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Investigational · Not FDA-approved · Not offered by REMEVi

Is retatrutide FDA-approved? Status, and how to get it.

No. Retatrutide is investigational: it is not FDA-approved and has not been submitted for approval — Lilly plans to submit in Q1 2027. It is available only inside clinical trials, not by prescription in the US, and under federal law it cannot be compounded. REMEVi does not offer it.

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For compounded semaglutide or tirzepatide — not retatrutide. No card to start.

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§ 01 · Status

01 / 07

Is retatrutide FDA-approved in 2026?

No. As of September 9, 2026 we located no FDA approval and no announcement of an accepted application, and Lilly describes the molecule on its own medical site as investigational and not approved anywhere.

“Retatrutide is an investigational molecule and is not currently approved in any countries or geographies.”

Eli Lilly Medical — mechanism of action, accessed September 9, 2026

The closest thing to a timeline that exists is an intention Lilly published itself, in its July 23, 2026 release:

“Lilly plans to submit a Biologics License Application (BLA) for retatrutide to FDA in Q1 2027”

Eli Lilly press release — TRIUMPH-2 and TRIUMPH-3 results, and the planned FDA submission, July 23, 2026

That is a plan to file. It is not a submitted application, it is not an approval, and it is not a date of availability. Any page telling you retatrutide is approved, has been submitted, or will reach pharmacies on a particular date is saying something no primary source supports today.

§ 03 · Online

03 / 07

Is there any legal way to get it online?

No. There is no lawful route to retatrutide online in the United States — not by prescription and not through a compounding pharmacy. The FDA says it in its own words:

“Retatrutide and cagrilintide cannot be used in compounding under federal law.”

“These are not components of FDA-approved drugs and have not been found safe and effective for any condition.”

The FDA also describes what the people selling these products do, and what it has seen as a result:

“Companies that have illegally sold unapproved drugs…falsely labeled 'for research purposes' or 'not for human consumption.'”

“FDA received multiple reports of adverse events, some requiring hospitalization, that may be related to dosing errors.”

FDA — FDA's Concerns with Unapproved GLP-1 Drugs Used for Weight Loss, last updated September 1, 2026

And on September 9, 2025 the FDA issued a warning letter naming compounded retatrutide directly. This page names, describes, links and ranks no seller: if federal law does not allow the product to be prepared at all, there is no version of that list that helps a patient.

“your compounded retatrutide drug products are unapproved new drugs and misbranded drugs introduced or delivered for introduction into interstate commerce”

FDA warning letter naming compounded retatrutide (MARCS-CMS 715883), September 9, 2025

§ 04 · Cost

04 / 07

How much does retatrutide cost?

It has no price, because it is not sold. There is no list price, no pharmacy price and no copay: an unapproved drug has no published price in the United States. Inside a clinical trial, the study drug is not billed to the participant.

So if you are looking at a price for retatrutide, you are looking at the price of an unapproved product. FDA states that compounded drugs are not FDA approved and that the agency does not review them for safety, effectiveness or quality — and retatrutide cannot lawfully be compounded at all.

“Compounded drugs are not FDA approved. This means the agency does not review compounded drugs for safety, effectiveness or quality.”

FDA — FDA's Concerns with Unapproved GLP-1 Drugs Used for Weight Loss, last updated September 1, 2026

What does have a published price is what we actually prescribe. It is further down this page, and on the pricing page.

§ 05 · Clinics

05 / 07

Is there a retatrutide clinic near me?

No. No clinic in the United States can lawfully prescribe retatrutide today, so a clinic offering it is offering an unapproved drug — whatever it calls the product and however close it is.

What a licensed telehealth platform can prescribe today, after an online evaluation with a provider licensed in your state, is compounded semaglutide or compounded tirzepatide. REMEVi does that; we are not a walk-in clinic and there is no patient-facing address to visit.

§ 06 · Las Vegas

06 / 07

Can I get retatrutide in Las Vegas?

No — not in Las Vegas or anywhere in the US outside a trial. What Nevada-licensed providers can prescribe today is compounded tirzepatide or semaglutide, with the evaluation, the prescription and the follow-up online and the medication shipped cold-chain to your address.

§ What you can get

07 / 07

What can I get today?

Two molecules that are FDA-approved as brand products and available as a compounded preparation on a licensed provider’s prescription after an online evaluation. The price is published, it is the same at every dose, and it does not go up.

