History of Semaglutide in Timeline

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Semaglutide

Semaglutide is a medication used to treat type 2 diabetes and obesity. It is a GLP-1 receptor agonist administered via subcutaneous injection (Ozempic and Wegovy) or orally (Rybelsus). Marketed by Novo Nordisk, Semaglutide helps manage blood sugar levels, promotes weight loss, and reduces the risk of major cardiovascular events in obese patients. Wegovy is also indicated for the treatment of metabolic-associated steatohepatitis.

1 hour ago : FDA Warns Novo Nordisk About Unreported Ozempic Side Effects and Potential Deaths.

The FDA issued a warning to Novo Nordisk regarding potential unreported side effects and deaths associated with Ozempic and other GLP-1 drugs. The warning highlights concerns over adverse event reporting.

1988: Discovery of GLP-1 potency

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

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 while inhibiting glucagon and bringing blood glucose to normal levels.

1998: Development of liraglutide

In 1998, Lotte Bjerre Knudsen led a team of researchers at Novo Nordisk that 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, a once-weekly diabetes therapy as a longer-acting alternative to liraglutide. It was given the brand name Ozempic.

2014: Meta-Analysis Finds Semaglutide Effective in Lowering Liver Enzymes

A 2014 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 of semaglutide started

In January 2016, clinical trials started for semaglutide.

December 2016: New drug application filed with 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 of semaglutide ended

In May 2017, clinical trials ended for semaglutide.

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 use by people with diabetes.

2017: Semaglutide approved 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, semaglutide (Ozempic) was approved in Canada.

February 2018: Semaglutide authorized in the European Union

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

March 2018: Semaglutide approved in Japan

In March 2018 semaglutide was approved in Japan.

August 2019: Semaglutide approved in Australia

In August 2019, semaglutide was approved in Australia.

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

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

2019: Meta-analysis on pancreatitis risk

A 2019 meta-analysis did not indicate a significantly elevated risk of acute pancreatitis related to semaglutide use.

April 2020: 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: Patent expiration in Canada

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

March 2021: Phase III trial results for semaglutide

In March 2021, a phase III randomized, double-blind trial involving 1,961 adults showed a mean percentage change in body weight at week 68 of −14.9% in the semaglutide group versus −2.4% with placebo.

June 2021: Wegovy approved by FDA as anti-obesity medication

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

2021: Warren Alpert Foundation Prize awarded for GLP-1 research

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 significantly 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 FDA declared a shortage for Ozempic and Wegovy, allowing compounding pharmacies to prepare compounded versions under certain conditions.

2022: 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 Adds 3,500 Jobs in Denmark

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

2022: High Wegovy prices in the US

In 2022, Wegovy had a list price of $1,349.02 per month in the US, leading to concerns that the high costs would make it unaffordable for many people who could benefit from weight loss.

2022: Initial ruling on invalidity of semaglutide patents in China

In 2022, a court initially ruled that all patents on semaglutide were invalid "for reasons related to experimental data availability" in China; this was later overturned.

January 2023: Rybelsus updated to first-line treatment for type 2 diabetes

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: Study Shows 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 (52 weeks) after discontinuing the drug. After two years (120 weeks), the patients retained roughly one-third of their original weight loss (5.6% of the original 17.3% loss).

July 2023: Safety Assessment of Semaglutide Due to Suicidal Thoughts Reports

In July 2023, the Icelandic Medicines Agency reported two cases of suicidal thoughts and one case of self-injury in users of the injection, prompting a safety assessment of Ozempic, Wegovy, Saxenda, and similar drugs.

October 2023: Reports of counterfeit Ozempic pens in Europe

In October 2023, there were reports of counterfeit Ozempic pens being sold in Europe, leading to hospitalizations due to possible insulin content.

December 2023: FDA warns about counterfeit Ozempic

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

2023: Novo Nordisk's Impact on the Danish Economy

By 2023, Novo Nordisk became the most valuable corporation in the European Union, exceeding US$500 billion, and accounted for almost all economic growth in Denmark.

2023: Ozempic price comparison across countries

In 2023, Ozempic had varying list prices across different countries, ranging from $936 in the US to $83 in France for a one-month supply, highlighting significant cost disparities.

2023: Semaglutide becomes 19th most prescribed medication in US

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

2023: Worldwide Semaglutide Supply Shortages

In 2023, high demand for semaglutide led to worldwide supply shortages, resulting in the suspension of new prescriptions in the UK.

2023: Highest medication sales in the US

In 2023, semaglutide had the highest earnings from sales of medications in the US, with expenditures of US$38.6 billion.

