At a glance
- Tirzepatide is an FDA-approved drug, marketed as Mounjaro, Zepbound (first approval: May 13, 2022).
- PubMed lists 2,748 publications mentioning it, including 137 randomized controlled trials and 78 animal-only studies.
- ClinicalTrials.gov lists 312 registered studies testing it (208 active).
- FDA's adverse event system (FAERS) holds 160,934 reports mentioning it; 28,681 classified as serious. Reports do not prove causation.
Research topics
Most frequent MeSH subject headings in the latest PubMed records (English, as indexed).
Regulatory status
Drugs@FDA applications
| Application | Product | Status | First approval | Sponsor |
|---|---|---|---|---|
| NDA215866 | MOUNJARO, MOUNJARO (AUTOINJECTOR), MOUNJARO KWIKPEN | Approved, marketed | May 13, 2022 | ELI LILLY AND CO |
| NDA217806 | ZEPBOUND, ZEPBOUND (AUTOINJECTOR), ZEPBOUND KWIKPEN | Approved, marketed | November 8, 2023 | ELI LILLY AND CO |
Source: Drugs@FDA (openFDA) · verified October 30, 2026 · API query
FDA compounding safety list
Not on FDA's list of bulk drug substances that may present significant safety risks in compounding.
Source: FDA.gov — Category 2 bulk drug substances · verified October 30, 2026
Removal of a substance from a regulatory list does not mean it has been approved. A "research use only" label does not make a product safe or legal for human use.
Scientific publications
Counts are PubMed records that mention the peptide in the title or abstract. Categories overlap, and a mention is not the same as testing the peptide as a treatment. Each number opens the exact PubMed search. Effects seen in laboratory or animal studies may not occur in humans. A registered clinical trial does not show that a substance is effective or safe.
Latest publications
- Glucagon-Like Peptide-1 Analog-Type Amyloidosis: A Case Report and Review of the Literature.
- Perioperative management of patients taking GLP-1 receptor agonists: A comparative review of international clinical guidelines.
- Single or multiple nutritional hormone receptor modulators for chronic kidney disease.
- Combined time-restricted feeding and resistance training enhance tirzepatide-induced improvements in adiposity and whole-body insulin sensitivity in female mice.
- Early Treatment Trajectory and Long-Term Persistence to Semaglutide for Obesity: A Population-Based Cohort Study.
- Neuropsychiatric Safety of GLP-1 Receptor Agonists and Tirzepatide in Adults with Type 2 Diabetes Mellitus or Obesity.
- Comparative Effects of Pharmacological Treatment on Heart Failure with Mildly Reduced or Preserved Ejection Fraction: A Systematic Review and Network Meta-analysis of Randomized Controlled Trials.
- Comparative adverse-event reporting patterns of semaglutide and tirzepatide: a disproportionality analysis of FAERS.
- Estimating the population eligible for Medicare's obesity-coverage demonstration.
- Switching between semaglutide and tirzepatide in obesity Management: an expert-consensus framework for approximate clinical Efficacy-matched switching doses.
Source: PubMed (NCBI) · verified October 30, 2026
Clinical trials
- Registered
- 312
- Active
- 208
- With posted results
- 47
Conditions studied
Show 40 more studies
All 312 studies on ClinicalTrials.gov ↗
Source: ClinicalTrials.gov · verified October 30, 2026
Adverse event reports
- Reports
- 160,934
- Serious
- 28,681
- With death outcome
- 900
Most reported reactions
Adverse event reports do not prove that the substance caused these effects. Side effects not listed here may still occur. Reaction terms are MedDRA terms as reported to FAERS.
Source: FDA FAERS (FAERS data as of July 30, 2026) · verified October 30, 2026 · API query
FDA prescribing information
Official US prescribing information. Dosing sections are intentionally not shown.
Original FDA text (English) WARNING: RISK OF THYROID C-CELL TUMORS In rats, tirzepatide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures. It is unknown whether ZEPBOUND causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as human relevance of tirzepatide-induced rodent thyroid C-cell tumors has not been determined [see Warnings and Precautions ( 5.1 ) and Nonclinical Toxicology ( 13.1 )]. ZEPBOUND is contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) [see Contraindications ( 4 )] . Counsel patients regarding the potential risk for MTC with the use of ZEPBOUND and inform them of symptoms of thyroid tumors (e.g., a mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with ZEPBOUND [see Contraindications ( 4 ) and Warnings and Precautions ( 5.1 )]. WARNING: RISK OF THYROID C-CELL TUMORS See full prescribing information for complete boxed warning. In rats, tirzepatide causes thyroid C-cell tumors. It is unknown whether ZEPBOUND causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as the human relevance of tirzepatide-induced rodent thyroid C-cell tumors has not been determined ( 5.1 , 13.1 ). ZEPBOUND is contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk of MTC and symptoms of thyroid tumors ( 4 , 5.1 ). - Zepbound, ZEPBOUND, Zepbound KwikPen
- Mounjaro, Mounjaro KwikPen
- MOUNJARO
- MOUNJARO
- MOUNJARO
- MOUNJARO
- MOUNJARO
- MOUNJARO
Source: DailyMed / openFDA
Change history
No changes since monitoring began on October 30, 2026.