source is recorded for this entry. FDA approval and compounding eligibility are not verified. Research information is not evidence of FDA approval. Approval, where applicable, is specific to a drug product, indication and route. Research information is not evidence of FDA approval. Approval, where applicable, is specific to a drug product, indication and route.

Regulatory source not verified; no checked date is assigned.

Regulatory context and verification limits are documented below.

Questions

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Educational only. Not medical advice. This page does not give doses or sourcing. See the medical and editorial disclaimer.

Short answer

Tirzepatide is an FDA-approved weekly GIP/GLP-1 agonist (Mounjaro for type 2 diabetes, Zepbound for obesity and sleep apnea) that produced about 21% average weight loss at the top dose in SURMOUNT-1.

What it is

A dual GIP and GLP-1 receptor agonist peptide made by Eli Lilly [R1].

Legal / FDA status (as of Oct 27 2026)

  • Mounjaro approved May 13 2022 (T2D) [R2]; Zepbound approved Nov 8 2023 (chronic weight management) [R8] and Dec 20 2024 (moderate-to-severe obstructive sleep apnea with obesity) [R3][R4].
  • FDA declared the tirzepatide shortage resolved on Dec 19 2024 [R5].

Human evidence

  • SURMOUNT-1 (72 wk): -20.9% at 15 mg vs -3.1% placebo [R1].
  • SURMOUNT-5: tirzepatide beat semaglutide head-to-head (-20.2% vs -13.7%) [R6].

Animal / lab evidence

Not needed to judge efficacy; large human RCTs exist. Rodent thyroid C-cell tumors led to a boxed warning [R3].

Risks and unknowns

Zepbound label: boxed warning for thyroid C-cell tumors seen in rats; warnings include severe GI reactions, acute kidney injury from volume depletion and acute gallbladder disease [R3]. Weight regain after stopping (SURMOUNT-4) [R7].

What's coming

Lilly reports Q3 2026 results Oct 29 2026 (re-check this page then).

Sources

  1. [R1] Jastreboff AM et al. Tirzepatide once weekly for the treatment of obesity. NEJM 2022;387:205-216. doi:10.1056/NEJMoa2206038
  2. [R2] FDA approval package, Mounjaro NDA 215866 (approved May 13 2022). https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/215866Orig1s000Approv.pdf
  3. [R3] Zepbound prescribing information (openFDA label, effective Aug 28 2026). https://dailymed.nlm.nih.gov/dailymed/search.cfm?query=zepbound
  4. [R4] FDA. FDA approves first medication for obstructive sleep apnea. Dec 20 2024. https://www.fda.gov/news-events/press-announcements/fda-approves-first-medication-obstructive-sleep-apnea
  5. [R5] FDA. Declaratory order: Resolution of shortages of tirzepatide injection products. Dec 19 2024. https://www.fda.gov/media/184606/download
  6. [R8] FDA. FDA approves new medication for chronic weight management. Nov 8 2023. https://www.fda.gov/news-events/press-announcements/fda-approves-new-medication-chronic-weight-management
  7. [R6] Aronne LJ et al. Tirzepatide as compared with semaglutide for the treatment of obesity. NEJM 2025. doi:10.1056/NEJMoa2416394
  8. [R7] Aronne LJ et al. SURMOUNT-4. JAMA 2024;331:38-48. doi:10.1001/jama.2023.24945

Last checked 2026-10-27

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