January 2024: FDA Review Finds No Evidence of Semaglutide Causing Suicidal Thoughts

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.

March 2024: FDA expands Wegovy indication to reduce cardiovascular risk

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 Expands Semaglutide Production to Meet Demand

In April 2024, Novo Nordisk announced it was running its production facilities 24/7 and had budgeted $6 billion to expand facilities and hired over 10,000 new employees in 2023 to meet the enormous demand for semaglutide.

June 2024: Generic semaglutide in final stages of clinical trials in China

As of June 2024, at least 11 generic versions of semaglutide are in the final stages of clinical trials for the Chinese market.

December 2024: Novo Nordisk's poor clinical trial results cause drop in 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 Finds Minor Changes in Lean Body Mass with Semaglutide

A 2024 systematic review of six studies found that "although reductions in body weight and fat mass were evident, changes in lean body mass were minor".

2024: Varied Semaglutide Coverage in Different Countries

As of 2024, semaglutide's availability and cost coverage varied significantly across countries. In the UK, it's available on NHS prescription for diabetes, and for obesity treatment is limited to two years. Finland includes semaglutide in its national price regulation scheme, with partial cost coverage for type 2 diabetes patients with a BMI over 27. Australia offers it on the Pharmaceutical Benefits Scheme for diabetes. However, in the US, coverage is inconsistent, with about half of private-sector employer plans covering weight-loss drugs, while federal Medicare Part D typically does not, and only a few Medicaid plans provide coverage for obesity treatments.

April 4, 2025: Trump Administration Declines Biden Administration Proposal for Medicare, Medicaid, and CHIP Coverage of GLP-1s

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 Product Information for Optic Neuropathy

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 as a very rare side effect, while the World Health Organization concluded that the risk management plan for semaglutide should be revised to include non-arteritic anterior ischemic optic neuropathy as a potential risk.

August 2025: FDA expands Wegovy indication for MASH treatment

In August 2025, the FDA expanded the indication for semaglutide, sold as Wegovy, to include the treatment of noncirrhotic metabolic-associated steatohepatitis (MASH) with moderate to advanced liver fibrosis in adults.

October 2025: FDA expands Rybelsus indication to reduce cardiovascular event risk

In October 2025, the FDA expanded the indication for semaglutide, sold 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 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 Medicaid and CHIP patients and $50 per month for Medicare patients if states opted in.

December 2025: Oral Wegovy approved for weight management

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 under Wegovy brand

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 Eye Condition with 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.

2025: Novo Nordisk partnership for Poviztra-branded semaglutide

In late 2025, Novo Nordisk partnered with Emcure to offer Poviztra-branded semaglutide for weight loss outside of metropolitan India.

January 2026: Estimated users of compounded GLP-1 drugs in the US

As of January 2026, there were up to 1.5 million users of compounded GLP-1 drugs (including semaglutide) in the United States.

January 2026: Semaglutide's data exclusivity expired in Canada

In January 2026, Semaglutide's pharmaceutical data exclusivity period expired in Canada. Several companies have applied to sell generic versions.

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 requests removal of suicidal behavior warning from GLP-1 RA medications

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's 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 semaglutide release expected in India

In March 2026, Biocon, Dr. Reddy's and Cipla expect to release generic semaglutide in India for weight loss after the patent expires. Dr. Reddy's will offer generic semaglutide under the Obeda brand.

March 2026: Patent protection expires in Brazil

In March 2026, Semaglutide's patent protection expires in Brazil.

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

Coverage for patients with obesity and at least one comorbidity (elevated LDL-cholesterol, high blood pressure and/or MASLD) will be implemented as early as April 1, 2026, under the TrumpRx initiative. However, the cost will be significantly higher to taxpayers, as most insurance companies do not cover it in their formulary.

2026: Dr. Reddy's plans to offer generic semaglutide in 87 countries

In 2026, Dr. Reddy's plans to offer generic semaglutide in 87 countries.

2026: Expiration of Chinese patent for semaglutide

In 2026, the Chinese patent for semaglutide was originally scheduled to expire.

January 2027: Planned Price Drop of Wegovy, Ozempic and Rybelsus

Effective January 2027, as announced in February 2026, the list price of Wegovy, Ozempic, and Rybelsus is scheduled to drop to $675 per month.

2027: Biocon hopes to offer generic semaglutide for diabetes and weight loss

By 2027, Biocon hopes to offer generic semaglutide for diabetes and weight loss.

2027: Dr. Reddy's plans to offer generic semaglutide in 87 countries

In 2027, Dr. Reddy's plans to offer generic semaglutide in 87 countries.

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

Semaglutide is expected to become patent-free in the United States, Europe and Japan in December 2031.