FDA Approval History of Semaglutide: Every Date, Explained

The FDA has approved semaglutide under three brand names across two dosage forms, with the first approval on December 5, 2017 (Ozempic injection) and the most recent on March 19, 2026 (Wegovy HD 7.2 mg injection) ^[2]. In between came Rybelsus tablets on September 20, 2019, Wegovy injection on June 4, 2021, the reformulated oral tablet on December 9, 2024, and the Wegovy pill on December 22, 2025 ^[2]. The oral diabetes pill was renamed from Rybelsus to Ozempic tablets by an FDA approval letter signed January 30, 2026 ^[7].

All of these products contain the same active ingredient, semaglutide, made by Novo Nordisk, but each approval covers a different brand name, dosage form, and patient population ^[2]. The table below shows each product, when it was first approved, and what the FDA has approved it for as of the most recent label updates ^[2].

Product	First FDA approval	Dosage forms	Current approved uses
Ozempic (injection)	December 5, 2017	2 mg/3 mL pen (0.25 or 0.5 mg doses), 4 mg/3 mL pen (1 mg), 8 mg/3 mL pen (2 mg)	Type 2 diabetes; cardiovascular risk reduction in T2D; kidney risk reduction in T2D with CKD
Rybelsus (tablets)	September 20, 2019	3 mg, 7 mg, 14 mg	Type 2 diabetes; cardiovascular risk reduction in T2D
Wegovy (injection)	June 4, 2021	0.25, 0.5, 1, 1.7, 2.4 mg pens	Weight reduction; cardiovascular risk reduction in obesity or overweight; noncirrhotic MASH
Rybelsus R2 (tablets)	December 9, 2024	1.5 mg, 4 mg, 9 mg	Type 2 diabetes; cardiovascular risk reduction in T2D
Wegovy (tablets)	December 22, 2025	1.5 mg, 4 mg, 9 mg, 25 mg	Weight reduction; cardiovascular risk reduction in obesity or overweight
Ozempic (tablets)	January 30, 2026 (rename of Rybelsus R2)	1.5 mg, 4 mg, 9 mg	Type 2 diabetes; cardiovascular risk reduction in T2D
Wegovy HD (injection)	March 19, 2026	7.2 mg pen	Weight reduction and maintenance in adults with obesity, or overweight with a weight-related condition

All of these dates come from published FDA approval letters, FDA press announcements, and the Drugs.com approval-history pages, and you can check each one yourself using the application numbers listed at the end of this page ^{[2] [4] [7] [10] [20]}.

When was Ozempic approved by the FDA, and what came before it?

Ozempic injection was approved on December 5, 2017, as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes, under application NDA 209637 ^{[2] [4]}. The road to that approval began a year earlier, when Novo Nordisk filed its new drug application for once-weekly semaglutide with the FDA on December 5, 2016 ^[2]. On October 18, 2017, an FDA advisory committee voted 16-0 in favor of approval ^[2].

The original approval came with a boxed warning about thyroid C-cell tumors, based on findings in rodent studies, and the drug is contraindicated in people with a personal or family history of medullary thyroid carcinoma or with Multiple Endocrine Neoplasia syndrome type 2 ^{[2] [16]}. The label lists pen strengths of 2 mg/3 mL (delivering 0.25 or 0.5 mg doses), 4 mg/3 mL (1 mg), and 8 mg/3 mL (2 mg) ^[2].

What is Ozempic approved for today?

Ozempic injection now carries three approved uses: improving glycemic control in adults with type 2 diabetes; reducing the risk of major adverse cardiovascular events in adults with type 2 diabetes and established cardiovascular disease; and reducing the risk of sustained eGFR decline, end-stage kidney disease, and cardiovascular death in adults with type 2 diabetes and chronic kidney disease ^[2].

The cardiovascular indication was added on January 16, 2020, through supplement NDA 209637/S-003, which had been submitted on March 20, 2019 ^{[4] [2]}. The approval letter states that the labeling revision was based on the results of the SUSTAIN 6 cardiovascular outcomes trial ^[4].

A higher 2 mg maintenance dose of Ozempic was approved on March 28, 2022 ^[2]. The kidney indication followed on January 28, 2025, based on the FLOW trial, which enrolled 3,533 adults with type 2 diabetes and chronic kidney disease across 28 countries ^{[15] [2]}. In FLOW, Ozempic 1 mg added to standard care produced a 24% relative risk reduction in kidney disease worsening, kidney failure, or cardiovascular death, a 4.9% absolute risk reduction at 3 years, and the trial was stopped early after a median follow-up of 3.4 years on the recommendation of an independent monitoring committee ^[15].

