Public record
Dulaglutide: the public record
Each table is computed from the named federal dataset as of its data date; the method is under each one.
Label
FDA label facts for dulaglutide
The FDA label read for dulaglutide (Trulicity, application BLA125469) was last revised on 2026-06-16. It carries a boxed warning headed "WARNING: RISK OF THYROID C-CELL TUMORS". Of the 4 population sections checked, 4 are present: pregnancy, lactation, pediatric use, geriatric use.
| Measure | Value | Note |
|---|---|---|
| Label revision date | 2026-06-16 | |
| Label read | Trulicity | BLA125469, brand-name application |
| Boxed warning | Yes | heading as printed: "WARNING: RISK OF THYROID C-CELL TUMORS" |
| Pregnancy section | Present | |
| Lactation section | Present | |
| Pediatric use section | Present | |
| Geriatric use section | Present |
How this was calculated
Selected the most recently revised prescription label for this single ingredient from an original manufacturer, preferring a brand-name application. Checked which sections exist and quoted headings and sentences exactly as printed.
One label: the newest prescription label for single-ingredient dulaglutide from an original manufacturer
Read from one label. Labels for other brands, strengths or forms of the same ingredient can differ. A missing section heading does not mean there is no guidance. Read the full label before relying on it.
Approvals
FDA approval history for dulaglutide
The earliest FDA approval on file for a dulaglutide product is 2014-09-18. Drugs@FDA lists 1 application for it and 21 approved supplements, the most recent on 2026-03-12.
| Measure | Value | Note |
|---|---|---|
| Earliest FDA approval on file | 2014-09-18 | |
| Applications with an approval on file | 1 | |
| New drug applications (NDA) | 0 | |
| Generic applications (ANDA) | 0 | |
| Biologics applications (BLA) | 1 | |
| Approved supplements | 21 | label, manufacturing and efficacy changes |
| Most recent supplement approval | 2026-03-12 | |
| Sponsoring companies | 1 |
How this was calculated
Selected applications with a product whose only active ingredient is this substance, then counted approved original and supplemental submissions. The earliest approved original submission is the first approval.
Applications with a single-ingredient dulaglutide product in Drugs@FDA, all sponsors and strengths
Older approvals can be missing dates, and tentative approvals are not counted. An approved application does not mean the product is currently marketed.
Medicare Part D
Medicare Part D claims for dulaglutide by age group
Of 4,303,409 Medicare Part D claims for dulaglutide in 2024, 3,412,707 (79.3%) were for enrollees aged 65 and over and 890,702 were for enrollees under 65.
| Measure | Value | Note |
|---|---|---|
| All Part D claims, 2024 | 4,303,409 | |
| Claims for enrollees aged 65 and over | 3,412,707 | |
| Claims for enrollees under 65 | 890,702 | mostly people who qualify through disability |
| Share of claims for enrollees aged 65 and over | 79.3% | share of claims, not of patients |
How this was calculated
Summed the national rows for every brand and generic row with this generic name. Claims under 65 are total claims minus claims for enrollees 65 and over.
National Part D claims for single-ingredient dulaglutide products, 2024, split at age 65
Medicare mostly covers people 65 and over, so this split describes Medicare enrollees and not use in the general population.
Medicare Part D
Medicare Part D claims for dulaglutide by state
California had the most Medicare Part D claims for dulaglutide in 2024 (323,595), followed by New York (307,212) and Pennsylvania (269,569). Prescribers in 59 states and territories wrote 4,303,406 claims in all.
| Measure | Value | Note |
|---|---|---|
| All states and territories, 2024 | 4,303,406 claims | |
| States and territories with reported claims | 59 | |
| California | 323,595 claims | $402.6M gross drug cost |
| New York | 307,212 claims | $397.6M gross drug cost |
| Pennsylvania | 269,569 claims | $320.6M gross drug cost |
| Texas | 262,491 claims | $368.7M gross drug cost |
| Ohio | 237,414 claims | $292.8M gross drug cost |
How this was calculated
Summed claims and drug cost by prescriber state over every brand and generic row with this generic name. Combination products excluded. Rows CMS suppressed for small counts are left out.
