Reference

GLP-1 Timeline: Every FDA Approval from 2005 to Today

The complete chronological history of GLP-1 medications. From the first approval of exenatide for diabetes in 2005 to expanded indications for heart disease, sleep apnea, liver disease, and kidney protection in 2024-2025.

Last Updated: December 2025
Primary Sources: FDA.gov
Reading Time: 8 min
The Bottom Line

GLP-1 medications evolved over 20 years from twice-daily diabetes injections to once-weekly treatments with expanding indications. The class now includes approvals for type 2 diabetes (2005), obesity (2014), cardiovascular risk reduction (2024), obstructive sleep apnea (2024), chronic kidney disease (2025), and liver fibrosis/MASH (2025). Dual GIP/GLP-1 agonists (tirzepatide) entered the market in 2022 with superior efficacy in head-to-head trials.

Quick Reference: All FDA-Approved GLP-1 Medications

Brand Name Generic Manufacturer FDA Approval Indication Dosing
Byetta exenatide AstraZeneca April 2005 Type 2 diabetes Twice daily
Victoza liraglutide Novo Nordisk January 2010 Type 2 diabetes Once daily
Bydureon exenatide ER AstraZeneca January 2012 Type 2 diabetes Once weekly
Trulicity dulaglutide Eli Lilly September 2014 Type 2 diabetes, CV risk Once weekly
Saxenda liraglutide 3.0mg Novo Nordisk December 2014 Weight management Once daily
Adlyxin lixisenatide Sanofi July 2016 Type 2 diabetes Once daily
Ozempic semaglutide Novo Nordisk December 2017 Type 2 diabetes, CKD Once weekly
Rybelsus oral semaglutide Novo Nordisk September 2019 Type 2 diabetes Once daily (oral)
Wegovy semaglutide 2.4mg Novo Nordisk June 2021 Weight, CV risk, MASH Once weekly
Mounjaro tirzepatide Eli Lilly May 2022 Type 2 diabetes Once weekly
Zepbound tirzepatide Eli Lilly November 2023 Weight, sleep apnea Once weekly

Note: Tanzeum (albiglutide), approved April 2014, was voluntarily withdrawn from the market by GlaxoSmithKline in 2018 due to low market uptake.

Complete Timeline

Era 1: Foundation (2005–2013)

The first GLP-1 medications established the class but required frequent dosing and had modest efficacy compared to later drugs.

April 28, 2005
Diabetes First GLP-1 Ever Byetta (exenatide) Approved
The FDA approves the first GLP-1 receptor agonist for type 2 diabetes. Byetta requires twice-daily injections and is based on exendin-4, a peptide isolated from Gila monster saliva. Developed by Amylin Pharmaceuticals and Eli Lilly.
January 25, 2010
Diabetes Victoza (liraglutide) Approved
Novo Nordisk's once-daily GLP-1 becomes the first medication in the class with daily (rather than twice-daily) dosing. Liraglutide achieves a longer half-life through fatty acid acylation, which allows it to bind to albumin in the blood.
January 27, 2012
Diabetes First Weekly GLP-1 Bydureon (exenatide ER) Approved
An extended-release formulation of exenatide becomes the first once-weekly GLP-1 medication. Sustained release is achieved by incorporating exenatide into biodegradable polymer microspheres that slowly release the drug over 7 days.
Era 2: Expansion (2014–2019)

The class expands with multiple once-weekly options and, critically, the first approval specifically for weight management.

April 15, 2014
Diabetes Tanzeum (albiglutide) Approved
GlaxoSmithKline's once-weekly GLP-1 gains approval. Albiglutide fuses two GLP-1 molecules with human albumin to extend the half-life to 120 hours. GSK will voluntarily withdraw it from the market in 2018 due to limited commercial success.
September 18, 2014
Diabetes Trulicity (dulaglutide) Approved
Eli Lilly's once-weekly dulaglutide joins the market. The AWARD clinical program demonstrates superiority over exenatide and non-inferiority to liraglutide. Trulicity will become one of the best-selling diabetes drugs globally.
December 23, 2014
Weight Loss First GLP-1 for Obesity Saxenda (liraglutide 3.0mg) Approved
The FDA approves the first GLP-1 specifically for chronic weight management—a watershed moment. Saxenda uses the same active ingredient as Victoza (liraglutide) but at a higher dose (3.0mg vs 1.8mg). It's the first new weight loss drug since 2012.
July 28, 2016
Diabetes Adlyxin (lixisenatide) Approved
Sanofi's once-daily GLP-1 gains approval. Lixisenatide is shorter-acting than other GLP-1s, which may have advantages for post-meal glucose control but limits overall efficacy. It later becomes a component of the combination product Soliqua.
December 5, 2017
Diabetes Semaglutide Arrives Ozempic (semaglutide) Approved
Novo Nordisk's once-weekly semaglutide enters the diabetes market. The SUSTAIN trials demonstrate superior efficacy compared to older GLP-1s, including greater A1C reduction and weight loss. Ozempic will become central to the GLP-1 revolution.
September 20, 2019
Diabetes First Oral GLP-1 Rybelsus (oral semaglutide) Approved
The first-ever oral GLP-1 gains approval. Rybelsus achieves oral bioavailability through a co-formulation with SNAC (sodium N-[8-(2-hydroxybenzoyl) amino] caprylate), which protects semaglutide from stomach acid and enhances absorption. Must be taken on an empty stomach.
Era 3: The Obesity Breakthrough (2021–Present)

Higher-dose formulations and new mechanisms (dual GIP/GLP-1 agonism) produce unprecedented weight loss. Indications expand far beyond diabetes.

