Hormones & metabolism GLP-1 receptor agonist
Dulaglutide
Regulatory status
Status at a glance
503A compounding status
Not nominated
We found no pending nomination for the 503A bulks list. Unless the substance has another legal pathway (for example, a USP monograph or use in an FDA-approved drug), 503A pharmacies generally may not compound with it.
- FDA approval
- An FDA-approved product contains this peptide
- 503B outsourcing
- Not determined
- Anti-doping (WADA)
- Not on the WADA Prohibited List
- DEA schedule
- Not a controlled substance
About peptide status
Most peptides discussed here are not FDA-approved for any use, and products labeled “research use only” are not for human use. Removal from Category 2 does not authorize compounding. PCAC votes are non-binding recommendations; FDA and HHS make the final decisions.
This is not medical or legal advice, and we do not publish dosing, sourcing or reconstitution information. Talk with a licensed clinician before using any peptide.
If you think you are having a medical emergency, call 911.
Key takeaway
Dulaglutide is a once-weekly GLP-1 receptor agonist built by fusing two GLP-1 analog chains to an antibody fragment, which extends its action to about five days. It was approved for type 2 diabetes in 2014 and gained a cardiovascular indication in 2020 after the REWIND trial showed a roughly 12% reduction in major cardiovascular events. It remains on the market as Trulicity.
At a glance
- FDA status
- FDA-approved GLP-1 peptide, sold as Trulicity for type 2 diabetes
- How it's taken
- Once-weekly injection that also lowers cardiovascular risk
- Research
- In trials, lowered blood sugar and reduced major cardiovascular events by about 12%
- Evidence strength
- FDA approved
Summary
Dulaglutide is an FDA-approved once-weekly GLP-1 receptor agonist for type 2 diabetes. Learn how it works, what trials showed, and its cardiovascular role.
What is dulaglutide?
Dulaglutide is a GLP-1 receptor agonist, a peptide that mimics the natural gut hormone GLP-1. It is built by attaching two GLP-1 analog chains to a fragment of an antibody, which makes the molecule large and long-lasting enough to be injected only once a week.
It is made by Eli Lilly and sold as Trulicity, given as a once-weekly subcutaneous injection.
How does it work?
Dulaglutide lowers blood sugar and curbs appetite by activating the GLP-1 receptor, mimicking a gut hormone the body releases after eating. Through that receptor it prompts the pancreas to release insulin when blood sugar is high. Because this effect is glucose-dependent, meaning it works mainly when blood sugar is already elevated, dulaglutide on its own carries a low risk of hypoglycemia. It also lowers glucagon (a hormone that raises blood sugar), slows the rate at which the stomach empties, and acts on appetite centers to reduce food intake.
The antibody fragment it is attached to keeps it in the blood for about five days, which is what allows once-weekly dosing. In its trials, it typically lowered A1c by around 1.5%. In the REWIND cardiovascular outcomes trial, it reduced major cardiovascular events by about 12% in people with type 2 diabetes.
Is it FDA-approved?
Editor’s note
Status: FDA-approved GLP-1 peptide, sold as Trulicity for type 2 diabetes
Category: FDA-approved · Primary body area: Hormones & metabolism
Yes. Dulaglutide's approval has expanded in stages:
| Year | Approval |
|---|---|
| 2014 | Type 2 diabetes |
| 2020 | Reducing the risk of major cardiovascular events in adults with type 2 diabetes, whether or not they already have heart disease |
| 2022 | Children 10 and older with type 2 diabetes |
It remains on the market as Trulicity.
What is dulaglutide prescribed for?
Dulaglutide is prescribed to improve blood sugar control in adults and children 10 and older with type 2 diabetes, alongside diet and exercise, and to reduce cardiovascular risk in adults with type 2 diabetes. It is not a treatment for type 1 diabetes. It should not be used by people with a personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia syndrome type 2.
What are the side effects?
The most common side effects are gastrointestinal, and they are usually strongest when the dose is increased:
- Nausea
- Diarrhea
- Vomiting
- Abdominal pain
- Decreased appetite
- Fatigue
Less common but more serious risks include:
- Thyroid C-cell tumors: dulaglutide carries a boxed warning based on rodent studies. It is not known whether this happens in humans.
- Pancreatitis, or inflammation of the pancreas
- Gallbladder problems, including gallstones
- Acute kidney injury, usually from dehydration caused by vomiting or diarrhea
- Low blood sugar, especially when combined with insulin or a sulfonylurea
- Worsening of diabetic retinopathy
- Serious allergic reactions
- Severe stomach and bowel side effects
- Food or liquid entering the lungs during anesthesia
Sources: FDA prescribing information for Trulicity (dulaglutide); and the REWIND cardiovascular outcomes trial (Gerstein et al., The Lancet, 2019, DOI: 10.1016/S0140-6736(19)31149-3), indexed on PubMed. This document is educational and does not constitute medical advice.
Registered human trials
0 registered human trials on ClinicalTrials.gov that we reviewed
Sources
- [1]
GLP-1 receptor agonist (PDF)
- [2]
- [3]
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