Part D claims for single-ingredient dulaglutide products by the prescriber's state, 2024
State counts follow population size and where the prescriber practises. They are not per-person rates and do not show any state's coverage rules.
Medicare Part D
Medicare Part D spending on dulaglutide
Medicare Part D spending on dulaglutide products was $5.45B in 2024 across 4,305,141 claims, compared with $7.36B in 2023 (-25.9%). Average spending per claim was $1,267, before rebates.
| Measure | Value |
|---|---|
| Total spending, 2024 | $5.45B |
| Total spending, 2023 | $7.36B |
| Change in spending, 2023 to 2024 | -25.9% |
| Claims (prescription fills), 2024 | 4,305,141 |
| Average spending per claim, 2024 | $1,267 |
How this was calculated
Summed total spending and claims over every brand and generic row with this generic name in the CMS file, using the Overall manufacturer rows. Combination products excluded. Average per claim is spending divided by claims.
Every single-ingredient dulaglutide product in Part D (Trulicity), 2024.
Gross drug cost before manufacturer rebates, so net cost is lower. Part D excludes some uses by law (for example erectile dysfunction, weight loss and hair growth), so claims reflect covered uses only. Compounded products are not included.
Medicaid
Medicaid prescriptions for dulaglutide by state
State Medicaid programmes paid for 1,939,514 dulaglutide prescriptions in 2025, with $1.95B reimbursed before rebates. Ohio reported the most (359,093), followed by Illinois (178,820) and California (127,774); 51 states and territories reported any.
| Measure | Value | Note |
|---|---|---|
| Prescriptions paid by Medicaid, 2025 | 1,939,514 | |
| Total reimbursed before rebates, 2025 | $1.95B | |
| States and territories reporting | 51 | with at least one count CMS did not suppress |
| Ohio | 359,093 prescriptions | $342.4M reimbursed |
| Illinois | 178,820 prescriptions | $192.1M reimbursed |
| California | 127,774 prescriptions | $124.1M reimbursed |
| Virginia | 115,903 prescriptions | $113.5M reimbursed |
| Pennsylvania | 110,864 prescriptions | $112.6M reimbursed |
How this was calculated
Matched each Medicaid product code to the FDA NDC Directory by labeler and product code, kept finished single-ingredient products, then summed prescriptions and reimbursement by state. National roll-up and suppressed rows dropped.
All single-ingredient dulaglutide products in the FDA NDC Directory, fee-for-service and managed care, 2025
Counts under 11 are suppressed by CMS and left out, so totals are a floor. Amounts are before rebates. Differences between states reflect programme size and coverage rules. Compounded products are not included.
Pharmacy cost
Pharmacy acquisition cost (NADAC) for dulaglutide
Retail pharmacies paid an average of $487.65 per mL for TRULICITY 0.75 MG/0.5 ML PEN as of 2026-11-11, compared with $478.09 twelve months earlier (+2.0%). This is a pharmacy purchase cost, not a patient price.
| Measure | Value | Note |
|---|---|---|
| TRULICITY 0.75 MG/0.5 ML PEN | $487.65 per mL | 12 months earlier $478.09 (+2.0%) |
| TRULICITY 1.5 MG/0.5 ML PEN | $487.62 per mL | 12 months earlier $478.06 (+2.0%) |
| TRULICITY 3 MG/0.5 ML PEN | $487.56 per mL | 12 months earlier $478.19 (+2.0%) |
| TRULICITY 4.5 MG/0.5 ML PEN | $487.42 per mL | 12 months earlier $478.05 (+2.0%) |
How this was calculated
Matched NADAC product codes to the FDA NDC Directory, kept finished single-ingredient products, and listed the product descriptions with the most package codes. The earlier price is the same package code in the file one year before.
Brand-name product of dulaglutide in the weekly NADAC file of 2026-11-11, compared with the file of 2025-11-12
NADAC is the average invoice price retail pharmacies pay, from a voluntary survey. It leaves out rebates, dispensing fees and markups, and it is not what a patient or insurer pays. Compounded products are not surveyed.
