Last reviewed 2026-06-02 · How we verify

Tresiba (INSULIN DEGLUDEC)

Tresiba (generic name: INSULIN DEGLUDEC) is a Insulin Analog [EPC] Recombinant protein drug developed by Novo Nordisk. It is currently FDA-approved (first approved 2015) for Diabetes mellitus.

Tresiba works by binding to the insulin receptor, mimicking the action of natural insulin to lower blood sugar levels.

Tresiba is a medication that belongs to the class of insulin receptor agonists, specifically targeting the insulin receptor as a protein modality. It is used to treat conditions such as diabetes, type 2 diabetes, and type 2 diabetes mellitus, often in combination with other insulin therapies.

At a glance

Mechanism of action

The primary activity of insulin, including TRESIBA, is regulation of glucose metabolism. Insulin and its analogs lower blood glucose by stimulating peripheral glucose uptake, especially by skeletal muscle and fat, and by inhibiting hepatic glucose production. Insulin also inhibits lipolysis and proteolysis, and enhances protein synthesis. TRESIBA forms multi-hexamers when injected into the subcutaneous tissue resulting in subcutaneous insulin degludec depot. The protracted time action profile of TRESIBA is predominantly due to delayed absorption of insulin degludec from the subcutaneous tissue to the systemic circulation and to lesser extent due to binding of insulin-degludec to circulating albumin.

Approved indications

• Diabetes mellitus

Boxed warnings

• WARNING: RISK OF THYROID C-CELL TUMORS • Liraglutide, one of the components of XULTOPHY 100/3.6, causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice. It is unknown whether XULTOPHY 100/3.6 causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as the human relevance of liraglutide-induced rodent thyroid C-cell tumors has not been determined [see Warnings and Precautions ( 5.1 ), Nonclinical Toxicology ( 13 )] . • XULTOPHY 100/3.6 is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk for MTC with the use of XULTOPHY 100/3.6 and inform them of symptoms of thyroid tumors (e.g., a mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with XULTOPHY 100/3.6 [see Contraindications ( 4 ), Warnings and Precautions ( 5.1 )] . WARNING: RISK OF THYROID C-CELL TUMORS See full prescribing information for complete boxed warning. • Liraglutide, one of the components of XULTOPHY 100/3.6, causes thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice. It is unknown whether XULTOPHY 100/3.6 causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as the human relevance of liraglutide-induced rodent thyroid C-cell tumors has not been determined. ( 5.1 , 13.1 ) • XULTOPHY 100/3.6 is contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk of MTC and the symptoms of thyroid tumors. ( 4 , 5.1 )

Common side effects

• Nasopharyngitis
• Upper respiratory tract infection
• Headache
• Severe hypoglycemia
• Novo Nordisk hypoglycemia
• Sinusitis
• Gastroenteritis
• Diarrhea

Key clinical trials

• A Trial Comparing Cardiovascular Safety of Insulin Degludec Versus Insulin Glargine in Subjects With Type 2 Diabetes at High Risk of Cardiovascular Events (PHASE3)
• A Study of LY4057996 in Healthy Participants and Participants With Type 1 and Type 2 Diabetes (PHASE1)
• The Effect and Safety of a Novel CGM-Based Titration Algorithm for Basal Insulin in T2DM Participants. (NA)
• A Study of LY3938577 in Participants With Type 2 Diabetes Previously Treated With Basal Insulin (PHASE2)
• Regimen Transition After Short-Term Intensive Insulin Therapy in Type 2 Diabetes (PHASE4)
• Evaluate the Efficacy and Safety of GZR101-80 Injection in Patients With Type 2 Diabetes (PHASE2)
• Single-ascending Dose Study of HEC-151 Injection (PHASE1)
• A Study of LY3938577 in Healthy Participants and Participants With Type 1 Diabetes Mellitus (T1DM) (PHASE1)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• Tresiba CI brief — competitive landscape report
• Tresiba updates RSS · CI watch RSS
• Novo Nordisk portfolio CI

Frequently asked questions about Tresiba

Related

• Drug class: All Insulin Analog [EPC] drugs
• Target: All drugs targeting Insulin receptor
• Manufacturer: Novo Nordisk — full pipeline
• Therapeutic area: All drugs in Metabolic
• Indication: Drugs for Diabetes mellitus

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing