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Updated: January 19, 2026

Adlyxin Starter Kit Discontinuation: What Providers and Prescribers Need to Know in 2026

Author

Peter Daggett

Peter Daggett

Healthcare provider reviewing medication supply data at desk

Adlyxin (lixisenatide) was discontinued in the US in January 2023. Here's what prescribers need to know about transitioning patients and selecting appropriate GLP-1 alternatives.

For prescribers who may still have patients asking about the Adlyxin Starter Kit or lixisenatide in 2026, this guide provides a complete clinical and practical overview. Adlyxin was permanently discontinued in the United States as of January 1, 2023, following Sanofi's voluntary market withdrawal. Any patients still searching for this medication need proactive transition support from their care team.

Clinical Background: What Was Lixisenatide?

Lixisenatide (Adlyxin) was a once-daily prandial GLP-1 receptor agonist approved by the FDA in July 2016 for adults with type 2 diabetes as an adjunct to diet and exercise. It is a 44-amino acid synthetic analog of GLP-1 with approximately 4-fold greater affinity for the GLP-1 receptor than human GLP-1. Its primary mechanism is increasing glucose-dependent insulin release, decreasing glucagon secretion, and — most distinctively — potent inhibition of gastric emptying, which made it particularly effective at blunting postprandial glucose excursions.

In the GetGoal clinical program, lixisenatide achieved HbA1c reductions of approximately 0.79% versus 0.96% for twice-daily exenatide — within the predefined noninferiority margin. Its modest weight loss profile (approximately -1.9 kg) and lack of demonstrated cardiovascular outcome benefit distinguished it from semaglutide and liraglutide. The ELIXA trial showed lixisenatide was cardiovascular safe (non-inferior to placebo) but did not demonstrate superiority, limiting its appeal in high-risk patient populations.

Why Sanofi Discontinued Adlyxin

Sanofi announced the US market withdrawal on October 20, 2022, citing competitive market conditions and financial performance. The GLP-1 receptor agonist landscape evolved rapidly after 2016, with once-weekly semaglutide demonstrating superior A1C reduction (1.0–1.8%), significant weight loss (3–6 kg), and proven cardiovascular benefit (SUSTAIN-6 and SELECT trials). Tirzepatide (Mounjaro, approved May 2022) further disrupted the market with dual GIP/GLP-1 action achieving A1C reductions of 1.8–2.4% and weight loss of 5–11 kg. Lixisenatide's daily dosing requirement and comparatively modest efficacy made the standalone product commercially unsustainable.

Lixisenatide Is Still Available Via Soliqua 100/33

For appropriate patients, lixisenatide remains accessible through Soliqua 100/33 (insulin glargine 100 units/mL + lixisenatide 33 mcg/mL), which remains on the US market. Soliqua is indicated for adults with type 2 diabetes inadequately controlled on basal insulin (<60 units daily) or lixisenatide alone. The combination pen delivers both basal and prandial GLP-1 coverage in a single daily injection.

Soliqua is delivered via a SoloStar pen, with dosing ranging from 15 to 60 units of insulin glargine (with corresponding lixisenatide 5–20 mcg). Each pen contains 100 units/mL of insulin glargine and 33 mcg/mL of lixisenatide. Clinically, Soliqua offers a pragmatic transition option for patients who require both basal insulin and prandial GLP-1 coverage and whose carbohydrate intake is relatively consistent at the main meal.

Transitioning Patients: Clinical Guidance

For patients who were on standalone Adlyxin (without concurrent basal insulin), the most evidence-based transitions are to once-weekly GLP-1 receptor agonists. Current ADA Standards of Care recommend GLP-1 receptor agonists with proven cardiovascular benefit for patients with type 2 diabetes and established atherosclerotic cardiovascular disease. Key transition options include:

Semaglutide (Ozempic, 0.5–2 mg weekly): Strongest standalone GLP-1 in class; HbA1c reduction 1.0–1.8%; cardiovascular benefit (SUSTAIN-6, SELECT); appropriate for most patients transitioning from lixisenatide

Dulaglutide (Trulicity, 0.75–4.5 mg weekly): Well-tolerated; proven cardiovascular benefit (REWIND trial); auto-injector improves adherence; multiple doses allow titration

Liraglutide (Victoza, 0.6–1.8 mg daily): Best option if patient strongly prefers daily dosing and familiar injection schedule; proven cardiovascular benefit (LEADER); generic liraglutide now available

Tirzepatide (Mounjaro, 5–15 mg weekly): Highest efficacy in class; appropriate for patients not at goal on GLP-1 monotherapy; notable GI side effects during titration require monitoring

Key Prescribing Considerations When Transitioning from Lixisenatide

GI tolerability: All GLP-1 agents carry nausea and GI side effect risk. Titration schedules reduce intolerance; all agents start at low doses

Hypoglycemia risk: Patients co-administered sulfonylureas or insulin will need dose adjustment when transitioning to a more potent GLP-1 agent

Renal function: Semaglutide, dulaglutide, and liraglutide do not require dose adjustment in moderate CKD; avoid exenatide if eGFR <30

Cardiovascular status: Semaglutide and liraglutide have the strongest ASCVD benefit data; both are guideline-preferred for patients with established cardiovascular disease or high cardiovascular risk

Insurance and access: Prior authorization requirements vary; Ozempic and Trulicity are generally well-covered for type 2 diabetes; manufacturer savings programs may reduce copays for commercially insured patients

Helping Patients Find Their New Medication

Even with a new prescription in hand, patients may struggle to locate their GLP-1 medication in stock — particularly for newer agents facing supply pressure. medfinder for providers is a service that calls pharmacies on behalf of patients to find which ones can fill their specific medication and dose. This reduces callbacks to your office and helps ensure your patients get uninterrupted treatment.

Frequently Asked Questions

Sanofi announced the discontinuation of Adlyxin on October 20, 2022, effective January 1, 2023. This was a voluntary market withdrawal, not an FDA-mandated shortage. The FDA Drug Shortage database does not list Adlyxin because this is a business decision, not a supply chain disruption.

Yes. Lixisenatide remains available in the US through Soliqua 100/33 (insulin glargine/lixisenatide), which combines basal insulin with lixisenatide in a single daily pen. It is indicated for adults with type 2 diabetes inadequately controlled on basal insulin (<60 units/day) or lixisenatide alone.

Current ADA guidelines recommend GLP-1 agents with proven cardiovascular benefit for patients with type 2 diabetes and ASCVD. Semaglutide (Ozempic) and liraglutide (Victoza) both have cardiovascular outcome data. Dulaglutide (Trulicity) is another evidence-based option. For patients not at glycemic goal, tirzepatide (Mounjaro) offers the highest efficacy in class.

Lixisenatide can typically be stopped and semaglutide started at its lowest dose (0.25 mg weekly for 4 weeks) on the same day. No washout period is required. Monitor for enhanced GI side effects during initial dose escalation, and consider reducing concurrent sulfonylurea or insulin doses to mitigate hypoglycemia risk.

GLP-1 agents including semaglutide and tirzepatide have faced intermittent availability. Consider directing patients to medfinder (medfinder.com/providers), which calls pharmacies on behalf of patients to identify which ones can fill their specific medication and dose, reducing patient frustration and callbacks to your office.

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