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Trulicity (DULAGLUTIDE)
Dulaglutide activates GLP-1 receptors, increasing insulin release and decreasing glucagon secretion and gastric emptying.
At a glance
| Generic name | DULAGLUTIDE |
|---|---|
| Sponsor | Eli Lilly |
| Drug class | GLP-1 Receptor Agonist [EPC] |
| Target | GLP-1 receptor |
| Modality | Recombinant protein |
| Therapeutic area | Metabolic |
| Phase | FDA-approved |
| First approval | 2014 |
| Annual revenue | 7200 |
Mechanism of action
Dulaglutide, a GLP-1 receptor agonist, works by activating GLP-1 receptors on pancreatic beta cells. This activation leads to increased insulin release when blood glucose levels are high, while also reducing glucagon secretion and slowing down the rate at which food leaves the stomach.
Approved indications
- Diabetes mellitus type 2
Boxed warnings
- WARNING: RISK OF THYROID C-CELL TUMORS In male and female rats, dulaglutide causes a dose-related and treatment-duration-dependent increase in the incidence of thyroid C-cell tumors (adenomas and carcinomas) after lifetime exposure. It is unknown whether TRULICITY causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as human relevance of dulaglutide-induced rodent thyroid C-cell tumors has not been determined [see Warnings and Precautions ( 5.1 ), and Nonclinical Toxicology ( 13.1 )] . TRULICITY 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 of MTC with use of TRULICITY and inform them of symptoms of thyroid tumors (e.g., 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 TRULICITY [see Contraindications ( 4 ) and Warnings and Precautions ( 5.1 )] . WARNING: RISK OF THYROID C-CELL TUMORS See full prescribing information for complete boxed warning. Dulaglutide causes thyroid C-cell tumors in rats. It is unknown whether TRULICITY causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as the human relevance of dulaglutide-induced rodent thyroid C-cell tumors has not been determined ( 5.1 , 13.1 ). TRULICITY 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 of MTC and symptoms of thyroid tumors ( 4 , 5.1 ).
Common side effects
- Blood glucose increased
- Injection site pain
- Accidental underdose
- Nausea
- Glycosylated haemoglobin increased
- Extra dose administered
- Pancreatitis
- Diabetic ketoacidosis
- Incorrect dose administered
- Inappropriate schedule of product administration
- Vomiting
- Injection site haemorrhage
Key clinical trials
- A Study of Dulaglutide (LY2189265) 3.0 mg and 4.5 mg in Pediatric Participants With Type 2 Diabetes Mellitus (AWARD-PEDS PLUS) (PHASE3)
- Impact of Pharmacogenetic-Guided Treatment on Type 2 Diabetes. (PHASE4)
- INcreTin-based thERapies for Cardiovascular Event PrevenTion in Patients With and Without ASCVD (INTERCEPT-ASCVD)
- Emulation of the REWIND Cardiovascular Outcomes Trial in Healthcare Claims Data.
- Effects of GLP-1 Agonists on CArdiac Steatosis Evaluated by Magnetic Resonance Imaging (NA)
- Glucagon-Like Peptide 1 Receptor Agonist in Diabetes Mellitus Management in Children and Adolescents With Transfusion-Dependent Thalassemia (PHASE2)
- Role of Glucagon-like Peptide-1 Receptor Agonists in Menstrual Irregularities in Adolescent Females With Type 1 Diabetes Mellitus (PHASE1,PHASE2)
- A Study to Evaluate the Effect of Fasting Duration and Dulaglutide (LY2189265) Withholding on Gastric Retention in Participants With Type 2 Diabetes Mellitus (PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| SEC EDGAR | Revenue + earnings |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Trulicity CI brief — competitive landscape report
- Trulicity updates RSS · CI watch RSS
- Eli Lilly portfolio CI