Semaglutide
Anti-diabetic and anti-obesity medication
From Wikipedia, the free encyclopedia
Semaglutide is an anti-diabetic medication used for the treatment of type 2 diabetes, and an anti-obesity medication used for long-term weight management and to reduce the risk of major adverse cardiovascular events.[23][24][25] It is a peptide similar to the hormone glucagon-like peptide-1 (GLP-1), modified with a side chain.[26][27] It can be administered by subcutaneous injection or taken orally.[13][14][15][28] It is sold by Novo Nordisk under the brand names Ozempic[13] and Rybelsus[14] for diabetes, and under the brand name Wegovy for weight management, weight loss,[12][15] and the treatment of metabolic-associated steatohepatitis (nonalcoholic steatohepatitis).[15][29]
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| Pronunciation | /sɛmˈæɡlʊtaɪd/ sem-AG-luu-tyde or /ˌsɛməˈɡluːtaɪd/ ⓘ SEM-ə-GLOO-tyde |
| Trade names | Ozempic, Rybelsus, Wegovy, others |
| AHFS/Drugs.com | Monograph |
| MedlinePlus | a618008 |
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| Routes of administration | Subcutaneous, oral |
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| Bioavailability | 89% (Subcutaneous),[13] 1–2% (Oral)[22] |
| Metabolism | Proteolysis |
| Elimination half-life | 7 days |
| Duration of action | 63.6 hours |
| Excretion | Urine and feces |
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| ECHA InfoCard | 100.219.541 |
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| Formula | C187H291N45O59 |
| Molar mass | 4113.641 g·mol−1 |
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Semaglutide is an incretin mimetic.[13][14][15] The most common side effects include nausea, vomiting, diarrhea, abdominal pain, and constipation.[13][16][17][18]
It was approved for medical use in the US in 2017.[13][30] In 2023, it was the nineteenth most commonly prescribed medication in the United States, with more than 25 million prescriptions.[31][32] It is on the World Health Organization's List of Essential Medicines.[33]
Medical uses
United States
In the US, semaglutide is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes,[13][14] and to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes and established cardiovascular disease.[13]
In combination with a reduced calorie diet and increased physical activity, semaglutide (as Wegovy) is indicated to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with established cardiovascular disease and who are either obese or overweight;[15] to reduce excess body weight and maintain weight reduction long term in obese individuals twelve years of age or older, or for overweight adults with at least one weight-related comorbid condition.[15][34][35] After stopping semaglutide, individuals on average regain about two-thirds (67%) of the weight they lost during treatment within the following year.[36][37] People return to their previous weight within a year and a half on average after stopping semaglutide.[38]
In August 2025, the Food and Drug Administration (FDA) expanded the indication for semaglutide (as Wegovy) to include the treatment of noncirrhotic metabolic-associated steatohepatitis (MASH), formerly known as nonalcoholic steatohepatitis (NASH), with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis) in adults.[15][29]
In October 2025, the FDA further expanded the indication for semaglutide (as Rybelsus) to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with type 2 diabetes who are at high risk for these events.[14][39]
In December 2025, the FDA approved an oral version of semaglutide for weight management, using the same brand name (Wegovy) as the injectable version.[40][41]
European Union
In the European Union, semaglutide is indicated for the treatment of adults with insufficiently controlled type 2 diabetes as an adjunct to diet and exercise as monotherapy when metformin is considered inappropriate due to intolerance or contraindications,[16][17] in addition to other medicinal products for the treatment of diabetes.[16][17]
Semaglutide (as Wegovy) is further indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management, including weight loss and weight maintenance, in adults with obesity (initial BMI ≥ 30 kg/m2) or who are overweight (initial BMI ≥ 27 kg/m2) and have at least one weight-related comorbidity such as dysglycemia (prediabetes or type 2 diabetes), hypertension, dyslipidemia, or cardiovascular disease.[18] It is also indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management in adolescents (aged twelve years and older) with obesity and body weight above 60 kg (130 lb).[18]
Side effects
