Semaglutides
FDA and regulation

Tirzepatide FDA Approval History: Mounjaro and Zepbound, Year by Year

The FDA approved tirzepatide as Mounjaro (NDA 215866) on May 13, 2022 for type 2 diabetes and as Zepbound (NDA 217806) on November 8, 2023 for weight management. Later approvals added sleep apnea (December 20, 2024), pediatric diabetes (December 19, 2025), and cardiovascular risk reduction (August 27, 2026).

Last checked ·25 sources cited·MounjaroZepbound
Two identical injection pens beside a glucose meter, a bathroom scale, an approval stamp, and documents.

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The FDA has approved tirzepatide twice, under two different brand names and two different application numbers. Mounjaro, application NDA 215866, was approved on May 13, 2022 as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes [1]. Zepbound, application NDA 217806, was approved on November 8, 2023 for chronic weight management in adults with obesity or overweight plus a weight-related condition [7]. Both are held by Eli Lilly and Company, and they are the only FDA-approved tirzepatide products [1][7][26].

Since those original approvals, the labels have grown through supplements (numbered S-001, S-002 and so on) that anyone can look up on the FDA’s Drugs@FDA site using the NDA number. The biggest additions: Zepbound gained an obstructive sleep apnea indication on December 20, 2024 [9][10], Mounjaro’s diabetes indication was expanded to children ages 10 and older on December 19, 2025 [13], and Mounjaro gained a cardiovascular risk indication on August 27, 2026 [17][18]. One requested indication, heart failure, was withdrawn by Lilly in May 2025 before a decision [16].

What is the full timeline at a glance?

DateProductApplication / supplementWhat the FDA approved
May 13, 2022MounjaroNDA 215866Original approval for glycemic control in adults with type 2 diabetes [1]
July 28, 2023MounjaroS-002, S-006Single-use glass vial presentation; anaphylaxis and angioedema added to labeling [5]
November 8, 2023ZepboundNDA 217806Original approval for chronic weight management in adults [7]
March 28, 2024Zepbound—Instructions for Use for the single-dose vial [8][20]
October 18, 2024ZepboundS-005, S-006, S-011, S-015, S-019GI warning retitle, SURMOUNT-3 and SURMOUNT-4 data, dysesthesia, indication edits, aspiration labeling [8]
November 1, 2024MounjaroS-010, S-015, S-022Severe GI reactions, dysgeusia, dysesthesia, aspiration labeling [6]
December 20, 2024ZepboundS-013New indication: moderate to severe obstructive sleep apnea in adults with obesity [9][10]
May 28, 2025MounjaroS-031Alopecia added to postmarketing experience; two 2022 Limitations of Use removed [11]
September 25, 2025MounjaroS-034Lactation section revised from breast milk study; PMR 4272-2 fulfilled [12]
December 19, 2025MounjaroS-039Indication expanded to pediatric patients 10 and older with type 2 diabetes [13]
January 7, 2026Mounjaro—Multi-dose vial Instructions for Use [14][17]
January 7, 2026Zepbound—2.4 mL multi-dose vial strengths, 10 to 60 mg [20]
January 20, 2026MounjaroS-009Mounjaro KwikPen, six presentations [14]
February 25, 2026ZepboundS-042Intestinal obstruction and severe constipation added; suicidal ideation section removed [15]
August 27, 2026MounjaroS-044, S-045New cardiovascular indication; 2.5 mg dose labeled for ongoing glycemic control [17]

Why are Mounjaro and Zepbound separate approvals for one drug?

Tirzepatide is a single molecule that acts as both a GIP (glucose-dependent insulinotropic polypeptide) receptor and GLP-1 (glucagon-like peptide-1) receptor agonist, given as a once-weekly injection [2][9]. The FDA approved it under two separate applications because the two brands carry different indications: Mounjaro for glycemic control in type 2 diabetes, and Zepbound for chronic weight management [1][7].

Both applications are held by Eli Lilly, and both drugs were initially approved as pre-filled single-dose pens [26]. Later supplements added vials and, in 2026, a KwikPen presentation for Mounjaro [5][14].

What did the original Mounjaro approval on May 13, 2022 cover?

