69 dated events
How we got here
Prices, lawsuits, approvals, regulatory crackdowns and politics, in order. Every entry links to its source.
2026
2026-09-18 · approval
Health Canada approves Sandoz's generic semaglutide
Sandoz Canada announced on 18 September 2026 that Health Canada had approved Sandoz Semaglutide, a generic version of Ozempic for adults with type 2 diabetes. It said it was preparing for commercialisation.
2026-08-28 · approval
FDA approves Mounjaro to lower cardiovascular risk in adults with type 2 diabetes
Eli Lilly announced on 28 August 2026 that the FDA approved Mounjaro to lower the risk of major cardiovascular events in adults with type 2 diabetes at high risk. The approval was based on SURPASS-CVOT, which compared tirzepatide with dulaglutide and showed non-inferiority.
2026-08-27 · legal
Fifth Circuit upholds the FDA's tirzepatide shortage decision
On 27 August 2026 the US Court of Appeals for the Fifth Circuit affirmed the lower court's ruling in Outsourcing Facilities Association v. FDA (No. 25-10600). It held that the FDA's decision to remove tirzepatide from its shortage list did not violate the Administrative Procedure Act, either for lack of notice-and-comment rulemaking or as arbitrary and capricious. The opinion is not designated for publication.
2026-08-24 · regulatory
FDA sends more warning letters to online peptide sellers
The FDA issued further warning letters to online peptide sellers dated 24 August 2026. One letter said 'research use only' and 'not for human consumption' labels did not change that website evidence showed the products were intended to be drugs for human use. These are the FDA's stated positions, not court findings.
Source: U.S. Food and Drug AdministrationSource 2: U.S. Food and Drug Administration
2026-08-12 · legal
Lilly files six lawsuits over unapproved retatrutide products
On 12 August 2026 Eli Lilly said it had filed six new lawsuits against US entities including compounding pharmacies, medical spas and online sellers over products marketed as retatrutide, which is not approved anywhere. Lilly said it had reported more than 14,000 websites, advertisements, social media posts and product listings and referred more than 200 parties to authorities. The allegations are Lilly's and had not been decided by a court at the time of the announcement.
2026-08-10 · approval
UK MHRA approves orforglipron, the first approval in Europe
The MHRA authorised orforglipron (Foundayo) on 10 August 2026 for weight management and for type 2 diabetes, saying the UK was the first country in Europe to do so. The MHRA noted it was not currently available via the NHS, where decisions follow established processes including a NICE evaluation.
2026-07-30 · legal
Owner of Paradigm Peptides sentenced to 70 months in prison
On 30 July 2026 the US Attorney's Office for the Northern District of Indiana announced that the owner of Paradigm Peptides had been sentenced to 70 months in prison and his sister to 16 months, after each pleaded guilty to introducing unapproved new drugs into interstate commerce with intent to defraud and mislead. The office said the business sold peptides and other drugs for human consumption without FDA approval; the owner also pleaded guilty to illegally importing merchandise.
Source: U.S. Attorney's Office, Northern District of Indiana
2026-07-23 · regulatory
FDA advisory committee votes on seven peptides for the 503A compounding list, against FDA staff advice
At a two-day Pharmacy Compounding Advisory Committee meeting on 23 and 24 July 2026, the panel voted to recommend BPC-157, KPV and TB-500 (each 8-6), MOTS-c, epitalon and semax for the 503A bulks list, but not emideltide (DSIP), according to a law-firm summary. It reports that FDA scientists recommended against inclusion in each case. The votes are advice only: adding a peptide requires FDA notice-and-comment rulemaking, and the votes do not make any of these peptides an approved medicine.
Source: U.S. Food and Drug AdministrationSource 2: McDermott Will & Schulte
2026-07-23 · trial
Lilly reports two more phase 3 retatrutide trials, with up to about 21% to 23% weight loss at 80 weeks
Lilly announced on 23 July 2026 that TRIUMPH-2 (adults with obesity or overweight and type 2 diabetes) reached up to 20.8% average weight loss and TRIUMPH-3 (severe obesity and established cardiovascular disease) up to 22.6% at 80 weeks, figures reported as if everyone had stayed on treatment. These are company-reported results. Lilly said it plans to submit retatrutide to the FDA for approval in the first quarter of 2027.
