GLP‑1 news from 2023
97 dated, sourced GLP-1 developments from 2023: approvals, trial results, prices, lawsuits, compounding and culture.
- Policy
FDA issues its first counterfeit Ozempic alert, naming lot NAR0074
The FDA warned consumers and pharmacies not to use counterfeit Ozempic found in the legitimate US drug supply chain, identifying lot NAR0074 and serial 430834149057. The seized product included counterfeit needles that raised sterility concerns, along with fake labels and carton materials. Five adverse events were reported, all consistent with authentic Ozempic side effects. It established that counterfeits were reaching retail pharmacies, not just gray-market websites.
- Business
Ro begins offering branded Zepbound through its telehealth platform
The telehealth company Ro added Zepbound to its weight-loss program, an early sign that direct-to-consumer platforms, not just doctors' offices, would drive a large share of prescriptions.
- Research
SURMOUNT-4 shows rapid weight regain when tirzepatide is stopped
JAMA published SURMOUNT-4. After 36 weeks of open-label tirzepatide at the maximum tolerated dose, participants had lost 20.9%. Randomized to continue or switch to placebo for 52 more weeks, the continuers lost a further 5.5% while the placebo group regained 14.0%. At the end, 89.5% of continuers had held at least 80% of their loss, versus 16.6% of the placebo group. The trial now appears in the Zepbound prescribing information as Study 4.
- Research
SURMOUNT-4 confirms rapid regain after stopping tirzepatide
After a 36-week lead-in producing 20.9% weight loss, continuing tirzepatide added 5.5% more loss while switching to placebo produced 14.0% regain.
- Culture
Oprah Winfrey tells People she uses a weight-loss medication
Winfrey confirmed she uses an unnamed prescription weight-loss drug as "a tool to manage not yo-yoing," and said she had wrongly blamed herself for decades. It was the single most consequential disclosure of the GLP-1 era.
- Research
First report that tirzepatide users drink less alcohol
A Scientific Reports paper combined a machine-learning analysis of about 68,250 Reddit posts with a 153-person remote study and found lower self-reported alcohol intake, fewer drinks per episode, lower binge-drinking odds and lower AUDIT scores among people on semaglutide or tirzepatide. It was the first published report of reduced drinking with tirzepatide specifically.
- Science
The first big real-world comparison finds more weight loss on tirzepatide
A Truveta analysis of electronic health records for more than 18,000 patients found people on tirzepatide were about three times more likely to reach 15% body weight loss than people on semaglutide. Observational data cannot settle the question the way a randomized trial can, but it framed the debate for a year.
- Business
Novo Nordisk commits 2.1 billion euros to expand its Chartres plant in France
One of a string of capacity announcements as the company raced to keep up with semaglutide demand.
- Business
Lilly files the Zepbound KwikPen application
NDA 217806 supplement S-002 proposed six four-dose KwikPen presentations of Zepbound, filed one week after the brand's original approval.
- Research
SELECT establishes cardiovascular benefit in obesity without diabetes
Semaglutide 2.4 mg cut major adverse cardiovascular events by 20 percent in 17,604 adults with overweight or obesity and established cardiovascular disease but no diabetes, the first outcome trial to show that treating obesity pharmacologically reduces cardiovascular events.
- FDA & regulation
Europe's regulator recommends Mounjaro for weight management
The European Medicines Agency's human medicines committee recommended extending Mounjaro's marketing authorization to chronic weight management, keeping the single European brand rather than creating a second one.
- FDA & regulation
CHMP recommends the EU weight management indication for Mounjaro
Opinion on variation II/0007, based on SURMOUNT-1 with five supportive SURPASS studies.
- Culture
FDA approves Zepbound, giving tirzepatide a weight-loss brand
Lilly launched tirzepatide for chronic weight management under a second name, Zepbound. The two-brand structure has confused American consumers ever since, and it is why UK coverage of "Mounjaro for weight loss" reads strangely to US readers.
- Safety
Zepbound approved for weight management, carrying a suicidal ideation warning
FDA approved tirzepatide as Zepbound for chronic weight management. Unlike Mounjaro, Zepbound launched with a Suicidal Behavior and Ideation warning, matching Saxenda and Wegovy. It would stay on the label for just over two years.
