The Complete FDA Approval History of Semaglutide (2017-2026)

Semaglutide has been through more than a dozen separate FDA actions in under nine years. It started as a once-weekly diabetes shot, became the best known weight loss drug in America, and now also carries approvals for heart risk, kidney disease and liver disease. Along the way it picked up a pill version, a higher dose and, in 2026, a confusing brand-name swap.

This page lays the whole thing out in order, with the application numbers and approval dates you can check yourself on the FDA’s own website. It is background information, not medical advice. Decisions about starting, stopping or changing any of these medicines belong with a licensed healthcare provider.

What is semaglutide and how many brands does it have?

Semaglutide is a GLP-1 receptor agonist. It copies the action of a gut hormone that helps control blood sugar and appetite. One molecule, several brands:

Brand	Form	First FDA approval	What it is approved to do
Ozempic	Once-weekly injection	December 5, 2017 [1]	Type 2 diabetes, cardiovascular risk reduction, chronic kidney disease in type 2 diabetes [2]
Rybelsus	Daily tablet (3/7/14 mg)	September 20, 2019 [3]	Type 2 diabetes, cardiovascular risk reduction [3]
Wegovy	Once-weekly injection	June 4, 2021 [5]	Chronic weight management, cardiovascular risk reduction, noncirrhotic MASH [6]
Rybelsus R2, renamed Ozempic tablets	Daily tablet (1.5/4/9 mg)	December 9, 2024, renamed January 30, 2026 [17][7]	Type 2 diabetes, cardiovascular risk reduction [2]
Wegovy tablets (“Wegovy pill”)	Daily tablet (1.5/4/9/25 mg)	December 22, 2025 [11][21]	Chronic weight management, cardiovascular risk reduction [6]
Wegovy HD	Once-weekly 7.2 mg injection	March 19, 2026 [10]	Chronic weight management, higher maintenance dose [10]

The important thing to hold onto: the brand name tells you the approved use, not the ingredient. Ozempic and Wegovy are both semaglutide. They are not interchangeable, they come in different pens, and insurance treats them very differently.

Semaglutide is also completely separate from tirzepatide (Mounjaro and Zepbound) and liraglutide (Victoza and Saxenda). Those are different molecules with their own approval histories.

When did the FDA approve Ozempic?

December 5, 2017. The FDA approved Ozempic under New Drug Application 209637 as an adjunct to diet and exercise to improve blood sugar control in adults with type 2 diabetes [1].

Seven weeks earlier, on October 18, 2017, the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee had voted 16 to 0 in favor of approval [2]. Unanimous advisory committee votes are not common, and this one signaled that the agency saw little controversy in the core diabetes data.

The 2017 label already carried the boxed warning that every semaglutide product still carries today: in rodents, semaglutide causes thyroid C-cell tumors at clinically relevant exposures. Whether it does the same in humans is unknown. The drugs are contraindicated in people with a personal or family history of medullary thyroid carcinoma, or with Multiple Endocrine Neoplasia syndrome type 2 [16].

What happened next: the diabetes-era approvals

September 20, 2019 — Rybelsus. The FDA approved oral semaglutide tablets under NDA 213051 [3]. This was genuinely new. GLP-1 drugs are peptides, and peptides are usually destroyed in the stomach. Rybelsus uses an absorption enhancer to get semaglutide into the bloodstream, which is why the label says to take it on an empty stomach with a small sip of water.

January 16, 2020 — heart protection in diabetes. The FDA approved a supplement (NDA 209637/S-003) letting Ozempic be used to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes and established heart disease, based on the SUSTAIN 6 outcomes trial [4].

March 28, 2022 — Ozempic 2 mg. A higher weekly maintenance dose was approved for blood sugar control [2].

January 12, 2023 — Rybelsus moves to first line. A label update removed language that had positioned oral semaglutide behind other type 2 diabetes treatments [3].

When was Wegovy approved for weight loss?

June 4, 2021. The FDA approved Wegovy, semaglutide 2.4 mg once weekly, for chronic weight management in adults with a BMI of 30 or higher, or 27 or higher with at least one weight-related condition [5]. It was the first new chronic weight management drug the agency had approved since 2014.

