TRULICITY (dulaglutide)
TRULICITY is indicated for the treatment of 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.
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.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2014-09-18
- Patent Cliff
- 2026
- Revenue
- $950M (Q4-2025)
- 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 Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in TRULICITY's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications TRULICITY treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to TRULICITY
FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
59 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06739122 | 27198 H9X-MC-GBGS | Ph 3 | recruiting | A Study of Dulaglutide (LY2189265) 3.0 mg and 4.5 mg in Pediatric Participants With Type 2 Diabetes Mellitus (AWARD-PEDS PLUS) |
| NCT07537088 | 2026-ethics-58 | Ph 4 | not yet recruiting | Efficacy and Safety of Triple Therapy With Dulaglutide, SGLT2 Inhibitors, and Finerenone in Chinese Adults With Type 2 Diabetes and Chronic Kidney Disease |
| NCT07313813 GBGT | 27367 H9X-MC-GBGT | Ph 1 | active not recruiting | A Study to Evaluate the Effect of Fasting Duration and Dulaglutide (LY2189265) Withholding on Gastric Retention in Participants With Type 2 Diabetes Mellitus |
| NCT05478707 KML002 | 210198 | Ph 2 | suspended | Therapeutic Strategies for Microvascular Dysfunction in Type 1 Diabetes |
| NCT06235086 | SYSA1803-009 | Ph 3 | completed | A Study of TG103 Injection Combined With Metformin in Treatment of Type 2 Diabetes Mellitus |
| NCT06851962 EPHIC-DIA2 | EPHIC-DIA2 2025-520686-46-00 | Ph 4 | active not recruiting | Impact of Pharmacogenetic-Guided Treatment on Type 2 Diabetes. |
| NCT07319286 | FMASU MD142/2025 | Ph 1, Ph 2 | enrolling by invitation | Role of Glucagon-like Peptide-1 Receptor Agonists in Menstrual Irregularities in Adolescent Females With Type 1 Diabetes Mellitus |
| NCT07282041 RADIANT | RADIANT01 | Ph 2, Ph 3 | recruiting | Role of GLP1 RA Dulaglutide on Severe Intracranial Atherosclerosis |
| NCT06257966 | DFBT-JY09-DM-302 | Ph 3 | active not recruiting | A Phase 3 Study to Evaluate the Efficacy of JY09 Compared With Dulaglutide in Combination Therapy Diabetes Mellitus Type 2 Patients With Metformin |
| NCT04255433 SURPASS-CVOT | 17073 I8F-MC-GPGN, 2019-002735-28 | Ph 3 | completed | A Study of Tirzepatide (LY3298176) Compared With Dulaglutide on Major Cardiovascular Events in Participants With Type 2 Diabetes |
| NCT05564039 SURPASS-SWITCH results posted | 18395 I8F-MC-GPIH, 2022-500101-41-00 | Ph 4 | completed | A Study of Tirzepatide (LY3298176) in Adult Participants With Type 2 Diabetes Switching From Dulaglutide (SURPASS-SWITCH) |
| NCT06901648 | HS-20094-203 | Ph 2 | completed | A Study of HS-20094 in Patients With T2DM |
| NCT05680129 | SCW0502-1032 | Ph 3 | completed | A Phase 3 Study to Evaluate the Efficacy of XW003 Compared With Dulaglutide in Participants With T2DM |
| NCT05659537 results posted | 18550 H9X-IN-GBGR | Ph 4 | completed | A Study of Dulaglutide (LY2189265) in Participants With Type 2 Diabetes Mellitus in India |
| NCT04862234 results posted | IRB00097659 K23DK122199 | Ph 4 | terminated | Perioperative Stress Hyperglycemia in General and Vascular Surgery Patients |
