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Retatrutide360

Eli Lilly Retatrutide: Who Makes It, Who Owns It and What Lilly Has Said

Eli Lilly retatrutide, traced: who created it, a patent expected to run to 2038, 32 of 33 registered trials, and why LillyDirect doesn't sell it yet.

JPWritten by Juan Pablo FríasMedically reviewed by Dr. Juan Pablo FríasUpdated October 31, 202634 sources9 min read

Eli Lilly and Company makes retatrutide. The Indianapolis drugmaker behind Mounjaro and Zepbound discovered it in its own labs under the code LY3437943, owns it, and is the lead sponsor on 32 of the 33 retatrutide studies listed on ClinicalTrials.gov. As of October 31, 2026, six of Lilly's Phase 3 retatrutide trials have reported positive results, but no approved version of Eli Lilly retatrutide exists yet, so Lilly doesn't sell it anywhere, LillyDirect included.

2019the year Lilly's first registered study in people began, a single-dose study that started March 13 (NCT03841630)
20 of 20authors of the 2022 discovery paper in Cell Metabolism who worked at Eli Lilly
32 of 33retatrutide studies on ClinicalTrials.gov with Lilly as lead sponsor, checked October 31, 2026
2038expected expiry of the primary retatrutide patent, per the Medicines Patent Pool

Key takeaways

  • Retatrutide came out of Lilly's own labs. Every author of the paper that first described it worked for Lilly, and no trial record names a co-developer.
  • Lilly doesn't sell retatrutide anywhere, LillyDirect included, and its FAQ says no one can legally sell it for human use. The legal routes are its clinical trials and a narrow expanded access program.
  • The primary patent runs to about 2038 in the countries where it's granted, but we couldn't confirm a US patent number from a primary record.
  • Lilly last said it plans to file with the FDA in the first quarter of 2027. On October 2 the FDA said it would have to be filed as a drug, not a biologic, and Lilly is appealing. There's no price or launch date.
  • Vials sold online as retatrutide aren't Lilly's. Lilly is suing sellers, and one vial tested in Australia held semaglutide and no retatrutide at all.

Who makes retatrutide?

Lilly's own FAQ answers it in four words: "Lilly is developing retatrutide." In the trial registry, none of the 33 retatrutide records on ClinicalTrials.gov lists a collaborator, and the Lilly releases we read name no licensing partner.

"Who makes it" hides a few separate questions, and they don't all have the same answer:

The questionThe answerWhere it comes from
Who created it?Lilly scientists; all 20 authors of the 2022 discovery paper worked at LillyCell Metabolism, August 2022
Who owns it?Eli Lilly and Company, which the patent pool names as the company behind retatrutideMedicines Patent Pool, checked October 31, 2026
Who runs the trials?Lilly, lead sponsor of 32 of 33 registered studiesClinicalTrials.gov, checked October 31, 2026
Who will make the approved drug?Lilly, which said it was completing the Chemistry, Manufacturing, and Controls (CMC) file for its FDA application; we found no statement naming a plantLilly release, July 23, 2026
Who makes the vials sold online?Not Lilly; Lilly says they're frequently made by unregulated foreign manufacturersLilly release, August 12, 2026

Lilly describes retatrutide as "an investigational once-weekly triple hormone receptor agonist," a single molecule that switches on the receptors for GIP, GLP-1 and glucagon. That's the "Lilly triple agonist" people search for. For what each of those receptors does, see how retatrutide works.

Who created retatrutide, and when?

The first full description came from Lilly's own scientists. Their paper in Cell Metabolism, published online August 18, 2022, introduced LY3437943 as "a novel triple agonist peptide" at the glucagon, GIP and GLP-1 receptors. All 20 authors list Eli Lilly as their employer: 19 at Lilly Corporate Center in Indianapolis and 1 in Vienna.

People were getting it years before that paper appeared. Lilly's first registered study in people, a single injection in healthy volunteers at the Lilly Centre for Clinical Pharmacology in Singapore (NCT03841630), started on March 13, 2019 and enrolled 45 people. A 12-week study in type 2 diabetes (NCT04143802) followed on December 18, 2019.

