History of Semaglutide in Timeline
Semaglutide is a medication primarily used to treat type 2 diabetes and obesity. It functions as a glucagon-like peptide-1 (GLP-1) receptor agonist. Administered via subcutaneous injection or orally, it is marketed by Novo Nordisk under the brand names Ozempic and Rybelsus for diabetes. The brand name Wegovy is used for weight management and to reduce the risk of major adverse cardiovascular events and the treatment of metabolic-associated steatohepatitis.
1988: Discovery of GLP-1's potency
In 1988, Jens Juul Holst and Joel Habener's research on hormones secreted during eating and testing them on pig pancreases led to the discovery of GLP-1's significant potency.
1993: GLP-1 infusion in people with type 2 diabetes
In 1993, Michael Nauck infused GLP-1 into people with type 2 diabetes, stimulating insulin, inhibiting glucagon, and normalizing blood glucose.
1998: Development of liraglutide
In 1998, Lotte Bjerre Knudsen led a Novo Nordisk team that developed liraglutide, a glucagon-like peptide-1 receptor agonist for treating diabetes.
June 2008: Phase II clinical trial of semaglutide began
In June 2008, a phase II clinical trial began studying semaglutide, a once-weekly diabetes therapy as a longer-acting alternative to liraglutide. It was given the brand name Ozempic.
2014: Meta-analysis found that semaglutide may be effective in lowering liver enzymes
In 2014, a meta-analysis found that semaglutide may be effective in lowering liver enzymes (transaminitis) and improving certain radiologically observed features of metabolic dysfunction–associated steatotic liver disease.
January 2016: Clinical trials started
In January 2016, clinical trials for semaglutide started.
December 2016: New drug application filed with the FDA
In December 2016, a new drug application for semaglutide was filed with the US Food and Drug Administration (FDA).
May 2017: Clinical trials ended
In May 2017, clinical trials for semaglutide ended.
October 2017: FDA advisory committee approved semaglutide unanimously
In October 2017, an FDA advisory committee approved semaglutide unanimously.
December 2017: Ozempic approved in the US
In December 2017, the injectable version of semaglutide, with the brand name Ozempic, was approved in the US for use by people with diabetes.
2017: FDA approval for medical use in the US
In 2017, Semaglutide was approved for medical use in the United States.
January 2018: Ozempic approved in Canada
In January 2018, Ozempic was approved in Canada.
February 2018: Ozempic authorized in the European Union
In February 2018, authorization was granted for Ozempic in the European Union.
March 2018: Ozempic authorized in Japan
In March 2018, authorization was granted for Ozempic in Japan.
August 2019: Ozempic approved in Australia
In August 2019, authorization was granted for Ozempic in Australia.
September 2019: Rybelsus approved in the US
In September 2019, Rybelsus, an oral version of semaglutide, was approved for medical use in the US.
2019: Meta-analysis on pancreatitis risk
In 2019, a meta-analysis did not indicate a significantly elevated risk of acute pancreatitis from GLP-1 medications.
April 2020: Rybelsus approved in the European Union
In April 2020, Rybelsus was approved in the European Union.
2020: Patent on the chemical structure of the drug expired
In 2020, Novo Nordisk failed to pay a required patent maintenance fee, and their patent on the chemical structure of the drug expired.
March 2021: Phase III trial results
In March 2021, a phase III randomized, double-blind trial showed that adults treated with once-weekly subcutaneous semaglutide experienced a mean body weight change of −14.9% compared to −2.4% with placebo at week 68.
June 2021: Wegovy approved by the FDA
In June 2021, Wegovy, a higher-dose version of semaglutide for injectable use, was approved by the FDA as an anti-obesity medication for long-term weight management in adults.
2021: Warren Alpert Foundation Prize awarded
In 2021, Jens Juul Holst, Joel Habener, and Daniel J. Drucker were awarded the Warren Alpert Foundation Prize for their work contributing to diabetes and obesity treatments.
January 2022: Wegovy approved in the European Union
In January 2022, Wegovy was approved for medical use in the European Union.
August 2022: FDA declared drug shortage for Ozempic and Wegovy
In August 2022, the FDA declared a shortage for Ozempic and Wegovy (but not Rybelsus), leading to compounded versions being prepared by compounding pharmacies.