Possible adverse effects include nausea, diarrhea, vomiting, constipation, abdominal pain, headache, fatigue, indigestion/heartburn, dizziness, abdominal distension, belching, hypoglycemia (low blood glucose) in people with type 2 diabetes, flatulence, gastroenteritis, and gastroesophageal reflux disease (GERD).[15] It has in the past been suspected to cause pancreatitis, and can cause gastroparesis and bowel obstruction.[42] Among people who were prescribed a glucagon-like peptide-1 (GLP-1) medication, 0.1% were diagnosed with gastroparesis at least six months later, which equates to a 52% increased risk of being diagnosed with gastroparesis while on a GLP-1 medication.[43] A 2019 meta-analysis did not indicate a significantly elevated risk of acute pancreatitis.[44]
The US prescription label for semaglutide contains a boxed warning for thyroid C-cell tumors in rodents.[13][14][15][45] It is unknown whether semaglutide causes thyroid C-cell tumors, including medullary thyroid carcinoma, in humans.[13][14][15][45][46]
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.[47]
Contraindications
Semaglutide is contraindicated in people with a personal or family history of medullary thyroid carcinoma or in people with multiple endocrine neoplasia type 2.[13][14][15][48]
Mechanism of action
Semaglutide is a glucagon-like peptide-1 receptor agonist.[13][14][15] The drug decreases blood sugar levels. The decrease is theorized to be caused by the mimicking of glucagon-like peptide-1 (GLP-1), an incretin.[49] It also appears to enhance growth of pancreatic beta cells, which are responsible for insulin production and release.[27][50] Additionally, it inhibits the production of glucagon, the hormone that increases glycogenolysis (release of stored carbohydrate from the liver) and gluconeogenesis (synthesis of new glucose). It reduces food intake by lowering appetite and slowing down digestion in the stomach,[26] helping reduce body weight.[51][52]
Structure and pharmacology
Semaglutide is chemically similar to human GLP-1.[53] The first six amino acids of GLP-1 are missing.[53] Substitutions are made at GLP positions 8 and 34 (semaglutide positions 2 and 28), where alanine and lysine are replaced by 2-aminoisobutyric acid and arginine, respectively.[53] The substitution of the alanine prevents chemical breakdown by dipeptidyl peptidase-4.[54] The lysine at GLP position 26 (semaglutide position 20) has a long chain attached, ending with a chain of 18 carbon atoms and a carboxyl group.[54] This increases the drug's binding to blood protein (albumin), which enables longer presence in the blood circulation.[54]
Semaglutide's half-life in the blood is about seven days (165–184 hours).[27][55]
History
In the 1970s, Jens Juul Holst and Joel Habener began research on the GLP-1 hormone, initially in relation to duodenal ulcer disease.[56] They were examining hormones secreted during eating, and testing them on pig pancreases, leading to the discovery of GLP-1's significant potency in 1988. Their work, which later contributed significantly to diabetes and obesity treatments, earned them and Daniel J. Drucker the 2021 Warren Alpert Foundation Prize.[56]
Research continued, and in 1993, Michael Nauck managed to infuse GLP-1 into people with type 2 diabetes, stimulating insulin while inhibiting glucagon and bringing blood glucose to normal levels. However, treating diabetes with GLP-1 hormones resulted in significant side effects, leading researchers financed by Novo Nordisk to start looking to develop a suitable compound for therapeutic use.[56] In 1998, a team of researchers at Novo Nordisk led by Lotte Bjerre Knudsen developed liraglutide, a glucagon-like peptide-1 receptor agonist that could be used to treat diabetes.[57] This was followed by the development of semaglutide by a team of researchers at Novo Nordisk, including Jesper Lau, Thomas Kruse, and Paw Bloch.[58][53]
Clinical trials and early approvals for diabetes
In June 2008, a phase II clinical trial began studying semaglutide, a once-weekly diabetes therapy as a longer-acting alternative to liraglutide.[59][60] It was given the brand name Ozempic. Clinical trials started in January 2016 and ended in May 2017.[23][61]
The US Food and Drug Administration (FDA) approved semaglutide based on evidence from seven clinical trials of 4087 participants with type 2 diabetes.[45] The trials were conducted at 536 sites in 33 countries, including Canada, Mexico, Russia, Ukraine, Turkey, India, South Africa, Japan, Hong Kong, multiple European countries, Argentina, and the United States.[45] In two of these trials (NCT02054897[62] and NCT02305381[63]), participants were randomly assigned to receive either semaglutide or placebo injection weekly.[45] Neither the participant nor the health care provider knew which treatment was being given until after the trials were completed.[45] Treatment was given for 30 weeks.[45] In the other five trials (NCT01930188,[64] NCT01885208,[65] NCT02128932,[66] NCT02207374,[67] and NCT02254291[68]), participants were randomly assigned to receive either semaglutide or another anti-diabetic medication, and the participant and provider knew which medication was being given in four trials.[45] Treatment was given for 30 weeks or 56 weeks.[45] In each trial, HbA1c was measured from the start of the trial to the end of the trial and compared between the semaglutide group and the other groups.[45]
The FDA also considered data from one separate trial (NCT01720446[69]), which was sponsored by Novo Nordisk, of 3297 participants with type 2 diabetes who were at high risk for cardiovascular events.[45] This trial was conducted in 20 countries: multiple European countries, Russia, Turkey, Brazil, Israel, Malaysia, Mexico, Thailand, Taiwan, Canada, and the United States.[45] The participants were randomly assigned to receive semaglutide or placebo.[45] Neither the participant nor the health care provider knew which treatment was being given.[45] Treatment was given for 104 weeks (2 years), and the occurrence of cardiovascular events, including heart attacks, strokes, and hospitalization due to unstable angina (near heart attack) were recorded and compared in the two groups of participants.[45]
Trials for obesity
In March 2021, in a phase III randomized, double-blind trial, 1,961 adults with a body mass index of 30 or greater were assigned in a 2:1 ratio to a treatment with once-weekly subcutaneous semaglutide or placebo, plus lifestyle intervention. The trials occurred at 129 sites in 16 countries in Asia, Europe, North America, and South America. The mean percentage change in body weight at week 68 was −14.9% in the semaglutide group vs −2.4% with placebo, for an estimated treatment difference of −12.4 percentage points (95% CI, −13.4 to −11.5).[70][71][72][73]
A 2022 review of anti-obesity treatments found that semaglutide as well as tirzepatide (which has an overlapping mechanism of action) were more promising than previous anti-obesity drugs, although less effective than bariatric surgery.[74]
Trials for cardiovascular health
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.[75] This was based on a placebo-controlled randomized double-blind trial, which was sponsored by Novo Nordisk, on the efficacy and safety of semaglutide for this indication.[76] 17,604 participant were randomly assigned to receive either semaglutide (Wegovy) or placebo.[75] Participants in both groups also received standard-of-care medical treatment (e.g., management of blood pressure and cholesterol) and healthy lifestyle counseling (including diet and physical activity).[75] The trial reported cumulative occurrence of major adverse cardiovascular events, a primary end-point event of the trial, for 569 of the 8803 patients in the semaglutide group, which were 6.5% of the participants, and for 701 of the 8801 patients in the placebo group, which were 8% of the participants, showing relative 18.8% less major adverse cardiovascular events, such as death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke, occurring for participants who had received semaglutide in the trial relative to those who had received placebo over the course of around 48 months, or 34.2±13.7 months, which was the mean (±SD) total duration of the participants in either group's exposure to the placebo or semaglutide during the trial.[76]
Society and culture
Legal status
In December 2016, a new drug application was filed with the US Food and Drug Administration (FDA), and in October 2017, an FDA advisory committee approved it unanimously.[77] In December 2017, the injectable version with the brand name Ozempic was approved in the US for use by people with diabetes,[30][78] and, in January 2018, in Canada.[79] In February 2018, authorization was granted in the European Union,[16][80] in March 2018 in Japan,[81] and in August 2019 in Australia.[1][3]
A version of semaglutide to treat diabetes that can be taken orally (Rybelsus) was approved for medical use in the US in September 2019,[82][83] and in the European Union in April 2020.[17] 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.[84]
In June 2021, a higher-dose version 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.[15] In January 2022, Wegovy was approved for medical use in the European Union.[18][21]
In December 2025, an oral version of semaglutide, sold under the brand name Wegovy, was approved in the US for weight management.[85]
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).[86] The applicant for this medicinal product is Novo Nordisk A/S.[86]
Generics and copies
Semaglutide's pharmaceutical data exclusivity period expired in Canada in January 2026.[87][88] (Novo Nordisk failed to pay a required patent maintenance fee, and their patent on the chemical structure of the drug expired in 2020.[87][89][90]) Several applications to sell generic drugs have been made, but not yet approved, including by Apotex, Aspen Pharmacare, Dr. Reddy's Laboratories, Sandoz, Taro Pharmaceuticals and Teva Pharmaceuticals.[88][91] Hims & Hers Health expects to partner with an approved manufacturer to market a generic version.[92] Sandoz' 2026 offering would be for diabetes only,[93] while Biocon hopes to offer generic semaglutide for diabetes and weight loss by 2027.[94] Novo Nordisk is considering competing against the new generic drugs with Plosbrio and Poviztra: additional brand names for semaglutide, but marketed at a lower price than Ozempic and Wegovy.[88] (In contrast to generics, which may be chemically synthesized versions manufactured using different processes than the original biologic drug, Health Canada confirmed that Plosbrio and Poviztra differ from the existing proprietary drugs Ozempic and Wegovy only in name and packaging, and are unrelated to the generics from a regulatory perspective.[88])
