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. Marketed by Novo Nordisk, it's available as Ozempic and Rybelsus for diabetes management and as Wegovy for weight loss and treatment of metabolic-associated steatohepatitis. It can be administered via subcutaneous injection or orally.

1988: Discovery of GLP-1's potency

In 1988, Jens Juul Holst and Joel Habener discovered GLP-1's significant potency while testing hormones on pig pancreases.

1993: GLP-1 infusion in type 2 diabetes patients

In 1993, Michael Nauck infused GLP-1 into people with type 2 diabetes, observing stimulation of insulin, inhibition of glucagon, and normalization of blood glucose levels.

1998: Development of liraglutide by Novo Nordisk

In 1998, Lotte Bjerre Knudsen and a team of researchers at Novo Nordisk developed liraglutide, a glucagon-like peptide-1 receptor agonist for treating diabetes.

June 2008: Phase II clinical trial of semaglutide begins

In June 2008, a phase II clinical trial began studying semaglutide as a once-weekly diabetes therapy, marketed later as Ozempic.

2014: Semaglutide May Improve Liver Conditions

A 2014 meta-analysis found that semaglutide may be effective in lowering liver enzymes and improving certain radiologically observed features of metabolic dysfunction–associated steatotic liver disease.

January 2016: Clinical trials started

Clinical trials for semaglutide started in January 2016.

December 2016: New drug application filed with the US 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

Clinical trials for semaglutide ended in May 2017.

October 2017: FDA advisory committee approves Semaglutide

In October 2017, an FDA advisory committee unanimously approved Semaglutide.

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 people with diabetes.

2017: Semaglutide approved for medical use in the US

In 2017, Semaglutide received approval for medical use in the United States.

January 2018: Ozempic approved in Canada

In January 2018, Semaglutide (Ozempic) was approved in Canada.

February 2018: Semaglutide (Ozempic) authorization in the European Union

In February 2018, authorization for Semaglutide was granted in the European Union.

March 2018: Semaglutide (Ozempic) authorization in Japan

In March 2018, authorization for Semaglutide was granted in Japan.

August 2019: Semaglutide (Ozempic) authorization in Australia

In August 2019, authorization for Semaglutide was granted in Australia.

September 2019: Oral semaglutide (Rybelsus) approved in the US

In September 2019, Rybelsus, an oral version of semaglutide for treating diabetes, was approved for medical use in the US.

2019: Meta-analysis on pancreatitis risk

A 2019 meta-analysis indicated no significantly elevated risk of acute pancreatitis associated with semaglutide use.

April 2020: Oral semaglutide (Rybelsus) approved in the European Union

In April 2020, Rybelsus, an oral version of semaglutide, was approved for medical use in the European Union.

2020: Semaglutide patent expired in Canada

In 2020, Novo Nordisk's patent on the chemical structure of semaglutide expired in Canada due to failure to pay a required patent maintenance fee.

March 2021: Phase III trial results show significant weight loss with semaglutide

In March 2021, a phase III trial showed that adults treated with once-weekly subcutaneous semaglutide experienced a mean body weight decrease of 14.9% compared to 2.4% with placebo at week 68.

June 2021: Wegovy approved by FDA for weight management

In June 2021, Wegovy, a higher-dose version of injectable semaglutide, was approved by the FDA as an anti-obesity medication for long-term weight management in adults.

2021: Warren Alpert Foundation Prize awarded to GLP-1 researchers

In 2021, Jens Juul Holst, Joel Habener, and Daniel J. Drucker were awarded the Warren Alpert Foundation Prize for their work on GLP-1, which contributed 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 declares shortage for Ozempic and Wegovy

In August 2022, the US FDA declared a shortage for Ozempic and Wegovy (but not Rybelsus), leading to compounded versions being prepared by compounding pharmacies.

2022: Review of anti-obesity treatments

A 2022 review indicated that semaglutide and tirzepatide are promising anti-obesity drugs, more effective than previous options but less effective than bariatric surgery.

