GLP-1 receptor agonists

Dulaglutide

Trulicity; LY2189265

US status
FDA-approved
Class
GLP-1 receptor agonists
Approved product
Trulicity (2014)
Route
Subcutaneous injection, once weekly

Regulatory record

3 dated actions on record.
September 2014
FDA licenses dulaglutide injection under biologics license application 125469, approval dated September 18, 2014, as a Type 1 new molecular entity. Drugs@FDA records the product as Trulicity, a prescription injection in four strengths of 0.75 mg, 1.5 mg, 3 mg and 4.5 mg per 0.5 mL, sponsored by Eli Lilly and Company.
June 2026
The label in effect June 16, 2026 indicates the product as an adjunct to diet and exercise to improve glycemic control in adults and in pediatric patients ten years of age and older with type 2 diabetes mellitus, and to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes who have established cardiovascular disease or multiple cardiovascular risk factors. No weight-management indication appears in that section.
September 2026
Dulaglutide appears in none of the three categories of the 503A bulks list published May 14, 2026; that list files substances nominated for compounding, and a licensed biologic is supplied by its own manufacturer. FDA's drug shortage database holds no entry for it, in a query whose control on liraglutide returned eleven records with the status Current.

Every entry above is dated; the record is current as of the review date.

Definition

Dulaglutide is a glucagon-like peptide-1 receptor agonist given once weekly by subcutaneous injection, and it is the member of this class that is not a peptide. The label describes a fusion protein of two identical disulfide-linked chains, each joining a GLP-1 analogue sequence to the Fc portion of a modified human immunoglobulin G4, with an overall molecular weight of about 63 kilodaltons [1].

That structure is why it sits here rather than outside the index. Readers meet dulaglutide in the same sentence as semaglutide and tirzepatide, under the same three words on a provider menu, and the shared class name hides a label that was written for a different purpose.

Evidence

PubMed returns 1,322 indexed records across three name variants, of which 843 carry the Humans subject heading, 160 the clinical-trial publication type and 149 the randomized-controlled-trial type [2]. That is a magnitude rather than a list, and the table reporting it says so.

The largest trial in the set is a cardiovascular outcome trial. REWIND randomized 9,901 people with type 2 diabetes to weekly dulaglutide at 1.5 mg or placebo and followed them a median 5.4 years; major adverse cardiovascular events occurred in 12.0 percent of the treated group against 13.4 percent on placebo, a hazard ratio of 0.88 [3]. All-cause mortality did not differ, and gastrointestinal adverse events were reported by 47.4 percent against 34.1 percent [3].

Where the class is compared head to head, this molecule is the weaker one on weight. SUSTAIN 7 randomized 1,201 patients to semaglutide or dulaglutide at two matched dose pairs, and body weight fell 4.6 kg against 2.3 kg at the lower pair and 6.5 kg against 3.0 kg at the higher [4]. Both differences favored the other molecule and both were the trial's stated confirmatory endpoint.

The dose range on the current label is itself a trial result: 3.0 mg and 4.5 mg were tested against 1.5 mg in metformin-treated patients before the higher strengths existed [5]. A reader comparing weekly injections should treat the strength on the box as the finding, not the molecule name.

Lawful access

The lawful supply route is the licensed product. FDA licensed dulaglutide injection under biologics license application 125469 on September 18, 2014 as a Type 1 new molecular entity, and Drugs@FDA records Trulicity in four strengths from 0.75 mg to 4.5 mg per 0.5 mL, sponsored by Eli Lilly and marketed as prescription-only [6].

The label is written for diabetes and for cardiovascular risk. In the version effective June 16, 2026 the product is indicated as an adjunct to diet and exercise to improve glycemic control in adults and in pediatric patients ten years of age and older with type 2 diabetes mellitus, and to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes who have established cardiovascular disease or multiple cardiovascular risk factors [1]. No weight-management indication appears anywhere in that section.

Neither compounding nor shortage arises. Dulaglutide appears in none of the three categories of the section 503A bulks list published May 14, 2026 [7], and FDA's drug shortage database holds no entry for it, in a query whose control on liraglutide returned eleven records with the status Current [8]. No supplier is listed here, and the rail is empty because no approved program on this profile has been verified as prescribing this molecule.

Elsewhere in this index

Filed under

Reference tables

Same class

References

  1. TRULICITY (dulaglutide) injection, prescribing information, structured product label version 62, effective June 16, 2026. Sections 1 Indications and Usage and 11 Description. Read 2026-09-02 through the openFDA label endpoint, taking the most recent of the seven labels that endpoint returns for the brand; the cited repository page resolves to 108,300 bytes naming TRULICITY, in a run whose nonsense-path control on the same host resolved to 75,120 bytes naming it none. Source
  2. PubMed, National Library of Medicine. Census run 2026-09-02 across three name variants — "dulaglutide" OR "Trulicity" OR "LY2189265" — returning 1,322 indexed records, 843 carrying the Humans MeSH term, 160 under "clinical trial"[Publication Type] and 149 under "randomized controlled trial"[Publication Type]. The trial-type records were not itemized: above twenty, this index reports a literature as a magnitude rather than pasting titles nobody read. The publication-type filter was proved live in the same run against a control term returning 8,907 records under the clinical-trial type and 6,116 under the randomized type; the invalid tag clinicaltrial[pt] returned 0 for that control term in the same run, and a deliberately invalid record identifier errored in the same run. Source
  3. Gerstein HC, Colhoun HM, Dagenais GR, et al. Dulaglutide and cardiovascular outcomes in type 2 diabetes (REWIND): a double-blind, randomised placebo-controlled trial. Lancet. 2019;394(10193):121–130. PMID 31189511
  4. Pratley RE, Aroda VR, Lingvay I, et al. Semaglutide versus dulaglutide once weekly in patients with type 2 diabetes (SUSTAIN 7): a randomised, open-label, phase 3b trial. Lancet Diabetes Endocrinol. 2018;6(4):275–286. PMID 29397376
  5. Frias JP, Bonora E, Nevarez Ruiz L, et al. Efficacy and Safety of Dulaglutide 3.0 mg and 4.5 mg Versus Dulaglutide 1.5 mg in Metformin-Treated Patients With Type 2 Diabetes in a Randomized Controlled Trial (AWARD-11). Diabetes Care. 2021;44(3):765–773. PMID 33397768
  6. Drugs@FDA, US Food and Drug Administration. Application BLA 125469, TRULICITY (dulaglutide), sponsor Eli Lilly and Company; injection in four strengths of 0.75 mg, 1.5 mg, 3 mg and 4.5 mg per 0.5 mL, marketing status Prescription, original approval dated September 18, 2014, submission class Type 1 - New Molecular Entity, with twenty-one approved supplements recorded through March 12, 2026. Read 2026-09-02 through the openFDA drugsfda endpoint, in a run whose control query on a nonexistent ingredient returned no match; the cited overview page resolves to 58,646 bytes naming TRULICITY, while a nonexistent application number on the same host resolves to 19,938 bytes naming nothing. Source
  7. Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act, US Food and Drug Administration, face date "Updated May 14, 2026". Read 2026-09-02. Dulaglutide appears in none of the three categories; the document was extracted in full and searched, in a run whose positive control terms — nicotinamide adenine dinucleotide, secretin and L-carnosine, each already recorded in this index — all appeared, and whose nonsense control term did not. Source
  8. FDA Drug Shortages database, US Food and Drug Administration. Queried 2026-09-02 through the openFDA shortages endpoint: no record for dulaglutide, tirzepatide or exenatide. The query was controlled in the same run against liraglutide, which returned 11 records with the status Current, and semaglutide, which returned 3. Source

The editor is not a licensed clinician; this monograph is a regulatory and evidence reference, not medical advice. Statuses are re-verified on the date shown, and every quantitative claim resolves to a numbered reference. Corrections: editor@peptideamerica.org. See how this reference is funded.