The big trial papers have outside lead authors. The Phase 2 obesity paper in the New England Journal of Medicine was led from Yale, with Lilly scientists among the co-authors, and it states plainly that it was "Funded by Eli Lilly." The first Phase 3 paper, TRANSCEND-T2D-1 in The Lancet, was led from a diabetes clinic in Ontario, Canada. TRIUMPH-1 (NEJM), TRIUMPH-2 (The Lancet) and their sleep apnea substudies (NEJM) followed in September and October 2026, and Lilly is the registered sponsor of every trial behind them.

Retatrutide's road to approval

The results so far and what comes next, as of October 2026

2022Phase 1b results: a half-life of about 6 days, suited to once-weekly shots
June 2023Phase 2 results: up to 24.2% average weight loss at 48 weeks
December 2025TRIUMPH-4, the first Phase 3 result, in knee osteoarthritis
March 2026TRANSCEND-T2D-1, the first Phase 3 result in type 2 diabetes
May 2026TRIUMPH-1: 28.3% average weight loss at 80 weeks on 12 mg
July 2026TRIUMPH-2 and TRIUMPH-3 results; Lilly plans its FDA submission
Sept 30, 2026Detailed TRIUMPH-2 results at the EASD meeting and in The Lancet: 20.8% weight loss at 80 weeks on 12 mg
Oct 2, 2026The FDA decides retatrutide is a drug, not a biologic, so it would be filed under section 505. Lilly is appealing
Oct 28, 2026TRANSCEND-T2D-2, the first head-to-head: more A1C and over twice the weight loss of Ozempic 2 mg
Early 2027UpcomingLilly's planned US filing (it said Q1 2027 on Sep 29). The FDA review comes after it.
No approved version of retatrutide exists yet. Sources: Lilly TRIUMPH-2 and TRIUMPH-3 topline results, July 2026; Lilly TRIUMPH-2 detailed results, September 2026.

How many Eli Lilly retatrutide trials are there?

We pulled every record that lists retatrutide as an intervention from the ClinicalTrials.gov API on October 31, 2026. There are 33, the same count as a month earlier, and Lilly is the lead sponsor on 32 of them:

StageLilly studiesFirst one startedStatus on October 31, 2026
Phase 114March 13, 201913 completed, 1 active and no longer recruiting
Phase 23May 13, 2021All 3 completed
Phase 314May 30, 2023 (TRIUMPH-3)5 completed, 8 active and no longer recruiting, 1 recruiting
Expanded access1Posted June 5, 2026Available, through your doctor

Six of those Phase 3 studies have reported: TRIUMPH-1 to TRIUMPH-4, TRANSCEND-T2D-1 and, on October 28, TRANSCEND-T2D-2, which still shows as active; about 650 people are in a 24-week extension. Adding up Lilly's figures for each trial, 7,720 people were randomized across the six.

Weight lost on 12 mg in each Phase 3 trial

Average % of body weight lost, 12 mg vs the comparator, efficacy estimand (as if everyone stayed on treatment)

Retatrutide, highest doseComparator (placebo or Ozempic)
TRIUMPH-4Knee osteoarthritis, no diabetes · 445 people · 68 weeks
28.7% (12 mg)
2.1% (placebo)
TRIUMPH-1Obesity or overweight, no diabetes · 2,339 people · 80 weeks
28.3% (12 mg)
2.2% (placebo)
TRIUMPH-3BMI 35+ with heart disease · 1,949 people · 80 weeks
22.6% (12 mg)
3.2% (placebo)
TRANSCEND-T2D-2Type 2 diabetes, head to head · 1,298 people · 80 weeks
20.9% (12 mg)
9.4% (Ozempic 2 mg)
TRIUMPH-2Obesity or overweight with type 2 diabetes · 1,152 people · 80 weeks
20.8% (12 mg)
4.0% (placebo)
TRANSCEND-T2D-1Type 2 diabetes on diet and exercise · 537 people · 40 weeks
16.8% (12 mg)
2.5% (placebo)
People with type 2 diabetes lose less weight on every drug in this class, and the trials ran for different lengths, so compare rows with care. Everyone-randomized (treatment-regimen) figures are lower where published, e.g. 25.0% vs 3.9% in TRIUMPH-1. Numbers of people are those randomized, as Lilly reports them. Sources: Lilly TRIUMPH-4 topline results, December 2025; Lilly TRIUMPH-1 topline results, May 2026; Lilly TRIUMPH-2 and TRIUMPH-3 topline results, July 2026; Lilly TRANSCEND-T2D-2 results, October 2026; Lilly TRIUMPH-2 detailed results, September 2026; Lilly TRANSCEND-T2D-1 topline results, March 2026.