Lilly’s new drug application for Mounjaro was dated September 14, 2021 and received by the FDA on September 15, 2021 [1]. The approval letter, signed by Lisa B. Yanoff on May 13, 2022, describes the indication as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [1]. The application was not referred to an FDA advisory committee, because the agency determined outside expertise was not necessary [1]. The expiry dating period was set at 24 months when stored at 2 to 8 °C [1].

The original label listed six strengths in a single-dose pen: 2.5, 5, 7.5, 10, 12.5, and 15 mg per 0.5 mL [2]. It carried a boxed warning that tirzepatide causes thyroid C-cell tumors in rats, and it contraindicated the drug in people with a personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia syndrome type 2 [2].

The 2022 label also included a Limitation of Use: Mounjaro was not indicated for type 1 diabetes [2]. That limitation was later removed, in May 2025 [11].

What postmarketing studies were attached in 2022?

The approval letter required three postmarketing studies [1]:

  • PMR 4271-1: a 30-week placebo-controlled study of Mounjaro in pediatric patients ages 10 to 17 with type 2 diabetes, followed by a 22-week open-label extension, with original study completion set for December 2027 [1].
  • PMR 4272-1: a medullary thyroid carcinoma registry-based case series of at least 15 years, with a final report due June 2040 [1].
  • PMR 4272-2: a milk-only lactation study measuring tirzepatide concentrations in breast milk [1].

Two of these have since been closed out. PMR 4272-2 was fulfilled as of the September 25, 2025 supplement [12], and PMR 4271-1 was fulfilled with the December 19, 2025 pediatric approval [13]. The MTC registry runs to 2040 [1].

What changed on the labels in 2023?

Mounjaro was added to the FDA’s drug shortage list in December 2022 [26]. On July 28, 2023, the FDA approved two Mounjaro supplements: S-002, which added a single-use glass vial presentation along with manufacturing, testing and packaging sites, and S-006, a Changes Being Effected supplement that added anaphylaxis and angioedema to sections 4, 5.4, 6.2 and 17 of the prescribing information [5].

Separately, on July 21, 2023, the FDA sent Lilly a Notification of Newly Identified Safety Signal regarding suicidal ideation for the GLP-1 receptor agonist class, of which Zepbound is a member [15]. That signal’s path through the labeling is traced below in the 2026 section.

What did the Zepbound approval on November 8, 2023 cover?

Lilly’s NDA for Zepbound was dated and received May 8, 2023, and the approval letter was signed by John M. Sharretts on November 8, 2023 [7]. The indication: an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with a BMI of 30 kg/m² or greater, or 27 kg/m² or greater with at least one weight-related comorbidity such as hypertension, dyslipidemia, type 2 diabetes, obstructive sleep apnea, or cardiovascular disease [7]. The expiry dating period was 24 months at 2 to 8 °C (36 to 46 °F) [7].

The letter waived pediatric studies for ages 0 to 5 and deferred three required pediatric studies [7]: PMR 4534-1, a 72-week study in ages 12 to 17 with completion set for February 2027; PMR 4534-2, a pharmacokinetic and pharmacodynamic study in ages 6 to 11; and PMR 4534-3, a 72-week study in ages 6 to 11 with completion set for December 2029. It also required PMR 4534-4, a prospective pregnancy exposure registry [7].

What label changes happened in 2024?

On September 6, 2024, the FDA sent Lilly a section 505(o)(4) letter notifying the company of new safety information that should be included in the labeling of GLP-1 receptor agonist products: the risk of pulmonary aspiration for patients undergoing elective surgeries or procedures requiring general anesthesia or deep sedation [6][8]. Both brands then added aspiration labeling.

For Zepbound, on October 18, 2024, the FDA approved five supplements: S-005 retitled section 5.2 as Severe Gastrointestinal Adverse Reactions and added dysgeusia; S-006 added data from the SURMOUNT-3 and SURMOUNT-4 trials; S-011 added dysesthesia; S-015 made indication edits and removed section 2.1, Patient Selection; and S-019 added the aspiration labeling [8]. The same letter notes the Zepbound single-dose vial Instructions for Use had been approved March 28, 2024 [8][20].

