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Diabetes and obesityDrug intelligence

Mounjaro

Tirzepatide

Dual GIP and GLP-1 receptor agonist. Developed by Eli Lilly. Clinical, regulatory, and source evidence are connected below.

Company
Eli Lilly
Target / MOA
GIPR · GLP-1R
Aliases
Mounjaro · Zepbound · LY3298176
Signals
25
Clinical trials
16
Approvals
1
Evidence sources
25

Latest signals

What changed

The three most recent source-backed changes linked to this drug.

clinical trialClinicalTrials.gov

A Study of a Weight Loss Intervention in People With Endometrial Cancer

EARLY/Phase 1 · ACTIVE_NOT_RECRUITING · Memorial Sloan Kettering Cancer Center

clinical trialClinicalTrials.gov

Real-World Outcomes of Tirzepatide in Pakistani Adults With Obesity, Prediabetes, and Type 2 Diabetes

N/A · NOT_YET_RECRUITING · Universiti Sains Malaysia

clinical trialClinicalTrials.gov

PROACT AYA: Preventing Overweight/Obesity-Associated Cardiotoxicity With Tirzepatide In Adolescent And Young Adult Cancer Survivors - A Phase 2 Single-Arm, Single-Center Feasibility Study

Phase 2 · RECRUITING · M.D. Anderson Cancer Center

Approved uses

What regulators have approved

The indications section of each current US label, word for word, and the EU summary of each authorised product. Official sources as of Oct 21, 2026.

United States (FDA label)

Mounjaro · NDA215866 · label version 40, effective Aug 27, 2026 · DailyMed

Label section 1

1 INDICATIONS AND USAGE MOUNJARO ® is indicated: • as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus. • to reduce the risk of major adverse cardiovascular (CV) events (CV death, non-fatal myocardial infarction (MI), or non-fatal stroke) in adults with type 2 diabetes mellitus who are at high risk for these events.

Zepbound · NDA217806 · label version 40, effective Aug 28, 2026 · DailyMed

Label section 1

1 INDICATIONS AND USAGE ZEPBOUND ® is indicated in combination with a reduced-calorie diet and increased physical activity: • to reduce excess body weight and maintain weight reduction long term in adults with obesity or adults with overweight in the presence of at least one weight-related comorbid condition. • to treat moderate to severe obstructive sleep apnea (OSA) in adults with obesity. Limitations of Use ZEPBOUND contains tirzepatide. Coadministration with other tirzepatide-containing products or with any glucagon-like peptide-1 (GLP-1) receptor agonist is not recommended.

European Union (EMA)

Mounjaro · EMEA/H/C/005620 · Authorised, authorised Sep 15, 2022 (Commission decision C(2022) 6727) · EPAR

Type 2 diabetes mellitus Mounjaro is indicated for the treatment of adults, adolescents and children aged 10 years and above with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise as monotherapy when metformin is considered inappropriate due to intolerance or contraindications in addition to other medicinal products for the treatment of diabetes. For study results with respect to combinations, effects on glycaemic control and the populations studied, see sections 4.4, 4.5 and 5.1. Weight management Mounjaro is indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management, including weight loss and weight maintenance, in adults with an initial Body Mass Index (BMI) of ≥ 30 kg/m2 (obesity) or ≥ 27 kg/m2 to < 30 kg/m2 (overweight) in the presence of at least one weight-related comorbid condition (e.g., hypertension, dyslipidaemia, obstructive sleep apnoea, cardiovascular disease, prediabetes, or type 2 diabetes mellitus). For trial results with respect to obstructive sleep apnoea (OSA) and heart failure with preserved ejection fraction (HFpEF), see section 5.1.

EMA's summary; the full indication is in the product information on the EPAR page.

Regulatory history

Approvals over time

US original approvals and efficacy supplements (new indications, populations or dosing) from Drugs@FDA; EU authorisations and CHMP opinions on extensions. Official sources as of Oct 21, 2026.