2022: Novo Nordisk Job Creation in Denmark

In 2022, Novo Nordisk added 3,500 jobs in Denmark, bringing the total number of employees in the country to 21,000, out of 59,000 worldwide.

2022: Court ruling on Chinese semaglutide patents

In 2022, a court ruled that all patents on semaglutide were invalid in China, but the decision was later overturned by the Supreme People's Court.

2022: Wegovy price in the US

In 2022, the list price of Wegovy in the US was $1,349.02 per month, leading to concerns that high costs may prevent those who could benefit from weight loss from affording it.

January 2023: Rybelsus updated as 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: Weight Regain After Discontinuing Semaglutide

In March 2023, Novo Nordisk reported that people using semaglutide to lose weight regained two-thirds of their original weight loss one year after discontinuing the drug, retaining roughly one-third of their original weight loss after two years.

July 2023: Safety Assessment of Semaglutide Drugs

In July 2023, the Icelandic Medicines Agency reported cases of suicidal thoughts and self-injury among users of semaglutide injections, leading to a safety assessment of Ozempic, Wegovy, Saxenda, and similar drugs.

October 2023: Counterfeit Ozempic pens reported in Europe

In October 2023, reports surfaced of counterfeit Ozempic pens being sold in Europe, leading to hospitalizations due to hypoglycemia and seizures.

December 2023: FDA warns about counterfeit Ozempic

In December 2023, the US FDA issued a warning about counterfeit Ozempic.

2023: Novo Nordisk Becomes Most Valuable Corporation in the EU

By 2023, Novo Nordisk became the most valuable corporation in the European Union, worth over US$500 billion. The company accounted for almost all economic growth in Denmark, putting upward pressure on the value of the Danish krone.

2023: Semaglutide Highest Earning Medication Sales

In 2023, Semaglutide achieved the highest earnings from medication sales in the US, reaching expenditures of US$38.6 billion.

2023: Semaglutide becomes a commonly prescribed medication

In 2023, Semaglutide was the nineteenth most commonly prescribed medication in the United States, with over 25 million prescriptions.

2023: Worldwide Semaglutide Supply Shortages and Novo Nordisk Expansion

In 2023, high demand caused worldwide supply shortages of semaglutide, leading to the halt of new UK prescriptions. In response, Novo Nordisk hired over 10,000 new employees to meet the demand.

2023: Ozempic Pricing Discrepancies and Insurance Scrutiny

In 2023, the list price for a one-month supply of Ozempic, a semaglutide injection for type 2 diabetes treatment, varied significantly across countries, costing $936 in the US but only $83 in France. High costs in the US led some insurance companies to investigate and deny coverage for individuals suspected of off-label prescribing for weight loss.

January 2024: FDA Preliminary Review Confirms No Evidence Linking Semaglutide to Suicidal Thoughts

In January 2024, a preliminary review by the US Food and Drug Administration (FDA) found no evidence suggesting semaglutide causes suicidal thoughts or actions.

March 2024: FDA expands Wegovy indication to reduce cardiovascular risk

In March 2024, the FDA expanded the indication for semaglutide (Wegovy) to reduce the risk of cardiovascular death, heart attack, and stroke in adults with cardiovascular disease who are either obese or overweight, based on a trial that showed an 18.8% reduction in major adverse cardiovascular events.

April 2024: Novo Nordisk Expands Production Facilities

In April 2024, Novo Nordisk revealed it was running its production facilities 24/7 and had budgeted $6 billion to expand its congested facilities in order to meet the high demand for semaglutide.

June 2024: Generic versions in clinical trials in China

As of June 2024, at least 11 generic versions of semaglutide were in the final stages of clinical trials in China, for both diabetes and weight loss.

December 2024: Novo Nordisk's Poor Clinical Trial Results Impact Krone Value

In December 2024, poor clinical trial results published by Novo Nordisk contributed to a drop in the value of the Danish krone.

