PharmaRadar360

PharmaRadar360

DiabetesDrug intelligence

Trulicity

Dulaglutide

GLP-1 receptor agonist. Developed by Eli Lilly. Clinical, regulatory, and source evidence are connected below.

Company
Eli Lilly
Target / MOA
GLP-1R · GLP1R
Aliases
Trulicity
Signals
21
Clinical trials
17
Approvals
1
Evidence sources
21

Latest signals

What changed

The three most recent source-backed changes linked to this drug.

clinical trialClinicalTrials.gov

Therapeutic Strategies for Microvascular Dysfunction in Type 1 Diabetes

Phase 2 · RECRUITING · AdventHealth Translational Research Institute

clinical trialClinicalTrials.gov

A Study of Orforglipron (LY3502970) Compared With Dulaglutide in Pediatric Participants With Type 2 Diabetes

Phase 3 · NOT_YET_RECRUITING · Eli Lilly and Company

clinical trialClinicalTrials.gov

Weekly GLP-1 Receptor Agonists in Obese Individuals Without Diabetes

Phase 3 · COMPLETED · Zagazig University

Approved uses

What regulators have approved

The indications section of each current US label, word for word, and the EU summary of each authorised product. Official sources as of Oct 18, 2026.

United States (FDA label)

Trulicity · BLA125469 · label version 62, effective Jun 16, 2026 · DailyMed

Label section 1

1 INDICATIONS AND USAGE 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.

European Union (EMA)

Trulicity · EMEA/H/C/002825 · Authorised, authorised Nov 21, 2014 (Commission decision C(2014) 9038) · EPAR

Trulicity is indicated for the treatment of patients 10 years and above with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise as monotherapy when metformin is considered inappropriate due to intolerance or contraindications in addition to other medicinal products for the treatment of diabetes. For study results with respect to combinations, effects on glycaemic control and cardiovascular events, and the populations studied, see sections 4.4, 4.5 and 5.1.

EMA's summary; the full indication is in the product information on the EPAR page.

Regulatory history

Approvals over time

US original approvals and efficacy supplements (new indications, populations or dosing) from Drugs@FDA; EU authorisations and CHMP opinions on extensions. Official sources as of Oct 18, 2026.

United States

BLA125469 · ELI LILLY AND CO · first approved Sep 18, 2014

7 efficacy supplements approved

European Union

  • Trulicity: Authorised since Nov 21, 2014

Patents and exclusivity

What FDA lists (US)

Patents and exclusivity as FDA lists them in the Orange Book (drugs) and the Purple Book (biologics), with approved generics and biosimilars. Expired listings are not shown. Official sources as of Oct 18, 2026.

BLA125469 (Purple Book)

No exclusivity date listed.

Generics and biosimilars

The Purple Book lists no licensed biosimilar.

FDA's listings only: an approved generic or licensed biosimilar may not be on the market yet. Not a forecast of when they may launch, and not legal advice.

Safety

Boxed warnings and FDA safety communications

The boxed warning on each current US label, and FDA Drug Safety Communications that name the drug (FDA's list from January 2020). Official sources as of Oct 18, 2026.

Boxed warning

Trulicity label

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 )] .

FDA Drug Safety Communications

None on FDA's list names this drug.

Clinical trials

Key active studies

A focused view of recently updated studies · 17 linked records.

Phase 2RECRUITINGNCT05478707

Therapeutic Strategies for Microvascular Dysfunction in Type 1 Diabetes

AdventHealth Translational Research Institute · Updated Oct 15, 2026

Phase 3NOT YET RECRUITINGNCT07668336

A Study of Orforglipron (LY3502970) Compared With Dulaglutide in Pediatric Participants With Type 2 Diabetes

Eli Lilly and Company · Updated Sep 25, 2026

Phase 3COMPLETEDNCT07834398

Weekly GLP-1 Receptor Agonists in Obese Individuals Without Diabetes

Zagazig University · Updated Sep 22, 2026

N/ACOMPLETEDNCT06779929

Comparative Study of Tirzepatide Versus Dulaglutide (SURPASS CVOT) or Semaglutide on Major Cardiovascular Events in Participants With Type 2 Diabetes

Brigham and Women's Hospital · Updated Sep 18, 2026

Phase 3COMPLETEDNCT07820111

Comparative Study of Different Weekly GLP-1 Receptor Agonists Among Diabetic and Non-Diabetic Patients: Clinical Trial

Zagazig University · Updated Sep 15, 2026

Phase 4COMPLETEDNCT06851962

Impact of Pharmacogenetic-Guided Treatment on Type 2 Diabetes.

Fundación para la Investigación del Hospital Clínico de Valencia · Updated Sep 4, 2026

Source evidence

Where this profile comes from

Facts link back to original registries, regulators, labels, and publishers. Counts change as source records update.

ClinicalTrials.govofficial · Latest Oct 15, 202620FDAofficial · Latest Mar 12, 20261
Professional referenceThis profile summarizes linked public evidence. It is not medical, legal, regulatory, or investment advice. Verify decisions against original sources.