2022: Semaglutide review of anti-obesity treatments
A 2022 review of anti-obesity treatments found that semaglutide and tirzepatide were more promising than previous anti-obesity drugs but less effective than bariatric surgery.
2022: Novo Nordisk added 3,500 jobs in Denmark
In 2022, Novo Nordisk added 3,500 jobs in Denmark, bringing the total in the country to 21,000 employees, out of 59,000 worldwide.
2022: High cost of Wegovy and Ozempic raises affordability concerns in the US
In 2022, Wegovy's list price reached $1,349.02 per month in the US, which raised concerns that the high cost may make it unaffordable for many people who could benefit from weight loss. High costs of Ozempic also prompted some insurance companies to investigate and refuse coverage for individuals with insufficient evidence to support a diabetes diagnosis, suspecting off-label prescribing for weight loss.
2022: Chinese court ruled patents invalid
In 2022, a Chinese court ruled that all patents on semaglutide were invalid "for reasons related to experimental data availability". However, this ruling was later overturned by the Supreme People's Court.
January 2023: Rybelsus label updated for first-line treatment
In January 2023, the US FDA prescription label for Rybelsus was updated to reflect that it can be used as a first-line treatment for adults with type 2 diabetes.
March 2023: People regained two-thirds of original weight loss one year after discontinuing semaglutide
In March 2023, a Novo Nordisk official said, based on a randomized, double-blind study (NCT03548935) funded by the company, that people using semaglutide to lose weight regained two-thirds of their original weight loss one year after discontinuing use of the drug.
July 2023: Icelandic Medicines Agency reports suicidal thoughts and self-injury in semaglutide users
In July 2023, the Icelandic Medicines Agency reported two cases of suicidal thoughts and one case of self-injury in users of semaglutide injection, prompting a safety assessment of Ozempic, Wegovy, Saxenda, and similar drugs.
October 2023: Counterfeit Ozempic pens reported in Europe
In October 2023, reports surfaced in Europe about counterfeit Ozempic pens being sold. These pens possibly contained insulin, leading to the hospitalization of several individuals due to hypoglycemia and seizures.
December 2023: US FDA issues warning about counterfeit Ozempic
In December 2023, the US FDA issued a warning to the public concerning counterfeit Ozempic pens.
2023: Novo Nordisk becomes most valuable EU corporation
By 2023, Novo Nordisk was the most valuable corporation in the European Union, worth more than US$500 billion, and accounted for almost all economic growth in Denmark. The foreign currency earned by Novo Nordisk from Wegovy and Ozempic sales exerted upward pressure on the value of the krone, making it necessary for Danmarks Nationalbank to maintain lower interest rates than the European Central Bank.
2023: Commonly Prescribed Medication
In 2023, Semaglutide became the nineteenth most commonly prescribed medication in the United States, with over 25 million prescriptions.
2023: Semaglutide leads US medication sales with expenditures of US$38.6 billion
In 2023, Semaglutide-based medications had the highest earnings from sales of medications in the US, reaching expenditures of US$38.6 billion.
2023: Worldwide supply shortages of semaglutide in 2023
In 2023, high demand caused worldwide supply shortages of semaglutide. New UK prescriptions were not issued during the shortage.
2023: Price of Ozempic varied widely across countries
In 2023, the list price of a one-month supply of Ozempic, a semaglutide injection used for type 2 diabetes treatment, was $936 in the US, $169 in Japan, $147 in Canada, $144 in Switzerland, $103 in Germany and the Netherlands, $96 in Sweden, $93 in the UK, and $87 in Australia; France had the lowest price at $83.
January 2024: FDA review finds no evidence of suicidal thoughts or actions caused by semaglutide
In January 2024, a preliminary review conducted by the US Food and Drug Administration (FDA) confirmed no evidence had been found to suggest that the medicine causes suicidal thoughts or actions.
February 2024: Dr. Reddy's Laboratories Applied For Permission to Sell Generic Semaglutide in Canada
In February 2024, Dr. Reddy's Laboratories applied for permission to sell generic semaglutide in injectable format in Canada.
March 2024: FDA expands Wegovy indication to reduce cardiovascular risks
In March 2024, the US Food and Drug Administration expanded the indication for semaglutide (brand name Wegovy) to reduce the risk of cardiovascular death, heart attack, and stroke in adults with cardiovascular disease and who are either obese or overweight.