Biocon, Dr. Reddy's and Cipla expect to release generic semaglutide in India for weight loss, after the patent expires there in March 2026.[94][95][96] According to Reuters, Dr. Reddy's will offer generic semaglutide under the Obeda brand in March 2026,[97] while competitor Novo Nordisk also plans to release its Wegovy-branded semaglutide into the Indian market this year.[95] (Novo Nordisk also partnered with other firms in offering additional brand names of semaglutide, to reach markets outside of metropolitan India: with Emcure in late 2025 to offer Poviztra-branded semaglutide for weight loss, and with Abbott in 2026 to offer the Extensior brand for type 2 diabetes alongside name-brand Wegovy and Ozempic.[98])
In Brazil, the supreme court refused to extend semaglutide's patent protection, which expires in March 2026.[99][100] Hypera plans to offer its own generic semaglutide in the Brazilian market immediately thereafter, and Biomm announced an agreement to offer Biocon's generic.[100]
The Chinese patent was scheduled to expire in 2026, but a court ruled in 2022 that all patents on semaglutide were invalid "for reasons related to experimental data availability".[101] Novo Nordisk appealed the ruling and the decision was overturned by the Supreme People's Court.[102] Government records indicate that at least 15 generic versions of semaglutide are being developed for the Chinese market, both for diabetes and weight loss; 11 were in the final stages of clinical trials as of June 2024[update].[101] Among others, Hangzhou Jiuyuan Gene Engineering, The United Laboratories, CSPC Pharmaceutical Group, Huadong Medicine (which also holds a majority stake in Jiuyuan Gene[103]) and Sihuan Pharmaceutical were all preparing generic offerings.[101]
Dr. Reddy's has made regulatory applications in 87 countries where it plans to offer generic semaglutide in 2026 or 2027.[96][104] Biocon plans to offer generic semaglutide in Mexico and Saudi Arabia.[95]
Semaglutide is expected to become patent-free in the United States no earlier than December 2031,[105] and in Europe and Japan in that same year.[89]
Compounded versions
In the US, compounding pharmacies may prepare compounded versions of a drug on the Food and Drug Administration's (FDA) drug shortages list if the compounded drug meets certain conditions detailed in federal law.[106][107][108] The FDA declared a shortage for Ozempic and Wegovy (but not Rybelsus) starting in August 2022.[109][110]
As of January 2026[update], 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.[111]
Some compounded versions contain salts of semaglutide, including the sodium and the acetate.[112] The FDA cautioned that formulations containing semaglutide sodium or semaglutide acetate had not yet been shown to be safe and effective, and stated that moreover, the FDA does not evaluate compounded drugs for safety and effectiveness.[113]
The National Association of Boards of Pharmacy, a trade organization for pharmacy regulators, claims that there are tens of thousands of online pharmacies operating illegally or outside of the association's recommendations.[114] Novo Nordisk has taken legal action against several businesses that it alleges are selling unfit semaglutide products.[114]
Counterfeits
In October 2023, there were reports of counterfeit Ozempic pens being sold in Europe.[115] The pens possibly contained insulin, and led to several people being hospitalised with hypoglycemia and seizures.[116][117][118][Note 1]
In December 2023, the US FDA issued a warning about counterfeit Ozempic.[120]
Economics
Semaglutide had the highest earnings from sales of medications in the US in 2023, with expenditures of US$38.6 billion.[121]
Cost, coverage and supply
In the US, Wegovy has a list price of $1,349.02 per month as of 2022, suggesting that because of the high costs many people "who could most benefit from weight loss may be unable to afford such expensive drugs".[122] High costs of Ozempic prompted some insurance companies to investigate and refuse to cover individuals with what the companies considered was insufficient evidence to support a diabetes diagnosis, alleging off-label prescribing for weight loss.[123] In 2023, Ozempic, the semaglutide injection used for type 2 diabetes treatment, had list price of one-month supply of $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.[124][125]
Novo Nordisk announced in February 2026, that effective January 2027 the list price of Wegovy, Ozempic and Rybelsus would drop to $675/month.[126]