The odd one out, NCT07467447, is a Phase 2 study at one hospital in Shenzhen, China, sponsored by a company listed as Hudson Biotech. Its record names no Lilly role and doesn't say where its supply of the drug comes from.

Our read: when 32 of 33 registered studies carry Lilly's name and none lists a partner, the question of who makes retatrutide is settled. What's open is approval and price. The retatrutide clinical trials hub covers what each study is testing.

What Eli Lilly has said about retatrutide

Lilly's wording has hardened. Its December 2025 release had no legal-status line at all; every retatrutide release we read since March 2026 has one.

DateWhat Lilly saidWhere
December 11, 2025First Phase 3 result (TRIUMPH-4); no statement on legal statusRelease
March 19, 2026Retatrutide is "legally available only to participants in Lilly's clinical trials"About retatrutide section of the TRANSCEND-T2D-1 release
July 2026"GLP-3" is "a scientifically inaccurate label"; the better term is "triple agonist" (still there in the October update)Lilly FAQ
July 23, 2026Retatrutide "cannot be legally sold or marketed for human use"; FDA submission planned for Q1 2027TRIUMPH-2 and TRIUMPH-3 release
August 12, 20266 new lawsuits against US sellers and more than 200 referrals to regulators and law enforcementRelease on the black market
September 29, 2026A Biologics License Application still planned for Q1 2027, Lilly's latest word on timingTRIUMPH-2 results release
October 2026"To date, Lilly has disclosed retatrutide Phase 3 data from six clinical trials"; retatrutide "has not been reviewed or approved by the FDA or any regulatory agency in the world, and no one can legally sell it for human use"Lilly FAQ, last updated October 2026
October 28, 2026"Anyone purporting to sell retatrutide to consumers is breaking the law"; no filing date givenTRANSCEND-T2D-2 release
October 29, 2026Lists "positive topline results from a head-to-head Phase 3 trial of retatrutide versus Ozempic 2 mg"; nothing on filing timingThird-quarter 8-K

If you know it as GLP-3, that's a media nickname for the same Lilly molecule, not a brand. Our GLP-3 guide explains where it came from, and the brand name page covers the other names.

Does Lilly hold a patent on retatrutide?

Yes, as far as public records show. The Medicines Patent Pool, which negotiates voluntary licenses for low- and middle-income countries, reports that the primary retatrutide patent has been granted in at least 16 of those countries, including India, and is pending in 30 more. It expects the patent to expire in 2038, and its watchlist names Eli Lilly as the company behind retatrutide.

The US picture is harder to pin down. We couldn't confirm the US patent number or its expiry from a primary record, so we won't quote one. Nobody outside Lilly can say when a generic could reach US pharmacies. That turns on the US patents and on any FDA exclusivity, which can't start before approval.

Other companies have filed patent applications that name retatrutide, though not on the molecule itself. Google Patents shows at least two applications filed in China in December 2023 by other firms for ways to synthesize it (CN117903284A and CN117777248A). A process patent, if granted, lets its owner stop others copying a method. It doesn't let anyone sell retatrutide for people; that takes a regulator's approval, and none has been given.

Can you get Eli Lilly retatrutide through LillyDirect?

No. On October 31, 2026, LillyDirect listed 10 Lilly medicines: Zepbound, Mounjaro, Foundayo, Trulicity, Basaglar, Rezvoglar, Humalog, Humulin, Lyumjev and Emgality. Retatrutide isn't on the list, and Lilly's FAQ says "no one can legally sell it for human use."