2026-07-21 · legal
Novo Nordisk sues Eli Lilly over GLP-1 advertising
On 21 July 2026 Novo Nordisk filed a lawsuit against Eli Lilly in federal court in New Jersey, according to CNBC. Novo alleges false advertising and unfair competition, including under the Lanham Act, in Lilly's advertising for its obesity and diabetes medicines such as Zepbound. Lilly said it stands firmly behind its advertising. These are allegations that no court had ruled on at the time of the report.
2026-07-01 · politics
Medicare GLP-1 Bridge set to start, with a $50 co-pay for eligible weight-management prescriptions
CMS's Medicare GLP-1 Bridge, a short-term demonstration, was set to give eligible Part D beneficiaries access to certain GLP-1 drugs for weight management at a $50 co-pay from 1 July 2026, outside the normal Part D benefit. CMS lists Wegovy (injection and tablets), Foundayo and Zepbound (KwikPen) as eligible. In April 2026 CMS extended the Bridge to run through 31 December 2027.
2026-06-11 · approval
UK MHRA approves the first GLP-1 tablet for weight loss
On 11 June 2026 the MHRA approved semaglutide (Wegovy) tablets in the UK for weight loss and weight management in adults who meet BMI criteria. The MHRA noted that, as with all GLP-1 receptor agonists, it is a prescription-only medicine.
2026-06-07 · trial
Survodutide phase 3 SYNCHRONIZE-1 results published in NEJM
In SYNCHRONIZE-1, 725 adults with obesity or overweight lost an average of 12.2% or 13.0% of body weight at week 76 on two survodutide dose levels, versus 5.4% on placebo (treatment-regimen estimand). Survodutide, a glucagon and GLP-1 receptor agonist, was investigational when the results were published; the trial was funded by Boehringer Ingelheim.
2026-05-29 · regulatory
UK regulator reports its largest seizure of unlicensed weight loss medicines
The MHRA said on 29 May 2026 that its Criminal Enforcement Unit had arrested two people on suspicion of offences under the Human Medicines Regulations 2012 after raiding a property near Northampton and recovering around 12,000 doses of unlicensed weight loss medicines. It said the site was believed to have been used to manufacture and distribute products including retatrutide, tirzepatide and peptide products. The investigation was ongoing.
2026-05-21 · trial
Lilly reports phase 3 TRIUMPH-1 results for retatrutide: up to about 28% weight loss at 80 weeks
Lilly announced topline results from the TRIUMPH-1 phase 3 trial on 21 May 2026. On the highest dose, average weight loss at 80 weeks was 28.3% (versus 2.2% on placebo) if everyone had stayed on treatment, and 25.0% (versus 3.9%) counting everyone regardless of whether they stayed on treatment. These are company-reported results from a press release. Retatrutide is investigational and was not approved anywhere at the time of the release.
2026-04-30 · regulatory
FDA proposes to bar bulk compounding of semaglutide, tirzepatide and liraglutide by outsourcing facilities
On 30 April 2026 the FDA proposed excluding semaglutide, tirzepatide and liraglutide from the 503B bulks list, saying it found no clinical need for outsourcing facilities to compound them from bulk substances. The FDA invited comments until 29 June 2026 and said it would consider them before making a final determination.
Source: U.S. Food and Drug AdministrationSource 2: Federal Register
2026-04-28 · approval
Health Canada approves the first generic semaglutide, a generic Ozempic from Dr. Reddy's
Health Canada announced on 28 April 2026 that Canada had become the first G7 country to approve a generic semaglutide, approving Dr. Reddy's generic version of Ozempic for adults with type 2 diabetes.
