The Evolution Path of Semaglutide, the "First Generation Divine Medicine": A Comprehensive Timeline
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- Nov 14,2025
Summary
First Generation Divine Medicine": A Comprehensive Timeline
[Early development stage: 2000-2012] In the early 2000s, breakthroughs were made in the study of GLP-1 receptor agonist mechanisms
2009-2012: Novo Nordisk launches next-generation GLP-1 analog development project, focusing on extending drug half-life
In 2012, the molecular structure of semaglutide was determined, and its binding to albumin was achieved by replacing the 8th and 34th amino acids and modifying the C18 fatty acid chain
【 Clinical validation period: 2013-2017 】 2013-2015: SUSTAIN 1-3 clinical trial was launched to verify the basic hypoglycemic effect
In 2016, the results of the SUSTAIN 6 cardiovascular outcome trial were announced, confirming cardiovascular safety
May 2017: Novo Nordisk submits Ozempic (injection) marketing application to FDA
December 5, 2017: FDA approved Ozempic (0.5mg and 1.0mg) for treatment of type 2 diabetes
[Formulation breakthrough period: 2018-2020] February 2018: EMA approves Ozempic for European market launch
September 2018: Ozempic officially commercialized in the United States
March 2019: Clinical trial results of oral semaglutide PIONEER announced
On September 20, 2019, the FDA approved the world's first oral GLP-1 drug, Rybelsus (oral semaglutide)
2020: STEP 1-4 clinical trial launched, targeting obesity indications
【 Indications Extension Period: 2021-2023 】 February 2021: STEP 1 trial results announced, with an average weight loss of 14.9% for high-dose semaglutide (2.4mg)
April 2021: China's State Food and Drug Administration approved Smeglutide injection for type 2 diabetes and reducing the risk of cardiovascular adverse events in type 2 diabetes patients with cardiovascular disease
June 4, 2021: FDA approves Wegovy (2.4mg semaglutide) for chronic weight management
2022-2023: Global supply shortage phenomenon, soaring black market prices
November 2023: The results of the SELECT cardiovascular outcome test were published in the New England Journal of Medicine, which showed that the risk of adverse cardiovascular events in non diabetes overweight/obese patients with BMI ≥ 27 and a history of cardiovascular disease was reduced by 20%
[Future outlook: 2024 and beyond] March 9, 2024: FDA approves Wegovy for reducing the risk of cardiovascular death, heart attack, and stroke in adults with cardiovascular disease and obesity/overweight
In 2024, a monthly clinical trial of long-acting injectable formulations will be conducted; Novo Nordisk has submitted a marketing application for oral Wegovy weight loss indication to the FDA, and is expected to complete the review in the fourth quarter of 2025
August 2025: FDA approves Wegovy for the treatment of metabolic dysfunction associated steatohepatitis (MASH) patients with advanced liver fibrosis (F2/F3 stage)
After 2025: More neurological disorders and addictive behavior indications may be approved