- FDA & regulation
Zepbound's approval label sets the same dose ladder as Mounjaro at a lower list price
The FDA approved Zepbound for chronic weight management in adults with obesity, or overweight with at least one weight-related condition. It is the same molecule as Mounjaro under a different brand and indication. Lilly set the list price at $1,059.87 a month, below Wegovy's list price at the time.
- Business
UK regulator authorizes Mounjaro for weight management, splitting the brand map
The MHRA authorized tirzepatide for weight management under the Mounjaro name in Great Britain. Because there is no Zepbound in the UK, British coverage of 'Mounjaro for weight loss' describes a label that does not exist in the United States.
- Search trends
Zepbound approval splits tirzepatide search demand across two brand names
FDA approved Zepbound for chronic weight management, giving one molecule two US brand identities with different labels, different prices and different coverage. Every comparison query in this lane traces back to this split, and 'are Mounjaro and Zepbound the same' remains one of the highest-volume questions in the entire GLP-1 space.
- Safety
EMA asks GLP-1 makers for data on suicidal thoughts
The European Medicines Agency's safety committee requested additional information from the companies behind Ozempic, Rybelsus, Wegovy, Victoza, Saxenda, Byetta, Bydureon, Lyxumia and Trulicity following reports of suicidal thoughts and self-harm. The review concluded five months later with no causal link found.
- Business
Ozempic and Wegovy reach $4.7 billion in a single quarter
Novo Nordisk reported that Ozempic and Wegovy combined for $4.7 billion in third-quarter sales, about 57% of company revenue. Eli Lilly's Mounjaro reached $1.4 billion in the same period.
- Competition
Gelesis files for Chapter 7 liquidation, putting Plenity's US availability in doubt
Gelesis Holdings and two affiliates cease operations and file a voluntary Chapter 7 petition in the District of Delaware (Case No. 23-11787), listing assets of $50 to $100 million against $44.34 million of liabilities. Assets are sold through the bankruptcy trustee in 2024. A demonstration that FDA clearance does not guarantee a product stays on the market.
- Compounding
Lilly files a Section 337 complaint with the ITC against 11 tirzepatide sellers
The complaint names U.S. firms including Arctic Peptides, Strate Labs, Supopeptide and Triggered Supplements, alongside sellers in the United Kingdom, Spain, Poland, China and Hong Kong, and asks the Commission to block imports of products containing or purporting to contain tirzepatide.
- Compounding
Lilly asks trade regulators to block imports of fake Mounjaro
Lilly sued online pharmacies and asked US authorities to stop imports of counterfeit and unapproved tirzepatide products arriving from overseas sellers, widening its enforcement from domestic compounders to the import channel.
- Safety
Reporting highlights tirzepatide's interaction with oral contraceptives
The labels for Mounjaro and Zepbound state that the drug can reduce the effectiveness of oral birth control around dose increases, and advise a backup method or a non-oral contraceptive for four weeks after starting and after each dose increase. The point got wide coverage as unplanned pregnancies were reported.
- Research
SURMOUNT-ADOLESCENTS begins: the first tirzepatide weight trial in teenagers
Lilly started a phase 3 trial of tirzepatide in 160 participants aged 12 to 17 with obesity, or overweight plus at least one weight-related condition, with percent change in BMI at week 72 as the primary endpoint and an optional 156-week extension. It is separate from the pediatric type 2 diabetes program that later produced Mounjaro's December 2025 pediatric approval. Primary completion was listed as June 2, 2026, with no published results as of 2026-09-14.
- Research
SURMOUNT-3 shows tirzepatide adds to successful lifestyle change
In 579 adults who had already lost at least 5% of body weight in a 12-week intensive lifestyle program, adding tirzepatide produced a further 18.4% weight loss while the placebo group regained 2.5%, a difference of -20.8 percentage points (95% CI -23.2 to -18.5).
- Safety
JAMA research letter links GLP-1 weight loss drugs to gastroparesis, pancreatitis and bowel obstruction
Sodhi and colleagues compared new users of semaglutide and liraglutide for weight loss against bupropion-naltrexone users in a US claims database and reported adjusted hazard ratios of 3.67 for gastroparesis, 9.09 for pancreatitis and 4.22 for bowel obstruction. The paper became the scientific backbone of the gastroparesis litigation.
