Twenty-one years from the first injection to the first small-molecule tablet. Dates are the submission status dates in Drugs@FDA or the date on the posted approval letter; the application number is the record to check. Original approvals are in bold in the entry title; supplements are the label additions that changed what a product is for or how it is dosed.
28 April 2005
Byetta (exenatide), NDA 021773: original approval
The first GLP-1 receptor agonist. Twice daily before meals, type 2 diabetes. No boxed warning then or since.
25 January 2010
Victoza (liraglutide), NDA 022341: original approval
First human GLP-1 analogue; once daily; type 2 diabetes.
27 January 2012
Bydureon (exenatide extended-release), NDA 022200: original approval
First once-weekly GLP-1, as microspheres reconstituted before injection.
15 April 2014
Tanzeum (albiglutide), BLA 125431: original approval
Albumin-fused weekly GLP-1. Later discontinued.
18 September 2014
Trulicity (dulaglutide), BLA 125469: original approval
Antibody-fragment-fused weekly GLP-1 in a ready-to-use pen.
23 December 2014
Saxenda (liraglutide 3 mg), NDA 206321: original approval
The first GLP-1 approved for chronic weight management.
27 July 2016
Adlyxin (lixisenatide), BLA 208471: original approval
Short-acting once-daily exendin-based agent. Soliqua 100/33, its fixed combination with insulin glargine, followed on 21 November 2016.
25 August 2017
Victoza, S-027: cardiovascular risk reduction
First GLP-1 with a cardiovascular indication, from LEADER.
20 October 2017
Bydureon BCise, NDA 209210: original approval
Autoinjector formulation of weekly exenatide.
5 December 2017
Ozempic (semaglutide), NDA 209637: original approval
Once-weekly semaglutide for type 2 diabetes, 0.5 and 1 mg.
17 June 2019
Victoza, S-031: pediatric type 2 diabetes from age 10
First GLP-1 approved for children.
20 September 2019
Rybelsus (oral semaglutide), NDA 213051: original approval
The first oral GLP-1 receptor agonist; 3, 7 and 14 mg tablets.
16 January 2020
Ozempic, S-003: cardiovascular risk reduction
From SUSTAIN-6.
21 February 2020
Trulicity, S-033: cardiovascular risk reduction
From REWIND; wording covers established disease or multiple risk factors.
3 September 2020
Trulicity, S-036: 3 mg and 4.5 mg doses
Maximum weekly dose tripled.
4 December 2020
Saxenda, S-012: pediatric obesity from age 12
Body weight above 60 kg.
4 June 2021
Wegovy (semaglutide 2.4 mg), NDA 215256: original approval
Chronic weight management in adults; the STEP program.
22 July 2021
Bydureon BCise, S-017: pediatric type 2 diabetes from age 10
28 March 2022
Ozempic, S-009: 2 mg dose
13 May 2022
Mounjaro (tirzepatide), NDA 215866: original approval
First GIP and GLP-1 dual agonist; type 2 diabetes; 2.5 to 15 mg.
17 November 2022
Trulicity, S-051: pediatric type 2 diabetes from age 10
23 December 2022
Wegovy, S-005: pediatric obesity from age 12
8 November 2023
Zepbound (tirzepatide), NDA 217806: original approval
Chronic weight management in adults; the SURMOUNT program.
8 March 2024
Wegovy, S-011: cardiovascular risk reduction
From SELECT; the first weight-management product with a cardiovascular indication.
27 November 2024
Wegovy, S-015: 1.7 mg pediatric maintenance dose
Severe gastrointestinal reactions added to warnings across the class.
20 December 2024
Zepbound, S-013: obstructive sleep apnea
Moderate to severe OSA in adults with obesity; from SURMOUNT-OSA.
28 January 2025
Ozempic, S-025: chronic kidney disease in type 2 diabetes
From FLOW.
15 August 2025
Wegovy, S-024: noncirrhotic MASH with F2 to F3 fibrosis
Accelerated approval, from the ESSENCE week-72 analysis.
17 October 2025
Rybelsus, S-024: cardiovascular risk reduction
The 1.5, 4 and 9 mg strengths are labelled Ozempic tablets from this label onward.
19 December 2025
Mounjaro, S-039: pediatric type 2 diabetes from age 10
22 December 2025
Wegovy tablets (oral semaglutide 25 mg), NDA 218316: original approval
Weight reduction and cardiovascular risk reduction in adults; the OASIS program.
