Semaglutide: A Year-by-Year History

Semaglutide went from a once-weekly diabetes injection almost nobody had heard of to one of the most talked-about medicines in the world in under a decade. If you have been trying to keep track of which brand does what, which approval came when, and why the price keeps changing, this is the timeline.

A quick note before we start: this page describes what happened and when. It is not medical advice, and it does not tell you whether any of these medicines are right for you. That is a conversation for you and a healthcare provider.

What is semaglutide, in one paragraph?

Semaglutide is a GLP-1 receptor agonist. It copies a natural gut hormone that tells your brain you have had enough to eat and helps the pancreas release insulin when blood sugar is high. Novo Nordisk sells it under several brand names: Ozempic (injection and, since 2026, tablets) for type 2 diabetes, Wegovy (injection, high-dose injection and tablets) for weight management, and Rybelsus, the original oral diabetes tablet, whose US brand was retired in 2026 in favor of a reformulated Ozempic tablet and which is still sold outside the US [1][2][3]. Tirzepatide, sold as Mounjaro and Zepbound by Eli Lilly, is a different molecule and is not interchangeable with semaglutide.

2016 to 2017: How did semaglutide get approved?

Novo Nordisk filed once-weekly semaglutide with the FDA on December 5, 2016, on the back of the SUSTAIN trial program [1]. An FDA advisory committee voted 16-0 in favor in October 2017, and the agency approved Ozempic for type 2 diabetes on December 5, 2017 [1]. The label carried a boxed warning for thyroid C-cell tumors, which every semaglutide product has carried since.

Ozempic reached US pharmacies in early 2018. Doctors soon noticed something the label did not mention prominently: patients were losing meaningful amounts of weight. Novo started the STEP phase 3 program to test a higher dose specifically for obesity.

2019 to 2020: What came next after the injection?

On September 20, 2019 the FDA approved Rybelsus, a semaglutide tablet and the first oral GLP-1 of any kind [3]. It worked, but it came with instructions that were easy to get wrong: take it on an empty stomach with no more than 4 ounces of plain water, then wait 30 minutes before eating, drinking or taking anything else.

In January 2020 the FDA added a cardiovascular indication to Ozempic, allowing it to be used to reduce the risk of heart attack, stroke and cardiovascular death in adults with type 2 diabetes and known heart disease [1].

2021: When was Wegovy approved?

The STEP 1 trial, published in February 2021, showed adults with obesity lost an average of 14.9% of their body weight over 68 weeks on semaglutide 2.4 mg, against 2.4% on placebo. On June 4, 2021 the FDA approved Wegovy for chronic weight management [2]. It was the first genuinely new obesity drug in years and the first semaglutide product aimed at weight rather than blood sugar.

Wegovy launched at a US list price that has stayed at $1,349.02 per package. At the time, almost no insurance plan covered obesity drugs, so most people faced the full amount.

2022: Why was Ozempic so hard to get?

Demand ran ahead of supply almost immediately. The FDA added Wegovy to its drug shortage list in March 2022 and Ozempic in August 2022 [4]. That listing mattered far beyond the pharmacy counter: under federal law, a shortage lets compounding pharmacies make their own versions of a drug. A whole industry grew up in that gap, sold largely through telehealth websites.

Two other things happened in 2022. In May the FDA approved Eli Lilly’s Mounjaro (tirzepatide) for type 2 diabetes, creating the rivalry that has defined the market since. And in December the FDA extended Wegovy to adolescents aged 12 and older [2].

Meanwhile “Ozempic” became a word people used at dinner parties. Social media, celebrity speculation and coverage of off-label use turned a diabetes drug into a cultural shorthand for rapid weight loss.

2023: What changed the argument about obesity drugs?

August 2023 was the turning point. Novo Nordisk announced that in the SELECT trial, semaglutide 2.4 mg cut the risk of heart attack, stroke or cardiovascular death by 20% in adults with overweight or obesity and established heart disease, none of whom had diabetes [2]. Full results landed at the American Heart Association meeting and in the New England Journal of Medicine that November.

That single result reframed obesity medicine as cardiovascular medicine, and it gave insurers a reason to cover a drug they had been resisting.

2023 also brought the first enforcement: the FDA warned in May that some compounded semaglutide contained salt forms of the drug rather than semaglutide itself, and Novo Nordisk began suing med spas, clinics and compounding pharmacies in June. Counterfeit Ozempic pens turned up in the legitimate US supply chain for the first time that same month. In November the FDA approved Lilly’s Zepbound for obesity, with about 20.9% average weight loss in its SURMOUNT-1 trial.

2024: What did the data show beyond weight?

2024 was the year the evidence broadened. In March, Novo reported that the FLOW trial showed semaglutide slowed kidney disease progression in people with type 2 diabetes and chronic kidney disease. That same month the FDA approved Wegovy to reduce cardiovascular risk [2], which for the first time gave Medicare Part D plans a legal path to cover a semaglutide product for people who also had obesity.

In October, the SOUL trial showed oral semaglutide cut major cardiovascular events by 14% in high-risk type 2 diabetes, and the STEP 9 trial published in the New England Journal of Medicine showed semaglutide reduced knee osteoarthritis pain alongside about 10.5% more weight loss than placebo.

On the safety side, researchers at Massachusetts Eye and Ear reported a link between semaglutide and NAION, a rare form of sudden vision loss. Separately, both the FDA and the European Medicines Agency finished reviews into reports of suicidal thoughts and concluded the evidence did not support a causal link.

Business-wise, Novo Holdings agreed in February to buy contract manufacturer Catalent for $16.5 billion and hand three fill-finish plants to Novo Nordisk, a direct attempt to fix the supply problem. The deal closed in December. By October 31, 2024 the FDA listed both Ozempic and Wegovy as available.