For Mounjaro, on November 1, 2024, the FDA approved S-010 (severe GI reactions and dysgeusia), S-015 (dysesthesia), and S-022 (aspiration labeling) [6]. On November 29, 2024, the FDA issued a New Postmarketing Requirement letter for Mounjaro; that letter’s requirements were still listed as open in 2025 correspondence [12][13].

When was Zepbound approved for obstructive sleep apnea?

On December 20, 2024, the FDA approved supplement S-013 (received June 21, 2024) adding a new Zepbound indication: moderate to severe obstructive sleep apnea in adults with obesity, used with a reduced-calorie diet and increased physical activity [9][10]. The FDA called it the first drug treatment option for certain patients with OSA, quoting Sally Seymour, M.D., director of the Division of Pulmonology, Allergy, and Critical Care [9].

The approval rested on two 52-week randomized, placebo-controlled studies of 469 adults without type 2 diabetes. One enrolled participants using positive airway pressure (PAP), the standard of care; the other enrolled people unable or unwilling to use PAP. Participants received 10 or 15 mg of Zepbound or placebo weekly, and the primary endpoint was the change in apnea-hypopnea index at week 52 [9]. The FDA stated the improvement in AHI is likely related to body weight reduction [9]. Zepbound received Fast Track, Priority Review, and Breakthrough Therapy designations for this indication [9].

The studies ran under the SURMOUNT-OSA master protocol, ClinicalTrials.gov NCT05412004, which is listed as completed [22]. The FDA deferred two pediatric OSA studies, PMR 4759-1 (ages 12 to 17) and PMR 4759-2 (ages 6 to 11), with protocols due in 2031 [10].

What happened with the shortage list and compounded tirzepatide?

Zepbound was added to the FDA drug shortage list in April 2024, joining Mounjaro, which had been listed since December 2022 [26]. While the drugs were on the list, federal restrictions on compounding essentially copies of approved drugs were suspended, so pharmacies and outsourcing facilities could compound tirzepatide [26].

On October 2, 2024, the FDA posted that the shortage of tirzepatide injection was resolved. After a lawsuit and a voluntary remand, the FDA confirmed the resolution on December 19, 2024, concluding Lilly’s supply would meet or exceed projected demand [26]. Removal from the list made compounding essentially copies of tirzepatide products unlawful again [26]. During the shortage period, Lilly spent about $23 billion to expand manufacturing capacity [26].

The Fifth Circuit Court of Appeals, in Outsourcing Facilities Association v. FDA, No. 25-10600, affirmed the FDA’s decision on August 27, 2026 in an unpublished per curiam opinion [26].

What changed in 2025?

Heart failure withdrawal. In a May 1, 2025 investor briefing, Lilly said it had withdrawn its U.S. application for a heart failure with preserved ejection fraction (HFpEF) indication after the FDA indicated an additional confirmatory trial would be required. Chief Scientific Officer Dan Skovronsky said Lilly believes the phase 3 SUMMIT data support an indication, and that regulatory reviews were ongoing in other countries [16].

May 28, 2025, Mounjaro S-031. Alopecia was added to section 6.2, Postmarketing Experience, at the FDA’s request in a February 3, 2025 Supplement Request letter. The same supplement removed both 2022 Limitations of Use — the pancreatitis-history statement and the type 1 diabetes statement [11].

September 25, 2025, Mounjaro S-034. Section 8.2, Lactation, was revised based on study I8F-MC-GPIN, a breast milk study in lactating women. The FDA declared PMR 4272-2 fulfilled, and the Medication Guide was revised for both Mounjaro and Zepbound [12].

December 19, 2025, Mounjaro S-039. The diabetes indication was expanded to pediatric patients 10 years and older, based on trial I8F-MC-GPGV (SURPASS-PEDS, NCT05260021) [13][23]. The FDA declared PMR 4271-1 fulfilled, and the supplement provided pediatric information under both the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act [13]. S-039 also aligned the warnings for acute pancreatitis (5.2), acute kidney injury (5.5), and severe GI reactions (5.6) with other GLP-1 receptor agonist labels [13].

What was the September 2025 FDA warning letter about?