Adverse event reports
Most reported events in FDA adverse event reports for dulaglutide
Through 2026-10-28, FDA had received 89,477 adverse event reports for dulaglutide, 23,583 of them marked serious by the reporter. The symptom terms named most often were nausea (10,607), injection site pain (10,022) and blood glucose increased (9,966).
| Measure | Value | Note |
|---|---|---|
| All reports received | 89,477 | |
| Reports the reporter marked serious | 23,583 | death, hospitalisation, disability or similar outcome |
| Nausea | 10,607 reports | |
| Injection site pain | 10,022 reports | |
| Blood glucose increased | 9,966 reports | |
| Diarrhoea | 6,220 reports | |
| Vomiting | 5,977 reports |
How this was calculated
Counted FAERS reports listing this active substance, then the reaction terms named most often. A report can name several reactions, and a term can describe the illness being treated and not an effect of the drug.
Reports where FDA recorded dulaglutide as a single-ingredient active substance (any brand), all years to 2026-10-28
FAERS reports are unverified and do not prove the drug caused the event. Reporting rises with use, publicity and lawsuits, so these counts cannot give rates or risks and cannot be compared between drugs.
Recalls
FDA drug recalls naming dulaglutide
FDA enforcement reports list 3 drug recall entries naming dulaglutide from 2021 to 2022-05-25. 1 of them are for compounded or other unlisted products and 2 for products FDA lists under a label. The most common stated reason was labelling or packaging error (3 of 3).
| Measure | Value | Note |
|---|---|---|
| Recall entries on record | 3 | |
| For products FDA lists under an approved or registered label | 2 | |
| For compounded or other unlisted products | 1 | matched by the name in the product description |
| Class I (most serious) | 0 | |
| Class II | 3 | |
| Class III | 0 | |
| Most recent recall reported | 2022-05-25 | |
| Most common stated reason | labelling or packaging error | 3 of 3 entries |
How this was calculated
Counted enforcement report entries matched by FDA's listed active substance, or by the name in the product description where FDA lists none. Reasons were grouped by keywords in FDA's stated reason.
Recalls of single-ingredient dulaglutide products, plus compounded or unlisted products whose description names it
Each recall covers specific lots from one firm and is not a statement about every product with this ingredient. One event can appear as several entries, one per product.
Clinical studies
Registered clinical studies of dulaglutide
ClinicalTrials.gov lists 144 registered studies that name dulaglutide as an intervention as of 2026-11-11. Of these, 10 are recruiting, 102 are completed and 36 are phase 3 studies.
| Measure | Value |
|---|---|
| Registered studies | 144 |
| Recruiting now | 10 |
| Not yet recruiting | 8 |
| Completed | 102 |
| Terminated, withdrawn or suspended | 3 |
| Phase 3 (including phase 2/3) | 36 |
| Phase 2 (including phase 1/2) | 26 |
| Phase 1 | 22 |
How this was calculated
Searched the ClinicalTrials.gov intervention field for the name, downloaded every matching record and counted by overall status and phase. Combined phases are counted under the higher phase. Phase not applicable covers observational, device and behavioural studies.
Studies whose intervention field matches dulaglutide, any condition, any country, all statuses
A registered study is not a result. Counts include studies where the drug is a comparator or background treatment, and studies that never finished or reported.
Articles on Dulaglutide
- Trulicity Compounded Equivalent: Access Options, Costs, and What Patients Need to Know in 2026
- Trulicity HSA/FSA Eligibility and Submission: A Complete 2026 Guide
- Trulicity International Purchase Legalities: What U.S. Patients Need to Know in 2026
- Trulicity Medicare Advantage Coverage: Costs, Formulary Tiers, and How to Lower Your Out-of-Pocket Price
- Trulicity Medicare Part D Coverage: What You Actually Pay in 2026
- Trulicity Patient Assistance for Low-Income: How to Get Dulaglutide at Reduced or No Cost