๐Ÿš€ Not FDA-approved. Lilly plans a Q1 2027 BLA filing.

Get notified when Lilly files โ€” or if FDA acts

Retatrutide is investigational and not FDA-approved. Join this siteโ€™s email list for regulatory milestones. This is not an Eli Lilly waitlist, not a consumer queue at Lilly, and not exclusive launch pricing.

Not approved
Investigational (2026)
โˆ’28.3%
80 weeks, TRIUMPH-1, 12 mg
Q1 2027
Planned BLA filing

Weight-change figure is the Lilly efficacy estimand (21 May 2026). BLA plan: Lilly, 23 Jul 2026. Filing is not approval; no PDUFA date has been assigned.

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Weโ€™ll email you when Lilly files a BLA or if FDA takes an action on retatrutide. This list is run by NextGenGLP1, not Eli Lilly.

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What this list is โ€” and isnโ€™t

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Filing and FDA updates

Weโ€™ll email you if Lilly submits a BLA or if FDA acts. A filing is not an approval, and no approval year has been announced.

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Trial readouts

Stay informed with sourced Phase 3 updates. We label Lillyโ€™s efficacy estimand when we quote weight-change figures.

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Not a Lilly queue

Lilly has not announced a consumer waitlist. Joining here does not reserve a prescription, a pharmacy slot, or launch pricing.

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Separate offer today

TrimRX is a compounded GLP-1 + GIP telehealth offer available today. It is not retatrutide and is not an FDA-approved branded product.

What the data actually says

Sourced Phase 3 figures, with the leftover Phase 2 โ€œ24%โ€ labeled so it is not mistaken for Phase 3.

โˆ’28.3%

TRIUMPH-1, 12 mg, 80 weeks โ€” Lilly efficacy estimand (21 May 2026). Treatment-regimen 12 mg was โˆ’25.0%. Not a head-to-head versus Zepbound.

Q1 2027

Planned BLA filing โ€” Lilly, 23 Jul 2026, reconfirmed 5 Aug 2026. CMC work is in progress. Filing is not approval. No PDUFA date.

Triple agonist

GIP, GLP-1, and glucagon โ€” investigational, no brand name. TRIUMPH-5 (NCT06662383) versus tirzepatide has not reported.

โˆ’24.2%

Phase 2 leftover โ€œ24%โ€ โ€” NEJM 2023, 48 weeks. That figure is not the Phase 3 lead result and should not be presented as if it were.

Note: Retatrutide is investigational and not FDA-approved. It is not for sale. Clinical trial results may not reflect individual outcomes. This page is informational, not medical advice. Talk with a licensed clinician before starting any medication.

Frequently Asked Questions

When will retatrutide be approved?

Unknown. Lilly plans a Q1 2027 BLA filing (23 Jul 2026; reconfirmed 5 Aug 2026). A filing is not an approval. No PDUFA date has been assigned, and we do not invent an approval year.

How much will retatrutide cost?

Unknown. Lilly has not announced a U.S. list price. This email list does not include exclusive launch pricing.

Is retatrutide better than tirzepatide?

They are different drugs. TRIUMPH-5 (NCT06662383), the Phase 3 head-to-head versus tirzepatide, has not reported. Do not treat cross-trial percentages as a ranking.

What are the side effects?

Phase 3 programs have reported gastrointestinal effects typical of incretins, plus dysesthesia (abnormal skin sensation) in some participants. That is not a complete safety list. Talk with a clinician.

Is this Lillyโ€™s waitlist?

No. This is NextGenGLP1โ€™s email list. Lilly has not announced a consumer waitlist. Joining here does not put you in a Lilly queue.

What is TrimRX doing on this page?

TrimRX is a separate compounded GLP-1 + GIP offer available today through a telehealth consult. It is not retatrutide, not Zepbound, and not Mounjaro. Compounded medication is not FDA-approved.

Want the FDA-path updates?

Join this siteโ€™s email list โ€” not a Lilly program โ€” for filing and decision news.

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