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Evidence profile · Metabolic & Body Composition

Tirzepatide

Tirzepatide is a dual GIP and GLP-1 receptor agonist. The FDA approved it on 13 May 2022.

EvidenceEstablishedRegulatoryFDA approvedWADANot prohibited

Checked by the PU Research editorial teamevidence-graded against primary sources. Last check: 23 July 2026. Sources: 2. Who checks this

01

Identity & Classification

Tirzepatide is a dual GIP and GLP-1 receptor agonist. The brand name Mounjaro covers diabetes. The brand name Zepbound covers obesity and obstructive sleep apnea. The FDA approved it on 13 May 2022 under NDA 215866.

02

Mechanism: How It Works

Tirzepatide binds and activates two receptors: the GIP receptor and the GLP-1 receptor.

It increases first-phase and second-phase insulin secretion. It decreases glucagon. Both effects depend on the glucose level. It slows gastric emptying.

The molecule carries a C20 fatty diacid. That group binds albumin.

03

Research Findings

Evidence tier: clinical.

SURPASS-2 enrolled 1,879 participants. At 40 weeks, tirzepatide 15 mg decreased HbA1c by 2.37%. Semaglutide 1 mg decreased HbA1c by 1.86%.

Body weight fell 11.2 kg in the tirzepatide 15 mg group. Body weight fell 5.7 kg in the semaglutide comparison group.

04

Reported Dosing & Delivery

Source: the FDA label.

  1. Start at 2.5 mg by subcutaneous injection, once each week.
  2. Increase to 5 mg after 4 weeks.
  3. Increase in 2.5 mg steps.
  4. The maximum adult dose is 15 mg each week.

Six strengths exist, from 2.5 mg to 15 mg. A prescriber controls the schedule.

05

Pharmacokinetics & Timing

Albumin binding makes the half-life long. One dose each week is enough. The label permits any time of day, with or without a meal.

06

Interactions & Combinations

Tirzepatide can decrease the effect of an oral hormonal contraceptive. Delayed gastric emptying causes this. The effect is largest after the first dose.

The label tells patients to use a non-oral method or a barrier method for 4 weeks after the start and after each dose increase.

The risk of low blood glucose increases with insulin or with a sulfonylurea.

Compare with Semaglutide and Retatrutide.

07

Safety & Contraindications

Boxed warning. Tirzepatide causes thyroid C-cell tumors in rats.

The label lists a contraindication for a history of medullary thyroid carcinoma (MTC). The label lists the same contraindication for multiple endocrine neoplasia syndrome type 2 (MEN 2).

Documented adverse events are pancreatitis, low blood glucose, acute kidney injury, hypersensitivity, gastrointestinal events, and gallbladder disease.

08

Monitoring & Biomarkers

  • HbA1c and glucose.
  • A gallbladder study, if a clinician suspects cholelithiasis.
09

Regulatory Status

The FDA approves tirzepatide. The EMA approves tirzepatide. WADA does not prohibit it.

See the regulatory tracker for the 503B bulks list proposal of 30 April 2026.

10

Works Cited

  1. 01FDA Prescribing Information, Mounjaro (NDA 215866). accessdata.fda.gov. View source →
  2. 02SURPASS-2 results, New England Journal of Medicine, as summarized in the FDA label documentation. View source →

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