| NCT04515576 results posted | 17530 J1X-MC-GZHC | Ph 1 | completed | A Study of LY3493269 in Participants With Type 2 Diabetes |
| NCT04387201 results posted | HSC-MS-19-0787 R21DK122234 | Ph 4 | completed | GLP-1 Therapy: The Role of IL-6 Signaling and Adipose Tissue Remodeling in Metabolic Response |
| NCT05218915 | BGLP-DKD | Ph 4 | completed | Basal Plus GLP1-ra on Glycemic Variability in CKD |
| NCT05606913 | CIBI362A302 | Ph 3 | completed | A Study of IBI362 in Participants With Type 2 Diabetes |
| NCT04809220 AWARD-JPN results posted | 17779 H9X-JE-GBGQ | Ph 3 | completed | A Study of Two Doses of Dulaglutide (LY2189265) in Japanese Patients With Type 2 Diabetes |
| NCT05407961 | 17835 2021-003257-31, J2V-MC-GZLB | Ph 1 | completed | A Study of LY3532226 in Participants With Type 2 Diabetes Mellitus |
| NCT02759107 results posted | 16119 I8F-MC-GPGA | Ph 1 | completed | A Study of Tirzepatide (LY3298176) in Healthy Participants and Participants With Type 2 Diabetes (T2DM) |
| NCT05377333 | 18129 J1R-MC-GZFB | Ph 1 | completed | A Study of LY3457263 Alone and in Combination With Dulaglutide (LY2189265) in Participants With Type 2 Diabetes |
| NCT05048719 results posted | 17787 J2A-MC-GZGE, 2021-002806-29 | Ph 2 | completed | A Study of LY3502970 in Participants With Type 2 Diabetes Mellitus |
| NCT04867785 results posted | 17774 J1I-MC-GZBD | Ph 2 | completed | A Study of LY3437943 in Participants With Type 2 Diabetes |
| NCT04591626 AWARD-CHN3 results posted | 17731 H9X-MC-GBGO | Ph 3 | completed | A Study of Dulaglutide (LY2189265) in Chinese Participants With Type 2 Diabetes |
| NCT04189848 results posted | NN9535-4648 2019-83003844-57, U1111-1241-0348 | Ph 4 | completed | Comparison of Injection Site Pain Experience for Semaglutide and Dulaglutide sc |
| NCT03204396 SKIP | 2017-00286 | Ph 2 | completed | Smoking Cessation Facilitated by Glucagon-like Peptide-1 (GLP-1) Analogues |
| NCT04687514 DESIRE | 2020-02572; me20ChristCrain3 | Ph 2 | completed | Effects of Glucagon-Like Peptide-1 Analogs on Sexuality |
| NCT02963766 AWARD-PEDS results posted | 14171 H9X-MC-GBGC, 2016-000361-22 | Ph 3 | completed | A Study of Dulaglutide (LY2189265) in Children and Adolescents With Type 2 Diabetes |
| NCT03861052 SURPASS J-mono results posted | 17077 I8F-JE-GPGO | Ph 3 | completed | A Study of Tirzepatide (LY3298176) Compared to Dulaglutide in Participants With Type 2 Diabetes |
| NCT02787551 LixiLan-G results posted | EFC13794 2014-004850-32, U1111-1168-4639 | Ph 3 | completed | Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC) Versus GLP-1 Receptor Agonist in Patients With Type 2 Diabetes, With a FRC Extension Period |
| NCT04641312 | 17261 2020-001828-34, J1R-MC-GZFA | Ph 1 | completed | A Study of LY3457263 in Healthy Participants and Participants With Type 2 Diabetes |
| NCT03684642 AMPLITUDE-D results posted | EFC14829 2017-002956-10, U1111-1205-3150 | Ph 3 | terminated | Efficacy and Safety of Efpeglenatide Versus Dulaglutide in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin |
| NCT04466904 | CIBI362A101 | Ph 1, Ph 2 | completed | Multiple-dose Tolerability and Pharmacokinetic of IBI362 in Chinese Patients With T2DM |
| NCT03668470 DIAMOND GLP1 | 69HCL18_0047 | Ph 2 | completed | Dulaglutide and Insulin MicrosecretiON in Type 1 Diabetes |
