History of Semaglutide in Timeline

Semaglutide is a medication used to treat type 2 diabetes and for long-term weight management. It is a GLP-1 receptor agonist, administered either by subcutaneous injection or orally. Novo Nordisk sells it under the brand names Ozempic and Rybelsus for diabetes, and Wegovy for weight management and weight loss.

1988: Discovery of GLP-1's significant potency

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

1993: GLP-1 infusion into people with type 2 diabetes

In 1993, Michael Nauck infused GLP-1 into people with type 2 diabetes, which stimulated insulin, inhibited glucagon, and normalized blood glucose levels; however, side effects led researchers to seek a suitable therapeutic compound with funding from Novo Nordisk.

1998: Development of liraglutide

In 1998, a Novo Nordisk research team led by Lotte Bjerre Knudsen 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 to study semaglutide, a once-weekly diabetes therapy, as a longer-acting alternative to liraglutide, under the brand name Ozempic.

2014: Meta-analysis on liver enzymes

A 2014 meta-analysis indicated 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 began.

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 approval

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

December 2017: Ozempic approved in the United States

In December 2017, the injectable version of Semaglutide, branded as Ozempic, was approved for use in people with diabetes in the United States.

2017: 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, Ozempic was approved for use in Canada.

February 2018: Authorization in the European Union

In February 2018, Semaglutide received authorization in the European Union.

March 2018: Authorization in Japan

In March 2018, Semaglutide received authorization in Japan.

August 2019: Authorization in Australia

In August 2019, Semaglutide received authorization in Australia.

September 2019: Rybelsus approved in the United States

In September 2019, Rybelsus, an oral version of semaglutide, was approved for medical use in the United States.

2019: Meta-analysis on pancreatitis risk

A 2019 meta-analysis did not find a significantly elevated risk of acute pancreatitis associated with Semaglutide use.

April 2020: Rybelsus approved in the European Union

In April 2020, Rybelsus was approved for medical use in the European Union.

March 2021: Phase III randomized trial results

In March 2021, a phase III trial involving 1,961 adults with a BMI of 30 or greater showed that once-weekly subcutaneous semaglutide, combined with lifestyle intervention, resulted in a mean body weight change of -14.9% at week 68, compared to -2.4% with placebo.

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.

November 2021: CHMP recommends marketing authorization for Wegovy

In November 2021, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency recommended granting marketing authorization for Wegovy to Novo Nordisk A/S.

2021: Warren Alpert Foundation Prize

In 2021, Jens Juul Holst, Joel Habener, and Daniel J. Drucker were awarded the Warren Alpert Foundation Prize for their work that contributed significantly 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 shortage for Ozempic and Wegovy

In August 2022, the FDA declared a shortage for Ozempic and Wegovy (but not Rybelsus), allowing compounding pharmacies to prepare compounded versions under certain conditions.

2022: Review of anti-obesity treatments

A 2022 review of anti-obesity treatments found semaglutide, along with tirzepatide, to be more promising than previous drugs but less effective than bariatric surgery.

2022: Job growth in Denmark

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

2022: 48th most commonly prescribed medication in the United States

In 2022, Semaglutide became the 48th most commonly prescribed medication in the United States, with over 13 million prescriptions.

2022: High cost and insurance coverage issues

In 2022, Wegovy's monthly list price in the US was $1,349.02, raising concerns about affordability. High Ozempic costs led some insurers to investigate and deny coverage for patients without sufficient diabetes evidence, alleging off-label prescribing for weight loss.

2022: Chinese patents invalidated

In 2022, a court ruled that all patents on semaglutide were invalid in China; Novo Nordisk appealed the ruling.

January 2023: Rybelsus updated as first-line treatment

In January 2023, the US FDA prescription label for Rybelsus was updated, reflecting its use 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 patients using semaglutide for weight loss regained two-thirds of their original weight loss one year after discontinuing the drug, retaining roughly one-third of the original weight loss after two years.

July 2023: 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, leading to a safety assessment of Ozempic, Wegovy, Saxenda, and similar drugs.

August 2023: Ozempic pricing comparison

In August 2023, the list price of a one-month supply of Ozempic was $936 in the United States and $169 in Japan, with other countries having even lower prices.

October 2023: Counterfeit Ozempic pens in Europe

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

December 2023: FDA warning about counterfeit Ozempic in the US

In December 2023, the FDA issued a warning regarding counterfeit Ozempic in the United States.

2023: Novo Nordisk becomes most valuable corporation in the EU

By 2023, Novo Nordisk had become the most valuable corporation in the European Union, valued at over US$500 billion, and its activities accounted for almost all recent economic growth in Denmark.

2023: Worldwide supply shortages

In 2023, high demand caused worldwide supply shortages of semaglutide, leading to the suspension of new prescriptions in the UK.

2023: Top-selling medication in the US

In 2023, semaglutide was the top-selling medication in the US, with expenditures of US$38.6 billion.

2023: Hiring to meet demand

In April 2024, Novo Nordisk disclosed it had hired over 10,000 new employees in 2023 to meet the enormous demand for semaglutide.

January 2024: FDA review finds no evidence of suicidal thoughts

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

March 2024: FDA expands indication for semaglutide (Wegovy)

In March 2024, the US Food and Drug Administration expanded the indication for semaglutide (Wegovy) to reduce the risk of cardiovascular death, heart attack, and stroke in adults with cardiovascular disease and who are either obese or overweight, based on a trial with over 17,600 participants.

April 2024: Production ramp-up to meet demand

In April 2024, Novo Nordisk disclosed it was operating its production facilities 24/7 to meet the enormous demand for semaglutide and had allocated $6 billion in 2024 for facility expansion. In 2023, the company hired over 10,000 new employees.

2024: Systematic review of body composition changes

A 2024 systematic review of six studies found that while reductions in body weight and fat mass were evident, changes in lean mass were minor with Semaglutide use.

2024: Limited insurance coverage in the US

As of 2024 in the United States, around half of private employer-sponsored health plans cover weight-loss drugs like semaglutide and tirzepatide; Federal Medicare Part D does not cover them, and only a few federally-funded, state-administered Medicaid plans provide coverage.