When was Rybelsus approved, and what made an oral GLP-1 possible?

Rybelsus was approved on September 20, 2019, under NDA 213051, as the first oral formulation of semaglutide, in 3 mg, 7 mg, and 14 mg tablets (the original formulation, called R1) ^{[2] [17]}. Its current approved uses are improving glycemic control in adults with type 2 diabetes and reducing the risk of major adverse cardiovascular events in adults with type 2 diabetes ^[2].

The tablets work orally because semaglutide is co-formulated with an absorption enhancer called SNAC (salcaprozate sodium) ^{[17] [8]}. Because of that enhancer, the pill must be taken with no more than four ounces of water and separated from other medications to optimize absorption ^{[17] [8]}. The daily dosing schedule reflects bioavailability limits, not fast clearance: oral semaglutide retains a half-life of about one week, comparable to the injectable formulations ^[8].

The September 20, 2019 approval letter also set a postmarketing requirement for a pediatric study in patients ages 10 to 17 with type 2 diabetes, with study completion due December 2026 and the final report due June 2027 ^[17].

What is the R2 formulation that later became Ozempic tablets?

On December 9, 2024, the FDA approved a reformulated version of oral semaglutide, called formulation R2, in 1.5 mg, 4 mg, and 9 mg strengths ^{[2] [9]}. Novo Nordisk describes the new formulation as a smaller pill that delivers the same efficacy and safety profile as the originally approved formulation ^[9].

The R2 approval came through two supplements to NDA 213051: S-020, received February 9, 2024, which added formulation R2, a new recommended dosage for it, switching guidance between formulations R1 and R2, and a new manufacturing site in Durham, North Carolina; and S-021, received June 6, 2024, which added lactation study results to the label ^[17]. During that same review, the FDA added dysesthesia and alopecia to the adverse reactions section and added a severe gastrointestinal adverse reactions warning to align the label with other GLP-1 receptor agonists ^[17].

When was Wegovy approved for weight management?

Wegovy 2.4 mg once-weekly injection was first approved on June 4, 2021, under NDA 215256, for chronic weight management ^{[6] [20]}. The current weight indication covers adults and pediatric patients aged 12 and older with obesity, and adults with overweight who have at least one weight-related comorbid condition, always alongside a reduced-calorie diet and increased physical activity ^{[6] [16]}.

The pediatric expansion came through supplement S-005, received June 29, 2022, and approved December 23, 2022, adding patients aged 12 and older with an initial BMI at the 95th percentile or greater for age and sex ^[20]. The approval was based on the STEP TEENS trial, a 68-week placebo-controlled study in patients ages 12 to under 18, which fulfilled a postmarketing requirement set in the original June 4, 2021 approval letter ^[20].

The label carries a limitation of use: Wegovy injection or tablets should not be used together with other semaglutide-containing products or with any other GLP-1 receptor agonist ^{[6] [16]}.

When did Wegovy get its cardiovascular indication, and why was it a first?

On March 8, 2024, the FDA approved Wegovy to reduce the risk of cardiovascular death, heart attack, and stroke in adults with established cardiovascular disease and either obesity or overweight ^{[14] [6]}. The FDA described it as the first weight-loss medication also approved to help prevent life-threatening cardiovascular events in this population, and the application received Priority Review ^[14].

The supporting trial randomly assigned over 17,600 participants to Wegovy or placebo on top of standard-of-care treatment; major adverse cardiovascular events occurred in 6.5% of the Wegovy group versus 8% of the placebo group ^[14]. That trial was named SELECT ^[11].

What does the accelerated approval for MASH mean?

On August 15, 2025, Wegovy 2.4 mg injection received accelerated approval for the treatment of noncirrhotic MASH (metabolic dysfunction-associated steatohepatitis) with moderate to advanced liver fibrosis, stages F2 to F3, in adults, making it the first GLP-1 receptor agonist approved for MASH ^{[12] [6]}.

Accelerated approval in this case was granted based on improvement of MASH and fibrosis, and the label states that continued approval for this indication may be contingent on verification and description of clinical benefit in a confirmatory trial ^{[16] [6] [12]}. That confirmatory work is ongoing: the ESSENCE trial randomized 1,197 participants 2:1 to semaglutide 2.4 mg or placebo for 240 weeks, and Part 2, which is still running, is measuring liver-related clinical events ^[12].

