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Is Eloralintide legal? FDA status and US regulatory standing
Current status
Investigational. Eloralintide is an investigational compound in active clinical trials, not yet FDA-approved.
Primary source: clinicaltrials.gov
Federal legal status
FDA approval status
Eloralintide is an investigational compound in active clinical trials, not yet FDA-approved. Selective amylin receptor agonist by Eli Lilly. Phase 2 complete (The Lancet, Nov 2025; n=263, 48 weeks). Phase 3 ENLIGHTEN programme opened Dec 2025-Feb 2026 across obesity (NCT07321886), type 2 diabetes (NCT07282600), obstructive sleep apnoea (NCT07369011) and knee osteoarthritis (NCT07353931). Not FDA-approved; no application on file; lead primary completion 2028.
Also known as
LY3841136 · LY-3841136 · Elora · Elora peptide
Frequently asked questions
- Is Eloralintide FDA approved?
- Eloralintide is an investigational compound in active clinical trials, not yet FDA-approved. Primary source linked on this page.
- Is Eloralintide legal to buy?
- Eloralintide is available in the U.S. as a research-use-only compound. It is an investigational compound in active clinical trials, not yet FDA-approved. Sale for human consumption is not permitted.
Content review: Regulatory status is sourced from the linked primary records and reviewed by the PeptideBase editorial team. This page is educational — not legal or medical advice. Last reviewed: .