December 23, 2022 brought the first big expansion: Wegovy was approved for pediatric patients aged 12 years and older with obesity, based on the STEP TEENS trial [20]. A second adolescent maintenance dose of 1.7 mg was added on November 27, 2024 [6].

Why does the Wegovy heart indication matter so much?

March 8, 2024. The FDA approved Wegovy to reduce the risk of cardiovascular death, non-fatal heart attack and non-fatal stroke in adults with established cardiovascular disease and either obesity or overweight [14]. It was the first treatment approved to reduce serious heart problems specifically in this population.

This was not only a clinical milestone. Medicare Part D is barred by statute from covering drugs used for weight loss alone. A cardiovascular indication gave plans a legal basis to cover Wegovy for some beneficiaries. If you have ever wondered why the March 2024 date comes up in every insurance conversation, that is why.

What other conditions is semaglutide approved for now?

January 28, 2025 — chronic kidney disease. The FDA approved Ozempic to reduce the risk of worsening kidney disease, kidney failure and cardiovascular death in adults with type 2 diabetes and chronic kidney disease. The FLOW trial found a 24% relative risk reduction on those combined outcomes compared with placebo, on top of standard care [15].

August 15, 2025 — liver disease. Wegovy received accelerated approval for adults with noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH) and moderate to advanced fibrosis, described on the label as stages F2 to F3 [12]. It is the first GLP-1 receptor agonist approved for MASH.

“Accelerated approval” is worth understanding. It means the FDA cleared the drug based on a measurement that is expected to predict real benefit, in this case improvement in liver inflammation and scarring on biopsy, rather than on hard outcomes like liver failure or death. The Wegovy label states plainly that continued approval for this use “may be contingent upon the verification and description of clinical benefit in a confirmatory trial” [16]. That confirmatory work is the second part of the ESSENCE study.

October 17, 2025 — heart protection from a pill. The FDA approved oral semaglutide to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes at high risk, based on the SOUL trial [3]. It made semaglutide the first GLP-1 in pill form with a cardiovascular outcomes claim.

What changed in 2026?

Three things, and they are easy to mix up.

December 22, 2025 — the Wegovy pill. The FDA approved once-daily oral semaglutide 25 mg for chronic weight management and cardiovascular risk reduction in adults, filed as its own application, NDA 218316 [11][21]. It is the first GLP-1 pill approved for weight management. In the OASIS 4 trial, participants who stayed on treatment lost an average of 16.6% of body weight, and about one in three lost 20% or more [11]. Novo Nordisk launched it in the United States in early January 2026.

January 30, 2026 — Rybelsus becomes Ozempic tablets. The FDA approved a supplement changing the proprietary name of the newer oral semaglutide formulation (the 1.5 mg, 4 mg and 9 mg tablets first approved December 9, 2024) from Rybelsus to Ozempic tablets [7][17]. Novo Nordisk announced the change publicly on February 4, 2026, and the tablets became available nationwide on May 4, 2026 [8][9].

Nothing about the medicine changed. The company’s stated reason was brand recognition: patients know the name Ozempic. The practical effect is that “Ozempic” now refers to both an injection and a tablet, and “Rybelsus” refers to the older 3/7/14 mg tablets. If a prescription, a pharmacy label or an insurance document is ambiguous, ask.

March 19, 2026 — Wegovy HD 7.2 mg. The FDA approved a higher 7.2 mg once-weekly dose for adults with obesity who have already tolerated 2.4 mg for at least four weeks [10]. Two details stand out. First, the review took 54 days from filing rather than the usual 10 to 12 months, because the application used the Commissioner’s National Priority Voucher pilot program. Second, the FDA’s own announcement noted that reports of altered skin sensation, described as sensitivity, pain or burning, were common and occurred more often at the higher dose, generally resolving on their own or with a dose reduction, and that “the FDA is currently conducting further investigations regarding this drug reaction” [10].

What is the Commissioner’s National Priority Voucher program?

It is an FDA pilot that gives selected applications enhanced communication with reviewers and rolling review, which compresses the review clock dramatically. Wegovy HD was the fourth product approved under it [10]. The program is aimed at applications the agency says advance national health priorities, including unmet need, domestic manufacturing and affordability. FDA said it would hold a public hearing on the pilot in June 2026 [10].

Fast review is not the same as a lower evidence bar, but it is a real change in how these decisions get made, and it is worth knowing about when you read that a drug was approved “in weeks.”