2024: Systematic Review on 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: Semaglutide Availability and Coverage Variances

In 2024, semaglutide has varying accessibility and cost coverage across different countries. In the UK, it is available on NHS prescription for diabetes, and for obesity treatment is limited to two years. In Finland, part of the cost is covered for people with type 2 diabetes and a BMI over 27. In Australia, it is available on the Pharmaceutical Benefits Scheme prescription for diabetes. In the United States, coverage is limited with about half of plans sponsored by private-sector employers covering the medication, federal Medicare Part D not covering weight-loss drugs, and only a few federally-funded, state-administered Medicaid plans covering drugs for obesity.

April 4, 2025: Trump Administration Declines Biden Administration Proposal

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.

June 2025: EMA Recommends Updating Semaglutide Medicines Product Information

In June 2025, the European Medicines Agency recommended updating the product information for semaglutide medicines to include non-arteritic anterior ischemic optic neuropathy (NAION) as a very rare side effect. The World Health Organization recommended that the risk management plan for semaglutide should be revised to include NAION as a potential risk.

August 2025: FDA expands indication for semaglutide (Wegovy)

In August 2025, the 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 expands indication for semaglutide (Rybelsus)

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 at high risk.

November 2025: Trump Administration Announces TrumpRx Initiative

In November 2025, the Trump Administration announced TrumpRx, an initiative to lower the price of GLP-1s to $245 per month for patients covered by Medicaid and CHIP and $50 per month for Medicare patients if states opted in.

December 2025: Oral version of 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 approves oral 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 Increased Risk of Serious Eye Condition

A 2025 observational study reported a modestly increased risk of a serious eye condition in people with diabetes taking glucagon-like peptide-1 (GLP-1) receptor agonists. 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: Number of compounded GLP-1 drug users

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's data exclusivity expired in Canada

In January 2026, Semaglutide's pharmaceutical data exclusivity period expired in Canada.

January 2026: Positive opinion for Kayshild

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 Requests Removal of Suicidal Ideation Warning

In January 2026, the US Food and Drug Administration requested the 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 had a market capitalization of $220.42 billion.

February 2026: Novo Nordisk Announces Price Reduction 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 Semaglutide Launched in India

Following the expiration of the semaglutide patent in India in March 2026, multiple domestic pharmaceutical companies, including Sun Pharmaceutical Industries, Dr. Reddy's Laboratories and Zydus Life Sciences, launched generic versions of the drug for the treatment of type 2 diabetes and obesity under brand names such as "Obeda", "Noveltreat", "Sematrinity", "Semaglyn", "Mashema", and "Alterme".

March 2026: Brazilian court refuses to extend semaglutide's patent protection

In Brazil, the supreme court refused to extend semaglutide's patent protection, which expires in March 2026, paving the way for generic versions.

April 1, 2026: Coverage for Patients with Obesity and Comorbidities Implementation

Coverage for patients with obesity and at least one comorbidity will be implemented as early as April 1, 2026, however, the cost will be significantly higher to taxpayers due to the fact that most insurance companies do not cover it in their formulary.

2026: Dr. Reddy's plans to offer generic semaglutide

Dr. Reddy's has made regulatory applications in 87 countries where it plans to offer generic semaglutide in 2026 or 2027.

2026: Expiration of Chinese patent scheduled

The Chinese patent on semaglutide was scheduled to expire in 2026.

January 2027: Price Reduction for Wegovy, Ozempic, and Rybelsus Takes Effect

Effective January 2027, Novo Nordisk's announced price reduction for Wegovy, Ozempic, and Rybelsus took effect, lowering the list price to $675 per month.

2027: Biocon plans to offer generic semaglutide

Biocon plans to offer generic semaglutide for diabetes and weight loss by 2027.

December 2031: Semaglutide is expected to become patent-free in the US, Europe and Japan

Semaglutide is expected to become patent-free in the United States no earlier than December 2031, and in Europe and Japan in that same year.

Mentioned in this timeline

Juul Labs is an American e-cigarette company formerly part of...

Japan is an East Asian island country located in the...

Australia officially the Commonwealth of Australia encompasses the Australian mainland...

France officially the French Republic is primarily in Western Europe...

Canada is a North American country the world's second-largest by...

Belgium officially the Kingdom of Belgium is a country in...