That leaves two legal routes. One is a trial; our near me page lists recruiting sites. The other is Lilly's single-patient expanded access program (NCT07629401), which is narrow: adults with a BMI of 35 or more despite the highest available dose of weight treatment, at least 2 serious obesity-related complications, and no way into a trial. Your doctor applies, not you, through the Lilly Answers Center at 1-800-LillyRx (1-800-545-5979). How to get retatrutide walks through both.

If you want a Lilly weight medicine now, LillyDirect's self-pay prices as of October 2026 start at $299 a month for Zepbound 2.5 mg (KwikPen or vial) and $149 a month for Foundayo 0.8 mg. Those are approved drugs your doctor can prescribe today, and switching from tirzepatide covers a later move to retatrutide.

Who makes the retatrutide sold online?

Not Lilly. Its August 12, 2026 release says sellers are "selling illegal drugs, frequently made by unregulated foreign manufacturers," and Lilly says it has reported more than 14,000 listings in more than 100 countries. The FDA adds that retatrutide can't be used in compounding under federal law, so a pharmacy can't legally make it for you either. Whether retatrutide is legal where you live is covered country by country.

What's inside those vials is the real problem. In a September 2026 alert, Australia's Therapeutic Goods Administration said it tested a vial sold as retatrutide after a buyer needed hospital treatment for uncontrollable vomiting and a torn esophagus. It held no retatrutide, and it held semaglutide at about 8 times the level in approved semaglutide products. In Victoria, a June 2026 health alert linked 6 cases of acute liver injury to products labeled as retatrutide.

If you're weighing a listing for retatrutide for sale, start there: whatever the label says, Lilly didn't make or check what's in the vial. That page covers batch test reports and red flags.

Get medical help now

If you've used a product sold as retatrutide and you notice yellowing skin or eyes, dark urine, belly pain, unusual bruising, or vomiting you can't stop, see a doctor today or go to an emergency department. Take the vial with you.

What Lilly has scheduled next

After the October 28 head-to-head with Ozempic, in which A1C fell 2.2 points on both retatrutide doses against 1.8 (efficacy estimand, Lilly's release), two more readouts are close by the registry's estimates. TRIUMPH-5, which pits retatrutide against Lilly's own tirzepatide in about 800 adults with obesity, has an estimated primary completion date of November 2026. Until then, retatrutide vs tirzepatide compares the separate trials. TRANSCEND-T2D-3, in about 320 people with type 2 diabetes and kidney impairment, was due to reach primary completion in October 2026; Lilly had announced no result by October 31.

The filing route is less settled than it looked in September. Lilly last said, on September 29, 2026, that it plans to submit retatrutide to the FDA in the first quarter of 2027 as a Biologics License Application (BLA). On October 2, 2026, the FDA decided that retatrutide is a drug, not a biological product, so an application would need to be filed under section 505 of the Federal Food, Drug, and Cosmetic Act. Lilly's appeal on that question is pending in the Seventh Circuit, and we found no ruling as of October 31, 2026. Our FDA approval and release date pages work through what that means for timing.

Price is the open question. Lilly's October 2026 FAQ says only that retatrutide will be "priced to reflect the overall value to the healthcare system" after review. No number, no launch date; the retatrutide price page tracks what's known.

Our read: even on Lilly's own timeline the filing is months away, with an FDA review after it, so the legal options for the next year or so are a trial, expanded access, or an approved drug such as Zepbound. The Ozempic comparison is in. The tirzepatide one, which matters more to anyone already on Zepbound, waits on TRIUMPH-5.

The Lilly Answers Center, 1-800-LillyRx, is the number Lilly gives both for expanded access requests from doctors and for reporting products sold as retatrutide.

Frequently asked questions

Who makes retatrutide?

Eli Lilly and Company. Lilly discovered retatrutide under the code LY3437943, owns it and sponsors 32 of the 33 retatrutide studies listed on ClinicalTrials.gov. It isn't sold by Lilly or anyone else legally, because no approved version exists yet.

Did Eli Lilly create retatrutide?

