No. As of October 2, 2026, eloralintide is not approved by the FDA or by any other regulator, and Eli Lilly has announced no date for filing an application. It is available only inside Lilly's clinical trials.
Its five phase 3 trials, the ENLIGHTEN programme, are recruiting, and ClinicalTrials.gov lists their primary completion dates from January to June 2028. EloraTZP, its combination with tirzepatide, has finished phase 2b, and Lilly plans to start phase 3 by the end of 2026.
The direct answer
Eloralintide has no marketing approval in the United States, the European Union, the United Kingdom, Canada or anywhere else. Lilly describes it as an investigational medicine, and no regulator has announced receiving an application for it. There is therefore no prescription route, no approved product, no approved dose and no label.
Where it is now
Lilly moved eloralintide into phase 3 in late 2025. The five ENLIGHTEN trials are all randomised, double-blind and placebo-controlled, and each measures the change in body weight at 64 weeks:
| Trial | Who it enrols | Started | Primary completion (registry) | Planned size |
|---|---|---|---|---|
| ENLIGHTEN-2 (NCT07282600) | Obesity or overweight with type 2 diabetes | December 15, 2025 | January 2028 | 1,035 |
| ENLIGHTEN-1 (NCT07321886) | Obesity or overweight without type 2 diabetes | February 6, 2026 | March 2028 | 1,980 |
| ENLIGHTEN-4 (NCT07353931) | Knee osteoarthritis pain with obesity or overweight | February 9, 2026 | March 2028 | 900 |
| ENLIGHTEN-3 (NCT07369011) | Obstructive sleep apnoea with obesity or overweight | February 10, 2026 | March 2028 | 800 |
| ENLIGHTEN-6 (NCT07392190) | Persistent obesity on a weekly incretin | February 10, 2026 | June 2028 | 900 |
A primary completion date is when the last participant reaches the main measurement, not when results are announced. Registry dates are estimates and often move.
The record so far
- 2022 to January 2024: the first trials in people, single doses and 12 weeks of multiple doses, published in October 2025 and January 2026.
- February 2024 to 2025: the 48-week phase 2 trial in 263 adults without diabetes, published in The Lancet on November 6, 2025, with results on ClinicalTrials.gov from June 24, 2026.
- December 2025 to February 2026: the five ENLIGHTEN phase 3 trials start.
- September 30, 2026: Lilly announces the EloraTZP phase 2b results in type 2 diabetes, presented at EASD 2026.
- By the end of 2026: Lilly plans to start phase 3 trials of a single-injection EloraTZP.
What has to happen before any approval
For eloralintide on its own, the phase 3 trials have to finish and report, Lilly has to decide to file, and a regulator has to review the application. On the registry's dates the trials reach their primary measurements in the first half of 2028, so no decision based on them can come before then, and a review normally takes most of a year after filing. Lilly has not said when it would file, and this page gives no forecast.
EloraTZP is further back. Its phase 3 trials have not started, and a combination of two drugs generally has to show that each one contributes to the effect, which is why its phase 2b included eloralintide-alone and tirzepatide-alone groups.
Can anyone get it now?
Only by joining one of Lilly's trials. ClinicalTrials.gov lists 22 studies of eloralintide, several of them recruiting, and none of them is an expanded-access programme. Anything sold online as eloralintide is not a regulated medicine, and its contents are unverified.
Frequently asked questions
Is eloralintide FDA approved?
No. As of October 2, 2026 it is approved by no regulator anywhere and is available only inside Eli Lilly's clinical trials.
When will eloralintide be approved?
There is no date. Its five phase 3 trials list primary completion dates from January to June 2028, Lilly has not announced a filing date, and a regulator's review would come after that.
Is EloraTZP approved?
No. EloraTZP has finished a phase 2b trial, and Lilly plans to start phase 3 trials of a single-injection version by the end of 2026.
Can my doctor prescribe eloralintide?
No. Without an approval there is no prescription route. The only lawful way to receive it is in a clinical trial.
Is there expanded access to eloralintide?
None of the 22 eloralintide studies on ClinicalTrials.gov is an expanded-access programme as of October 2, 2026.
Related on Grey Peptides
Sources
- ClinicalTrials.gov: ENLIGHTEN-1 (NCT07321886), ENLIGHTEN-2 (NCT07282600), ENLIGHTEN-3 (NCT07369011), ENLIGHTEN-4 (NCT07353931), ENLIGHTEN-6 (NCT07392190), NCT06230523 and the 22 studies naming eloralintide or LY3841136. Read October 2, 2026.
- Eli Lilly and Company. EloraTZP (combination of eloralintide and tirzepatide) phase 2b results. News release, September 30, 2026. Read October 2, 2026.
- Billings LK, et al. "Eloralintide, a selective amylin receptor agonist for the treatment of obesity: a 48-week phase 2, multicentre, double-blind, randomised, placebo-controlled trial." Lancet. 2025;406(10520):2631-2643.
Medical disclaimer: This page is for education only and is not medical advice. EloraTZP and eloralintide are investigational and not approved for use. Do not start, stop, or self-administer any drug based on this page; consult a licensed clinician.