GLP-1 Approval Timeline: Every FDA Approval From Byetta in 2005 to Foundayo in 2026, Read From Drugs@FDA

The FDA approved its first GLP-1 drug, Byetta, on 28 April 2005. Twenty-one years later the table below holds fourteen first approvals, three of those brands since discontinued, and a series of new uses — heart, kidney, liver and sleep apnoea — added to the original diabetes and weight labels. This page puts every one of those decisions on one timeline, with the date the FDA acted and, for each new use, the wording of the FDA's own approval letter.

Every date below comes from Drugs@FDA, the agency's approvals database, queried through openFDA on 26 October 2026. Each new indication was then checked against the approval letter the FDA publishes with it. One caution before the tables: an approval date is not a label date. Labels are revised many times; the dates here are the FDA's action on the application.

First approvals: the brands, in order

Two combination products sit beside the list: Xultophy (insulin degludec with liraglutide) and Soliqua (insulin glargine with lixisenatide), both approved on 21 November 2016. Bydureon BCise, a reformulated weekly exenatide pen, was approved on 20 October 2017 and is also now discontinued. Adlyxin's status is shown exactly as Drugs@FDA lists it; that listing describes the application, not whether pharmacies stock it.

Reading the table: after exenatide, six more molecules entered with a "new molecular entity" classification — liraglutide (2010), albiglutide and dulaglutide (2014), lixisenatide (2016), semaglutide (2017), tirzepatide (2022) — and then orforglipron in 2026, the first that is not a peptide at all. Every other row is an existing molecule in a new brand, dose or form. Saxenda, Wegovy and Zepbound were filed as "new indication submitted as a distinct NDA" — the same molecule as an existing diabetes brand, sold under a second name for weight. That is why Ozempic and Wegovy, or Mounjaro and Zepbound, are the same drug with different labels; the difference is set out on our Wegovy vs Ozempic and Mounjaro vs Zepbound pages.

New uses added later: the indication timeline

Drugs@FDA records every approved "efficacy supplement" but not what it was for. The table below lists only the ones whose approval letter, opened for this page, states a new indication or population.

Two patterns stand out. The cardiovascular and organ-protection claims came years after the first approvals — Mounjaro's heart indication 51 months after the drug, Ozempic's kidney indication more than seven years after it. And the weight brands now carry indications that have nothing to do with weight as such: Wegovy's heart and liver uses and Zepbound's sleep apnoea use are medical indications in their own right, which matters to payers that exclude weight loss — how coverage works is on our GLP-1 insurance coverage page.

Drugs@FDA also lists earlier efficacy supplements — several each on Victoza, Trulicity, Saxenda and Bydureon between 2012 and 2022, and on Ozempic in 2020 and 2022 — whose letters were not opened for this page, so they are not described here. The brand pages (Victoza, Trulicity, what is Ozempic) carry those labels' current indications with their own sources.

Generics: the first copies

The patent and exclusivity story is on our pages on when Ozempic will go generic and when tirzepatide will go generic. Drugs@FDA's own dates for the first abbreviated applications:

No generic semaglutide, dulaglutide or tirzepatide is approved in the US.

What this timeline does not show

• Shortages. FDA's drug shortage list is separate from Drugs@FDA; semaglutide and tirzepatide were on it for long stretches of 2022–2025, which is the background to compounding — covered on our compounded semaglutide page.
• Approvals outside the US. Several drugs — including Mounjaro for weight in the UK and ecnoglutide in China — have approvals the FDA does not.
• What comes next. The late-stage pipeline (retatrutide, CagriSema, amycretin, survodutide and others) is tracked on the individual pages linked from which drugs are GLP-1s.

Sources

• FDA, Drugs@FDA via the openFDA drug/drugsfda endpoint: applications NDA 021773, 022341, 022200, 209210, 206321, 209637, 213051, 215256, 215866, 217806, 218316, 220934; BLA 125431, 125469, 208471, 208583, 208673; and the exenatide and liraglutide ANDAs listed. Submission type, classification and action date read 2026-10-26, api.fda.gov.
• FDA approval letters, accessdata.fda.gov: NDA 215256 S-005 (2022), S-011 (2024), S-024 (2025), S-029 with NDA 218316 S-005 (2026); NDA 217806 S-013 (2024), S-041 (2026); NDA 209637 S-025 (2025); NDA 213051 S-024 (2025); NDA 215866 S-039 (2025), S-044/S-045 (2026); NDA 220934 original (2026). Opened 2026-10-26.