United States

NDA215866 · ELI LILLY AND CO · first approved May 13, 2022

3 efficacy supplements approved

NDA217806 · ELI LILLY AND CO · first approved Nov 8, 2023

3 efficacy supplements approved

European Union

  • Mounjaro: Authorised since Sep 15, 2022

Patents and exclusivity

What FDA lists (US)

Patents and exclusivity as FDA lists them in the Orange Book (drugs) and the Purple Book (biologics), with approved generics and biosimilars. Expired listings are not shown. Official sources as of Oct 21, 2026.

NDA215866 (Orange Book)

8 listed patents, latest expiry Dec 30, 2041
  • US 9474780 · expires May 13, 2036 · drug substance, drug product, U-4374
  • US 11357820 · expires Jun 14, 2039 · drug substance, drug product · listed for some products only: MOUNJARO (AUTOINJECTOR) 2.5MG/0.5ML (2.5MG/0.5ML), MOUNJARO (AUTOINJECTOR) 5MG/0.5ML (5MG/0.5ML), MOUNJARO (AUTOINJECTOR) 7.5MG/0.5ML (7.5MG/0.5ML), MOUNJARO (AUTOINJECTOR) 10MG/0.5ML (10MG/0.5ML), MOUNJARO (AUTOINJECTOR) 12.5MG/0.5ML (12.5MG/0.5ML), MOUNJARO (AUTOINJECTOR) 15MG/0.5ML (15MG/0.5ML), MOUNJARO 2.5MG/0.5ML (2.5MG/0.5ML), MOUNJARO 5MG/0.5ML (5MG/0.5ML), MOUNJARO 7.5MG/0.5ML (7.5MG/0.5ML), MOUNJARO 10MG/0.5ML (10MG/0.5ML), MOUNJARO 12.5MG/0.5ML (12.5MG/0.5ML), MOUNJARO 15MG/0.5ML (15MG/0.5ML)
  • US 12453755 · expires Jun 14, 2039 · U-4375, U-4376, U-4377, U-4378, U-4379, U-4380, U-4381, U-4382, U-4383, U-4384, U-4385, U-4386 · listed for some products only: MOUNJARO (AUTOINJECTOR) 2.5MG/0.5ML (2.5MG/0.5ML), MOUNJARO (AUTOINJECTOR) 5MG/0.5ML (5MG/0.5ML), MOUNJARO (AUTOINJECTOR) 7.5MG/0.5ML (7.5MG/0.5ML), MOUNJARO (AUTOINJECTOR) 10MG/0.5ML (10MG/0.5ML), MOUNJARO (AUTOINJECTOR) 12.5MG/0.5ML (12.5MG/0.5ML), MOUNJARO (AUTOINJECTOR) 15MG/0.5ML (15MG/0.5ML), MOUNJARO 2.5MG/0.5ML (2.5MG/0.5ML), MOUNJARO 5MG/0.5ML (5MG/0.5ML), MOUNJARO 7.5MG/0.5ML (7.5MG/0.5ML), MOUNJARO 10MG/0.5ML (10MG/0.5ML), MOUNJARO 12.5MG/0.5ML (12.5MG/0.5ML), MOUNJARO 15MG/0.5ML (15MG/0.5ML)
  • US 12453756 · expires Jun 14, 2039 · drug product · listed for some products only: MOUNJARO (AUTOINJECTOR) 2.5MG/0.5ML (2.5MG/0.5ML), MOUNJARO (AUTOINJECTOR) 5MG/0.5ML (5MG/0.5ML), MOUNJARO (AUTOINJECTOR) 7.5MG/0.5ML (7.5MG/0.5ML), MOUNJARO (AUTOINJECTOR) 10MG/0.5ML (10MG/0.5ML), MOUNJARO (AUTOINJECTOR) 12.5MG/0.5ML (12.5MG/0.5ML), MOUNJARO (AUTOINJECTOR) 15MG/0.5ML (15MG/0.5ML), MOUNJARO 2.5MG/0.5ML (2.5MG/0.5ML), MOUNJARO 5MG/0.5ML (5MG/0.5ML), MOUNJARO 7.5MG/0.5ML (7.5MG/0.5ML), MOUNJARO 10MG/0.5ML (10MG/0.5ML), MOUNJARO 12.5MG/0.5ML (12.5MG/0.5ML), MOUNJARO 15MG/0.5ML (15MG/0.5ML)
  • US 12629404 · expires Jun 14, 2039 · drug product, U-4533, U-4534 · listed for some products only: MOUNJARO (AUTOINJECTOR) 2.5MG/0.5ML (2.5MG/0.5ML), MOUNJARO (AUTOINJECTOR) 5MG/0.5ML (5MG/0.5ML), MOUNJARO (AUTOINJECTOR) 7.5MG/0.5ML (7.5MG/0.5ML), MOUNJARO (AUTOINJECTOR) 10MG/0.5ML (10MG/0.5ML), MOUNJARO (AUTOINJECTOR) 12.5MG/0.5ML (12.5MG/0.5ML), MOUNJARO (AUTOINJECTOR) 15MG/0.5ML (15MG/0.5ML), MOUNJARO 2.5MG/0.5ML (2.5MG/0.5ML), MOUNJARO 5MG/0.5ML (5MG/0.5ML), MOUNJARO 7.5MG/0.5ML (7.5MG/0.5ML), MOUNJARO 10MG/0.5ML (10MG/0.5ML), MOUNJARO 12.5MG/0.5ML (12.5MG/0.5ML), MOUNJARO 15MG/0.5ML (15MG/0.5ML)
  • US 12343382 · expires Jul 22, 2039 · U-4229, U-4400, U-4232, U-4401, U-4230, U-4231
  • US 12616740 · expires Jul 22, 2039 · U-4500, U-4501, U-4502
  • US 12295987 · expires Dec 30, 2041 · U-4192, U-4193