2026-04-21 · politics
CMS delays the Medicare part of the BALANCE model and extends the GLP-1 Bridge through 2027
On 21 April 2026 CMS announced it would not implement the BALANCE model in Medicare Part D in 2027 and would instead extend the temporary Medicare GLP-1 Bridge to the end of 2027. The Medicaid part of BALANCE, which state Medicaid programmes can join, continues.
Source: KFFSource 2: Centers for Medicare & Medicaid Services
2026-04-15 · regulatory
FDA removes 12 peptides from the 'Category 2' safety-risk list
According to a law-firm summary, the FDA announced on 15 April 2026 that 12 peptides would leave Category 2 of the compounding bulk-substances process, and GHK-Cu would leave Category 1, because their nominators withdrew the nominations. Leaving Category 2 does not by itself place a peptide on the 503A bulks list, and it does not make any of them an approved medicine. FDA's Category 2 page now lists a group of peptides, including BPC-157 and GHK-Cu, as 'nominated but withdrawn'.
Source: Orrick, Herrington & SutcliffeSource 2: U.S. Food and Drug Administration
2026-04-01 · approval
FDA approves Foundayo (orforglipron), a once-daily GLP-1 pill
The FDA approved Foundayo (orforglipron), a tablet GLP-1 receptor agonist made by Eli Lilly, on 1 April 2026. It is taken by mouth as a tablet.
Source: U.S. Food and Drug Administration (openFDA Drugs@FDA)Source 2: U.S. Food and Drug Administration
2026-03-31 · regulatory
US Customs reports about 5,000 mis-manifested peptide shipments seized in Cincinnati
US Customs and Border Protection said on 31 March 2026 that officers in Cincinnati had seized about 5,000 individual shipments concealed in master cartons between December 2025 and 25 March 2026. It said a shipper in China was involved and that the seized peptides included retatrutide, semaglutide and tirzepatide.
2026-03-31 · regulatory
FDA warning letter says 'research use only' labels do not change intended human use of peptide products
In a warning letter dated 31 March 2026, the FDA told an online peptide seller that, despite 'research use only' labelling, evidence from its website showed the products, including retatrutide, were intended for human use and were therefore unapproved drugs. This is the FDA's stated position in a letter, not a court finding.
2026-03-21 · market
Generic semaglutide launches in India after Novo Nordisk's core patent expires
On 21 March 2026 several Indian drugmakers, including Dr Reddy's, Zydus, Alkem, Sun Pharma and Glenmark, launched generic semaglutide products, described as day-one entry on expiry of Novo Nordisk's core Indian semaglutide patent.
2026-03-09 · legal
Novo Nordisk drops its patent lawsuit against Hims & Hers and the two companies agree a deal
On 9 March 2026 Novo Nordisk said it was dropping a lawsuit that claimed Hims & Hers infringed a Wegovy patent, and reserved the right to refile. Hims & Hers agreed to stop advertising compounded GLP-1 products and to offer branded Wegovy, but said it may still provide compounded versions when a provider judges them clinically necessary, according to STAT News.
2026-03-03 · regulatory
FDA announces 30 warning letters to telehealth companies over compounded GLP-1 marketing
On 3 March 2026 the FDA announced 30 warning letters to telehealth companies over what it called false or misleading claims about compounded GLP-1 products. The FDA said the main issues were claims implying sameness with approved products and branding that obscured who actually compounded the drug. Warning letters state the FDA's view and are not court findings.
2026-02-06 · regulatory
FDA says it will act against mass-marketed compounded GLP-1 products
On 6 February 2026 the FDA announced its intent to take steps to restrict GLP-1 active ingredients intended for use in non-approved compounded drugs that are being mass-marketed as alternatives to approved products, naming Hims & Hers and other compounding pharmacies. It also said companies cannot claim that compounded products are generic versions of, or the same as, approved drugs. This is the FDA's stated intent, not a court finding.
Source: U.S. Food and Drug AdministrationSource 2: Pharmacy Times
2026-02-05 · pricing
TrumpRx.gov launches with GLP-1 cash prices from Lilly and Novo Nordisk
The White House launched TrumpRx.gov on 5 February 2026. Its fact sheet said Ozempic and injectable Wegovy would cost an average of $350 and as low as $199 per month, the Wegovy pill as low as $149, and Zepbound an average of $346 and as low as $299. These are government-stated prices for cash purchases.
2025
2025-12-22 · approval
FDA approves the Wegovy pill (oral semaglutide) for weight loss
Novo Nordisk announced on 22 December 2025 that the FDA had approved Wegovy tablets for weight management in adults with obesity or overweight and a related condition, and for reducing cardiovascular risk in people with established cardiovascular disease. In the OASIS 4 trial, the company said people who stayed on treatment lost about 17% of body weight versus about 3% on placebo, or about 14% versus about 2% when everyone was counted regardless of whether they stayed on treatment.
Source: Novo Nordisk (PR Newswire)Source 2: U.S. Food and Drug Administration (openFDA Drugs@FDA)
2025-12-19 · regulatory
Australia's PBAC publishes advice on subsidising GLP-1 obesity treatments
The Pharmaceutical Benefits Advisory Committee published its November 2025 outcome on 19 December 2025. It advised a slow, managed roll-out to priority groups such as people with established cardiovascular disease, and separately recommended listing Wegovy on the PBS for people with established cardiovascular disease and obesity.
Source: Australian Government, Pharmaceutical Benefits Scheme
2025-12-01 · regulatory
WHO issues its first guideline on GLP-1 medicines for obesity
On 1 December 2025 the World Health Organization published a global guideline on using GLP-1 medicines to treat obesity in adults. It issued conditional recommendations, to be used as part of a comprehensive approach that includes diet and physical activity.
2025-11-07 · market
Metsera accepts Pfizer's offer after a bidding contest with Novo Nordisk
According to BioPharma Dive, Metsera's board accepted Pfizer's offer of up to $86.25 per share (more than $10 billion including contingent payments) on 7 November 2025. The deal ended a contest with Novo Nordisk that had involved lawsuits.
2025-11-06 · politics
White House announces pricing agreements with Eli Lilly and Novo Nordisk
On 6 November 2025 the White House announced agreements with Lilly and Novo Nordisk that it said would set Medicare and Medicaid prices for Ozempic, Wegovy, Mounjaro and Zepbound at $245, with a $50 monthly co-pay for Medicare patients covered for obesity. It also described lower cash prices through TrumpRx, and US manufacturing investment pledges from both companies.
2025-11 · pricing
CMS publishes a Medicare negotiated price for semaglutide, effective 2027
In November 2025 CMS published negotiated Medicare prices for the 2027 price applicability year. For Ozempic, Rybelsus and Wegovy it lists a negotiated price of $274 for a 30-day supply, against a 2024 list price of $959, a 71% discount. The prices apply from 2027.
Source: Centers for Medicare & Medicaid ServicesSource 2: Centers for Medicare & Medicaid Services
2025-09-09 · regulatory
FDA launches a crackdown on misleading drug advertising, including compounded GLP-1 marketing
On 9 September 2025 the FDA announced it was sending thousands of letters asking drug companies to remove misleading ads and about 100 cease-and-desist letters. A law-firm summary reports that more than 50 warning letters went to compounders and manufacturers of GLP-1 products, mainly over claims that compounded products are 'generic' or contain the 'same active ingredient'. Warning letters state the FDA's view and are not court findings.
Source: U.S. Food and Drug AdministrationSource 2: Wilson Sonsini
2025-09 · pricing
Mounjaro's UK list price rises from September 2025
The Drug Tariff reimbursement prices for Mounjaro (tirzepatide) were redetermined from September 2025 to reflect an increase in the NHS list price. For example, the highest-priced pack rose from £122 to £330 and the lowest-priced pack from £92 to £133.
2025-08-28 · approval
FDA approves and Teva launches the first generic GLP-1 for weight loss in the US
Teva announced on 28 August 2025 that the FDA had approved, and it had launched, a generic version of Saxenda (liraglutide). Teva described it as the first generic GLP-1 medicine indicated for weight loss.
