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
- 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.
Side effects
The Trulicity label names nausea, diarrhea, vomiting, abdominal pain and decreased appetite as the most common adverse reactions, each reported in at least 5 percent of treated patients [9]. In the label's pool of placebo-controlled trials, gastrointestinal reactions of any kind occurred in 32 and 41 percent of patients on the two strengths studied, against 21 percent on placebo; indigestion and fatigue also cleared the 5 percent line at the higher strength [9].
The label carries a boxed warning for thyroid C-cell tumors: dulaglutide caused them in rats, whether it does so in humans is unknown, and the drug is contraindicated for anyone with a personal or family history of medullary thyroid carcinoma or with multiple endocrine neoplasia syndrome type 2 [9]. It is also contraindicated after a serious hypersensitivity reaction to dulaglutide or any component of the product [9].
The other warnings cover acute pancreatitis, hypoglycemia when combined with insulin or an insulin secretagogue, serious allergic reactions including anaphylaxis and angioedema, acute kidney injury from dehydration, severe gastrointestinal reactions, diabetic retinopathy complications in patients with a history of retinopathy, acute gallbladder disease, and pulmonary aspiration during general anesthesia or deep sedation [9]. The label does not recommend the drug for people with severe gastroparesis [9].
The cardiovascular outcome trial gives the same picture over years rather than weeks: in REWIND, gastrointestinal adverse events were reported by 47.4 percent of the dulaglutide group against 34.1 percent on placebo across a median 5.4 years [3].
Educational summary of the cited sources, not medical advice; a prescriber weighs these risks against a person’s own history.
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].
Supply
The approved product (Trulicity (2014)) is the supply route; no telehealth supplier is listed in this index yet. The index notes suppliers as they are verified.
Questions
Is dulaglutide FDA-approved?
Yes. The FDA licensed dulaglutide as Trulicity on September 18, 2014, and the index records it as approved as of September 2026 [6]. It is indicated for glycemic control in type 2 diabetes in adults and children 10 years and older, and for cardiovascular risk reduction in adults with type 2 diabetes [9].
Is Trulicity approved for weight loss?
No. The label's indications cover glycemic control and cardiovascular risk reduction in type 2 diabetes, and no weight-management indication appears among them [9]. Weight loss seen in its trials is a trial result, not an approved use [4].
What are the most common side effects of dulaglutide?
Nausea, diarrhea, vomiting, abdominal pain and decreased appetite are the most common, each reported in at least 5 percent of treated patients [9]. The side effects section above lists the label's warnings as well.
Does dulaglutide cause thyroid cancer?
It is not known. Dulaglutide caused thyroid C-cell tumors in rats, the label carries a boxed warning for that finding, and the drug is contraindicated in people with a personal or family history of medullary thyroid carcinoma or with MEN 2 [9].
Is dulaglutide a peptide?
Not strictly. The label describes a fusion protein of about 63 kilodaltons, in which a GLP-1 analogue sequence is joined to an antibody fragment, so it is far larger than peptide drugs such as semaglutide [1].
How is dulaglutide different from semaglutide?
Both are weekly GLP-1 receptor agonists, but in the head-to-head SUSTAIN 7 trial semaglutide lowered body weight about twice as much at each matched dose pair [4]. Dulaglutide is approved for diabetes and cardiovascular risk only, while semaglutide also carries a weight-management approval as Wegovy.
Elsewhere in this index
Filed under
- ApprovedFDA-approved
- GLP-1 receptor agonists5 molecules in this class
- The molecule indexEvery molecule, filterable by status and class
Evidence reviews
- Dulaglutide vs Semaglutide: Trial ResultsWhat does the dulaglutide-versus-semaglutide evidence actually compare?
- Retatrutide and Lean Mass: Trial EvidenceDoes retatrutide preserve muscle while reducing body fat?
- Incretin Pipeline: Retatrutide and CagriSemaWhich incretin drugs are approved, which are still in trials, and which of them are peptides?
Reference tables
- The 2026 recordWhat happened to United States peptide compounding law in 2026, in order?
- The nomination trackerWhat became of each peptide's nomination to the 503A bulks list?
- Approved peptide drugsWhich peptides in this index are actually approved drugs?
- The human trial record, by moleculeHow many human clinical trials exist for each peptide in this index?
- The WADA Prohibited ListWhich peptides in this index are prohibited in sport, and under which class?
Same class
- SemaglutideFDA-approved
- TirzepatideFDA-approved
- LiraglutideFDA-approved
- RetatrutideNo lawful route
References
- TRULICITY (dulaglutide) injection, prescribing information, structured product label version 62, effective June 16, 2026. Sections 1 Indications and Usage and 11 Description. Read September 2026 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
- PubMed, National Library of Medicine. Census run September 2026 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
- 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
- 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
- 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
- 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 September 2026 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
- 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 September 2026. 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
- FDA Drug Shortages database, US Food and Drug Administration. Queried September 2026 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
- Eli Lilly and Company. TRULICITY (dulaglutide) injection, US prescribing information. Revised March 2026 (structured product label version 62, effective June 16, 2026). DailyMed set ID 463050bd-2b1c-40f5-b3c3-0a04bb433309. Read September 2026. Source