Tirzepatide

For type 2 diabetes mellitus. Sold as Mounjaro, Zepbound. Every FDA application for this active ingredient.

As of Nov 15, 2026, FDA lists 2 applications for Tirzepatide (sold as Mounjaro, Zepbound), first approved May 13, 2022, with 6 new uses approved and 0 published complete response letters.

First approved: May 13, 2022
Applications: 2
New uses approved: 6
Complete response letters: 0
Medicare spending, 2025: $15.1B
First approved in the EU: Sep 15, 2022
First approved in Japan: Sep 26, 2022

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name


Mounjaro	Part D	$14.1B	+122%	1,592,517
Zepbound	Part D	$1.04B	+267274%	160,298
Zepbound Kwikpen	Part D	$0K	New	0

What Pharmacies Pay

Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change

MOUNJARO 10 MG/0.5 ML PEN: $538.76 per MLBrand · +3% in a year
MOUNJARO 12.5 MG/0.5 ML PEN: $538.59 per MLBrand · +3% in a year
MOUNJARO 15 MG/0.5 ML PEN: $538.57 per MLBrand · +3% in a year
MOUNJARO 2.5 MG/0.5 ML PEN: $538.75 per MLBrand · +3% in a year
MOUNJARO 5 MG/0.5 ML PEN: $538.70 per MLBrand · +3% in a year
MOUNJARO 7.5 MG/0.5 ML PEN: $538.74 per MLBrand · +3% in a year
ZEPBOUND 10 MG/0.5 ML PEN: $526.07 per MLBrand · +0% in a year
ZEPBOUND 10 MG/DOSE (40 MG/2.4 ML) KWIKPEN: $281.78 per MLBrand · new this year
ZEPBOUND 12.5 MG/0.5 ML PEN: $525.83 per MLBrand · 0% in a year
ZEPBOUND 12.5 MG/DOSE (50 MG/2.4 ML) KWIKPEN: $282.23 per MLBrand · new this year
ZEPBOUND 15 MG/0.5 ML PEN: $525.93 per MLBrand · 0% in a year
ZEPBOUND 15 MG/DOSE (60 MG/2.4 ML) KWIKPEN: $281.68 per MLBrand · new this year

FDA Drug Safety Communications

3 communications since 2020 that name this drug; see all communications

Who Was in the Trials

7,769 participants in the largest population FDA reports for the May 13, 2022 approval, from FDA's Drug Trials Snapshot; see every snapshot

Women: 43%
65 and older: 32%
White: 74%
Black: 4%
Asian: 14%
Hispanic or Latino: 43%

Approvals in the EU (EMA)

First approved in the EU 4 months after the US. Centrally authorised medicines, matched by ingredient; see all EU approvals

Mounjaro, new substanceEli Lilly Nederland B.V. · Sep 15, 2022

Approvals in Japan (PMDA)

First approved in Japan 4 months after the US. PMDA's English list since 2008, matched by ingredient; see all Japanese approvals

Zepbound, new approvalDrugs with a new indication, a new dosage, and other characteristics for the treatment of obesity. · Eli Lilly Japan K.K. · Dec 27, 2024 · Review report
Mounjaro, new ingredientDrugs with a new active ingredient indicated for the treatment of type 2 diabetes mellitus. · Eli Lilly Japan K.K. · Sep 26, 2022

Clinical Trials

213 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


Breath Acetone During Tirzepatide Treatment and Resistance Training in Adults With ObesityObesity (Disorder) · Technical University of Munich	—	Not yet recruiting	Nov 12, 2026
Molecular and Microbiome Changes During Tirzepatide Treatment and Resistance Training in ObesityObesity (BMI Equal to or >30) · Technical University of Munich	—	Not yet recruiting	Nov 12, 2026
24-hour Clear Liquid Diet vs. Standard Fasting for Upper Gastrointestinal Endoscopy in Patients Taking Agonists of the GLP-1 ReceptorRetained Gastric Content, Delayed Gastric Emptying · Portuguese Oncology Institute, Coimbra	Not applicable	Not yet recruiting	Nov 10, 2026
Functional, Cognitive, and Behavioral Correlates of Resistance Training During Tirzepatide-Induced Weight LossObesity (Disorder) · Technical University of Munich	—	Not yet recruiting	Nov 10, 2026
Ocular Changes in Patients Using Tirzepatide or SemaglutideType 2 Diabetes Mellitus, Obesity · Istanbul University	—	Recruiting	Nov 9, 2026
Exercise and Protein to Reduce Muscle Loss During GLP-1-Based Treatment in Type 2 DiabetesType 2 Diabetes (T2DM), Obesity & Overweight · German Diabetes Center	Not applicable	Not yet recruiting	Nov 9, 2026
Changes in Body Composition Following Pharmacological Treatment for Obesity.Obesity (BMI Equal to or >30), Weight Regain After Bariatric Surgery · Hospital San Carlos, Madrid	—	Enrolling by invitation	Nov 2, 2026
Tirzepatide and Organ-specific Biological AgingLongevity, Preventive Medicine · Atria Research and Global Health Institute (ARGHI)	Phase 2	Enrolling by invitation	Oct 30, 2026

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


May 13, 2022	MounjaroNDA 215866 · New molecular entity	Eli Lilly And Co	12	Marketed
Nov 8, 2023	ZepboundNDA 217806 · New indication	Eli Lilly And Co	14	Marketed

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA