When were Ozempic (semaglutide) and Mounjaro (tirzepatide) approved for the treatment of type 2 diabetes mellitus (DM) and weight loss?

FDA Approval Timeline for Ozempic and Mounjaro

Ozempic (semaglutide) was approved by the FDA for type 2 diabetes in December 2017, while the higher-dose formulation Wegovy (semaglutide 2.4 mg) was approved for weight loss in June 2021. 1, 2 Mounjaro (tirzepatide) was approved for type 2 diabetes in May 2022, and subsequently received FDA approval for obesity treatment under the brand name Zepbound in November 2023. 1

Detailed Approval History

Semaglutide (Ozempic/Wegovy)

For Type 2 Diabetes:

• The lower-dose formulation (Ozempic) received FDA approval for type 2 diabetes management in 2017, though the specific month is not detailed in the highest-quality sources 3
• This formulation is administered as a once-weekly subcutaneous injection at doses up to 1.0 mg for diabetes management 1

For Weight Loss:

• On June 4,2021, the FDA approved semaglutide 2.4 mg once weekly (marketed as Wegovy) for chronic weight management in adults with obesity (BMI ≥30 kg/m²) or overweight (BMI ≥27 kg/m²) with at least one weight-related condition 1, 2
• This marked the first approved drug for chronic weight management in adults with general obesity or overweight since 2014 2
• The approval was based on results from the STEP clinical trial program (STEP 1-4), which demonstrated mean weight loss of 14.9-16.0% at 68 weeks 1, 4

Tirzepatide (Mounjaro/Zepbound)

For Type 2 Diabetes:

• Tirzepatide (Mounjaro) received FDA approval for type 2 diabetes in May 2022 3
• This dual GIP/GLP-1 receptor agonist is administered as a once-weekly subcutaneous injection with doses up to 15 mg 1

For Weight Loss:

• The FDA approved tirzepatide for obesity treatment in November 2023 (marketed as Zepbound for this indication) 1
• The approval was based on clinical trial data showing superior weight loss of 20.9% compared to semaglutide's 14.9% 1
• Eli Lilly sought fast-track FDA approval for weight loss following the diabetes approval, with projections for approval within 2023, which materialized in November 2023 3, 1

Key Clinical Context

Important Distinction:

• Both medications require different brand names and dosing for diabetes versus weight management indications 1, 5
• Semaglutide: Ozempic (diabetes) vs. Wegovy (weight loss) 1
• Tirzepatide: Mounjaro (diabetes) vs. Zepbound (weight loss) 1

Off-Label Use:

• Many clinicians began prescribing Ozempic off-label for weight loss despite it not being FDA-approved for this indication, largely because insurance companies often do not cover Wegovy for weight management alone 3
• This off-label prescribing created supply shortages for patients with type 2 diabetes who needed these medications for their FDA-approved diabetes indication 3