- Culture
Walmart says GLP-1 users are buying less food
Walmart US CEO John Furner told Bloomberg the retailer could see, in anonymized data, that shoppers filling GLP-1 prescriptions bought "less units, slightly less calories." It was the first hard corporate confirmation that the drugs were moving grocery baskets.
- Business
Lilly reshuffles its diabetes and obesity leadership weeks before the Zepbound decision
Lilly announced that Mike Mason, who had led the diabetes business through the Mounjaro launch, would retire, with Patrik Jonsson taking over the newly important cardiometabolic unit. The move landed just before the FDA decision on tirzepatide for obesity.
- Culture
Goldman Sachs sizes the anti-obesity drug market at $100 billion by 2030
Goldman Sachs Research forecast a roughly $100 billion global market by 2030 based on about 15 million treated US adults, kicking off the "GLP-1 economy" investor thesis that drove years of sector research.
- Safety
UK and EU regulators warn of falsified Ozempic pens
Health authorities in the United Kingdom and Europe warned pharmacies and distributors about falsified Ozempic pens circulating in wholesale channels. German regulators later detailed complex cross-border trades in the fake product.
- Business
Lilly files the Mounjaro KwikPen application with FDA
The supplement (NDA 215866/S-009) proposed six presentations of a single-patient-use KwikPen, each holding four fixed weekly doses. It would take more than two years and a complete response cycle to reach approval.
- Safety
Eli Lilly opens its legal campaign against compounded tirzepatide sellers
Lilly filed its first wave of lawsuits against med spas, wellness centers and compounding pharmacies selling products claimed to contain tirzepatide, publishing an open letter warning patients about counterfeit and compounded versions of Mounjaro and Zepbound. Lilly alleged some products contained bacteria, high impurity levels, the wrong color, a different chemical structure, or in one instance nothing but sugar alcohol.
- Competition
ConsumerLab finds problems in nearly 45% of berberine and goldenseal supplements
Independent testing of 10 products found five of six berberine supplements passed (one short on berberine) while all three goldenseal products failed: one contained almost no berberine and two were contaminated with lead.
- Policy
England's NICE reverses course and backs Mounjaro for type 2 diabetes
After an initial refusal in June, the National Institute for Health and Care Excellence recommended tirzepatide for type 2 diabetes on the NHS. For US readers the case is mostly a reminder that Mounjaro is the weight-loss brand in Britain, where Zepbound does not exist.
- Compounding
Eli Lilly sues med spas and compounders over copycat tirzepatide
Eli Lilly filed lawsuits against ten US medical spas, wellness centers and compounding pharmacies selling products they claimed contained tirzepatide. The suits mirrored Novo Nordisk's campaign against compounded semaglutide.
- Compounding
Lilly files its first round of lawsuits over products sold as tirzepatide
Eli Lilly begins suing med-spas, wellness centers and sellers that advertise compounded products as Mounjaro or as FDA-approved tirzepatide. This is the opening of a campaign that runs for the next three years.
- Science
STEP-HFpEF published: semaglutide eases heart failure symptoms
The New England Journal of Medicine published STEP-HFpEF, showing semaglutide 2.4 mg produced larger reductions in symptoms and physical limitations, better exercise capacity and more weight loss than placebo in people with obesity-related heart failure with preserved ejection fraction.
- Prices
Peterson-KFF publishes the US-versus-peer-country price gap for semaglutide
The analysis found a month of Ozempic listed at $936 in the US against $169 in Japan and about $93 to $103 in the UK and Germany, and Wegovy at $1,349 against $328 in Germany. It became the most cited evidence in the US GLP-1 pricing debate.
- Prices
Peterson-KFF puts US tirzepatide at three times the Netherlands price
The analysis listed a month of Mounjaro at $1,023 in the US against $444 in the Netherlands and $319 in Japan, using June 2023 exchange rates. It became the standard citation for the US-versus-peer-country tirzepatide price gap.
- Culture
Tracy Morgan tells TODAY his weight loss is Ozempic
Morgan turned the disclosure into comedy on TODAY with Hoda & Jenna, saying, "That's Ozempic. That's how this weight got lost." He later joked he had "out-eaten Ozempic" and gained 40 pounds.
