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FDA Approved Metabolic & Weight Loss

Insulin glargine

also known as: Lantus, Basaglar, Toujeo, Semglee, Rezvoglar

The dominant once-daily basal insulin for two decades (Lantus, Sanofi, 2000) — the pI-shift design causes microprecipitation in subcutaneous tissue for a nearly peakless 24-hour absorption profile; Toujeo (U-300) is the same molecule at 3× concentration.

A once-daily basal insulin analog (Lantus, Sanofi, FDA-approved 2000) engineered to shift the isoelectric point to physiologic pH, causing the drug — soluble at pH 4 in the vial — to microprecipitate after SC injection at pH 7.4, producing slow, nearly peakless 24-hour absorption; available as Lantus (U-100), Toujeo (U-300), and biosimilars Basaglar, Semglee, and Rezvoglar.

Mechanism of action

Insulin receptor agonism with a unique absorption profile driven by pI engineering. The addition of two C-terminal arginines to the B-chain shifts the isoelectric point from ~5.4 to ~6.7; the drug is formulated as a soluble acidic (pH 4) solution but precipitates into microcrystals on contact with subcutaneous tissue at pH 7.4, then slowly redissolves to deliver monomers over ~24 hours.

Primary uses

  • Type 1 diabetes mellitus (basal)
  • Type 2 diabetes mellitus (basal)

Typical dosing

once daily (same time each day) (subcutaneous)

Fully individualized. Typical T2DM starting dose 10 units or 0.1–0.2 units/kg, titrated to target fasting glucose.

Regulatory status

FDA-approved 2000 as Lantus (Sanofi). Toujeo (U-300 formulation) approved 2015. Basaglar (Lilly biosimilar) approved 2015. Semglee (Mylan) approved 2020 and granted interchangeable designation in 2021.

References

  1. [fda-pi] FDA. Lantus (insulin glargine) prescribing information. Sanofi, updated 2024.
  2. [fda-pi] FDA. Toujeo (insulin glargine U-300) prescribing information. Sanofi, 2015.
  3. [pubmed] Rosenstock J, et al. "Basal insulin therapy in type 2 diabetes: 28-week comparison of insulin glargine (HOE 901) and NPH insulin." Diabetes Care, 2001;24:631-636.

Related peptides

NPH insulin (isophane)

The classical intermediate-acting insulin — regular human insulin co-crystallized with protamine to produce ~12-hour action; still widely used for cost reasons despite being largely superseded by analog basal insulins for T1DM.

Insulin detemir

Novo Nordisk's fatty-acid-acylated basal insulin (Levemir, 2005) — the myristoyl chain enables reversible albumin binding, extending the half-life; Novo Nordisk announced global discontinuation in December 2023 (US supply ended 2024).

Insulin degludec

Novo Nordisk's ultra-long-acting insulin (Tresiba, 2015) — forms soluble multi-hexamers in SC tissue that slowly dissociate for a >42-hour half-life and a flat, forgiving dosing window; the basal insulin with the lowest hypoglycemia risk profile.

Insulin icodec

Novo Nordisk's once-weekly basal insulin (Awiqli, EMA 2024) — the first weekly insulin to reach market; FDA refused to approve in July 2024 (CRL citing type 1 diabetes hypoglycemia data), leaving it approved in the EU, UK, Canada, Switzerland, and Japan while pending US resubmission.

Guides & tools

Disclaimer

This entry is for educational purposes only and does not constitute medical advice. Dosing information reflects published regulatory or research data and is not a recommendation. Many compounds described here are not approved for human use in the United States. Consult a licensed medical professional before considering any peptide therapy.