In the UK, semaglutide is available on NHS prescription for diabetes at nominal or no cost to the individual.[127] It is also available for obesity, limited to treatment for two years.[128] In Finland, semaglutide is included in the national price regulation scheme and is available by prescription; however, for people with type 2 diabetes and a BMI over 27, part of the cost is covered by Kela, the Finnish social insurance institution.[129][failed verification] In Australia, semaglutide is available on the Pharmaceutical Benefits Scheme prescription for diabetes at the regular co-payment rates of $31.60, or $7.70 for concession card holders.[130] By contrast, in the United States, due to high costs, some health plans do not cover weight-loss drugs like semaglutide and tirzepatide.[131][132][133] (As of 2024[update], about half of plans sponsored by private-sector employers cover these drugs,[134] federal Medicare Part D does not cover weight-loss drugs, and only a few federally-funded, state-administered Medicaid plans cover drugs for obesity.[135])
High demand caused worldwide supply shortages of semaglutide in 2023;[123] new UK prescriptions were not issued during the shortage. Novo Nordisk revealed in April 2024, that to meet the enormous demand for semaglutide, it was running its production facilities 24/7; it had budgeted $6 billion in 2024 to expand its crowded and congested facilities; and it had hired over 10,000 new employees in 2023 alone.[136]
Economic impact on Denmark
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.[137] The large amounts of foreign currency earned by Novo Nordisk from Wegovy and Ozempic sales, when converted to Danish krone, have 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.[138][139] Poor clinical trial results published by Novo Nordisk in December 2024 contributed to a drop in the krone's value.[140]
Profits from Novo Nordisk result in increased Danish tax revenues and employment.[141] Novo Nordisk added 3,500 jobs in Denmark in 2022, bringing the total in the country to 21,000 employees, out of 59,000 worldwide.[141]
As of February 2026, Novo Nordisk has a market capitalization of $220.42 billion.[142]
Rejection of Biden-Era 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. Despite the rejection, CMS has indicated that it might cover obesity medication in future rulemaking. However, 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. 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. However, 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.[143]
Research
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.[144] The French national health care insurance system database had previously suggested that one to three years of use of glucagon-like peptide-1 receptor agonists like exenatide, liraglutide, and dulaglutide may be linked with increased occurrence of thyroid cancer. Semaglutide belongs to the same family of medicine. A meta-analysis involving data from 37 randomized controlled trials and 19 real-world studies (46,719 individuals) showed that semaglutide use over 18 months was not associated with increased risk of any cancer, supported by high-quality evidence.[145]
In March 2023, a Novo Nordisk official said, based on a randomized, double-blind study (NCT03548935[146]) funded by the company, that people using semaglutide to lose weight regained two-thirds of their original weight loss one year (52 weeks) after discontinuing use of 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).[147][148]
In July 2023, the Icelandic Medicines Agency reported two cases of suicidal thoughts and one case of self-injury of users of the injection, prompting a safety assessment of Ozempic,[149] Wegovy, Saxenda, and similar drugs.[150] 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.[151][152]
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,[153] 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.[154]
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.[155] 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.[156]
In the STEP-HFpEF trial including people with obesity and heart failure with preserved ejection fraction, weight loss was associated with improvements in heart failure symptoms and functional capacity.[157] An observational study on people with obesity and type 2 diabetes and heart failure with preserved ejection fraction, semaglutide had about a 42% lower risk of hospitalization for heart failure and all-cause death combined compared with sitagliptin.[158]
An analysis of events in the US FDA Adverse Event Reporting System suggests an association between several GLP-1 agonists (including semaglutide) and some skin-related reactions.[159][better source needed]
Effect 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.[160]
Notes
- Although an insulin icodec/semaglutide combination drug named Kyinsu was authorized in Europe in 2025,[119] this incident was not linked to that product.