Semaglutide

Semaglutide from $159/mo on the 24-week plan — $169/mo on the 12-week plan, $199/mo month-to-month. The same price at every dose, all-inclusive.

In STEP 1 (NEJM, 2021), semaglutide 2.4 mg weekly produced a mean body-weight change of −14.9% at 68 weeks, against −2.4% on placebo.

Trial results, not REMEVi averages; individual results vary.

STEP 1 (NEJM, 2021)

Everything about compounded semaglutide

Tirzepatide

Tirzepatide from $225/mo on the 24-week plan — $233/mo on the 12-week plan, $269/mo month-to-month. The same price at every dose, all-inclusive.

In SURMOUNT-1 (NEJM, 2022), tirzepatide 15 mg weekly produced a mean body-weight reduction of −20.9% at 72 weeks, on the treatment-regimen estimand.

Trial results, not REMEVi averages; individual results vary.

SURMOUNT-1 (NEJM, 2022)

Everything about compounded tirzepatide

That price includes

a licensed provider visit · the medication · cold-chain shipping · monthly follow-up · the portal and a care coordinator in English or Spanish

No membership fee · cancel any time · refund if a provider doesn't approve you.

And to check us

Semaglutide is the medication in Ozempic® and Wegovy®; tirzepatide is the medication in Mounjaro® and Zepbound®. Those are FDA-approved products of Novo Nordisk and Eli Lilly; REMEVi is not affiliated with either company. A compounded preparation from a state-licensed US 503A pharmacy is not FDA-approved and is not a generic version of any of them.

§ FAQ

04 entries

Regulatory status, answered.

  1. No. In its July 23, 2026 release Lilly stated that it plans to submit a Biologics License Application to FDA in the first quarter of 2027. That is a plan, not a submission, and we located no later announcement of an application that has been filed or accepted.

  2. There is no way to know, and that is the answer. FDA states that these products are not approved, that they are not components of FDA-approved drugs, and that the agency does not review them for safety, effectiveness or quality. It also reported adverse events, some requiring hospitalization, that may be related to dosing errors. We say nothing beyond that, because nothing beyond that is supported by a primary source.

  3. If it is approved and available through our pharmacy partners, we will say so here. Nothing is planned or promised.

  4. No. La FDA indica que la retatrutida y la cagrilintida no pueden usarse en preparaciones compuestas bajo la ley federal, y el 9 de septiembre de 2025 emitió una carta de advertencia que describe productos de retatrutida compuesta como medicamentos nuevos no aprobados y mal etiquetados. Las citas completas y sus enlaces están en la sección «en línea» de esta página.

§ Sources

Every number on this page comes from one of these.

Primary sources only: peer-reviewed journals, the FDA, and Eli Lilly’s own medical and investor sites. If a figure is not in this list, it is not on the page.

  1. Eli Lilly Medical — mechanism of action Eli Lilly and Company (Lilly Medical) · accessed September 9, 2026
  2. Eli Lilly press release — TRIUMPH-2 and TRIUMPH-3 results, and the planned FDA submission Eli Lilly and Company · July 23, 2026
  3. Eli Lilly Medical — the registered retatrutide trials Eli Lilly and Company (Lilly Medical) · page last reviewed February 11, 2026
  4. FDA — FDA's Concerns with Unapproved GLP-1 Drugs Used for Weight Loss U.S. Food and Drug Administration · last updated September 1, 2026
  5. FDA warning letter naming compounded retatrutide (MARCS-CMS 715883) U.S. Food and Drug Administration · September 9, 2025
  6. Eli Lilly press release — TRIUMPH-1 results Eli Lilly and Company · May 21, 2026
  7. Jastreboff AM, et al. Tirzepatide Once Weekly for the Treatment of Obesity. NEJM New England Journal of Medicine (DOI 10.1056/NEJMoa2206038) · July 21, 2022
  8. Wilding JPH, et al. Once-Weekly Semaglutide in Adults with Overweight or Obesity. NEJM New England Journal of Medicine (DOI 10.1056/NEJMoa2032183) · March 18, 2021

What we can actually prescribe.

REMEVi does not offer retatrutide. What our licensed providers do prescribe is compounded semaglutide and compounded tirzepatide, with the price published before you give us anything. The secure intake takes about 2 minutes, no card to start, in English or Spanish.

A free 2-minute questionnaire No card required · a licensed provider reviews everything
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