- Business
Novo warns Wegovy starter-dose limits will run into 2024
Novo Nordisk said supply restrictions on lower starting doses of Wegovy would persist into 2024, months longer than it had previously signaled. New patients struggled to begin treatment.
- Business
Novo Nordisk agrees to buy Inversago Pharma for up to $1 billion
The Montreal company brought the CB1 receptor program that became monlunabant, which Novo Nordisk terminated in 2026.
- Research
SELECT trial: semaglutide 2.4 mg cuts major cardiovascular events by 20%
Novo Nordisk announced that in the SELECT trial, semaglutide 2.4 mg reduced the risk of heart attack, stroke or cardiovascular death by 20% in adults with overweight or obesity and established cardiovascular disease, none of whom had diabetes. The result changed the argument for insurance coverage of obesity drugs.
- Business
Lilly hits a record high as Mounjaro drives an 85% profit jump
Second-quarter results sent Lilly shares to their best day in more than two decades. The chief executive called meeting Mounjaro demand his top priority, an early public admission that supply, not demand, was the constraint.
- Safety
The first 'stomach paralysis' lawsuits name both Ozempic and Mounjaro
A Louisiana woman sued Novo Nordisk and Eli Lilly, alleging the companies failed to warn that their GLP-1 drugs could cause gastroparesis. The filing was the opening move in litigation that grew into a federal multidistrict proceeding with thousands of cases.
- FDA & regulation
First Mounjaro label revision adds carton, Medication Guide and package insert changes
NDA 215866 supplements S-002 and S-006 were approved together, the first of more than a dozen labeling actions that would reshape the Mounjaro insert over the next three years.
- Research
SURMOUNT-3 and SURMOUNT-4 topline: 26% total weight loss, and fast regain after stopping
Lilly reported two results on the same day. SURMOUNT-3 showed people who had already lost weight through intensive lifestyle change lost a further 21.1% on tirzepatide, for 26.6% in total. SURMOUNT-4 showed that people switched to placebo after 36 weeks regained much of what they had lost, an early sign that these drugs work only while they are being taken.
- Business
Liraglutide injection goes on the FDA drug shortage list
Liraglutide joins the GLP-1 supply crisis. The shortage persists for years and prompts the FDA to prioritize review of generic liraglutide applications, which becomes the reason liraglutide is genericized before any other GLP-1.
- Business
Lilly buys Versanis for up to $1.93 billion to chase muscle-sparing weight loss
Lilly agreed to acquire Versanis Bio and its activin receptor antibody bimagrumab, betting that pairing an incretin with a muscle-preserving drug would answer the growing complaint that GLP-1 weight loss takes lean mass along with fat.
- Safety
Tirzepatide labeling changed to add ileus, alongside a similar semaglutide change
Tirzepatide labeling was changed in July 2023 to reflect ileus, two months before FDA added ileus to the Ozempic label in September 2023. Both changes came from postmarketing reports rather than trial data, which is why the label says frequency cannot be reliably estimated.
- Safety
ASA tells anesthesiologists to hold GLP-1 drugs before elective procedures
The American Society of Anesthesiologists issued consensus guidance advising that weekly injectable GLP-1 drugs be held for a week and daily agents on the day of a procedure, after case reports of food remaining in the stomach despite standard fasting.
- Compounding
Poison control case series documents 10-fold compounded semaglutide overdoses
A peer-reviewed case series in the Journal of the American Pharmacists Association described patients who self-administered ten times the intended dose of compounded semaglutide after confusing syringe measurement units.
- Research
Retatrutide's phase 2 data show 24.2% weight loss, the biggest yet
Lilly published phase 2 results for retatrutide, a triple agonist hitting GIP, GLP-1 and glucagon receptors, showing up to 24.2% average weight loss at 48 weeks. Reporters called it the first drug to approach bariatric surgery territory, and it became the benchmark every later obesity candidate was measured against.
- Research
OASIS 1 shows a daily semaglutide pill can match the injection
Oral semaglutide 50 mg produced 15.1% weight loss versus 2.4% on placebo over 68 weeks in adults without diabetes.
