Public record

Dulaglutide: the public record

10 tables from US federal sources. Latest data date: Nov 11, 2026.

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.

FDA label facts for dulaglutide: the figures
MeasureValueNote
Label revision date2026-06-16
Label readTrulicityBLA125469, brand-name application
Boxed warningYesheading as printed: "WARNING: RISK OF THYROID C-CELL TUMORS"
Pregnancy sectionPresent
Lactation sectionPresent
Pediatric use sectionPresent
Geriatric use sectionPresent

Source: FDA drug label via openFDA, viewable on NIH DailyMed, data as of Nov 11, 2026

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.

Scope: 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.

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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.

FDA approval history for dulaglutide: the figures
MeasureValueNote
Earliest FDA approval on file2014-09-18
Applications with an approval on file1
New drug applications (NDA)0
Generic applications (ANDA)0
Biologics applications (BLA)1
Approved supplements21label, manufacturing and efficacy changes
Most recent supplement approval2026-03-12
Sponsoring companies1

Source: FDA, Drugs@FDA, data as of Nov 11, 2026

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.

Scope: 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.

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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.

Medicare Part D claims for dulaglutide by age group: the figures
MeasureValueNote
All Part D claims, 20244,303,409
Claims for enrollees aged 65 and over3,412,707
Claims for enrollees under 65890,702mostly people who qualify through disability
Share of claims for enrollees aged 65 and over79.3%share of claims, not of patients

Source: CMS, Medicare Part D Prescribers by Geography and Drug, data as of 2024

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.

Scope: 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.

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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.

Medicare Part D claims for dulaglutide by state: the figures
MeasureValueNote
All states and territories, 20244,303,406 claims
States and territories with reported claims59
California323,595 claims$402.6M gross drug cost
New York307,212 claims$397.6M gross drug cost
Pennsylvania269,569 claims$320.6M gross drug cost
Texas262,491 claims$368.7M gross drug cost
Ohio237,414 claims$292.8M gross drug cost

Source: CMS, Medicare Part D Prescribers by Geography and Drug, data as of 2024

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.

Scope: 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.

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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.

Medicare Part D spending on dulaglutide: the figures
MeasureValue
Total spending, 2024$5.45B
Total spending, 2023$7.36B
Change in spending, 2023 to 2024-25.9%
Claims (prescription fills), 20244,305,141
Average spending per claim, 2024$1,267

Source: CMS, Medicare Part D Spending by Drug, data as of 2024

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.

Scope: 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.

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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.

Medicaid prescriptions for dulaglutide by state: the figures
MeasureValueNote
Prescriptions paid by Medicaid, 20251,939,514
Total reimbursed before rebates, 2025$1.95B
States and territories reporting51with at least one count CMS did not suppress
Ohio359,093 prescriptions$342.4M reimbursed
Illinois178,820 prescriptions$192.1M reimbursed
California127,774 prescriptions$124.1M reimbursed
Virginia115,903 prescriptions$113.5M reimbursed
Pennsylvania110,864 prescriptions$112.6M reimbursed

Source: CMS, Medicaid State Drug Utilization Data 2025, data as of 2025

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.

Scope: 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.

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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.

Pharmacy acquisition cost (NADAC) for dulaglutide: the figures
MeasureValueNote
TRULICITY 0.75 MG/0.5 ML PEN$487.65 per mL12 months earlier $478.09 (+2.0%)
TRULICITY 1.5 MG/0.5 ML PEN$487.62 per mL12 months earlier $478.06 (+2.0%)
TRULICITY 3 MG/0.5 ML PEN$487.56 per mL12 months earlier $478.19 (+2.0%)
TRULICITY 4.5 MG/0.5 ML PEN$487.42 per mL12 months earlier $478.05 (+2.0%)

Source: CMS, National Average Drug Acquisition Cost (NADAC), data as of Nov 11, 2026

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.

Scope: 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.

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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).

Most reported events in FDA adverse event reports for dulaglutide: the figures
MeasureValueNote
All reports received89,477
Reports the reporter marked serious23,583death, hospitalisation, disability or similar outcome
Nausea10,607 reports
Injection site pain10,022 reports
Blood glucose increased9,966 reports
Diarrhoea6,220 reports
Vomiting5,977 reports

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, data as of Oct 28, 2026

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.

Scope: 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.

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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).

FDA drug recalls naming dulaglutide: the figures
MeasureValueNote
Recall entries on record3
For products FDA lists under an approved or registered label2
For compounded or other unlisted products1matched by the name in the product description
Class I (most serious)0
Class II3
Class III0
Most recent recall reported2022-05-25
Most common stated reasonlabelling or packaging error3 of 3 entries

Source: FDA, Enforcement Reports (drug recalls) via openFDA, data as of Nov 10, 2026

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.

Scope: 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.

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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.

Registered clinical studies of dulaglutide: the figures
MeasureValue
Registered studies144
Recruiting now10
Not yet recruiting8
Completed102
Terminated, withdrawn or suspended3
Phase 3 (including phase 2/3)36
Phase 2 (including phase 1/2)26
Phase 122

Source: NIH National Library of Medicine, ClinicalTrials.gov, data as of Nov 11, 2026

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.

Scope: 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.

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Articles on Dulaglutide