19 March 2026
Wegovy, S-029: 7.2 mg weekly dose
Wegovy HD pen; combined injection and tablet label.
1 April 2026
Foundayo (orforglipron), NDA 220934: original approval
First small-molecule GLP-1 receptor agonist; once-daily tablet for chronic weight management.
26 August 2026
Zepbound, S-041: SURPASS-CVOT data added
Retinopathy warning revised; no new indication.
27 August 2026
Mounjaro, S-044 and S-045: cardiovascular risk reduction; 2.5 mg for ongoing glycemic control
From SURPASS-CVOT against dulaglutide.
Reading the pattern
Three things stand out once the dates are in a line.
Indications arrive in the same order for each molecule. Diabetes first (Victoza 2010, Ozempic 2017, Mounjaro 2022), then weight (Saxenda 2014, Wegovy 2021, Zepbound 2023), then cardiovascular (Victoza 2017, Ozempic 2020, Wegovy 2024, Mounjaro 2026), then organ-specific indications (kidney, liver, sleep apnea). Orforglipron broke the order by launching with weight.
The intervals are shrinking. Liraglutide took four years and eleven months from diabetes approval to weight approval; semaglutide took three and a half; tirzepatide took eighteen months.
Nothing has been withdrawn for safety. Two agents left the market (albiglutide, exenatide) with their approvals intact, and the labels of the others have grown warnings (severe gastrointestinal reactions, aspiration under anaesthesia) rather than lost indications. The status guide explains the difference between discontinued and withdrawn.
What is not on this list
Investigational agents (retatrutide, survodutide, CagriSema, mazdutide) have no dates because they have no applications. Compounded products have no dates because they are not approved. Generic entries (a tentatively approved semaglutide ANDA, liraglutide generics) are omitted because they add no new agent.
Questions people ask
Which was the first GLP-1 drug?
Byetta (exenatide), approved 28 April 2005 under NDA 021773, injected twice daily before meals. The first once-weekly was Bydureon in January 2012, the first once-daily human analogue was Victoza in January 2010, and the first tablet was Rybelsus in September 2019.
How many weight-management approvals are there?
Five products for chronic weight management, by first approval date: Saxenda (December 2014), Wegovy injection (June 2021), Zepbound (November 2023), Wegovy tablets (December 2025) and Foundayo (April 2026). Ozempic, Mounjaro, Rybelsus, Trulicity, Victoza, Byetta, Bydureon and Adlyxin are diabetes products without a weight indication.
Sources
- Drugs@FDA: NDA 021773 Byetta Accessed September 4, 2026.
- Drugs@FDA: NDA 022341 Victoza Accessed September 4, 2026.
- Drugs@FDA: NDA 022200 Bydureon and NDA 209210 Bydureon BCise Accessed September 4, 2026.
- Drugs@FDA: BLA 125431 Tanzeum Accessed September 4, 2026.
- Drugs@FDA: BLA 125469 Trulicity Accessed September 4, 2026.
- Drugs@FDA: NDA 206321 Saxenda Accessed September 4, 2026.
- Drugs@FDA: BLA 208471 Adlyxin and BLA 208673 Soliqua 100/33 Accessed September 4, 2026.
- Drugs@FDA: NDA 209637 Ozempic Accessed September 4, 2026.
- Drugs@FDA: NDA 213051 Rybelsus and Ozempic tablets Accessed September 4, 2026.
- Drugs@FDA: NDA 215256 Wegovy injection and NDA 218316 Wegovy tablets Accessed September 4, 2026.
- Drugs@FDA: NDA 215866 Mounjaro and NDA 217806 Zepbound Accessed September 4, 2026.
- Drugs@FDA: NDA 220934 Foundayo Accessed September 4, 2026.
- FDA approval letters cited on the individual agent pages (Ozempic S-025; Wegovy S-015, S-024, S-029; Wegovy tablets original; Rybelsus S-024; Mounjaro S-039, S-044/045; Zepbound S-013, S-041; Foundayo original) Accessed September 4, 2026.
Canonical URL: https://formblendsglp1s.com/guides/approval-timeline. Written by the FormBlends editorial team. This page is educational and is not medical advice; see the medical disclaimer.