On September 9, 2025, the FDA’s Center for Drug Evaluation and Research sent a warning letter to Lilly CEO David A. Ricks concerning NDA 217806 and NDA 215866 [19]. The subject was a direct-to-consumer video, “An Oprah Special: Shame, Blame, and the Weight Loss Revolution,” which aired on ABC on March 18, 2024, and appeared on Hulu on March 19, 2024 [19].

The FDA determined the video was false or misleading: it omitted the MEN 2 contraindication from the boxed warning and several warnings, and it minimized the drugs’ risks. The agency also cited Lilly for not submitting the video at the time of dissemination, as required by 21 CFR 314.81(b)(3)(i) [19]. The video featured two paid Lilly consultants, Dr. W. Scott Butsch and Dr. Amanda Velazquez, and Lilly Group Vice President Rhonda Pacheco [19]. The letter also noted prior advisory comments to Lilly dated June 13 and June 21, 2022, on draft Mounjaro promotion [19].

What has changed in 2026 so far?

On January 7, 2026, the FDA approved Instructions for Use for a Mounjaro multi-dose vial, per the versions listed in later Mounjaro approval letters [14][17]. Separately, Drugs.com lists Zepbound 2.4 mL vial strengths from 10 to 60 mg with a January 7, 2026 approval date [20]. On January 20, 2026, the FDA approved Mounjaro supplement S-009 for Mounjaro KwikPen, six presentations each containing four fixed-volume once-weekly doses. That application was originally submitted September 28, 2023, received an FDA action letter January 29, 2025, and was answered with a complete response December 2, 2025 [14].

On February 25, 2026, the FDA approved Zepbound S-042, which covers both Zepbound and Zepbound KwikPen. It added “intestinal obstruction, severe constipation including fecal impaction” to Postmarketing Experience, following a safety signal notification of April 28, 2025 and a supplement request letter of October 14, 2025. The same supplement removed subsection 5.9, Suicidal Ideation and Behavior, and removed “depression or thoughts of suicide” from the Medication Guide, per a supplement request letter dated January 13, 2026 [15].

On April 22, 2026, revised Instructions for Use were approved for the Mounjaro single-dose vial and single-dose pen [17].

What is the cardiovascular indication, and what did SURPASS-CVOT show?

On August 27, 2026, the FDA approved two Mounjaro supplements (sNDAs received October 27 and November 5, 2025), signed by Mahtab Niyyati; Lilly announced the approval on August 28, 2026 [17][18]. S-044 added a new indication: to reduce the risk of major adverse cardiovascular events — cardiovascular death, non-fatal heart attack, or non-fatal stroke — in adults with type 2 diabetes at high risk for these events. It also revised the diabetic retinopathy warning and waived the pediatric study requirement for this application [17]. S-045 updated the label to state that the 2.5 mg dose can be used for ongoing glycemic control in patients with type 2 diabetes — a labeling change, not a treatment recommendation [17].

The evidence base is SURPASS-CVOT (NCT04255433), in which 13,299 patients were randomized 1:1 across 640 sites in 30 countries to tirzepatide up to 15 mg or dulaglutide 1.5 mg weekly, with a median follow-up of 210.1 weeks [18][25][21]. It was a non-inferiority trial with a margin of 1.05 for the upper limit of the 95.3% confidence interval [25].

A primary endpoint event occurred in 801 patients (12.2%) on tirzepatide versus 862 (13.1%) on dulaglutide: hazard ratio 0.92, 95.3% CI 0.83 to 1.01, P=0.003 for non-inferiority and P=0.09 for superiority [25][18]. In other words, tirzepatide was non-inferior to dulaglutide, and superiority was not established. Lilly’s announcement frames the same result as an 8% lower rate of events [18]. Full results were published in the New England Journal of Medicine on December 18, 2025 (393(24):2409-2420) [25][18].

What is not approved, and when could a generic arrive?

As of October 2026, there is no FDA-approved generic version of Zepbound, according to Drugs.com, last updated August 13, 2026 [20]. Tirzepatide has new active moiety exclusivity of five years under 21 U.S.C. 355(c)(3)(E)(ii), and Lilly’s exclusive right to manufacture tirzepatide products extends to 2027 [26].

