Track lixisenatide in Peptimes
Lixisenatide is a synthetic analog of human glucagon-like peptide-1 (GLP-1) and a GLP-1 receptor agonist: a 44-amino-acid peptide amidated at its C-terminal end. FDA-approved lixisenatide products are injected under the skin. (Source: DailyMed label.)
Is lixisenatide FDA-approved?
Yes, as specific products: Adlyxin injection was approved but is no longer marketed in the US. Lixisenatide is still sold in Soliqua 100/33 injection, prescription only, for the uses in its label.
Lixisenatide
Also: Adlyxin, Lyxumia, AVE0010, ZP10
- Status label in the Peptimes Library
- FDA Approved
- Routes in Peptimes
- Subcutaneous
- Updated
- 25 Oct 2026
US regulatory status
FDA approval belongs to each product below, for its route and the uses in its label. Label uses are shortened unless quoted.
Adlyxin (lixisenatide) injection
Subcutaneous
Approved as Adlyxin; no longer marketed in the US.
Source: FDA, checked 25 Oct 2026
Soliqua 100/33 (insulin glargine and lixisenatide) injection
Subcutaneous
Still sold in the US. The uses in its label.
Source: DailyMed label, checked 25 Oct 2026
Prescription
Prescription only. Drugs@FDA lists Soliqua 100/33 as "Prescription".
Source: Drugs@FDA, checked 25 Oct 2026
Investigational
No, for the products and uses above.
Source: Drugs@FDA, checked 25 Oct 2026
How to track it in Peptimes
Add lixisenatide in My Protocols and set the schedule you already follow: days of the week, times of day and a start date. Peptimes never suggests an amount when you log or schedule a dose. Its Library entry shows the status label “FDA Approved”; the list above gives the detail by product. Soliqua 100/33 has no Library entry.
- Logging: the amount you took and how you feel.
- Injection sites: each dose records the site, and Insights shows where you’ve injected and how recently. It never suggests where to inject next.
- Reminders and history: reminders at your times, Dose History, the Calendar and CSV or JSON export work as described on the GLP-1 tracker app page.
Peptimes is a tracking app, not medical advice. Talk to a licensed clinician about your treatment. Peptimes doesn’t sell lixisenatide or any other compound.
More sources
- FDA, introductory remarks for the 21 September 2023 Endocrinologic and Metabolic Drugs Advisory Committee meeting, checked 25 Oct 2026: its list of GLP-1 medicines marks Adlyxin as no longer marketed in the United States.
- FDA, Drugs@FDA: BLA 208471 (Adlyxin) and BLA 208673 (Soliqua 100/33), checked 25 Oct 2026: product and route (its Adlyxin listing still reads “Prescription”; see the FDA source above for marketing). Both were approved as new drug applications and deemed biologics license applications on 23 March 2020.
- FDA, Global Substance Registration System, Lixisenatide, checked 25 Oct 2026: the names Lyxumia, AVE0010 and ZP10.
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