April 2024: Novo Nordisk increases production and budget to meet semaglutide demand
In April 2024, Novo Nordisk revealed that to meet the enormous demand for semaglutide, it was running its production facilities 24/7, had budgeted $6 billion in 2024 to expand its crowded and congested facilities, and had hired over 10,000 new employees in 2023 alone.
June 2024: Generic semaglutide in clinical trials in China
As of June 2024, government records indicate that at least 11 generic versions of semaglutide were in the final stages of clinical trials for the Chinese market.
December 2024: Poor clinical trial results published by Novo Nordisk contributed to a drop in the krone's value
In December 2024, poor clinical trial results published by Novo Nordisk contributed to a drop in the krone's value.
2024: Systematic review discusses decrease in lean body mass
A 2024 systematic review of six studies found that while lean body mass was unchanged in some cases, there were instances of significant decreases in lean body mass ranging from 0 to 40%. However, the review concluded that in all studies the ratio of lean body mass to total body mass increased, supporting continued use of the medication.
2024: Coverage disparities for semaglutide between Australia and the United States
In 2024, in Australia, semaglutide is available on the Pharmaceutical Benefits Scheme prescription for diabetes at regular co-payment rates. By contrast, in the United States, due to high costs, some health plans do not cover weight-loss drugs like semaglutide and tirzepatide. About half of plans sponsored by private-sector employers cover these drugs, federal Medicare Part D does not cover weight-loss drugs, and only a few federally-funded, state-administered Medicaid plans cover drugs for obesity.
April 4, 2025: Trump Administration declines to finalize proposal from the Biden Administration for Medicare, Medicaid, and CHIP coverage of GLP-1s for weight loss
On April 4, 2025, the Trump Administration declined to finalize a proposal from the Biden Administration that would have required Medicare, Medicaid, and CHIP to broadly cover GLP-1s for weight loss. Despite the rejection, CMS has indicated that it might cover obesity medication in future rulemaking.
June 2025: EMA recommends update to product information for semaglutide medicines to include NAION as a very rare side effect
In June 2025, the European Medicines Agency recommended that the product information for semaglutide medicines be updated to include non-arteritic anterior ischemic optic neuropathy (NAION) as a very rare side effect, while the World Health Organization concluded that the risk management plan for semaglutide should be revised to include NAION as a potential risk.
August 2025: FDA expanded indication for semaglutide (Wegovy) to treat MASH
In August 2025, the Food and Drug Administration (FDA) expanded the indication for semaglutide, marketed as Wegovy, to include the treatment of noncirrhotic metabolic-associated steatohepatitis (MASH) with moderate to advanced liver fibrosis in adults.
October 2025: FDA expanded Rybelsus indication to reduce cardiovascular risks
In October 2025, the FDA expanded the indication for semaglutide, marketed as Rybelsus, to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes who are at high risk for these events.
November 2025: Donald Trump announces deal to lower Ozempic costs
In November 2025, United States President Donald Trump announced a deal with NovoNordisk to lower the costs of Ozempic, including monthly prices of about $245 for injectables and $149 for some oral versions for people on Medicare and Medicaid and for those who use his TrumpRx platform.
November 2025: Trump Administration announces TrumpRx to lower GLP-1 prices
In November 2025, the Trump Administration announced TrumpRx, an initiative similar to GoodRx, to lower the price of GLP-1s to $245 per month for patients covered by Medicaid and CHIP and $50 month for Medicare patients if states opted in.
December 2025: Oral Wegovy Approved in the US
In December 2025, an oral version of semaglutide, sold under the brand name Wegovy, was approved in the US for weight management.
December 2025: FDA approved oral version of semaglutide for weight management
In December 2025, the FDA approved an oral version of semaglutide for weight management, using the same brand name (Wegovy) as the injectable version.
2025: Observational study reports modest increased risk of serious eye condition in people with diabetes taking GLP-1 receptor agonists
A 2025 observational study reported a modest increased risk of a serious eye condition in people with diabetes taking glucagon-like peptide-1 (GLP-1) receptor agonists. The analysis found that individuals using the medications had a slightly higher incidence of neovascular age-related macular degeneration compared to similar individuals not on the medications.
January 2026: Users of compounded GLP-1 drugs
As of January 2026, there were up to 1.5 million users of compounded GLP-1 drugs (including semaglutide) in the United States, according to Novo Nordisk CEO Mike Doustdar.
