Dulaglutide regulatory status
Current status of Dulaglutide in the United States: FDA approved. In sport: Not WADA prohibited. Details, sources, and the dated timeline follow.
By the PeptideAgent Editorial Team. Draft, pending editorial review. Last verified
What is the current status of Dulaglutide?
Regulatory: FDA approvedWADA: Not WADA prohibitedVerified: Verified Sep 27, 2026
- FDA and compounding
- FDA approved product (Trulicity, September 2014; 3.0 mg and 4.5 mg doses added in 2020; pediatric indication in 2022; cardiovascular risk reduction indication based on REWIND). Because dulaglutide is a component of an approved drug, 503A pharmacies may compound it only for a documented patient specific need and may not produce essentially a copy of the commercial product. Dulaglutide is not available in a bulk powder form suitable for compounding. FDA listed dulaglutide injection as in shortage in its October 2024 to February 2025 GLP-1 updates, with all presentations available; it is not listed in FDA's shortage database as of September 27, 2026.
- WADA
- Not WADA prohibited
- Access path
- Prescription from a licensed provider (in person or telehealth) filled at a retail pharmacy as Trulicity.
- Not available as a compounded product; dulaglutide is not on any FDA bulks list. FDA listed dulaglutide injection as in shortage, with all presentations available, in its October 2024 to February 2025 GLP-1 updates; it is not listed in FDA's shortage database as of September 27, 2026.
- Products labeled research use only are not lawful for human use.
Full Dulaglutide page: evidence, dosing in the literature, and sources
How has the status of Dulaglutide changed over time?
- FDA
FDA approves Trulicity (dulaglutide) for type 2 diabetes
FDA approved once-weekly dulaglutide injection (Trulicity) to improve glycemic control in adults with type 2 diabetes.
Regulatory: FDA approvedSource: Drugs@FDA: Trulicity (dulaglutide) BLA 125469
Sources
Numbered citations in the answers above point here, followed by the regulatory sources on record for Dulaglutide and the source of each dated event.
- [1]FDA prescribing information for Trulicity (dulaglutide) injection, via DailyMedFDA, 2025
- [2]WADA Prohibited ListWADA, 2026
- [3]WADA 2027 Prohibited List (published September 21, 2026, in force January 1, 2027)WADA, 2026
- [4]FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize (GLP-1 shortage status updates, including liraglutide, and the April 1, 2026 policy update on essentially copies)FDA, 2026
- [5]FDA Drug Shortages database (dulaglutide not listed as of September 27, 2026)FDA, 2026
- [6]Drugs@FDA: Trulicity (dulaglutide) BLA 125469FDA, 2014