Sanofi's only marketed GLP-1 drug is lixisenatide, sold as Adlyxin in the United States and Lyxumia in Europe. It is a short-acting, once-daily injection for type 2 diabetes. Sanofi pulled standalone Adlyxin from the US market in early 2023, and the European Commission withdrew the EU marketing authorisation for Lyxumia on 18 December 2025 at Sanofi's own request. The insulin combination Soliqua still contains lixisenatide and is still on sale in both regions.
What is lixisenatide (Adlyxin / Lyxumia)?
Lixisenatide is a short-acting GLP-1 receptor agonist taken once daily by injection before a meal. Chemically it is an exendin-4 analogue, in the same family as exenatide (Byetta), rather than a human GLP-1 analogue like liraglutide or semaglutide.
Because it is short-acting, lixisenatide mainly blunts the after-meal blood sugar spike rather than providing the steady, all-day GLP-1 effect of newer weekly drugs. Its weight-loss effect is modest compared with current obesity medications. For background on the broader category, see GLP-1 diabetes drugs.
What was lixisenatide approved to treat?
Lixisenatide was approved only for type 2 diabetes, never for weight loss. The European Medicines Agency approved it as Lyxumia on January 31, 2013, and the FDA approved Adlyxin on July 27, 2016 to improve glycemic control in adults with type 2 diabetes (Drugs.com).
It was always positioned as a glucose-lowering add-on, often combined with basal insulin, rather than a standalone obesity therapy.
Why did Sanofi discontinue Adlyxin in the US?
In early 2023, Sanofi stopped marketing standalone Adlyxin in the United States. The decision was a commercial one, not a safety withdrawal: the once-daily, short-acting product could not compete with newer once-weekly GLP-1s like semaglutide and dulaglutide, which offer stronger glucose and weight effects with more convenient dosing.
Lixisenatide simply lost relevance as the market shifted toward more potent, longer-acting molecules. Europe followed three years later: on 18 December 2025 the European Commission withdrew the Lyxumia marketing authorisation after Sanofi Winthrop Industrie requested it, again for commercial reasons and again with no safety finding attached (EMA). Standalone lixisenatide now survives in neither of its two original major markets — only inside the Soliqua combination.
Adlyxin discontinued: the current status, market by market
"Discontinued" means different things in different registries, so here is exactly what each regulator shows as of August 2026.
| Product | Molecule | Market | Status now |
|---|---|---|---|
| Adlyxin | Lixisenatide | United States | Not marketed. The FDA still carries the licence (BLA 208471, Sanofi-Aventis US), but there is no active NDC listing for Adlyxin in the FDA National Drug Code Directory and no current Adlyxin prescribing information in DailyMed |
| Lyxumia | Lixisenatide | European Union | Authorisation withdrawn by the European Commission on 18 December 2025, at the company's request, for commercial reasons. It had been authorised since 1 February 2013 |
| Soliqua 100/33 | Insulin glargine + lixisenatide | United States | Marketed. NDC 0024-5761, listed since 21 November 2016; prescribing information last updated 18 March 2026 |
| Suliqua | Insulin glargine + lixisenatide | European Union | Authorised since 11 January 2017 and still authorised |
Two things follow. First, this was a commercial retirement, not a recall: no safety withdrawal, no FDA enforcement action, and the US licence is still on the books. Nobody who took Adlyxin needs to worry that it was pulled for harm. Second, the December 2025 EU decision closed the last major market for standalone lixisenatide, so in both the US and Europe the molecule now reaches patients only as one half of a basal-insulin pen.
What is Soliqua, and is it still available?
Soliqua 100/33 is a fixed-ratio combination of insulin glargine (a long-acting basal insulin) and lixisenatide in a single daily injection. The FDA approved it on November 21, 2016 for adults with type 2 diabetes (Drugs.com).
Soliqua remains on the US market, so lixisenatide is still prescribed in America — just as part of a combo rather than on its own. It is a diabetes therapy and is not approved or used for weight loss.
The pen delivers 100 units of insulin glargine and 33 mcg of lixisenatide per mL, injected once a day within the hour before the first meal. Insulin-naive patients start at 15 units (15 units glargine plus 5 mcg lixisenatide) and the label caps dosing at 60 units daily, which works out to 60 units of glargine plus 20 mcg of lixisenatide (DailyMed). The GLP-1 dose is not adjustable on its own: it moves only when the insulin dose moves.
Lixisenatide vs modern GLP-1 drugs
| Drug | Molecule | Maker | Indication | Dosing | US status |
|---|---|---|---|---|---|
| Adlyxin | Lixisenatide | Sanofi | Type 2 diabetes | Daily injection | Discontinued (2023) |
| Soliqua | Lixisenatide + insulin glargine | Sanofi | Type 2 diabetes | Daily injection | Available |
| Victoza | Liraglutide | Novo Nordisk | Type 2 diabetes | Daily injection | Available |
| Ozempic | Semaglutide | Novo Nordisk | Type 2 diabetes | Weekly injection | Available |
| Wegovy | Semaglutide | Novo Nordisk | Obesity | Weekly / daily | Available |
How does lixisenatide compare to modern GLP-1s?