2025-08-05 · legal
Novo Nordisk announces 14 more lawsuits over compounded 'semaglutide'
On 5 August 2025 Novo Nordisk said it had filed 14 new lawsuits over compounded products marketed as semaglutide, extending its cases to certain compounding pharmacies and telehealth companies. It said it had by then filed 132 complaints in federal courts across 40 states, and that courts had issued 44 permanent injunctions in similar cases. The company's statements are its own account of the litigation, and the new complaints are allegations.
2025-07-01 · market
CVS Caremark stops covering Zepbound and keeps Wegovy
From 1 July 2025, CVS Caremark, a large US pharmacy benefit manager, stopped covering Zepbound for its members and continued to cover Wegovy. CVS said the decision was intended to make the two manufacturers compete on price.
2025-06-27 · approval
China approves mazdutide for chronic weight management
Innovent announced on 27 June 2025 that China's NMPA approved mazdutide, a dual glucagon and GLP-1 receptor agonist, for chronic weight management in adults with overweight or obesity. The approval was supported by the GLORY-1 phase 3 trial.
2025-06-23 · trial
MariTide phase 2 trial: up to about 16% weight loss at 52 weeks with monthly dosing
In Amgen's phase 2 trial of 592 participants, the obesity cohort lost between 12.3% and 16.2% of body weight at week 52 (treatment-policy estimand) versus 2.5% with placebo. Maridebart cafraglutide was investigational when these results were published.
2025-06-22 · trial
REDEFINE 1: CagriSema leads to about 20% weight loss at 68 weeks
In the REDEFINE 1 phase 3 trial of 3,417 adults with obesity or overweight, the cagrilintide-semaglutide combination (CagriSema) produced an estimated mean weight change of -20.4% at week 68, versus -3.0% with placebo. CagriSema was an investigational combination when these results were published.
2025-05-25 · trial
GLORY-1: mazdutide produces about 14% weight loss at 48 weeks in Chinese adults
In the GLORY-1 phase 3 trial of 610 Chinese adults with obesity or overweight, mean body weight fell by up to 14.0% at week 48 with mazdutide, while the placebo group changed by +0.3%.
2025-05-12 · politics
Executive Order 14297 sets a most-favored-nation drug pricing policy
On 12 May 2025 President Trump signed an executive order directing officials to seek prices for US patients in line with those paid in other developed countries. It also directed HHS to facilitate direct-to-consumer purchasing programmes that sell at the most-favored-nation price.
2025-05-11 · trial
SURMOUNT-5: tirzepatide beats semaglutide for weight loss in a head-to-head trial
In a 72-week randomised trial of 751 adults with obesity, average weight loss was 20.2% with tirzepatide and 13.7% with semaglutide. Results were published in NEJM.
2025-04-24 · legal
Court denies compounders' request to block the semaglutide shortage decision
On 24 April 2025 the federal district court in the Northern District of Texas denied the preliminary injunction sought by the Outsourcing Facilities Association in its case over the FDA's semaglutide decision. The court had denied a similar request about tirzepatide on 5 March 2025, so the FDA's enforcement grace periods proceeded.
2025-04-23 · legal
Lilly files lawsuits against four telehealth companies over compounded tirzepatide
On 23 April 2025 Eli Lilly filed complaints against four telehealth companies, according to NPR. One complaint alleges the defendant switched patients to compounded tirzepatide with added ingredients such as niacinamide. These are allegations in complaints that had not been decided by a court when they were reported.
2025-04-04 · politics
Trump administration declines to finalise a rule allowing Medicare to cover obesity drugs
According to STAT News, the administration chose not to finalise a Biden-era proposed rule that would have let Medicare cover weight-loss drugs. STAT reported the rule would have made millions more people eligible for the treatments.
2025-02-21 · regulatory
FDA declares the semaglutide shortage resolved
On 21 February 2025 the FDA determined that the shortage of semaglutide injection products was resolved. Its enforcement grace periods for compounders ended on 22 April 2025 for state-licensed pharmacies and 22 May 2025 for outsourcing facilities, or later depending on a pending court decision.