Also in December, the first phase 3 readout for CagriSema, Novo’s combination of semaglutide and the amylin analog cagrilintide, landed below what analysts expected, and the shares fell hard. It was an early sign of the year to come.

2025: Why was this the hardest year for Novo Nordisk?

Start with the good news. In January the FDA approved Ozempic for chronic kidney disease in type 2 diabetes [1]. In August it granted accelerated approval for Wegovy to treat noncirrhotic MASH, a serious liver disease, making it the first GLP-1 with a liver indication [5]. In October, Rybelsus gained a cardiovascular indication [3].

Now the rest. On February 21, 2025 the FDA declared the semaglutide shortage resolved, giving compounding pharmacies until April 22 and outsourcing facilities until May 22 to stop making copies [4]. That set off a year of legal fights.

In March, Novo opened NovoCare Pharmacy selling Wegovy directly to cash-paying patients for $499 a month, then cut Ozempic to the same price in August. In May, CVS Caremark made Wegovy its preferred obesity GLP-1 and dropped Zepbound from its main formularies, affecting an estimated 200,000 patients.

Then the company itself came apart. On May 16 the board ousted chief executive Lars Fruergaard Jorgensen after a collapsing share price [8]. Maziar Mike Doustdar took over in August and announced 9,000 job cuts in September, the largest layoff in Danish corporate history. In October the chair and several independent directors resigned over governance disagreements, and in November the Novo Nordisk Foundation installed former chief executive Lars Rebien Sorensen as chair at an extraordinary general meeting.

November also brought the most consequential policy change of the decade. On November 6 the White House announced most-favored-nation pricing deals with Novo Nordisk and Eli Lilly, setting Medicare and Medicaid prices for GLP-1 drugs at $245 a month with a $50 patient copay, cash prices starting near $350 on a new government site called TrumpRx, and starting doses of the coming pills at about $149 [9]. For the first time, Medicare would cover obesity treatment.

Two weeks later came the year’s biggest scientific disappointment: the EVOKE and EVOKE+ trials of oral semaglutide in early Alzheimer’s disease missed their primary endpoint in 3,808 adults, and Novo ended the program [11].

The year closed on a high note. On December 22 the FDA approved the Wegovy pill, once-daily oral semaglutide 25 mg, the first GLP-1 pill approved anywhere for weight loss [6].

2026: What has happened so far this year?

The Wegovy pill launched on January 5 at $149 a month for starter doses and quickly became one of the fastest US pharmaceutical launches by volume, passing three million prescriptions by early June. Novo says more than 80% of new pill prescriptions were for people new to GLP-1 therapy, based on the company’s own prescription data.

Then the bill arrived. On February 3 Novo Nordisk guided to an adjusted 2026 sales decline of 5% to 13% at constant exchange rates, far worse than the roughly 2% decline analysts expected, citing “unprecedented” US pricing pressure. The shares fell about 16% the next day. Three weeks later the company said it would cut US list prices for Wegovy, Ozempic and Rybelsus to $675 a month from January 1, 2027, a roughly 50% cut for Wegovy.

Regulators moved fast in both directions. On March 5 the FDA sent Novo Nordisk a warning letter over failures in reporting adverse events, including three unreported deaths among semaglutide patients, one of them a suicide, though the letter did not link the deaths to the drug. On March 19 the same agency approved Wegovy HD, a 7.2 mg dose, just 54 days after filing under a new priority voucher pilot [7]. Two weeks later it approved Eli Lilly’s orforglipron pill, Foundayo.

Patents started falling abroad. Canada in January, India in March, then China and Brazil, part of a first wave covering eight markets [10]. US protection runs to roughly 2032.

On July 1 the Medicare GLP-1 Bridge went live, letting eligible Part D enrollees get Wegovy injections and tablets, the Zepbound KwikPen or Foundayo tablets for a flat $50 a month through the end of 2027. And on September 7 Novo reported that in the STEP Young trial, in 165 children, 40.4% of children aged 6 to under 12 were no longer classified as having obesity after 68 weeks on semaglutide, assuming full adherence, against none on placebo [12].

What should you take away from all this?

Three things. First, semaglutide is no longer one drug with one purpose: its label now covers diabetes, heart risk, kidney disease, weight, and liver disease, which is broader than any competitor. Second, the price you see depends entirely on which door you walk through, and those doors keep changing. Third, the competitive picture has shifted: Eli Lilly’s tirzepatide leads on US prescriptions, and a triple-hormone drug called retatrutide has posted larger weight-loss numbers in trials than anything semaglutide has produced.

If you are weighing any of this for yourself, the useful next step is a conversation with a healthcare provider about your own health history, not a headline.

Sources

1. Ozempic (semaglutide) FDA Approval History — Drugs.com
2. Wegovy (semaglutide) FDA Approval History — Drugs.com
3. Rybelsus (semaglutide) FDA Approval History — Drugs.com
4. Declaratory Order: Resolution of Shortages of Semaglutide Injection Products — FDA
5. FDA Approves Treatment for Serious Liver Disease Known as ‘MASH’ — FDA
6. FDA approves Novo Nordisk’s Wegovy pill — PR Newswire
7. FDA Approves Fourth Product Under National Priority Voucher Program, Higher Dose Semaglutide — FDA
8. Novo Nordisk ousts CEO after falling behind in weight loss market — Reuters
9. Trump announces deals with Eli Lilly, Novo Nordisk to slash weight loss drug prices — CNBC
10. Your Questions Answered: Off-patent Semaglutide in 2026 — IQVIA
11. Novo Nordisk A/S: evoke phase 3 trials did not demonstrate a statistically significant reduction in Alzheimer’s disease progression — GlobeNewswire
12. Novo Nordisk says semaglutide cut obesity rates in young children in trial — Reuters