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Is Eloralintide Approved? Status and Timeline

Published by Lora Lintide

Last verified How this was verified

Clinical development

The short answer is no. Eloralintide is an investigational medicine from Eli Lilly and Company. It has no approval from any regulator that this site has found, and no release date.

Where eloralintide stands today

Lilly’s public explainer on eloralintide, last updated in September 2026, calls it investigational and says Phase III studies are planned or underway in obesity and in related conditions such as sleep apnea and knee osteoarthritis pain. Separately, Lilly announced Phase II results for EloraTZP, the combination of eloralintide and tirzepatide, on 30 September 2026. Neither of those sources says that an application has been filed or that any approval has been given.

[Verified V-55] Checked 2026-10-02 against Lilly’s own public page, the ClinicalTrials.gov registry, the approved-drug data published by the FDA, the MHRA products database and Health Canada’s list of new drug submissions under review. The European Medicines Agency and Australian Therapeutic Goods Administration checks are not yet complete, so this page does not say what those two databases show.

What regulators’ own databases show

These searches for eloralintide were run on 2 October 2026. They show what a regulator has published, which can be less than what a sponsor has filed.

FDA, United States: the FDA’s approved-drug data (Drugs@FDA, searched through the FDA’s openFDA service) has no entry for eloralintide. The FDA does not publish applications that are still pending, so this shows there is no approval, not whether an application exists.

MHRA, United Kingdom: a search of the MHRA products database returns no results for eloralintide.

Health Canada: eloralintide is not on Health Canada’s list of new drug submissions under review, which was current as of 31 August 2026.

European Medicines Agency and Australian TGA: searches of these two have not yet been completed for this page.

None of the databases checked shows an approval of eloralintide. Each is a snapshot, and a later filing would not appear until the regulator publishes it.

What the registry says about timing

The five registered ENLIGHTEN studies are the Phase III program. Their registry records list the following primary completion dates: ENLIGHTEN-2 (NCT07282600) January 2028, ENLIGHTEN-1 (NCT07321886), ENLIGHTEN-3 (NCT07369011) and ENLIGHTEN-4 (NCT07353931) March 2028, and ENLIGHTEN-6 (NCT07392190) June 2028. Primary completion is when the last participant is examined for the main outcome; analysis, reporting and any regulatory submission come after it.

Trial records

A trial registration shows that a study exists. It does not show that the compound works, is safe, or has been approved, and recruitment says nothing about the eventual result.

Phase II, 48-week obesity trial

Phase IICompleted(confirmed 2026-10-01 via ClinicalTrials.gov; primary completion 2025-05-30, completion 2025-08-14)

Registry NCT06230523

Adults with obesity or overweight without type 2 diabetes

Last verified

ENLIGHTEN-2

Phase IIIRecruiting(confirmed 2026-10-01 via ClinicalTrials.gov; primary completion 2028-01, completion 2028-02)

Registry NCT07282600

Adults with obesity or overweight with type 2 diabetes

Last verified

ENLIGHTEN-1

Phase IIIRecruiting(confirmed 2026-10-01 via ClinicalTrials.gov; primary completion 2028-03, completion 2030-07)

Registry NCT07321886

Adults with obesity or overweight without type 2 diabetes

Last verified

ENLIGHTEN-4

Phase IIIRecruiting(confirmed 2026-10-01 via ClinicalTrials.gov; primary completion 2028-03, completion 2028-05)

Registry NCT07353931

Adults with knee osteoarthritis pain and obesity or overweight

Last verified

ENLIGHTEN-3

Phase IIIRecruiting(confirmed 2026-10-01 via ClinicalTrials.gov; primary completion 2028-03, completion 2028-04). EU CT number 2025-523769-11-00: authorised and recruiting in Germany and Spain per the EU Clinical Trials Information System, checked 2026-10-01

Registry NCT07369011

Adults with moderate-to-severe obstructive sleep apnea and obesity or overweight

Last verified

ENLIGHTEN-6

Phase IIIRecruiting(confirmed 2026-10-01 via ClinicalTrials.gov; primary completion 2028-06, completion 2028-07)

Registry NCT07392190

Adults with persistent obesity or overweight on stable weekly incretin therapy

Last verified

Phase I, hepatic impairment pharmacokinetic study

Phase IRecruiting(confirmed 2026-10-01 via ClinicalTrials.gov; primary completion and completion 2027-03)

Registry NCT07401862

Participants with mild, moderate or severe hepatic impairment and participants with normal hepatic function

Last verified

Phase I, renal impairment pharmacokinetic study

Phase IActive, not recruiting(confirmed 2026-10-01 via ClinicalTrials.gov; primary completion and completion 2026-10)

Registry NCT07426380

Participants with severe renal impairment or end-stage kidney disease on hemodialysis, and participants with normal renal function

Last verified

Phase I, insulin sensitivity study

Phase IRecruiting(confirmed 2026-10-01 via ClinicalTrials.gov; primary completion and completion 2027-08)

Registry NCT07665879

Adults with overweight or obesity

Last verified

Phase I, gastric emptying study

Phase IRecruiting(confirmed 2026-10-01 via ClinicalTrials.gov; primary completion and completion 2026-12)

Registry NCT07738614

Adults with obesity or overweight

Last verified

Phase I, oral contraceptive interaction study

Phase INot yet recruiting(confirmed 2026-10-01 via ClinicalTrials.gov; registered start 2026-09, completion 2027-06)

Registry NCT07808060

Women with obesity or overweight

Last verified

[Verified V-11 to V-15] Primary completion dates read from the ClinicalTrials.gov records on 2026-10-02. Dates can move, so the live record is the authority and this page carries a last-verified date.

What approval involves, in general terms

In general a sponsor completes its pivotal trials, analyses them, submits an application to each regulator, and waits for that regulator’s review and decision. Each country decides separately. None of those later steps can be shown from a trial registry, which is why this page does not offer a date and why a registration, a trial result or a conference presentation should not be read as approval.

Products sold online as eloralintide

Because eloralintide is not approved, anything sold online under its name is not an approved medicine and is not clinical-trial material from Lilly. It has not been through the regulatory review that gives an approved medicine its labelling, its manufacturing standards and its monitoring. This site does not support self-administration of any investigational compound and gives no dosing instructions. The only way to receive eloralintide as a treatment today is inside a registered clinical trial, through that trial’s own team.

How this page is kept current

Status is rechecked against the registry and the sponsor’s own announcements before this page is approved or updated, and the date of the last check is shown above. Dated entries for each milestone are in Research News.

Related

The ENLIGHTEN program sets out what each Phase III trial studies, the Phase II results are the most developed evidence so far, and side effects reported in trials covers safety.

Related reading: Eloralintide CAS number and identifiers

References

  1. US National Library of Medicine. ClinicalTrials.gov registry records for the eloralintide clinical program. ClinicalTrials.gov. P1
  2. Eli Lilly and Company. What to know about eloralintide. Eli Lilly and Company, public explainer. 2026. P1