Exclusivity: NCE until May 13, 2027; NPP until Dec 19, 2028 (some products only: MOUNJARO (AUTOINJECTOR) 2.5MG/0.5ML (2.5MG/0.5ML), MOUNJARO (AUTOINJECTOR) 5MG/0.5ML (5MG/0.5ML), MOUNJARO (AUTOINJECTOR) 7.5MG/0.5ML (7.5MG/0.5ML), MOUNJARO (AUTOINJECTOR) 10MG/0.5ML (10MG/0.5ML), MOUNJARO 2.5MG/0.5ML (2.5MG/0.5ML), MOUNJARO 5MG/0.5ML (5MG/0.5ML), MOUNJARO 7.5MG/0.5ML (7.5MG/0.5ML), MOUNJARO 10MG/0.5ML (10MG/0.5ML), MOUNJARO 10MG/2.4ML (4.17MG/ML), MOUNJARO 20MG/2.4ML (8.33MG/ML), MOUNJARO 30MG/2.4ML (12.5MG/ML), MOUNJARO 40MG/2.4ML (16.7MG/ML), MOUNJARO 50MG/2.4ML (20.8MG/ML), MOUNJARO 60MG/2.4ML (25MG/ML), MOUNJARO KWIKPEN 10MG/2.4ML (4.17MG/ML), MOUNJARO KWIKPEN 20MG/2.4ML (8.33MG/ML), MOUNJARO KWIKPEN 30MG/2.4ML (12.5MG/ML), MOUNJARO KWIKPEN 40MG/2.4ML (16.7MG/ML)) · Orange Book entry

NDA217806 (Orange Book)