Modern GLP-1 drugs outclass lixisenatide on nearly every axis that patients care about. Weekly semaglutide and tirzepatide provide continuous receptor activation, larger reductions in blood sugar, and substantial weight loss — none of which were strengths of a short-acting daily agent. See our Ozempic guide and Wegovy guide for what current standards of care look like.
In practical terms, lixisenatide is now a footnote in the GLP-1 story: historically important as an early entrant, but eclipsed by drugs that work better and dose less often.
Sanofi's GLP-1 portfolio, past and present
Lixisenatide is the only GLP-1 Sanofi ever brought to market, but it is not the only one Sanofi has owned. Two other incretin programs reached human trials, and neither survived.
| Asset | What it is | How far it got | Where it ended |
|---|---|---|---|
| Lixisenatide (Adlyxin / Lyxumia) | Short-acting exendin-4-based GLP-1 agonist, once daily | Approved — EU 2013, US 2016 | Standalone product retired: US in early 2023, EU authorisation withdrawn December 2025 |
| Insulin glargine + lixisenatide (Soliqua 100/33 / Suliqua) | Fixed-ratio basal insulin plus GLP-1, once daily | Approved — US 2016, EU 2017 | Still marketed in both regions |
| Efpeglenatide | Long-acting exendin-based GLP-1 agonist, once weekly | Phase 3 (the AMPLITUDE program) | All four Sanofi-run Phase 3 trials terminated in 2020–2021 |
| SAR425899 | Dual GLP-1 receptor / glucagon receptor agonist | Phase 1 only | Last Phase 1 study in overweight and obese participants completed in 2018; never advanced |
Efpeglenatide: the GLP-1 Sanofi walked away from
Efpeglenatide is the part of this story most people have never heard, and it is the more interesting one. It was a once-weekly, exendin-based GLP-1 agonist that Sanofi took into a four-trial Phase 3 program. Hanmi Pharmaceutical ran a separate Phase 3 trial of the same molecule as lead sponsor.
Sanofi stopped the program partway through. All four of its Phase 3 records on ClinicalTrials.gov — including the cardiovascular outcomes trial — are logged as terminated, with completion dates between November 2020 and January 2021, and each carries the same recorded reason: "Sponsor decision to cancel TRIAL, not related to safety concern."
The outcomes trial had already accrued enough events to report, and it worked. AMPLITUDE-O, published in the New England Journal of Medicine in 2021, randomized 4,076 people with type 2 diabetes and either established cardiovascular disease or kidney disease to weekly efpeglenatide 4 mg, 6 mg, or placebo. Over a median 1.81 years:
- Major adverse cardiovascular events: 7.0% on efpeglenatide vs 9.2% on placebo (hazard ratio 0.73; 95% CI 0.58–0.92; P = 0.007 for superiority)
- Composite kidney outcome: 13.0% vs 18.4% (hazard ratio 0.68; 95% CI 0.57–0.79; P < 0.001)
- Gastrointestinal side effects — diarrhea, constipation, nausea, vomiting, bloating — were more common than on placebo
So Sanofi shelved a GLP-1 that went on to post a positive cardiovascular outcomes result. Efpeglenatide has never been approved: there is no FDA label and no DailyMed entry for it. It is a useful reminder that the GLP-1 race was decided by commercial timing and dosing convenience at least as much as by pharmacology.
Is Sanofi developing any new GLP-1 or weight-loss drugs?
No. As of August 2026, Sanofi has no marketed obesity GLP-1 product and no obesity or incretin candidate in its published pipeline at all. Sanofi's own pipeline page groups its assets into immunology, neurology, oncology, rare disease and vaccines; the only metabolic-adjacent entry is an immunology candidate for type 1 diabetes (Sanofi pipeline). A search of ClinicalTrials.gov for Sanofi-sponsored obesity studies turns up nothing started since the efpeglenatide program ended.
The company's obesity history did not begin with GLP-1s, either. Sanofi's earlier weight-loss drug was rimonabant (Acomplia), a cannabinoid CB1 receptor blocker authorised in the EU on 19 June 2006 and voluntarily withdrawn on 16 January 2009 after psychiatric safety concerns halted its development (EMA). It was never approved in the US. Between rimonabant, lixisenatide and efpeglenatide, Sanofi has now exited obesity and incretin research three times.
Any future metabolic plans should be confirmed against Sanofi's official pipeline rather than assumed. For a sense of who the active players are, see our overview of the GLP-1 receptor agonist drug class.
How is lixisenatide dosed, and what are its side effects?
