FDA Approved Metabolic & Weight Loss

Insulin degludec

also known as: Tresiba, Xultophy (combo), NN1250

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.

An ultra-long-acting basal insulin analog (Tresiba, Novo Nordisk, FDA-approved 2015) engineered to self-assemble into soluble multi-hexamer chains in subcutaneous tissue via its hexadecanedioic-acid-glutamyl side chain — these slowly dissociate over days, producing a plasma half-life of approximately 25 hours and a clinical effect duration >42 hours, which translates into flat pharmacokinetics, flexible dosing windows, and the lowest rates of hypoglycemia among basal insulins in the SWITCH and DEVOTE trials.

Mechanism of action

Insulin receptor agonism with pharmacokinetics driven by self-assembly into soluble multi-hexamer chains in the subcutaneous depot. Slow disassembly releases monomers over multiple days. The flat profile gives a uniquely forgiving dosing window — injections can be given at different times each day within an 8-to-40-hour range without loss of control.

Primary uses

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

Typical dosing

once daily (subcutaneous)

Flexible timing. Typical T2DM starting dose 10 units.

Regulatory status

FDA-approved 2015 as Tresiba (Novo Nordisk). Also available as Xultophy (insulin degludec / liraglutide fixed-ratio combination).

References

  1. [fda-pi] FDA. Tresiba (insulin degludec) prescribing information. Novo Nordisk, updated 2024.
  2. [pubmed] Marso SP, et al. "Efficacy and safety of degludec versus glargine in type 2 diabetes (DEVOTE)." N Engl J Med, 2017;377:723-732.
  3. [pubmed] Jonassen I, et al. "Design of the novel protraction mechanism of insulin degludec, an ultra-long-acting basal insulin." Pharm Res, 2012;29:2104-2114.

Related peptides

Insulin glargine

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.

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 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.

Liraglutide

The first once-daily GLP-1 analog to be FDA-approved for both type 2 diabetes (Victoza) and chronic weight management (Saxenda).
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.