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Insulin degludec

Generic Name
Insulin degludec
Brand Names
Ryzodeg, Tresiba, Xultophy
Drug Type
Biotech
CAS Number
844439-96-9
Unique Ingredient Identifier
54Q18076QB

Overview

Insulin degludec is an ultra-long-acting form of insulin used for the treatment of hyperglycemia caused by Type 1 and Type 2 Diabetes. Insulin is typically prescribed for the management of diabetes mellitus to mimic the activity of endogenously produced human insulin, a peptide hormone produced by beta cells of the pancreas that promotes glucose metabolism. Insulin is released from the pancreas following a meal to promote the uptake of glucose from the blood into internal organs and tissues such as the liver, fat cells, and skeletal muscle. Absorption of glucose into cells allows for its transformation into glycogen or fat for storage. Insulin also inhibits hepatic glucose production, enhances protein synthesis, and inhibits lipolysis and proteolysis among many other functions. Insulin is an essential treatment in the management of Type 1 Diabetes (T1D) which is caused by an autoimmune reaction that destroys the beta cells of the pancreas, resulting in the body not being able to produce or synthesize the insulin needed to manage circulating blood sugar levels. As a result, people with T1D rely primarily on exogenous forms of insulin, such as insulin degludec, to lower glucose levels in the blood. Insulin is also used in the treatment of Type 2 Diabetes (T2D), another form of diabetes mellitus that is a slowly progressing metabolic disorder caused by a combination of genetic and lifestyle factors that promote chronically elevated blood sugar levels. Without treatment or improvement in non-pharmacological measures such as diet and exercise to lower blood glucose, high blood sugar eventually causes cellular resistance to endogenous insulin, and in the long term, damage to pancreatic islet cells. Insulin is typically prescribed later in the course of T2D, after several oral medications such as Metformin, Gliclazide, or Sitagliptin have been tried, when sufficient damage has been caused to pancreatic cells that the body is no longer able to produce insulin on its own. Marketed as the brand name product Tresiba, insulin degludec has a duration of action up to 42 hours allowing for once-daily dosing, typically at bedtime. Due to its duration of action, Tresiba is considered "basal insulin" as it provides low concentrations of background insulin that can keep blood sugar stable between meals or overnight. Basal insulin is often combined with short-acting "bolus insulin" such as Insulin lispro, Insulin glulisine, or Insulin aspart to provide higher doses of insulin required following meals. Use of basal and bolus insulin together is intended to mimic the pancreas' production of endogenous insulin, with the goal of avoiding any periods of hypoglycemia. Compared to endogenous insulin, insulin degludec has an added hexadecanedioic acid on lysine at the B29 position, allowing for the formation of multi-hexamers. When injected subcutaneously, these multi-hexamers form a drug depot store from which monomers are slowly and continuously absorbed into circulation. As a result, Insulin Degludec has a protracted time action profile due to the delayed absorption from subcutaneous tissue depots into the systemic circulation. Compared to available long-acting analogs such as Insulin glargine and Insulin detemir, which have a duration of action of 20-24 hours, insulin degludec provides a consistent level of basal insulin over 42 hours with a low peak: trough ratio. Limitations of shorter-acting analogs include more frequent dosing and less stable pharmacokinetics, which may negatively impact patient adherence and glucose control, particularly nocturnal control. Without an adequate supply of insulin to promote absorption of glucose from the bloodstream, blood sugar levels can climb to dangerously high levels and can result in symptoms such as fatigue, headache, blurred vision, and increased thirst. If left untreated, the body starts to break down fat, instead of glucose, for energy which results in a build-up of ketone acids in the blood and a syndrome called ketoacidosis, which is a life-threatening medical emergency. In the long term, elevated blood sugar levels increase the risk of heart attack, stroke, and diabetic neuropathy. Insulin Degludec was approved by the FDA in September 2015 as the product Tresiba, for use in providing glycemic control to adults with diabetes mellitus.

Indication

Insulin degludec is indicated to improve glycemic control in patients 1 year of age and older with diabetes mellitus.

Associated Conditions

  • Diabetes Mellitus
  • Type 1 Diabetes Mellitus
  • Type 2 Diabetes Mellitus

Research Report

Published: Jul 23, 2025

Insulin Degludec: A Comprehensive Monograph

Executive Summary

Insulin degludec is a second-generation, ultra-long-acting basal insulin analog developed and manufactured by Novo Nordisk. Marketed under the brand name Tresiba®, it is a cornerstone therapy for improving glycemic control in adult and pediatric patients (aged 1 year and older) with Type 1 and Type 2 diabetes mellitus.[1] Its development represents a significant evolution in insulin therapy, addressing the limitations of earlier long-acting analogs by offering a more stable and predictable glycemic profile.

The defining characteristic of insulin degludec is its novel protraction mechanism. Following subcutaneous injection, the drug is engineered to self-assemble into soluble, high-molecular-weight multi-hexamer chains. This assembly creates a depot from which active insulin monomers are slowly and continuously released into the circulation. The result is an exceptionally long duration of action, exceeding 42 hours, with a flat, peakless pharmacokinetic profile.[1] This mechanism is distinct from first-generation analogs like insulin glargine U100, which rely on microprecipitation in subcutaneous tissue.

Continue reading the full research report

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2025/06/24
Phase 1
Not yet recruiting
2025/06/12
Phase 2
Not yet recruiting
2025/01/10
Phase 3
Recruiting
2024/11/12
Phase 1
Recruiting
2024/08/16
Phase 1
Completed
Gan and Lee Pharmaceuticals, USA
2024/08/14
Phase 1
Completed
Gan and Lee Pharmaceuticals, USA
2024/03/01
Phase 1
Completed
2024/02/28
Phase 1
Recruiting
2024/01/11
Phase 2
Completed
Gan and Lee Pharmaceuticals, USA
2023/12/21
Not Applicable
Completed

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Novo Nordisk
0169-2660
SUBCUTANEOUS
100 U in 1 mL
7/1/2022
Novo Nordisk
0169-2662
SUBCUTANEOUS
100 U in 1 mL
7/1/2022
A-S Medication Solutions
50090-7094
SUBCUTANEOUS
200 U in 1 mL
7/1/2022
Novo Nordisk
0169-2911
SUBCUTANEOUS
100 [iU] in 1 mL
6/10/2022
A-S Medication Solutions
50090-3491
SUBCUTANEOUS
200 U in 1 mL
7/1/2022
Novo Nordisk
0169-2550
SUBCUTANEOUS
200 U in 1 mL
7/1/2022
Novo Nordisk Pharma, Inc.
73070-503
SUBCUTANEOUS
200 U in 1 mL
7/1/2022
Novo Nordisk Pharma, Inc.
73070-403
SUBCUTANEOUS
100 U in 1 mL
7/1/2022
Novo Nordisk Pharma, Inc.
73070-400
SUBCUTANEOUS
100 U in 1 mL
7/1/2022

EMA Drug Approvals

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
RYZODEG FLEXTOUCH SOLUTION FOR INJECTION IN PRE-FILLED PEN 100U/ML 70/30 3ML
N/A
novo nordisk hong kong ltd.
N/A
N/A
4/28/2025

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
TRESIBA
Novo Nordisk Canada Inc
02467860
Solution - Subcutaneous
100 UNIT / ML
1/30/2023
XULTOPHY
Novo Nordisk Canada Inc
02474875
Solution - Subcutaneous
100 UNIT / ML
6/6/2018
TRESIBA
Novo Nordisk Canada Inc
02467887
Solution - Subcutaneous
200 UNIT / ML
9/15/2017

CIMA AEMPS Drug Approvals

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
TRESIBA 100 UNIDADES/ML PENFILL SOLUCION INYECTABLE EN CARTUCHO
1120807007
SOLUCIÓN INYECTABLE EN CARTUCHO
Medicamento Sujeto A Prescripción Médica
Commercialized
RYZODEG 100 UNIDADES/ML SOLUCION INYECTABLE EN PLUMA PRECARGADA
12806001
SOLUCIÓN INYECTABLE EN PLUMA PRECARGADA
Medicamento Sujeto A Prescripción Médica
Not Commercialized
TRESIBA 100 UNIDADES/ML FLEXTOUCH SOLUCION INYECTABLE EN PLUMA PRECARGADA
112807004
SOLUCIÓN INYECTABLE
Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración
Commercialized
TRESIBA 100 UNIDADES/ML SOLUCION INYECTABLE EN PLUMA PRECARGADA
112807004IP1
SOLUCIÓN INYECTABLE
Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración
Not Commercialized
TRESIBA 200 UNIDADES/ML FLEXTOUCH SOLUCION INYECTABLE EN PLUMA PRECARGADA
112807013
SOLUCIÓN INYECTABLE EN PLUMA PRECARGADA
Medicamento Sujeto A Prescripción Médica
Commercialized
XULTOPHY 100 U/ML + 3,6 MG/ML SOLUCION INYECTABLE
114947003
SOLUCIÓN INYECTABLE EN PLUMA PRECARGADA
Medicamento Sujeto A Prescripción Médica
Not Commercialized

Philippines FDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product
Company
Registration Number
Dosage Form
Strength
Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name
MA Holder
MA Number
Pharmaceutical Form
Active Ingredient
Authorization Date
No UK EMC drug information found for this drug.

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