At week 72 in ESSENCE Part 1, 63% of people on Wegovy achieved resolution of steatohepatitis without worsening of fibrosis, versus 34% on placebo, and 37% achieved improvement in fibrosis without worsening of steatohepatitis, versus 22% on placebo ^[12].

When was the oral Wegovy pill approved?

The Wegovy pill, once-daily oral semaglutide 25 mg, was approved on December 22, 2025, for weight reduction and maintenance and for reducing the risk of major adverse cardiovascular events in adults ^{[11] [6]}. It was approved under a separate new drug application from the Wegovy injection ^[11].

It is the first oral GLP-1 receptor agonist approved for weight management, and the approval was based on the OASIS trial program plus the SELECT trial ^[11]. In OASIS 4, a 64-week trial in 307 adults with obesity or overweight plus at least one comorbidity, oral semaglutide 25 mg demonstrated 16.6% mean weight loss when treatment was adhered to, and one in three people lost 20% or more of their body weight ^[11].

The tablets come in 1.5 mg, 4 mg, 9 mg, and 25 mg strengths, with 25 mg as the labeled maintenance dose, taken once daily on an empty stomach ^{[16] [6]}. Novo Nordisk expected the US launch in early January 2026 ^[11]. The application number 218316 appears in the FDA label filename for Wegovy tablets ^[16].

Is Rybelsus now called Ozempic?

Yes. The FDA approval letter for supplement NDA 213051/S-030, submitted June 23, 2025, was signed January 30, 2026, and changed the product name from Rybelsus (formulation R2) to Ozempic (semaglutide) tablets ^[7]. Novo Nordisk announced the Ozempic pill on February 4, 2026, with US availability planned for Q2 2026 ^{[2] [8]}.

Ozempic tablets became available nationwide on May 4, 2026, in 1.5 mg, 4 mg, and 9 mg strengths ^[9]. The strengths are not mg-to-mg interchangeable with the old Rybelsus doses, and Rybelsus continues to be marketed outside the US ^[9]. Novo Nordisk said the name change is intended to help patients and clinicians more easily recognize the type 2 diabetes treatment options under one brand ^[9]. Clinicians interviewed about the change reported that uptake of Rybelsus had been perceived as modest, and that the Ozempic name has generated more patient interest ^{[8] [9]}.

Ozempic tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes, and to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes who are at high risk for these events ^{[2] [9]}.

What is Wegovy HD 7.2 mg?

Wegovy HD is a 7.2 mg weekly injection approved on March 19, 2026, to reduce excess body weight and maintain weight reduction long term in adults with obesity, or overweight with at least one weight-related condition ^{[10] [6]}. The FDA approved it just 54 days after filing, making it the fourth approval under the Commissioner’s National Priority Voucher pilot program ^[10].

Under that pilot, a selected company receives a voucher entitling it to enhanced communications and rolling review to shorten review time, and the program targets applications that address large unmet medical needs, promote domestic manufacturing, and increase affordability ^[10]. The FDA said it will hold a public hearing in June to gather feedback about the program ^[10].

The most common adverse reactions in the Wegovy HD data were gastrointestinal, and reports of altered skin sensation, described as sensitivity, pain, or burning, were common, occurred more frequently at the higher dose than at lower doses, and generally resolved on their own or with dose reduction; the FDA is conducting further investigations regarding this reaction ^[10]. The current Wegovy label lists Dosage and Administration changes dated 03/2026 in its Recent Major Changes box, and shows the Suicidal Behavior and Ideation warning removed as of 01/2026 ^[16].

What other GLP-1 decisions get confused with semaglutide approvals?

A few nearby decisions involve semaglutide or its competitors but are separate from the approval history above.

Foundayo (orforglipron), made by Lilly, is not semaglutide at all. It is a small-molecule, non-peptide GLP-1 pill approved on April 1, 2026, for adults with obesity or overweight with weight-related medical problems, and it can be taken any time of day without food or water restrictions ^[18]. In the ATTAIN-1 trial, adults on the highest dose lost an average of 12.4% of body weight when they stayed on treatment ^[18].

