TRULICITY
Trulicity (dulaglutide) is a GLP-1 receptor agonist indicated to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus as an adjunct to diet and exercise. It is also approved to reduce the risk of major adverse cardiovascular events, such as cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke, in adults with type 2 diabetes and established cardiovascular disease or multiple cardiovascular risk factors. The medication is not indicated for the treatment of type 1 diabetes or for patients with a history of pancreatitis or severe gastrointestinal disease.
How TRULICITY Works
Dulaglutide is a human GLP-1 receptor agonist that binds to and activates the GLP-1 receptor on the surface of pancreatic beta cells. This activation increases intracellular cyclic AMP, which stimulates the release of insulin in a glucose-dependent manner. Furthermore, the drug helps manage blood glucose levels by decreasing glucagon secretion and slowing the rate of gastric emptying.
Details
- Status
- Prescription
- First Approved
- 2014-09-18
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
TRULICITY Approval History
What TRULICITY Treats
3 indicationsTRULICITY is approved for 3 conditions since its original approval in 2014. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Glycemic control in adults with type 2 diabetes mellitus
- Glycemic control in pediatric patients 10 years of age and older with type 2 diabetes mellitus
- Reduction of major adverse cardiovascular events in adults with type 2 diabetes mellitus and established cardiovascular disease or multiple cardiovascular risk factors
TRULICITY Boxed 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 Toxicolog...
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 ).
TRULICITY Target & Pathway
ProTarget
A hormone released after eating that stimulates insulin secretion, suppresses glucagon, slows gastric emptying, and promotes satiety. GLP-1 receptor agonists mimic these effects, improving blood sugar control and promoting weight loss in diabetes and obesity.
TRULICITY Competitors
Pro6 other drugs also target GLP-1. Compare mechanisms, indications, and trial activity.
Competitors share the same molecular target (GLP-1). Earlier expiry dates signal biosimilar/generic opportunities.
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Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
TRULICITY FDA Label Details
ProIndications & Usage
FDA Label (PDF)TRULICITY ® is indicated: As an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus. To reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with type 2 diabetes mellitus who have established cardiovascular disease or multiple cardiovascular risk factors. TRULICITY ® is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated : As an adjunct to diet and exercise to improve glycemic control in adults and pediat...
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, inclu...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.