June 4, 2021
Weight Loss Wegovy Launch Wegovy (semaglutide 2.4mg) Approved
A higher-dose formulation of semaglutide becomes the first new obesity drug since 2014. The STEP trials show average weight loss of 15-17%, approaching the efficacy of bariatric surgery for the first time with a medication. Demand quickly outstrips supply.
May 13, 2022
Diabetes First Dual GIP/GLP-1 Mounjaro (tirzepatide) Approved
Eli Lilly's tirzepatide becomes the first dual GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 receptor agonist. The SURPASS trials show tirzepatide produces greater A1C reduction and weight loss than semaglutide in head-to-head comparisons—a "first-in-class" medication.
November 8, 2023
Weight Loss Tirzepatide for Obesity Zepbound (tirzepatide) Approved
Tirzepatide gains obesity indication under a new brand name. The SURMOUNT trials show average weight loss of 20-22.5%, the highest ever achieved with medication. In November 2025, the head-to-head SURMOUNT-5 trial will confirm tirzepatide produces 47% greater weight loss than semaglutide.
March 8, 2024
Cardiovascular Beyond Metabolic Disease Wegovy for Cardiovascular Risk Reduction
Wegovy becomes the first weight loss medication also approved to reduce cardiovascular events (heart attack, stroke, cardiovascular death) in adults with established heart disease and obesity. The SELECT trial (n=17,600) showed a 20% reduction in major adverse cardiovascular events.
December 20, 2024
Sleep Apnea First Drug for OSA Zepbound for Obstructive Sleep Apnea
Zepbound becomes the first medication ever approved for moderate-to-severe obstructive sleep apnea (OSA) in adults with obesity. The SURMOUNT-OSA trial showed significant reduction in the apnea-hypopnea index at 52 weeks. Prior to this, the only treatments were CPAP, oral devices, and surgery.
January 28, 2025
Kidney Disease Ozempic for Diabetic Nephropathy
Ozempic receives approval to reduce the risk of kidney disease progression, kidney failure (end-stage kidney disease), and cardiovascular death in adults with type 2 diabetes and chronic kidney disease. Based on the FLOW trial showing significant reduction in kidney-related events.
August 2025
Liver Disease Wegovy for MASH (Accelerated Approval)
Wegovy receives accelerated approval for the treatment of metabolic dysfunction-associated steatohepatitis (MASH, formerly NASH) with moderate to advanced liver fibrosis (F2-F3). Full approval contingent on confirmatory trials demonstrating clinical benefit.

Market Milestones

Generic Entry Begins (2024)

After nearly two decades of brand-name exclusivity, the first generic GLP-1 medications reached the U.S. market in late 2024:

Generic versions of semaglutide and tirzepatide remain years away due to patent protections extending into the 2030s. Multiple companies are challenging these patents, but no generics are expected before 2031-2033 at the earliest.

Drug Shortages (2022–2025)

Unprecedented demand led to persistent shortages:

Drug Shortage Declared Shortage Resolved
Wegovy/Ozempic (semaglutide) Early 2022 February 21, 2025
Mounjaro/Zepbound (tirzepatide) 2023 October 2, 2024
Trulicity (dulaglutide) 2024 Still in shortage

During shortages, compounding pharmacies were permitted to prepare custom versions of these medications under Section 503A and 503B of the Federal Food, Drug, and Cosmetic Act. When shortages are resolved, specific timelines govern when compounding must cease (60 days for 503A pharmacies, 90 days for 503B outsourcing facilities).

What's Next: Pipeline Medications

Several next-generation GLP-1-related medications are in late-stage development:

Oral semaglutide for obesity: Novo Nordisk has submitted an application for oral semaglutide (25mg) for weight management. FDA decision expected Q4 2025. If approved, would be the first oral GLP-1 for obesity.

Retatrutide (Eli Lilly): A triple agonist targeting GLP-1, GIP, and glucagon receptors. Phase 3 trials underway. Early data showed up to 24% weight loss—potentially exceeding tirzepatide.

CagriSema (Novo Nordisk): Combines semaglutide with cagrilintide (an amylin analog). Phase 3 trials (REDEFINE program) ongoing. Designed to produce greater weight loss than semaglutide alone.

Orforglipron (Eli Lilly): An oral, non-peptide GLP-1 receptor agonist. Unlike Rybelsus, doesn't require special formulation for absorption—can be taken with food. Phase 3 trials underway.

Sources

FDA Approval Documents

  • FDA. "Drug Trials Snapshots: MOUNJARO." FDA.gov, May 2022
  • FDA. "FDA Approves First Treatment to Reduce Risk of Serious Heart Problems Specifically in Adults with Obesity or Overweight." FDA.gov, March 2024
  • FDA. "FDA Approves First Generic of Once-Daily GLP-1 Injection." FDA.gov, December 2024
  • Accessdata.fda.gov prescribing information for Ozempic, Wegovy, Mounjaro, Trulicity, Zepbound

Historical References

Drug Information

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Medical Disclaimer

This article is for informational and educational purposes only. All GLP-1 medications are prescription drugs that require evaluation by a healthcare provider. Do not start, stop, or modify any medication without consulting a qualified medical professional.

Accuracy Note

While we make every effort to ensure accuracy, FDA approval dates and indication language may have minor variations across sources. For official labeling information, consult FDA.gov or the medication's prescribing information. This timeline will be updated as new approvals occur.

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