January 2026: Semaglutide exclusivity expired in Canada
In January 2026, Semaglutide's pharmaceutical data exclusivity period expired in Canada.
January 2026: Positive opinion for Kayshild marketing authorization
In January 2026, the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion, recommending the granting of a conditional marketing authorization for the medicinal product Kayshild, intended for the treatment of adults with non-cirrhotic metabolic dysfunction-associated steatohepatitis (MASH).
January 2026: FDA requested removal of suicidal behavior warning from GLP-1 RAs
In January 2026, the US Food and Drug Administration requested removal of suicidal behavior and ideation warning from glucagon-like peptide-1 receptor agonist (GLP-1 RA) medications.
February 2026: Novo Nordisk market capitalization
As of February 2026, Novo Nordisk has a market capitalization of $220.42 billion.
February 2026: Novo Nordisk announces price drop for Wegovy, Ozempic, and Rybelsus
In February 2026, Novo Nordisk announced that, effective January 2027, the list price of Wegovy, Ozempic, and Rybelsus would drop to $675 per month.
March 2026: Generic versions of semaglutide launched in India
In March 2026, following the expiration of the semaglutide patent in India, several domestic pharmaceutical companies launched generic versions of the drug for the treatment of type 2 diabetes and obesity, significantly reducing treatment costs compared to the innovator products Wegovy and Ozempic.
March 2026: Patent refusal in Brazil
In March 2026, the supreme court in Brazil refused to extend semaglutide's patent protection, which expires in March 2026, leading to plans for generic offerings by Hypera and Biomm.
April 1, 2026: Coverage for patients with obesity and at least one comorbidity will be implemented.
Coverage for patients with obesity and at least one comorbidity like (elevated LDL-cholesterol, high blood pressure and/or MASLD), will be implemented as early as April 1, 2026. The cost will be significantly higher to taxpayers due to the fact that most insurance companies do not cover it in their formulary. Prior to this change, most Medicaid and CHIP patients only paid $3 a month, the same price for brand-name medication.
April 28, 2026: Dr. Reddy's Laboratories received approval to sell generic semaglutide in Canada
On April 28, 2026, Dr. Reddy's Laboratories received approval to sell generic semaglutide in injectable format in Canada, after applying for permission in February 2024.
May 2026: Amazon announced same-day prescription delivery for Ozempic
In May 2026, Amazon announced same‑day prescription delivery for Ozempic in about 3,000 U.S. cities and towns, expanding toward 4,500 locations by year‑end.
May 2026: Ozempic list price
In May 2026, the list price of brand-name Ozempic is $228 for 4 weeks' supply, plus retail markup, based on the number of generic versions available.
2026: Telehealth program prices for semaglutide in the United States showed substantial state-level variation
By 2026, telehealth program prices for semaglutide in the United States showed substantial state-level variation, with a directory analysis of 797 telehealth clinics across 21 U.S. states reporting a median monthly low price of approximately $499.
2026: Apotex received tentative approval for generic semaglutide
In 2026, Apotex received a tentative approval from the United States Food and Drug Administration to produce generic semaglutide. This allows contracts and supply chains to be established, but selling the drug depends on intellectual property constraints.
2026: Dr. Reddy's Regulatory applications
In 2026, Dr. Reddy's has made regulatory applications in 87 countries where it plans to offer generic semaglutide.
2026: Sandoz plans to offer generic for diabetes
In 2026, Sandoz plans to offer a generic version of semaglutide for diabetes only.
2026: Chinese patent scheduled to expire
In 2026, the Chinese patent was scheduled to expire.
January 2027: Price drop of Wegovy, Ozempic, and Rybelsus
In January 2027, the list price of Wegovy, Ozempic, and Rybelsus would drop to $675 per month.
2027: Biocon plans to offer generic semaglutide
By 2027, Biocon hopes to offer generic semaglutide for diabetes and weight loss.
2027: Dr. Reddy's Regulatory applications
In 2027, Dr. Reddy's has made regulatory applications in 87 countries where it plans to offer generic semaglutide.
December 2031: Patent-free in US
Semaglutide is expected to become patent-free in the United States no earlier than December 2031.
2031: Drug patents on semaglutide in Europe and Japan are expected to expire
In 2031, drug patents on semaglutide in Europe and Japan are expected to expire.
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