- Research
SURMOUNT-2 shows smaller but substantial weight loss in type 2 diabetes
In 938 adults with type 2 diabetes and BMI 27 or higher, tirzepatide produced 12.8% and 14.7% weight loss at week 72 versus 3.2% on placebo — the same pattern of reduced effect in diabetes that semaglutide shows.
- Research
Orforglipron's phase 2 results put an oral GLP-1 pill on the map
Lilly published phase 2 results in the New England Journal of Medicine showing its once-daily small molecule pill orforglipron produced up to 14.7% weight loss at 36 weeks. Unlike Rybelsus, orforglipron is not a peptide, so it does not need the fasting and water rules that make oral semaglutide awkward to take.
- Research
Phase 2 obesity results: up to 14.7% weight loss at 36 weeks
Lilly's Phase 2 trial of orforglipron in adults with obesity or overweight, published in the New England Journal of Medicine, reported body weight reductions of 8.6% to 12.6% at 26 weeks and 9.4% to 14.7% at 36 weeks, versus 2.0% and 2.3% with placebo. It made orforglipron the clear front-runner among oral small-molecule GLP-1s.
- Compounding
Novo Nordisk begins legal action against med spas and compounders
Novo Nordisk said it had started legal proceedings against US medical spas, weight-loss clinics and compounding pharmacies over false advertising, trademark infringement and sales of non-FDA-approved products claiming to contain semaglutide. It was the opening move in what became dozens of lawsuits.
- Science
Selective GIP receptor agonist produces weight loss without nausea in Phase 1
Lilly reports at ADA that LY3537021, a selective long-acting GIP receptor agonist, produced weight loss over four weekly doses with no nausea or vomiting and no gastric emptying delay - early support for the idea that GIP contributes to weight loss on its own terms.
- Culture
Amy Schumer calls on celebrities to stop lying about Ozempic
On Watch What Happens Live, Schumer said Ozempic made her too sick to function and attacked peers who credited "smaller portions" for dramatic weight loss. The remark framed honesty as the ethical question of the disclosure wave.
- Research
Cystatin C analysis confirms the tirzepatide kidney signal is not a muscle-mass artifact
Because large weight loss reduces muscle mass and therefore creatinine, there was a worry that tirzepatide's apparent kidney benefit was a measurement illusion. A SURPASS-4 post hoc analysis using cystatin C, which does not depend on muscle mass, found the same benefit, with a between-group difference of 1.8 mL/min/1.73 m2 at one year.
- Safety
Counterfeit Ozempic pens found at a US retail pharmacy
Novo Nordisk confirmed that fake Ozempic pens had been discovered at a US retail pharmacy, the first such finding inside the legitimate supply chain. The company warned patients to check lot and serial numbers.
- Compounding
FDA warns that compounded semaglutide may contain salt forms, not the approved ingredient
FDA alerted the public that some compounded products used semaglutide sodium or semaglutide acetate, which the agency treats as different active ingredients from the semaglutide base in Ozempic, Wegovy and Rybelsus.
- Culture
Charles Barkley says he lost 62 pounds on Mounjaro
One of the first major US celebrities to name tirzepatide rather than semaglutide, Barkley's disclosure helped make Mounjaro a household word a year before it had a weight-loss brand of its own.
- Research
SURPASS-AP-Combo reports Asia-Pacific results against insulin glargine
In 917 insulin-naive adults across China, South Korea, Australia and India, tirzepatide lowered HbA1c by 1.29 to 1.54 points more than titrated insulin glargine at week 40, and produced 5.0 to 7.2 kg of weight loss where insulin caused a 1.5 kg gain.
- Research
Randomized trial finds exenatide lowers intracranial pressure in IIH
A placebo-controlled trial using telemetric pressure catheters found the GLP-1 drug exenatide reduced intracranial pressure in women with active idiopathic intracranial hypertension, opening a new research direction for the drug class.
- Research
SURMOUNT-2 topline: up to 15.7% weight loss in people with type 2 diabetes
Lilly reported that tirzepatide produced average weight loss of 13.4% at 10 mg and 15.7% at 15 mg over 72 weeks in adults with obesity or overweight who also had type 2 diabetes, and said it would complete its FDA submission for obesity within weeks. People with diabetes typically lose less weight on incretin drugs than people without it.