8 listed patents, latest expiry Jul 22, 2039
  • US 9474780 · expires May 13, 2036 · drug substance, drug product
  • US 11357820 · expires Jun 14, 2039 · drug product · listed for some products only: ZEPBOUND (AUTOINJECTOR) 2.5MG/0.5ML (2.5MG/0.5ML), ZEPBOUND (AUTOINJECTOR) 5MG/0.5ML (5MG/0.5ML), ZEPBOUND (AUTOINJECTOR) 7.5MG/0.5ML (7.5MG/0.5ML), ZEPBOUND (AUTOINJECTOR) 10MG/0.5ML (10MG/0.5ML), ZEPBOUND (AUTOINJECTOR) 12.5MG/0.5ML (12.5MG/0.5ML), ZEPBOUND (AUTOINJECTOR) 15MG/0.5ML (15MG/0.5ML), ZEPBOUND 2.5MG/0.5ML (2.5MG/0.5ML), ZEPBOUND 5MG/0.5ML (5MG/0.5ML), ZEPBOUND 7.5MG/0.5ML (7.5MG/0.5ML), ZEPBOUND 10MG/0.5ML (10MG/0.5ML), ZEPBOUND 12.5MG/0.5ML (12.5MG/0.5ML), ZEPBOUND 15MG/0.5ML (15MG/0.5ML)
  • US 11918623 · expires Jun 14, 2039 · U-3855 · listed for some products only: ZEPBOUND (AUTOINJECTOR) 2.5MG/0.5ML (2.5MG/0.5ML), ZEPBOUND (AUTOINJECTOR) 5MG/0.5ML (5MG/0.5ML), ZEPBOUND (AUTOINJECTOR) 7.5MG/0.5ML (7.5MG/0.5ML), ZEPBOUND (AUTOINJECTOR) 10MG/0.5ML (10MG/0.5ML), ZEPBOUND (AUTOINJECTOR) 12.5MG/0.5ML (12.5MG/0.5ML), ZEPBOUND (AUTOINJECTOR) 15MG/0.5ML (15MG/0.5ML), ZEPBOUND 2.5MG/0.5ML (2.5MG/0.5ML), ZEPBOUND 5MG/0.5ML (5MG/0.5ML), ZEPBOUND 7.5MG/0.5ML (7.5MG/0.5ML), ZEPBOUND 10MG/0.5ML (10MG/0.5ML), ZEPBOUND 12.5MG/0.5ML (12.5MG/0.5ML), ZEPBOUND 15MG/0.5ML (15MG/0.5ML)
  • US 12453756 · expires Jun 14, 2039 · drug product · listed for some products only: ZEPBOUND (AUTOINJECTOR) 2.5MG/0.5ML (2.5MG/0.5ML), ZEPBOUND (AUTOINJECTOR) 5MG/0.5ML (5MG/0.5ML), ZEPBOUND (AUTOINJECTOR) 7.5MG/0.5ML (7.5MG/0.5ML), ZEPBOUND (AUTOINJECTOR) 10MG/0.5ML (10MG/0.5ML), ZEPBOUND (AUTOINJECTOR) 12.5MG/0.5ML (12.5MG/0.5ML), ZEPBOUND (AUTOINJECTOR) 15MG/0.5ML (15MG/0.5ML), ZEPBOUND 2.5MG/0.5ML (2.5MG/0.5ML), ZEPBOUND 5MG/0.5ML (5MG/0.5ML), ZEPBOUND 7.5MG/0.5ML (7.5MG/0.5ML), ZEPBOUND 10MG/0.5ML (10MG/0.5ML), ZEPBOUND 12.5MG/0.5ML (12.5MG/0.5ML), ZEPBOUND 15MG/0.5ML (15MG/0.5ML)
  • US 12629404 · expires Jun 14, 2039 · drug product, U-4531, U-4532 · listed for some products only: ZEPBOUND (AUTOINJECTOR) 2.5MG/0.5ML (2.5MG/0.5ML), ZEPBOUND (AUTOINJECTOR) 5MG/0.5ML (5MG/0.5ML), ZEPBOUND (AUTOINJECTOR) 7.5MG/0.5ML (7.5MG/0.5ML), ZEPBOUND (AUTOINJECTOR) 10MG/0.5ML (10MG/0.5ML), ZEPBOUND (AUTOINJECTOR) 12.5MG/0.5ML (12.5MG/0.5ML), ZEPBOUND (AUTOINJECTOR) 15MG/0.5ML (15MG/0.5ML), ZEPBOUND 2.5MG/0.5ML (2.5MG/0.5ML), ZEPBOUND 5MG/0.5ML (5MG/0.5ML), ZEPBOUND 7.5MG/0.5ML (7.5MG/0.5ML), ZEPBOUND 10MG/0.5ML (10MG/0.5ML), ZEPBOUND 12.5MG/0.5ML (12.5MG/0.5ML), ZEPBOUND 15MG/0.5ML (15MG/0.5ML)
  • US 12343382 · expires Jul 22, 2039 · U-4409, U-4228, U-4227, U-4410
  • US 12453758 · expires Jul 22, 2039 · U-4310, U-4309, U-4308, U-4311
  • US 12616740 · expires Jul 22, 2039 · U-4497, U-4498, U-4499