Drugs.com also lists Orange Book patents for Zepbound, including patent 11,357,820 with an expiry date of June 14, 2039, and patent 12,343,382 with an expiry date of July 22, 2039; patents 12,453,756 and 12,453,758 were issued October 28, 2025 [20]. These expiry dates come from Drugs.com’s patent table rather than the Orange Book directly, so they are reported figures rather than confirmed entries.

On indications: the U.S. HFpEF application was withdrawn in May 2025 [16]. Zepbound’s pediatric weight-management studies (PMR 4534-1, -2, -3) and pediatric OSA studies (PMR 4759-1, -2) remain deferred [7][10], and the MTC registry runs to a final report in June 2040 [1].

Does Medicare’s GLP-1 Bridge program cover tirzepatide?

A separate but related question for U.S. readers: starting July 1, 2026, the Medicare GLP-1 Bridge program covers certain GLP-1 drugs for $50 per month regardless of income. For tirzepatide, the CMS fact sheet states the program covers Zepbound KwikPen only — the single-dose Zepbound pen and Zepbound vials are not covered [24].

The fact sheet lists four eligibility requirements set by CMS: Part D drug coverage (standalone or through a health plan), no current GLP-1 drug received through a Medicare drug plan, no type 2 diabetes, moderate-to-severe sleep apnea, or fatty liver disease, and age 18 or older with a BMI of 35 or higher, or a BMI of 30 or higher with certain types of heart failure, hard-to-control high blood pressure, or stage 3a-or-above chronic kidney disease, or a BMI of 27 or higher with prediabetes or a history of heart attack, stroke, or blocked arteries in the legs or arms [24]. The $50 monthly payment does not count toward the Medicare drug plan deductible or yearly out-of-pocket limit, and these drugs are not eligible for the Medicare Prescription Payment Plan [24]. The fact sheet directs people to Medicare.gov or 1-800-MEDICARE for more information and notes it is general information only [24].

Sources

  1. US Food and Drug Administration. Mounjaro (tirzepatide) injection approval letter (NDA 215866).
  2. US Food and Drug Administration. Mounjaro prescribing information (NDA 215866). 2022.
  3. US Food and Drug Administration. Drugs@FDA API record for NDA 215866.
  4. US Food and Drug Administration. Drugs@FDA API record for NDA 217806.
  5. US Food and Drug Administration. Mounjaro supplement approval letter (NDA 215866/S-002, S-006). 2023.
  6. US Food and Drug Administration. Mounjaro supplement approval letter (NDA 215866/S-010, S-015, S-022). 2024.
  7. US Food and Drug Administration. Zepbound (tirzepatide) injection approval letter (NDA 217806). 2023.
  8. US Food and Drug Administration. Zepbound supplement approval letter (NDA 217806/S-005, S-006, S-011, S-015, S-019). 2024.
  9. US Food and Drug Administration. FDA approves first medication for obstructive sleep apnea.
  10. US Food and Drug Administration. Zepbound (tirzepatide) solution for subcutaneous injection supplement approval letter (NDA 217806/S-013). 2024.
  11. US Food and Drug Administration. Mounjaro (tirzepatide) injection supplement approval letter (NDA 215866/S-031). 2025.
  12. US Food and Drug Administration. Mounjaro (tirzepatide) injection supplement approval letter (NDA 215866/S-034). 2025.
  13. US Food and Drug Administration. Mounjaro (tirzepatide) injection supplement approval letter (NDA 215866/S-039). 2025.
  14. US Food and Drug Administration. Mounjaro KwikPen (tirzepatide) supplement approval letter (NDA 215866/S-009). 2026.
  15. US Food and Drug Administration. Zepbound (tirzepatide) injection supplement approval letter (NDA 217806/S-042). 2026.
  16. ConscienHealth. Lilly withdraws tirzepatide application to FDA for heart failure. May 3, 2025.
  17. US Food and Drug Administration. Mounjaro supplement approval letter (NDA 215866/S-044, S-045). 2026.
  18. Eli Lilly and Company. FDA approves Lilly’s Mounjaro (tirzepatide) to reduce cardiovascular risk in adults with type 2 diabetes. August 28, 2026.
  19. US Food and Drug Administration. Warning letter to Eli Lilly and Company (716485). September 9, 2025.
  20. Drugs.com. Generic Zepbound availability. August 13, 2026.
  21. ClinicalTrials.gov. Study NCT04255433 study details.
  22. ClinicalTrials.gov. Obstructive sleep apnea master protocol GPIF: a study of tirzepatide (LY3298176) in participants with obstructive sleep apnea (NCT05412004).
  23. ClinicalTrials.gov. A study to evaluate tirzepatide (LY3298176) in pediatric and adolescent participants with type 2 diabetes mellitus inadequately controlled with metformin or basal insulin or both (NCT05260021).
  24. Medicare. Medicare GLP-1 Bridge: GLP-1 drugs for $50 a month. July 1, 2026.
  25. New England Journal of Medicine. Cardiovascular outcomes with tirzepatide versus dulaglutide in type 2 diabetes.
  26. US Court of Appeals for the Fifth Circuit. Outsourcing Facilities Association v. FDA, No. 25-10600. August 27, 2026.