Source: U.S. Food and Drug AdministrationSource 2: Alston & Bird
2024
2024-12-23 · regulatory
NICE recommends tirzepatide for obesity on the NHS in England, with a phased roll-out
NICE published its final guidance TA1026 on 23 December 2024, recommending tirzepatide (Mounjaro) for adults with obesity who meet BMI and weight-related condition criteria. Funding was set to be introduced in phases, following NHS England's interim commissioning guidance.
Source: National Institute for Health and Care Excellence (NICE)
2024-12-19 · regulatory
FDA reevaluates and again finds the tirzepatide shortage resolved
On 19 December 2024 the FDA issued a declaratory order that revoked and replaced its October decision and again determined the tirzepatide shortage was resolved. The FDA said it would not act against compounders for shortage-dependent conditions until 18 February 2025 for state-licensed pharmacies and 19 March 2025 for outsourcing facilities.
Source: U.S. Food and Drug AdministrationSource 2: U.S. Food and Drug Administration
2024-10-02 · regulatory
FDA declares the tirzepatide shortage resolved and removes it from the shortage list
The FDA determined on 2 October 2024 that the shortage of tirzepatide injection products (Mounjaro and Zepbound) was resolved and removed them from its shortage list. A compounder trade group and a compounding business challenged the decision in court, and the FDA later reevaluated it.
Source: U.S. Food and Drug AdministrationSource 2: U.S. Food and Drug Administration
2024-05-22 · regulatory
Australia announces a ban on compounded GLP-1 medicines, effective 1 October 2024
Health Minister Mark Butler announced on 22 May 2024 that compounded copies of GLP-1 medicines such as Ozempic and Mounjaro would be removed from the pharmacy compounding exemption from 1 October 2024. The Minister said at least 20,000 Australians were using such products at the time.
Source: Australian Government Department of Health, Disability and Ageing
2024-03-08 · approval
FDA adds a heart-protection indication to Wegovy
On 8 March 2024 the FDA approved a new indication for Wegovy: reducing the risk of cardiovascular death, heart attack and stroke in adults with established cardiovascular disease and either obesity or overweight. The approval followed the SELECT trial.
2023
2023-11-11 · trial
SELECT trial: semaglutide lowers heart-attack and stroke risk in people with obesity and heart disease
In the SELECT trial of 17,604 adults with overweight or obesity and existing cardiovascular disease but no diabetes, a major cardiovascular event occurred in 6.5% of the semaglutide group and 8.0% of the placebo group (hazard ratio 0.80) over an average of about 40 months.
2023-11-08 · approval
FDA approves Zepbound (tirzepatide) for chronic weight management
The FDA approved Zepbound on 8 November 2023 for chronic weight management in adults with obesity, or with overweight and at least one weight-related condition, alongside diet and physical activity.
Source: U.S. Food and Drug AdministrationSource 2: U.S. Food and Drug Administration (openFDA Drugs@FDA)
2023-09-29 · regulatory
FDA lists several peptides, including ipamorelin and kisspeptin-10, in 'Category 2' of its compounding bulk-substances process
The FDA's Category 2 page identifies bulk substances that may present significant safety risks and shows entries with a Category 2 date of 29 September 2023, including ipamorelin acetate (for outsourcing facilities) and kisspeptin-10 (for pharmacies). Category 2 is where the FDA places bulk substances it has identified as potentially presenting significant safety risks under its interim policies.
2023-06-26 · trial
Retatrutide phase 2 trial: up to about 24% weight loss at 48 weeks
In a phase 2 trial of 338 adults with obesity or overweight, retatrutide, an investigational triple GIP, GLP-1 and glucagon receptor agonist, produced average weight loss of up to 24.2% at 48 weeks versus 2.1% with placebo. Retatrutide was an investigational medicine at the time of this trial.
2022
2022-12-15 · regulatory
FDA adds tirzepatide (Mounjaro and Zepbound) to its drug shortage list
According to the FDA's later declaratory order, tirzepatide injection products were first added to the FDA drug shortage list on 15 December 2022. This opened the same temporary room for compounded copies that applied to semaglutide.
