Lantus
A long-acting basal insulin for type-1 and type-2 diabetes.
Where Insulin Glargine is approved
All regulators →Of the three regulators tracked here, the first to approve Insulin Glargine was the US, on 20 Apr 2000. It is approved in 3 of the 3 regulators tracked here.
- 3 FDA-approved biosimilars, 3 interchangeable: Langlara, Rezvoglar, Semglee
From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.
What health systems spend on Insulin Glargine
All medicines →From NHSBSA Prescription Cost Analysis (Open Government Licence v3.0) and CMS State Drug Utilization Data. Both are gross amounts: neither system publishes its discounts or rebates per drug. Products combining several substances are not counted here.
How Insulin Glargine works
All drug targets →- Insulin receptor agonist AgonistTarget: INSR insulin receptorChEMBL only
- Burkitt lymphomaPhase 3
- HyperglycemiaPhase 3
- HypoglycemiaPhase 3
- ST Elevation Myocardial InfarctionPhase 3
- Acute lymphoblastic leukemiaPhase 3
- Chronic kidney diseasePhase 3
- Cystic fibrosisPhase 3
- Gestational diabetesPhase 3
- Lymphoblastic lymphomaPhase 3
- MalariaPhase 3
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL1201497, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3), ligand 7572, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.
NICE appraisals of Insulin Glargine
All NICE appraisals →NICE, which decides whether the NHS in England should fund new medicines, has published 1 technology appraisal of Insulin Glargine.
| Appraisal | NICE recommendation | Published | Status |
|---|---|---|---|
| Guidance on the use of long‑acting insulin analogues for the treatment of diabetes – insulin glargine NICE TA53 | Recommended Optimised | 6 Dec 2002 Updated 1 Aug 2015 | Replaced |
NICE decisions apply to the NHS in England. In Ireland the HSE decides on reimbursement, advised by the National Centre for Pharmacoeconomics. Titles, categories and dates link to the guidance on nice.org.uk. © NICE 2026 technology appraisal guidance. Available from www.nice.org.uk/guidance. All rights reserved. Subject to Notice of rights. NICE guidance is prepared for the National Health Service in England. All NICE guidance is subject to regular review and may be updated or withdrawn. NICE accepts no responsibility for the use of its content in this product/publication.
Patient leaflets for Insulin Glargine
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 13 products on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- EUEuropean Union: Lantus, Toujeo (previously Optisulin), Abasaglar (previously Abasria) (biosimilar), Ondibta (biosimilar), Semglee (biosimilar)EMA product information: package leaflet and summary of product characteristics in every EU language.
- UKUnited Kingdom: Search MHRA ProductsPatient information leaflets and SmPCs for UK-licensed products.
- USUnited States: Search DailyMedFDA-approved labels, including patient and medication guides.
Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.
Reference identifiers for Insulin Glargine
- ATC code
- A10AE04
- ChEMBL
- CHEMBL1201497
- PubChem CID
- 44146714
- CAS number
- 160337-95-1
- FDA UNII
- 2ZM8CX04RZ
- Wikidata
- Q417317
- Wikipedia
- Insulin glargine
Codes that identify this medicine in other databases, from Wikidata (CC0), matched by its ChEMBL ID. The ATC code is the WHO classification of what the medicine is used for.
What Lantus is used for
LANTUS is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. LANTUS is a long-acting human insulin analog indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. ( 1 ) Limitations of Use Not recommended for the treatment of diabetic ketoacidosis. ( 1 ) Limitations of Use LANTUS is not recommended for the treatment of diabetic ketoacidosis.
How it works
12.1 Mechanism of Action The primary activity of insulin, including insulin glargine, is regulation of glucose metabolism. Insulin and its analogs lower blood glucose by stimulating peripheral glucose uptake, especially by skeletal muscle and fat, and by inhibiting hepatic glucose production. Insulin inhibits lipolysis and proteolysis, and enhances protein synthesis.
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How this page is built
The facts on this page are pulled directly from official U.S. FDA datasets — they are not written from memory. Each field below names the dataset it came from, so you can check it yourself.
- FDA Drug Label (openFDA) ↗ Indications, mechanism of action and pharmacologic class
- Drugs@FDA ↗ First FDA approval date and the company holding the application
- FDA Drug Shortage Database ↗ Current US supply / shortage status
Plain-English summaries and drug-class explainers are written and reviewed by Sreepriya Prasannan (MSc Digital Transformation of Life Sciences (Innopharma Education / Griffith College); MSc & BSc Botany). Data is retrieved automatically from the sources above and cross-checked with AI-assisted verification (Anthropic's Claude) — brand and generic names are matched against the exact FDA product record so that a combination product or a different formulation cannot be mistaken for the drug on this page. An editor reviews the result before publication. We describe this in full in our editorial standards and corrections policy. The FDA data on this page was last retrieved on 10 Oct 2026. How every register is built: methodology · fixes we have made: corrections log.