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When Did Ozempic Come Out?

Ozempic was approved by the FDA on 5 December 2017, for type 2 diabetes — not for weight loss. The full semaglutide approval timeline, every date read off the FDA's own application records.

Written by , who builds and maintains this site and is not a clinician. Every figure links to its primary source. · Last reviewed

Ozempic was approved by the FDA on 5 December 2017 — more than 8 years on the US market. It was approved for type 2 diabetes. It was not approved for weight loss; that is Wegovy, and it arrived three and a half years later.

Nearly every date attached to this drug online is a different event than the one being asked about, so the table below separates them. Each row comes from the FDA’s own application record for the relevant submission, not from press coverage of it.

The semaglutide approval timeline

DateWhat was approved
5 Dec 2017Ozempic injection approvedNDA 209637, classified by FDA as a type 1 new molecular entity. Type 2 diabetes, up to 1 mg weekly.
20 Sep 2019Rybelsus tablets approvedNDA 213051, a type 3 new dosage form — the same molecule taken orally, at 3, 7 and 14 mg.
16 Jan 2020Ozempic gains a cardiovascular indicationReduction in the risk of major adverse cardiovascular events in adults with type 2 diabetes and established cardiovascular disease, on the SUSTAIN 6 outcomes trial.
4 Jun 2021Wegovy approved — the first semaglutide for weight managementNDA 215256, filed as a new indication in its own application rather than as a supplement to Ozempic.
28 Mar 2022Ozempic 2 mg strength approvedThe dose ceiling for the diabetes brand doubles from 1 mg to 2 mg weekly.
23 Dec 2022Wegovy extended to adolescentsChronic weight management in patients aged 12 and older at or above the 95th BMI percentile, on the STEP TEENS trial.
8 Mar 2024Wegovy gains a cardiovascular indicationReduction of the risk of cardiovascular death, heart attack and stroke in adults with cardiovascular disease and either obesity or overweight.
9 Dec 2024Higher oral strengths approved1.5 mg, 4 mg and 9 mg tablets added to the oral application; the Orange Book lists them under the brand name Ozempic.
28 Jan 2025Ozempic gains a kidney indicationReduction in the risk of sustained eGFR decline, end-stage kidney disease and cardiovascular death in adults with type 2 diabetes and chronic kidney disease.
15 Aug 2025Wegovy gains a MASH indicationNoncirrhotic metabolic dysfunction-associated steatohepatitis with stage F2–F3 fibrosis, granted under accelerated approval.
22 Dec 2025Wegovy tablets approvedNDA 218316, a type 3 new dosage form at 1.5, 4, 9 and 25 mg — oral semaglutide for weight management.
19 Mar 2026The 7.2 mg dose approvedA new Wegovy injection 7.2 mg weekly dose for weight reduction and long-term maintenance, sold as Wegovy HD.
18 Jun 2026Multi-dose Wegovy pen approvedA 9.6 mg/3 mL FlexTouch presentation — a delivery change, not a new dose or indication.

Dates are the FDA approval dates recorded in Drugs@FDA and, for individual strengths, in the Orange Book product file. Labelling-only supplements are left out; there have been many.

How long has Ozempic been on the market?

More than 8 years in the United States, counting from the approval date. Approval and availability are not quite the same thing — a drug is approved before it ships — but for semaglutide the gap was short: Health Canada’s database records Ozempic as marketed there from 22 February 2018, about eleven weeks after the FDA approval.

For comparison, the drug it is usually measured against is younger. Mounjaro (tirzepatide) was approved 13 May 2022 and Zepbound 8 November 2023, so Ozempic had four and a half years of market alone before a dual-agonist arrived. Why that does not make the doses interchangeable.

Ozempic was never approved for weight loss

This is the single most useful thing on the page. The 2017 approval was for type 2 diabetes. Weight reduction arrived as a separate product with a separate application — Wegovy, 4 June 2021 — filed as a new indication in its own right rather than as a supplement to the diabetes label. Same molecule, higher ceiling, different label.

That is why prescriptions of Ozempic for weight loss are off-label prescriptions, and why the two brands have diverged since: Ozempic has added cardiovascular and kidney indications, Wegovy has added cardiovascular and liver ones. The full brand-by-brand breakdown, including the tablets.

How long has semaglutide been around?

As a medicine anyone could be prescribed, the answer is the same one: since 5 December 2017. Ozempic is semaglutide’s first approval anywhere in the FDA record, and everything since has been a new dose, form or indication of the same molecule.

Before that it was an investigational compound, and this page does not publish a date for when it was first synthesised or first dosed in a human, because no primary document was found that states one. The oldest verifiable marker is indirect: the substance patent listed against every semaglutide application in the Orange Book, US 8,129,343, runs to 5 December 2031, and a US patent term is granted long before the drug reaches a pharmacy.

What changed most recently

Two things worth knowing if your information is more than a year old. Semaglutide now exists as a weight-management tablet — Wegovy tablets, approved 22 December 2025 at up to 25 mg daily — and the injection ceiling has moved: the 7.2 mg weekly dose approved 19 March 2026 is three times the 2.4 mg that STEP 1 and most of the published trial literature used.

The 7.2 mg dose is reached only after at least four more weeks of tolerating 2.4 mg, which puts it a long way down the escalation schedule. The full titration timetable and what happens at each step.

Related

Common questions

Sources

Every number on this page comes from one of the documents below. Where no reliable source exists, the page says so instead of filling the gap.

  1. RegulatorFDA / CDER· 2026-09
    Drugs@FDA — application and approval records for semaglutide (NDA 209637, 213051, 215256, 218316) and tirzepatide (NDA 215866, 217806)
  2. RegulatorFDA· 2026-09
    Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) — product, patent and exclusivity data files
  3. RegulatorFDA· 2024-03-08
    FDA Approves First Treatment to Reduce Risk of Serious Heart Problems Specifically in Adults with Obesity or Overweight
  4. FDA labelFDA / DailyMed· 2026-05
    OZEMPIC (semaglutide) injection — FDA prescribing information
  5. FDA labelFDA· 2026-03
    WEGOVY (semaglutide) injection and tablets — FDA prescribing information
  6. FDA labelFDA / DailyMed
    RYBELSUS / OZEMPIC (semaglutide) tablets — FDA prescribing information
  7. FDA labelFDA / DailyMed· 2026-08
    MOUNJARO (tirzepatide) injection — FDA prescribing information
  8. FDA labelFDA / DailyMed· 2026-08
    ZEPBOUND (tirzepatide) injection — FDA prescribing information
  9. RegulatorHealth Canada· 2026-09
    Drug Product Database — semaglutide product, marketing status and active ingredient records