Yes. The 2022 Cell Metabolism paper that first described it in full had 20 authors, all at Eli Lilly, 19 of them in Indianapolis. Lilly's first registered study in people began on March 13, 2019.

Does Eli Lilly own the retatrutide patent?

Yes, as far as public records show. The Medicines Patent Pool names Lilly as the company behind retatrutide and reports its primary patent granted in at least 16 low- and middle-income countries, including India, and pending in 30 more, with an expected expiry in 2038. We couldn't confirm the US patent number from a primary record.

Can I get retatrutide from LillyDirect?

No. As of October 31, 2026, LillyDirect lists 10 Lilly medicines, including Zepbound, Mounjaro and Foundayo, and retatrutide isn't one of them. Lilly's FAQ says "no one can legally sell it for human use." The legal routes are a clinical trial and a narrow expanded access program that your doctor applies for.

Who manufactures the retatrutide sold online?

Not Lilly. Lilly says black-market retatrutide is frequently made by unregulated foreign manufacturers, and in August 2026 it filed 6 new lawsuits against US sellers. Australia's TGA tested one vial sold as retatrutide and found semaglutide instead.

What is Lilly's triple agonist?

It's retatrutide. Lilly describes it as a once-weekly triple hormone receptor agonist: a single molecule that activates the receptors for GIP, GLP-1 and glucagon. Tirzepatide, Lilly's drug in Mounjaro and Zepbound, acts on the first two.

