Insulin icodec

Summary

Insulin icodec (Awiqli) is an ultra-long-acting basal insulin analogue designed for once-weekly subcutaneous injection in adults with type 1 or type 2 diabetes mellitus. It features albumin-binding modifications that extend its half-life to approximately 196 hours (~8 days), enabling stable once-weekly dosing. It was approved by the FDA in late 2023/2024 and by the EMA in 2023.

Mechanism of Action

Binds to insulin receptors to lower blood glucose by promoting cellular glucose uptake, inhibiting hepatic glucose production, and suppressing lipolysis. Icodec has fatty acid and albumin-binding modifications enabling an ultra-long half-life (~1 week) via reversible albumin binding, allowing once-weekly subcutaneous dosing.

Routes of Administration

Goals & Uses

• Reduction of fasting hyperglycemiaMetabolic / EndocrineHigh
• Glycemic control in type 2 diabetesMetabolicHigh
• Improved treatment adherence through reduced injection frequencyPatient Convenience / AdherenceModerate
• Glycemic control in type 1 diabetesMetabolic / EndocrineHigh

Contraindications

• Hypoglycemia (during active episode)MetabolicHigh
• Hypersensitivity to insulin icodec or excipientsAllergy / ImmunologicHigh

Adverse Effects

• HypokalemiaElectrolyteUncommon
• HypoglycemiaMetabolicCommonAbnormally low blood glucose
• Allergic reactionsImmunologicalRare
• Injection site reactionsLocalCommon
• Weight gainMetabolicCommonIncrease in body weight
• LipodystrophyDermatologicUncommon

Drug Interactions

• Oral antidiabetics (e.g., sulfonylureas, meglitinides)Moderate
• Beta-blockersModerate
• AlcoholModerate
• GLP-1 receptor agonistsLow
• CorticosteroidsModerate

Population Constraints

• PregnancyReproductive SafetyRelative
• Hepatic impairmentOrgan FunctionRelative
• Renal impairmentOrgan ImpairmentRelative
• Pediatric patients (<18 years)AgeRelative
• Type 1 diabetesDisease SpecificRelative

Regulatory Status

• European UnionApprovedApproved: Type 1 diabetes mellitus in adults, Type 2 diabetes mellitus in adultsEMA granted marketing authorization for Awiqli in 2023 as a once-weekly basal insulin for adults.
• United StatesApprovedApproved: Type 1 diabetes mellitus in adults, Type 2 diabetes mellitus in adultsFDA approved Awiqli (insulin icodec injection, 700 units/mL) in November 2023 for adults with diabetes mellitus as a basal insulin.
• United KingdomApprovedApproved: Type 1 diabetes mellitus in adults, Type 2 diabetes mellitus in adultsMHRA approval granted following EMA decision; indicated for adults with type 1 and type 2 diabetes.

Approved by the EMA (2023) and Health Canada (2023). FDA approved Awiqli in late 2023. Indicated for adults with diabetes mellitus (type 1 and type 2) as a basal insulin replacement.

Evidence & Sources

No sources recorded yet.