Where do tirzepatide and orforglipron fit in?

Semaglutide does not exist in a vacuum, and the FDA has been busy across the whole class:

• Mounjaro (tirzepatide) was approved May 13, 2022 for type 2 diabetes, and Zepbound (tirzepatide) on November 8, 2023 for chronic weight management. Zepbound added obstructive sleep apnea on December 20, 2024, and Mounjaro added a cardiovascular risk reduction indication on August 28, 2026.
• Foundayo (orforglipron) was approved April 1, 2026 as the first oral small-molecule GLP-1 receptor agonist for chronic weight management. Unlike oral semaglutide it can be taken at any time of day, with or without food or water [18].
• CagriSema, a fixed-dose combination of cagrilintide and semaglutide, was submitted to the FDA on December 18, 2025 [19]. As of September 14, 2026 no approval had been announced. Novo Nordisk has said it expects an FDA decision in 2026; no PDUFA date has been made public, so treat any specific date you see online as an estimate.

These are separate molecules with separate labels. A pharmacist cannot substitute one for another, and comparisons between them should always name the specific drug and dose.

What has semaglutide not been approved for?

Plenty. The clearest example: on November 24, 2025 Novo Nordisk reported that the evoke and evoke+ trials, covering 3,808 adults with early symptomatic Alzheimer’s disease, did not show that oral semaglutide slowed disease progression [13]. No Alzheimer’s application was filed anywhere.

Headlines about GLP-1 drugs and addiction, fertility, cancer prevention or other conditions usually describe early research, not approvals. The reliable test is simple: if it is an approved use, it appears in the Indications and Usage section at the top of the prescribing information [16].

How can I check any of this myself?

Three free, public tools:

1. Drugs@FDA. Search a brand name and you get every approval action, with dates and links to the actual approval letters and labels. Ozempic is NDA 209637, Rybelsus and Ozempic tablets are NDA 213051, Wegovy injection is NDA 215256 and Wegovy tablets are NDA 218316.
2. The prescribing information. The Indications and Usage section lists exactly what the drug is approved to treat. A “Recent Major Changes” box near the top shows what the FDA changed and when. The current combined Wegovy label, for example, records that the suicidal behavior and ideation warning was removed in 01/2026 [16].
3. ClinicalTrials.gov. Each approval traces to named trials. SELECT is NCT03574597, FLOW is NCT03819153, ESSENCE is NCT04822181, OASIS 4 is NCT05564117 and STEP UP is NCT05646706.

If you are trying to work out whether a specific product is legitimate and approved, those three sources will settle it faster than any marketing page. And for any question about whether a medicine is right for you, that conversation belongs with your own healthcare provider.

Sources

1. Drugs@FDA record for NDA 209637 (Ozempic)
2. Ozempic FDA Approval History, Drugs.com
3. Drugs@FDA record for NDA 213051 (Rybelsus / Ozempic tablets)
4. FDA approval letter, NDA 209637/S-003
5. Drugs@FDA record for NDA 215256 (Wegovy injection)
6. Wegovy FDA Approval History, Drugs.com
7. FDA approval letter, NDA 213051/S-030
8. Novo Nordisk Rebrands Rybelsus as Ozempic, HCPLive
9. Ozempic tablets available nationwide starting May 4, MPR
10. FDA Approves Fourth Product Under National Priority Voucher Program, Higher Dose Semaglutide
11. Wegovy pill approved in the US as first oral GLP-1 for weight management, Novo Nordisk
12. Wegovy approved by FDA for noncirrhotic MASH with moderate to advanced liver fibrosis
13. Novo Nordisk Form 6-K: evoke and evoke+ topline results
14. FDA Approves First Treatment to Reduce Risk of Serious Heart Problems Specifically in Adults with Obesity or Overweight
15. FDA approves Ozempic for chronic kidney disease in type 2 diabetes
16. Wegovy injection and tablets prescribing information
17. FDA approval letter, NDA 213051/S-020, S-021
18. FDA approves Lilly’s Foundayo (orforglipron)
19. Novo Nordisk files for FDA approval of CagriSema
20. FDA approval letter, NDA 215256/S-005
21. Drugs@FDA record for NDA 218316 (Wegovy tablets)