- Competition
Lilly starts SURMOUNT-5, the first head-to-head trial against Wegovy
Lilly launched a trial directly comparing tirzepatide with semaglutide 2.4 mg for weight loss in adults with obesity. Running a head-to-head study against a rival's marketed drug is unusual, and the result, reported in December 2024, became the single most cited comparison in the category.
- Business
Lilly breaks ground in Lebanon and adds $1.6 billion
Construction began on the LEAP campus with a second commitment and 200 more planned jobs.
- Business
Novo Nordisk suspended from the UK pharmaceutical trade association
The Association of the British Pharmaceutical Industry suspended Novo Nordisk for two years over misleading marketing practices characterized as inducements to prescribe. Two royal colleges ended corporate partnerships as a result.
- Business
Lilly cuts insulin list prices by 70% and caps patient costs at $35 a month
The first major insulin price cut by a US manufacturer. Humalog and Humulin list prices fell 70%, non-branded Insulin Lispro dropped to $25 a vial, and out-of-pocket costs were capped at $35 for people with commercial insurance at most retail pharmacies.
- FDA & regulation
Japan approves Wegovy under a narrow obesity indication
Japan cleared semaglutide 2.4 mg only for patients with obesity disease who also have hypertension, dyslipidemia or type 2 diabetes.
- Culture
Rosie O'Donnell posts about Mounjaro on TikTok
O'Donnell became one of the first entertainers to narrate a GLP-1 experience in real time on social media, posting weight updates that she continued for three years.
- Business
Lilly's fourth-quarter 2022 results disappoint on Mounjaro, and the stock falls
Lilly reported fourth-quarter Mounjaro sales below Wall Street forecasts and gave cautious 2023 guidance. Analysts said the market was really waiting on the obesity decision, which would decide whether tirzepatide became a diabetes drug or something much larger.
- Business
Full-year 2022 results: sales up 26% to DKK 177.0 billion
Operating profit rose 28% to DKK 74.8 billion. North America Operations grew 35% in Danish kroner as GLP-1 demand took off.
- Culture
Chelsea Handler says she took Ozempic without knowing it
On the Call Her Daddy podcast, Handler said her anti-aging doctor "just hands it out to anybody" and that she did not realize she was on Ozempic until a friend described the same nausea. The anecdote became shorthand for casual concierge prescribing.
- Business
Lilly adds $450 million to its North Carolina plant as an obesity decision nears
Lilly said it would invest another $450 million and add about 100 jobs at its Research Triangle Park site in North Carolina, expanding capacity for tirzepatide ahead of a possible obesity approval. It was the first of many capital announcements tied to incretin supply.
- Business
Novo Nordisk sues Mylan over generic semaglutide ANDA
Novo Nordisk filed suit in the District of Delaware asserting five patents against Mylan's abbreviated new drug application for generic semaglutide, opening the litigation that will shape when US generics arrive.
- Research
American Academy of Pediatrics issues its first childhood obesity clinical practice guideline
The AAP guideline's Key Action Statement 12 says providers should offer adolescents 12 and older with obesity weight loss pharmacotherapy as an adjunct to health behavior and lifestyle treatment, with a weaker consensus recommendation for children aged 8 through 11. The guideline states no evidence supports medication as monotherapy.
- Culture
"Ozempic face" enters the mainstream vocabulary
Coverage of rapid facial fat loss among people using semaglutide popularized the phrase "Ozempic face." The term became shorthand for a wider cultural conversation about appearance, weight and the drugs.
- Culture
Remi Bader says her binge eating worsened after stopping Ozempic
The plus-size creator told People she was prescribed Ozempic while prediabetic and that her binge eating got significantly worse after she stopped. Hers was one of the earliest widely read accounts linking GLP-1s to disordered eating.
- Competition
Berberine goes viral as 'nature's Ozempic'
Social media adopts berberine as a low-cost GLP-1 substitute. Academic and government reviewers push back: UCLA Health calls the evidence inconclusive, the American Academy of Family Physicians says the fad lacks rigorous evidence and has potential harms, and the Department of Defense Operation Supplement Safety program concludes the reported weight reduction does not hold when low-quality studies are excluded.