Frequently asked questions

What is the difference between Mounjaro and Zepbound?

Both contain the same active ingredient, tirzepatide, made by Eli Lilly, but they are separate FDA applications with different indications. Mounjaro (NDA 215866, approved May 13, 2022) is for glycemic control in type 2 diabetes, now including patients 10 and older. Zepbound (NDA 217806, approved November 8, 2023) is for chronic weight management and, since December 2024, obstructive sleep apnea.

Is Zepbound approved for sleep apnea?

Yes. On December 20, 2024, the FDA approved Zepbound (supplement S-013) for moderate to severe obstructive sleep apnea in adults with obesity, used with a reduced-calorie diet and increased physical activity. The FDA described it as the first drug treatment option for certain patients with OSA. The approval was based on two 52-week studies of 469 adults.

Is Mounjaro approved for children?

Yes, for type 2 diabetes. On December 19, 2025, supplement S-039 expanded Mounjaro's indication to pediatric patients 10 years and older with type 2 diabetes, based on the SURPASS-PEDS trial (NCT05260021). Zepbound's pediatric weight-management and pediatric sleep apnea studies remain deferred postmarketing requirements.

Does Mounjaro have a cardiovascular indication?

Yes. On August 27, 2026, supplements S-044 and S-045 added an indication to reduce the risk of major adverse cardiovascular events — cardiovascular death, non-fatal heart attack, or non-fatal stroke — in adults with type 2 diabetes at high risk. The SURPASS-CVOT trial showed tirzepatide was non-inferior to dulaglutide, with a hazard ratio of 0.92; superiority was not established.

Is tirzepatide approved for heart failure?

No. Lilly withdrew its U.S. application for a heart failure with preserved ejection fraction indication in May 2025, after the FDA indicated an additional confirmatory trial would be required. Lilly's Chief Scientific Officer said the company believes the SUMMIT phase 3 data support an indication, and reviews were continuing in other countries.

Is there a generic tirzepatide, and when could one arrive?

As of October 2026, no generic Zepbound has been approved by the FDA, according to Drugs.com. Lilly's exclusive right to manufacture tirzepatide products extends to 2027 under new active moiety exclusivity. Drugs.com lists Orange Book patents with reported expiry dates in 2039, but those dates come from Drugs.com, not the Orange Book directly.

Why was compounded tirzepatide restricted?

While Mounjaro and Zepbound were on the FDA drug shortage list, compounding of essentially copies was permitted. The FDA declared the tirzepatide shortage resolved on October 2, 2024, and confirmed it on December 19, 2024 after a voluntary remand. Removal from the list made compounding essentially copies of tirzepatide products unlawful; the Fifth Circuit upheld the FDA's decision on August 27, 2026.

What does the Medicare GLP-1 Bridge cover for Zepbound?

Starting July 1, 2026, the program covers certain GLP-1 drugs for $50 per month. For tirzepatide, it covers Zepbound KwikPen only — the single-dose pen and vials are not covered. Per the CMS fact sheet, eligibility requires Part D drug coverage, no GLP-1 already received through a Medicare drug plan, no type 2 diabetes, moderate-to-severe sleep apnea, or fatty liver disease, and specific BMI and condition thresholds at age 18 or older.

This article summarizes FDA labeling, published research and company information current as of September 14, 2026. It is not medical advice and does not replace a conversation with your own healthcare provider. How we research and verify.