2022-06-04 · trial
SURMOUNT-1 trial: tirzepatide leads to up to about 21% weight loss over 72 weeks
In the SURMOUNT-1 phase 3 trial of adults with obesity or overweight without diabetes, average weight change at week 72 was between -15.0% and -20.9% across three tirzepatide groups, versus -3.1% with placebo. Results were published in NEJM.
2022-05-13 · approval
FDA approves Mounjaro (tirzepatide) for type 2 diabetes
The FDA approved Mounjaro on 13 May 2022 for adults with type 2 diabetes. Tirzepatide is a dual GIP and GLP-1 receptor agonist.
Source: U.S. Food and Drug Administration (openFDA Drugs@FDA)
2022-03 · regulatory
FDA lists Wegovy, then Ozempic, as in shortage
According to a law-firm summary of the FDA's actions, the FDA added Wegovy to its drug shortage list in March 2022 and Ozempic in August 2022. While an approved drug is listed as in shortage, US compounders may make copies of it under conditions that otherwise do not apply.
Source: Alston & BirdSource 2: U.S. Food and Drug Administration
2021
2021-06-04 · approval
FDA approves Wegovy (semaglutide) for chronic weight management
The FDA approved Wegovy, a weekly injected form of semaglutide, on 4 June 2021 for chronic weight management in adults with obesity or with overweight plus a weight-related condition.
Source: U.S. Food and Drug Administration (openFDA Drugs@FDA)
2021-02-10 · trial
STEP 1 trial: weekly semaglutide leads to about 15% weight loss over 68 weeks
The STEP 1 phase 3 trial, published in NEJM, enrolled adults with overweight or obesity without diabetes. Average body weight fell 14.9% at week 68 with semaglutide versus 2.4% with placebo, alongside lifestyle support.
2019
2019-09-20 · approval
FDA approves Rybelsus, a tablet form of semaglutide, for type 2 diabetes
The FDA approved Rybelsus (semaglutide tablets) on 20 September 2019 for adults with type 2 diabetes. It is a tablet version of semaglutide taken by mouth rather than by injection.
Source: U.S. Food and Drug Administration (openFDA Drugs@FDA)Source 2: U.S. Food and Drug Administration
2017
2017-12-05 · approval
FDA approves Ozempic (semaglutide) for type 2 diabetes
The FDA approved Ozempic, a once-weekly injected form of semaglutide, on 5 December 2017 for adults with type 2 diabetes. Semaglutide is the active ingredient later sold as Wegovy for weight management.
Source: U.S. Food and Drug Administration (openFDA Drugs@FDA)
2014
2014-12-23 · approval
FDA approves Saxenda (liraglutide) for chronic weight management
The FDA approved Saxenda, a daily injected form of liraglutide, on 23 December 2014 for long-term weight management in adults with obesity or with overweight plus a weight-related condition. It was a GLP-1 medicine approved for weight loss before semaglutide and tirzepatide.
Source: U.S. Food and Drug Administration (openFDA Drugs@FDA)Source 2: U.S. Food and Drug Administration
2010
2010-01-25 · approval
FDA approves Victoza (liraglutide) for type 2 diabetes
The FDA approved Victoza, a once-daily injected form of liraglutide, on 25 January 2010. Liraglutide is also the active ingredient of Saxenda, which is approved for weight management.
Source: U.S. Food and Drug Administration (openFDA Drugs@FDA)Source 2: U.S. Food and Drug Administration
2005
2005-04-28 · approval
FDA approves Byetta (exenatide) for type 2 diabetes
The US FDA approved Byetta, an injected form of exenatide, on 28 April 2005 for adults with type 2 diabetes. Exenatide is a GLP-1 receptor agonist, which means it acts on the same receptor as the natural gut hormone GLP-1.
Source: U.S. Food and Drug Administration (openFDA Drugs@FDA)Source 2: U.S. Food and Drug Administration