Insulin Glargine
Insulins and Analogues For Injection, Long-Acting
Sold as Lantus · Ondibta · Suliqua · Lusduna · TOUJEO Max
- Drug class
- Insulins and Analogues For Injection, Long-Acting
- Availability
- Prescription only
- Routes
- Subcutaneous
- Markets covered
- 4
- Products on record
- 218
- FDA reports (12 mo)
- 13,761
Overview
Plain-language summary, compiled from the cited regulatory records
Insulin glargine is a long-acting insulin analog [1]. It belongs to the drug class of insulins and analogues for injection, long-acting [1].
Insulin glargine is approved to improve glycemic control in adults and pediatric patients diagnosed with type 1 diabetes mellitus [1]. It is also indicated for adults with type 2 diabetes mellitus [1]. It is not recommended for the treatment of diabetic ketoacidosis [1].
This medication is available under various brand names, including BASAGLAR KwikPen, TOUJEO, and LANTUS SOLOSTAR [1]. In the past 12 months, there have been 13,761 adverse event reports associated with this active ingredient [2].
This is not medical advice. Consult a qualified healthcare professional.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| GB United Kingdom | MHRA | 186 | May 29, 2026 |
| US United States | FDA | 17 | March 18, 2026 |
| CA Canada | Health Canada | 9 | January 5, 2026 |
| EU European Union | EMA | 6 | April 24, 2026 |
GBUnited Kingdom· MHRA
186 products
Uses
Treatment of diabetes mellitus in adults, adolescents and children from the age of 6 years.
How to take
USUnited States· FDA
17 products
Uses
1 INDICATIONS AND USAGE SOLIQUA 100/33 is a combination of insulin glargine and lixisenatide and is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. SOLIQUA 100/33 is a combination of insulin glargine, an insulin analog, and lixisenatide, a glucagon-like peptide-1 (GLP-1) receptor agonist, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
( 1 ) Limitations of Use ( 1 ) : Concomitant use in combination with any other product containing a GLP-1 receptor agonist is not recommended. Not recommended for the treatment of diabetic ketoacidosis. Has not been studied in combination with prandial insulin.
Limitations of Use :
SOLIQUA 100/33 contains lixisenatide. 5) ] . SOLIQUA 100/33 is not recommended for the treatment of diabetic ketoacidosis. SOLIQUA 100/33 has not been studied in combination with prandial insulin.
CACanada· Health Canada
9 products
Uses
Indications have been granted on the basis of similarity between Semglee and the reference biologic drug Lantus®. Semglee [Insulin Glargine Injection (rDNA Origin)] is a recombinant human insulin analog indicated: • for once-daily subcutaneous administration in the treatment of patients over 17 years of age with Type 1 or Type 2 diabetes mellitus who require basal (long-acting) insulin for the control of hyperglycemia.
• in the treatment of pediatric patients (˃6 years old) with Type 1 diabetes mellitus who require basal (long-acting) insulin for the control of hyperglycemia. 1 Pediatrics (> 6 years of age) Pediatrics (> 6 years of age): Based on the data submitted and reviewed by Health Canada, the safety and efficacy of Semglee in pediatric patients over 6 years of age with Type 1 diabetes mellitus has been established.
Therefore, Health Canada has authorized an indication for pediatric use. 2 Geriatrics (> 65 years of age) Geriatrics: Evidence from clinical studies and experience suggests that use in the geriatric population is associated with differences in safety or effectiveness.
EUEuropean Union· EMA
6 products
Uses
Treatment of diabetes mellitus in adults, adolescents and children aged 2 years and above.
How to take
Drug interactions
Known interactions involving Insulin Glargine. Select one for details. This list is informational and not a complete interaction checker.
Showing 240 of 315. Type above to find a specific drug.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
Sources & citations
- [1]MHRA (UK) · PLGB044250818 · revised May 15, 2026
- [2]FDA DailyMed · 4bba538b-cf7c-43… · revised March 18, 2026 [PDF]
- [3]Health Canada (DPD) · 02526441 · revised September 23, 2025
- [4]European Medicines Agency · EMEA/H/C/006136 · revised April 24, 2026
- [5]OpenFDA adverse-event reports (US), 12 months ending June 4, 2026.
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.