CagriSema is a fixed-dose combination of cagrilintide 2.4 mg and semaglutide 2.4 mg. Novo Nordisk submitted its NDA to the FDA on December 18, 2025, and the FDA is expected to review the application in 2026 ^[19]. In the REDEFINE 1 trial, adults on CagriSema lost an average of 20.4% of body weight regardless of whether they stayed on treatment, and 22.7% when evaluating the effect if all patients stayed on treatment ^[19].

On November 24, 2025, Novo Nordisk announced that the evoke and evoke+ phase 3 trials, which enrolled 3,808 adults with early symptomatic Alzheimer’s disease treated with oral semaglutide 14 mg, did not demonstrate a statistically significant reduction in disease progression on the CDR-SB score compared to placebo, and the one-year extension period was discontinued ^[13].

How can you verify an FDA approval date yourself?

Every approval in this history can be checked against primary FDA records using the application numbers. Ozempic injection is NDA 209637; Rybelsus and Ozempic tablets are NDA 213051; and Wegovy injection is NDA 215256 ^{[4] [7] [17] [20]}.

FDA approval letters state the supplement number, the submission date, and the effective date of approval, and the signature page at the end of each letter carries the signing date, which is the approval date ^{[4] [7] [20]}. For example, the letter for Ozempic’s cardiovascular supplement, NDA 209637/S-003, shows the electronic signature dated January 16, 2020 ^[4], and the letter renaming Rybelsus shows the signature dated January 30, 2026 ^[7].

The prescribing information for each product also carries verification clues. The Highlights section states the Initial U.S. Approval year, and the Recent Major Changes box lists each label section that changed along with the month and year of the change ^[16]. For example, the current Wegovy label shows Initial U.S. Approval: 2017, Indications and Usage changes dated 08/2025 and 12/2025, and Dosage and Administration changes dated 03/2026 ^[16].

Drugs.com maintains approval-history pages for Ozempic and Wegovy that list each approval event with its date, drawn from FDA records ^{[2] [6]}.

Sources

1. US Food and Drug Administration. Drugs@FDA record for NDA 209637.
2. Drugs.com. Ozempic (semaglutide) FDA Approval History. April 23, 2026.
3. US Food and Drug Administration. Drugs@FDA record for NDA 213051.
4. US Food and Drug Administration. Ozempic (semaglutide) injection approval letter (NDA 209637/S-003). 2020.
5. US Food and Drug Administration. Drugs@FDA record for NDA 215256.
6. Drugs.com. Wegovy (semaglutide) FDA Approval History. May 18, 2026.
7. US Food and Drug Administration. Ozempic (semaglutide) tablets and Rybelsus (semaglutide) tablets approval letter (NDA 213051/S-030). 2026.
8. HCPLive. Novo Nordisk Rebrands Rybelsus as Ozempic to Increase Patient Awareness. February 17, 2026.
9. MPR. Ozempic (Semaglutide) Tablets Available Nationwide Starting May 4. 2026.
10. US Food and Drug Administration. FDA Approves Fourth Product Under National Priority Voucher Program, Higher Dose Semaglutide.
11. Novo Nordisk. Wegovy pill approved in the US as first oral GLP-1 for weight management. December 22, 2025.
12. PR Newswire. Wegovy approved by FDA for the treatment of adults with noncirrhotic MASH with moderate to advanced liver fibrosis.
13. US Securities and Exchange Commission. Novo Nordisk A/S Form 6-K. November 24, 2025.
14. US Food and Drug Administration. FDA Approves First Treatment to Reduce Risk of Serious Heart Problems Specifically in Adults with Obesity or Overweight.
15. PR Newswire. FDA approves Ozempic (semaglutide) as the only GLP-1 RA to reduce the risk of worsening kidney disease and cardiovascular death in adults with type 2 diabetes and chronic kidney disease. January 28, 2025.
16. US Food and Drug Administration. Wegovy (semaglutide) prescribing information. 2026.
17. US Food and Drug Administration. Rybelsus (semaglutide) tablets approval letter (NDA 213051/S-020, S-021). 2024.
18. Eli Lilly and Company. FDA approves Lilly’s Foundayo (orforglipron), the only GLP-1 pill for weight loss that can be taken any time of day without food or water restrictions. April 1, 2026.
19. PR Newswire. Novo Nordisk files for FDA approval of CagriSema, the first once-weekly combination of GLP-1 and amylin analogues for weight management.
20. US Food and Drug Administration. Wegovy (semaglutide) injection approval letter (NDA 215256/S-005). 2022.
21. US Food and Drug Administration. Drugs@FDA record for NDA 218316.