Exclusivity: NP until Nov 8, 2026 (some products only: ZEPBOUND (AUTOINJECTOR) 2.5MG/0.5ML (2.5MG/0.5ML), ZEPBOUND (AUTOINJECTOR) 5MG/0.5ML (5MG/0.5ML), ZEPBOUND (AUTOINJECTOR) 7.5MG/0.5ML (7.5MG/0.5ML), ZEPBOUND (AUTOINJECTOR) 10MG/0.5ML (10MG/0.5ML), ZEPBOUND (AUTOINJECTOR) 12.5MG/0.5ML (12.5MG/0.5ML), ZEPBOUND (AUTOINJECTOR) 15MG/0.5ML (15MG/0.5ML)); NCE until May 13, 2027; M-82 until Oct 18, 2027; I-958 until Dec 20, 2027 · Orange Book entry

Generics and biosimilars

The Orange Book lists no approved generic (ANDA).

FDA's listings only: an approved generic or licensed biosimilar may not be on the market yet. Not a forecast of when they may launch, and not legal advice.

Safety

Boxed warnings and FDA safety communications

The boxed warning on each current US label, and FDA Drug Safety Communications that name the drug (FDA's list from January 2020). Official sources as of Oct 21, 2026.

Boxed warning

Mounjaro label

WARNING: RISK OF THYROID C-CELL TUMORS • In both male and female rats, tirzepatide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures. It is unknown whether MOUNJARO 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 )]. • MOUNJARO 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 MOUNJARO 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 MOUNJARO [see Contraindications ( 4 ) and Warnings and Precautions ( 5.1 )].

Zepbound label

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 )].

FDA Drug Safety Communications

None on FDA's list names this drug.

Clinical trials

Key active studies

A focused view of recently updated studies · 16 linked records.

EARLY/Phase 1ACTIVE NOT RECRUITINGNCT06751589

A Study of a Weight Loss Intervention in People With Endometrial Cancer

Memorial Sloan Kettering Cancer Center · Updated Oct 21, 2026

N/ANOT YET RECRUITINGNCT07809568

Real-World Outcomes of Tirzepatide in Pakistani Adults With Obesity, Prediabetes, and Type 2 Diabetes

Universiti Sains Malaysia · Updated Oct 20, 2026

Phase 2RECRUITINGNCT07874828

PROACT AYA: Preventing Overweight/Obesity-Associated Cardiotoxicity With Tirzepatide In Adolescent And Young Adult Cancer Survivors - A Phase 2 Single-Arm, Single-Center Feasibility Study

M.D. Anderson Cancer Center · Updated Oct 20, 2026

Phase 4RECRUITINGNCT07777575

Resistance Training to Prevent Muscle Loss During Treatment With Tirzepatide

Technical University of Munich · Updated Oct 20, 2026

NARECRUITINGNCT07574723

Tirzepatide Titration to Reduce Side Effects in Individuals With Obesity

Dasman Diabetes Institute · Updated Oct 20, 2026

Phase 3NOT YET RECRUITINGNCT07881458

A Study of EloraTZP in Adult Participants With Obesity or Overweight and Type 2 Diabetes

Eli Lilly and Company · Updated Oct 19, 2026

Regulatory timeline

Approvals and agency activity

Verified regulatory records in reverse chronological order.

MOUNJARO

Human medicines European public assessment report (EPAR): Mounjaro, tirzepatide, Date of authorisation: 15/09/2022, Revision: 22, Status: Authorised

Wegovy and Mounjaro for weight loss not funded

Drug label update: MOUNJARO

DHPC – Mounjaro KwikPen (tirzepatidum)

Source evidence

Where this profile comes from

Facts link back to original registries, regulators, labels, and publishers. Counts change as source records update.

ClinicalTrials.govofficial · Latest Oct 21, 202620FDAofficial · Latest Aug 27, 20261EMA Human Medicinesofficial · Latest Oct 8, 20261Pharmac New Zealandofficial · Latest Sep 9, 20261openFDA Drug Labelsofficial · Latest Jul 29, 20261Swissmedic - Medical Devices & SaMDofficial · Latest Date unavailable1
Professional referenceThis profile summarizes linked public evidence. It is not medical, legal, regulatory, or investment advice. Verify decisions against original sources.