Lixisenatide is injected once daily within an hour before the first meal of the day, starting at a low dose and stepping up to reduce stomach upset. Its most common side effects are gastrointestinal — nausea, vomiting and diarrhea — along with headache, and a higher risk of low blood sugar when it is combined with insulin or sulfonylureas. Because it is short-acting, these effects are tied closely to mealtime dosing.
What did the ELIXA trial show?
Lixisenatide was the subject of ELIXA, one of the first large cardiovascular outcome trials for a GLP-1 drug, published in 2015. In patients with type 2 diabetes who had recently had a heart attack or unstable angina, lixisenatide proved cardiovascular-safe but did not reduce cardiovascular events versus placebo. That neutral result contrasted with later trials of semaglutide and liraglutide, which demonstrated clear cardiovascular benefit — another reason the newer agents pulled ahead.
What should patients use instead of lixisenatide?
For most people who would once have been candidates for lixisenatide, modern guidelines favor a once-weekly GLP-1 or a dual agonist. Semaglutide (Ozempic for diabetes, Wegovy for weight) and tirzepatide offer stronger glucose control and far greater weight loss with weekly dosing. Liraglutide-based options like Victoza remain a daily alternative. Any switch should be guided by a prescriber based on your goals, kidney function and insurance. Our tirzepatide vs semaglutide comparison covers the two leading molecules.
Is lixisenatide being studied for anything else?
Interestingly, lixisenatide has had a second life in neurology research. The LixiPark Phase 2 trial, published in the New England Journal of Medicine in April 2024, tested whether lixisenatide could slow early Parkinson's disease. Over 12 months, the lixisenatide group showed less worsening of motor disability than placebo on the MDS-UPDRS scale, though the effect was modest and the trial flagged gastrointestinal side effects (NEJM). This reflects broader scientific interest in GLP-1 receptors in the brain, but it is investigational only — lixisenatide is not approved for Parkinson's or any neurological condition.
Where does lixisenatide sit in the GLP-1 story today?
Lixisenatide is best understood as a transitional drug. It arrived when GLP-1 therapy still meant short-acting, mealtime injections, and it was quickly outpaced once weekly molecules and multi-receptor agonists arrived. For type 2 diabetes, it has been almost entirely supplanted; for weight loss, it was never a contender. Its main living legacy in the US is the Soliqua combination and its role as an early data point in the long arc toward today's far more effective therapies.
Can you still get lixisenatide in the US, and how?
You cannot get standalone Adlyxin in the United States anymore — Sanofi stopped supplying it in early 2023. The only way to receive lixisenatide domestically is through Soliqua 100/33, the fixed-ratio combination with insulin glargine, which a clinician can prescribe for type 2 diabetes when both a basal insulin and a GLP-1 effect are wanted in one daily injection. That said, for most patients today a prescriber is more likely to reach for a once-weekly GLP-1 or a dual agonist, which generally control blood sugar better and produce more weight loss. If you were previously on Adlyxin, do not simply stop or substitute on your own; ask your provider about an appropriate modern replacement and how to transition safely.
Frequently Asked Questions
Is Adlyxin still available in the United States?
Standalone Adlyxin was discontinued in the US in early 2023. Lixisenatide is still available domestically inside the combination product Soliqua.
What is Sanofi's GLP-1 drug?
Lixisenatide — brand names Adlyxin in the US and Lyxumia in Europe. It is Sanofi's only GLP-1 ever to reach market, and it is a short-acting, once-daily injection approved for type 2 diabetes, never for weight loss. Sanofi also owns two GLP-1s that never made it: efpeglenatide, halted in Phase 3 in 2020–2021, and SAR425899, a GLP-1/glucagon dual agonist that stopped after Phase 1. Today the only Sanofi product containing a GLP-1 that you can actually fill in a US pharmacy is Soliqua 100/33.
Was Adlyxin discontinued for safety reasons?
No. Sanofi withdrew it commercially in both regions. The US decision in early 2023 and the EU authorisation withdrawal on 18 December 2025 were both company requests, and the EMA record for the EU withdrawal explicitly cites commercial reasons. There was no recall, no safety-based withdrawal, and no regulator action against the drug.
Can you use lixisenatide for weight loss?
No. Lixisenatide is approved only for type 2 diabetes and was never indicated for weight management. Its weight effect is modest compared with drugs like semaglutide.
Why is lixisenatide barely used now?
It is a short-acting, once-daily injection that could not compete with more effective once-weekly GLP-1 drugs. Sanofi withdrew the standalone product for commercial reasons.
Is lixisenatide the same as semaglutide?
No. Lixisenatide is an exendin-4-based short-acting GLP-1 agonist, while semaglutide is a long-acting human GLP-1 analogue. They differ in structure, duration of action, and potency.
This article is for educational purposes and is not medical advice. Talk to a licensed healthcare professional before starting, stopping, or changing any medication.