| NCT03015220 PIONEER 10 results posted | NN9924-4282 U1111-1181-4133, JapicCTI-173485 | Ph 3 | completed | Safety and Efficacy of Oral Semaglutide Versus Dulaglutide Both in Combination With One OAD (Oral Antidiabetic Drug) in Japanese Subjects With Type 2 Diabetes |
| NCT04143802 | 17137 J1I-MC-GZBB | Ph 1 | completed | A Study of LY3437943 in Participants With Type 2 Diabetes Mellitus (T2DM) |
| NCT02597049 AWARD-10 results posted | 15361 H9X-MC-GBGE, 2015-002095-24 | Ph 3 | completed | A Study of Dulaglutide (LY2189265) in Participants With Type 2 Diabetes Mellitus |
| NCT03495102 AWARD-11 results posted | 16877 H9X-MC-GBGL, 2017-003490-33 | Ph 3 | completed | A Study of the Efficacy and Safety of Dulaglutide (LY2189265) in Participants With Type 2 Diabetes |
| NCT02770885 GOLD | GOLD 2016 | Ph 2 | completed | Effects of GLP-1 Analogues on Fluid Intake in Patients With Primary Polydipsia (The GOLD-Study) |
| NCT02648204 SUSTAIN 7 results posted | NN9535-4216 2014-005375-91, U1111-1164-8495 | Ph 3 | completed | Efficacy and Safety of Semaglutide Versus Dulaglutide as add-on to Metformin in Subjects With Type 2 Diabetes. |
| NCT01394952 REWIND results posted | 13438 H9X-MC-GBDJ | Ph 3 | completed | Researching Cardiovascular Events With a Weekly Incretin in Diabetes (REWIND) |
| NCT02152371 AWARD-9 results posted | 13195 H9X-MC-GBDI, 2012-004229-25 | Ph 3 | completed | A Study of Dulaglutide (LY2189265) in Participants With Type II Diabetes |
| NCT02750410 results posted | 15803 H9X-JE-GBGF | Ph 4 | completed | A Study of Dulaglutide in Japanese Participants With Type 2 Diabetes |
| NCT02973100 results posted | 16568 H9X-MC-GBGJ, 2016-002494-34 | Ph 2 | completed | A Study of Investigational Dulaglutide Doses in Participants With Type 2 Diabetes on Metformin Monotherapy |
| NCT01621178 AWARD-7 results posted | 13798 H9X-MC-GBDX, 2012-000829-44 | Ph 3 | completed | A Study Comparing Dulaglutide With Insulin Glargine on Glycemic Control in Participants With Type 2 Diabetes (T2D) and Moderate or Severe Chronic Kidney Disease (CKD) |
| NCT01648582 AWARD-CHN2 results posted | 13439 H9X-CR-GBDK | Ph 3 | completed | A Study Comparing the Effects and Safety of Dulaglutide With Insulin Glargine in Type 2 Diabetes Mellitus |
| NCT01644500 AWARD-CHN1 results posted | 11991 H9X-JE-GBCG | Ph 3 | completed | A Study Comparing the Effects and Safety of Dulaglutide With Glimepiride in Type 2 Diabetes Mellitus |
| NCT03315780 results posted | 16730 H9X-JE-GBGK | Ph 4 | completed | A Study of the Glucodynamic Effects of Dulaglutide (LY2189265) in Japanese Participants With Type 2 Diabetes |
Showing 50 of 59 trials
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
Indications & Usage
FDA Label (PDF)TRULICITY is indicated for the treatment of 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.
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...
Pro Intelligence Preview
Deep insights for TRULICITY
Revenue Insights
- • Q4-2025: $950M
- • Historical trend analysis
Patent Timeline
- • Cliff: 2026
- • Generic/biosimilar risk
Trial Analysis
- • 59 total trials
- • Stage: Declining
Competitive Landscape
- • 1 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment