Zepbound FDA Approval History
Last updated by Judith Stewart, BPharm on Nov 12, 2023.
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)
Zepbound (tirzepatide) is a glucose-dependent insulinotropic polypeptide (GIP) receptor and glucagon-like peptide-1 (GLP-1) receptor agonist used for chronic weight management in adults.
- Zepbound is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of:
- 30 kg/m2 or greater (obesity) or
- 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition (e.g., hypertension, dyslipidemia, type 2 diabetes mellitus, obstructive sleep apnea or cardiovascular disease). - 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, and suicidal behavior and ideation.
- Common adverse reactions include nausea, diarrhea, vomiting, constipation, abdominal pain, indigestion, injection site reactions, fatigue, hypersensitivity reactions, belching, hair loss, and heartburn.
Development timeline for Zepbound
Further information
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