Sources

  1. What to know about retatrutide (FAQ, last updated October 2026). Eli Lilly and Company, 2026. lilly.com
  2. Search results for retatrutide (API v2, all study records). ClinicalTrials.gov, 2026. clinicaltrials.gov
  3. LillyDirect: available medicines. Eli Lilly and Company, 2026. lilly.com
  4. Lilly's triple agonist, retatrutide, successful in two additional Phase 3 obesity trials, delivering significant improvements in weight and A1C. Eli Lilly and Company (PR Newswire), 2026. prnewswire.com
  5. Lilly calls on online platforms, payment companies and regulators to shut down the illegal retatrutide black market. Eli Lilly and Company (PR Newswire), 2026. prnewswire.com
  6. LY3437943, a novel triple glucagon, GIP, and GLP-1 receptor agonist for glycemic control and weight loss: From discovery to clinical proof of concept. Cell Metabolism, 2022. doi.org
  7. A Safety Study of LY3437943 Given as a Single Injection in Healthy Participants (NCT03841630). ClinicalTrials.gov, 2019. clinicaltrials.gov
  8. A Study of LY3437943 in Participants With Type 2 Diabetes Mellitus (NCT04143802). ClinicalTrials.gov, 2019. clinicaltrials.gov
  9. Triple-Hormone-Receptor Agonist Retatrutide for Obesity: A Phase 2 Trial. New England Journal of Medicine, 2023. doi.org
  10. Efficacy and safety of retatrutide, a GIP, GLP-1, and glucagon receptor agonist, in people with type 2 diabetes and inadequate glycaemic control with diet and exercise (TRANSCEND-T2D-1): a double-blind, randomised, phase 3 trial. The Lancet, 2026. doi.org
  11. Retatrutide, a Triple Hormone Receptor Agonist, for Treatment of Obesity. New England Journal of Medicine, 2026. doi.org
  12. Retatrutide in adults with obesity and type 2 diabetes (TRIUMPH-2): a double-blind, parallel-group, randomised, placebo-controlled, phase 3 trial. The Lancet, 2026. doi.org
  13. Retatrutide Once Weekly for Treatment of Obstructive Sleep Apnea. New England Journal of Medicine, 2026. doi.org
  14. Effect of Retatrutide Compared With Semaglutide in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Metformin With or Without SGLT2 Inhibitor (TRANSCEND-T2D-2, NCT06260722). ClinicalTrials.gov, 2026. clinicaltrials.gov
  15. Effect of LY3437943 Versus Placebo in Participants Who Have Obesity or Are Overweight (NCT07467447). ClinicalTrials.gov, 2026. clinicaltrials.gov
  16. Lilly's Phase 2 retatrutide results published in The New England Journal of Medicine show the investigational molecule achieved up to 17.5% mean weight reduction at 24 weeks in adults with obesity and overweight. Eli Lilly and Company (PR Newswire), 2023. prnewswire.com
  17. Lilly's triple agonist, retatrutide, delivered weight loss of up to an average of 71.2 lbs along with substantial relief from osteoarthritis pain in first successful Phase 3 trial. Eli Lilly and Company (PR Newswire), 2025. prnewswire.com
  18. Lilly's triple agonist, retatrutide, demonstrated significant reductions in A1C and weight in first Phase 3 trial for treatment of type 2 diabetes. Eli Lilly and Company (PR Newswire), 2026. prnewswire.com
  19. Lilly's triple agonist, retatrutide, delivered substantial weight loss and A1C reduction, underscoring its potential promise for people with obesity and type 2 diabetes. Eli Lilly and Company (PR Newswire), 2026. prnewswire.com
  20. Lilly's retatrutide delivered greater A1C reduction and more than double the weight loss of Ozempic's highest approved dose in head-to-head trial. Eli Lilly and Company (PR Newswire), 2026. prnewswire.com
  21. Third-quarter 2026 sales and earnings (Form 8-K, exhibit 99.1). Eli Lilly and Company (SEC), 2026. sec.gov
  22. Prioritisation: priority list and watchlist (retatrutide entry). Medicines Patent Pool, 2026. medicinespatentpool.org
  23. CN117903284A: Retatrutide synthesis method. Google Patents, 2024. patents.google.com
  24. CN117777248A: Water-based solid phase synthesis method of multi-receptor agonist polypeptide Retatrutide. Google Patents, 2024. patents.google.com
  25. Pre-approval Expanded Access of Retatrutide (LY3437943) (NCT07629401). ClinicalTrials.gov, 2026. clinicaltrials.gov
  26. Zepbound self-pay pricing on LillyDirect. Eli Lilly and Company, 2026. lilly.com
  27. Foundayo self-pay pricing on LillyDirect. Eli Lilly and Company, 2026. lilly.com
  28. FDA's concerns with unapproved GLP-1 drugs used for weight loss. U.S. Food and Drug Administration, 2026. fda.gov
  29. TGA tests counterfeit retatrutide product following serious adverse event report. Therapeutic Goods Administration (Australia), 2026. tga.gov.au
  30. Toxicity linked to unapproved peptide Retatrutide. Department of Health, Victoria, 2026. health.vic.gov.au
  31. A Study of Retatrutide (LY3437943) Compared to Tirzepatide (LY3298176) in Adults Who Have Obesity (TRIUMPH-5, NCT06662383). ClinicalTrials.gov, 2026. clinicaltrials.gov
  32. Effect of Retatrutide Compared With Placebo in Participants With Type 2 Diabetes and Moderate or Severe Renal Impairment (TRANSCEND-T2D-3, NCT06297603). ClinicalTrials.gov, 2026. clinicaltrials.gov
  33. FDA letter to Eli Lilly on the regulatory status of retatrutide, Oct 2, 2026 (filed as Doc. 46-2, 7th Cir. No. 26-1301). U.S. Food and Drug Administration (via CourtListener RECAP), 2026. storage.courtlistener.com
  34. Eli Lilly and Company v. Robert Kennedy Jr., No. 26-1301 (docket). U.S. Court of Appeals for the Seventh Circuit (via CourtListener), 2026. courtlistener.com
JPF
Author & Medical ReviewerVerified Physician Reviewer

Dr. Juan Pablo Frías, MD

Physician-Scientist & Clinical Trialist • Endocrinology, Diabetes & Metabolism

Dr. Frías earned his M.D. from Vanderbilt University School of Medicine and completed his endocrinology fellowship at UC San Diego. A principal investigator on landmark incretin trials (including retatrutide, tirzepatide and semaglutide), he reviews all guides on Retatrutide360 for clinical accuracy, dosing safety and evidence fidelity.

Medical disclaimer. Retatrutide is an investigational medicine and no approved version exists yet. This page is educational, not medical advice. Talk to a doctor before starting, changing or stopping any medication, and get urgent care for severe symptoms.
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