Zepbound FDA Approval History
Last updated by Judith Stewart, BPharm on June 21, 2025.
FDA Approved: Yes (First approved November 8, 2023)
Brand name: Zepbound
Generic name: tirzepatide
Dosage form: Injection
Company: Eli Lilly and Company
Treatment for: Weight Loss (Obesity/Overweight), Obstructive Sleep Apnea/Hypopnea Syndrome
Zepbound (tirzepatide) is a glucose-dependent insulinotropic polypeptide (GIP) receptor and glucagon-like peptide-1 (GLP-1) receptor agonist used for weight reduction in adults with obesity or adults with overweight, and severe obstructive sleep apnea in adults with obesity.
- 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: Coadministration with other tirzepatide-containing products or with any GLP-1 receptor agonist is not recommended.
- Tirzepatide was first approved under the brand name Mounjaro in May 2022 to improve glycemic control in adults with type 2 diabetes mellitus.
- Zepbound (tirzepatide) is a GIP and GLP-1 agonist that works in the treatment of people with obesity or with excess weight and weight-related medical problems by activating the receptors for the natural incretin hormones GIP and GLP-1 to decrease food intake and slow gastric emptying.
- FDA approval of Zepbound was based on results from the phase 3 SURMOUNT-1 (adults with obesity or overweight and without type 2 diabetes) and SURMOUNT-2 (adults with obesity or overweight and with type 2 diabetes) trials which both demonstrated a statistically significant reduction in body weight compared to those who received placebo after 72 weeks of treatment.
- In SURMOUNT-1, people taking Zepbound at the highest dose (15 mg) lost on average 48 pounds, and people taking the lowest dose (5 mg) lost on average 34 pounds (compared to 7 pounds on placebo).
- In SURMOUNT-2, people taking Zepbound at the 15 mg dose experienced average weight reductions of 15.7% (34.4 pounds) and people taking Zepbound at the 10 mg dose experienced average weight reductions of 13.4% (29.8 pounds) compared to placebo 3.3% (7.0 pounds).
- Zepbound is administered by subcutaneous injection into the abdomen, thigh, or upper arm once weekly.
- Zepbound carries a Boxed Warning for the risk of thyroid C-cell tumors. Warnings and precautions include severe gastrointestinal adverse reactions, acute kidney injury, acute gallbladder disease, acute pancreatitis, serious hypersensitivity reactions, increased risk of hypoglycemia with concomitant use of an insulin secretagogue or insulin, diabetic retinopathy complications in patients with type 2 diabetes, suicidal behavior and ideation, and pulmonary aspiration during general anesthesia or deep sedation.
- Common adverse reactions include nausea, diarrhea, vomiting, constipation, abdominal pain, dyspepsia, injection site reactions, fatigue, hypersensitivity reactions, belching, hair loss, and heartburn.
Development timeline for Zepbound
| Date | Article |
|---|
| Jun 16, 2025 | Lilly to Offer All Approved Doses of Zepbound (tirzepatide) Single-Dose Vials Through LillyDirect Self Pay Pharmacy Solutions |
| May 11, 2025 | Zepbound (tirzepatide) Showed Superior Weight Loss Over Wegovy (semaglutide) in Complete SURMOUNT-5 Results Published in The New England Journal of Medicine |
| Dec 20, 2024 | Approval FDA Approves Zepbound (tirzepatide) as the First and Only Prescription Medicine for Moderate-to-Severe Obstructive Sleep Apnea in Adults with Obesity |
| Aug 27, 2024 | Lilly Releases Zepbound (tirzepatide) Single-Dose Vials, Expanding Supply and Access for Adults Living with Obesity |
| Aug 20, 2024 | Tirzepatide Reduced the Risk of Developing Type 2 Diabetes by 94% in Adults with Pre-Diabetes and Obesity or Overweight |
| Dec 12, 2023 | Zepbound achieved additional 6.7% weight loss following a 36-week open-label lead-in period, for a total mean weight loss of 26.0% from study entry over 88 weeks |
| Nov 9, 2023 | FDA Approves Zepbound for Chronic Weight Management, a New Treatment of Obesity or Overweight with Weight-Related Medical Problems |
| Nov 8, 2023 | Approval FDA Approves Zepbound (tirzepatide) for Chronic Weight Management |
| Jul 27, 2023 | Tirzepatide Demonstrated Significant and Superior Weight Loss Compared to Placebo in Two Pivotal Studies |
| Apr 27, 2023 | Lilly's Tirzepatide Achieved up to 15.7% Weight Loss in Adults with Obesity or Overweight and Type 2 Diabetes in SURMOUNT-2 |
| Oct 6, 2022 | Lilly Receives U.S. FDA Fast Track Designation for Tirzepatide for the Treatment of Adults with Obesity, or Overweight with Weight-Related Comorbidities |
| May 13, 2022 | Approval FDA Approves Mounjaro (tirzepatide) Injection for the Treatment of Adults with Type 2 Diabetes |
| Oct 19, 2021 | Tirzepatide Results Published in The Lancet Show Superior A1C and Body Weight Reductions Compared to Insulin Glargine in Adults with Type 2 Diabetes with Increased Cardiovascular Risk |
| Sep 30, 2021 | Lilly's Tirzepatide Led to Greater Time in Range Compared to Insulin Degludec in Adults with Type 2 Diabetes in SURPASS-3 CGM Sub-Study |
| Sep 30, 2021 | Lilly's Tirzepatide Led to Greater Improvements in Liver Fat Content Compared to Insulin Degludec in Adults with Type 2 Diabetes in SURPASS-3 MRI Sub-Study |
| Jun 26, 2021 | Lilly's SURPASS-1 Results Published in The Lancet Show Tirzepatide's Superior A1C and Body Weight Reductions Versus Placebo in Adults with Type 2 Diabetes |
| Jun 25, 2021 | Lilly's SURPASS-2 Results Published in The New England Journal of Medicine Show Tirzepatide Achieved Superior A1C and Body Weight Reductions Compared to Injectable Semaglutide in Adults with Type 2 diabetes |
| May 20, 2021 | Lilly's Tirzepatide Achieves All Primary and Key Secondary Study Outcomes Against Insulin Glargine in Adults with Type 2 Diabetes and Increased Cardiovascular Risk in SURPASS-4 Trial |
| Mar 4, 2021 | Tirzepatide Achieved Superior A1C and Body Weight Reductions Across All Three Doses Compared to Injectable Semaglutide in Adults with Type 2 Diabetes |
| Feb 17, 2021 | Tirzepatide Significantly Reduced A1C and Body Weight in People with Type 2 Diabetes in Two Phase 3 Trials from Lilly's SURPASS Program |
| Dec 9, 2020 | Lilly's Tirzepatide Significantly Reduced A1C and Body Weight in People with Type 2 Diabetes |
| Jun 9, 2020 | First Patient Dose Delivered for Lilly's Tirzepatide Cardiovascular Outcomes Trial |
| Jun 8, 2019 | Lilly's Tirzepatide Demonstrates Benefits in Data Presented at the American Diabetes Association's® 79ᵗʰ Scientific Sessions |
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Medical Disclaimer
