Is retatrutide available yet? Here’s the real timeline

In this article:

• Is retatrutide FDA approved?
• Availability
• How is retatrutide different from other GLP-1s
• Clinical trials
• Is it safe to buy retatrutide online?
• Cost
• FAQs

In this article

• Is retatrutide FDA approved?
• Availability
• How is retatrutide different from other GLP-1s
• Clinical trials
• Is it safe to buy retatrutide online?
• Cost
• FAQs

Experts typically suggest maintaining a healthy skepticism about the fantastic promises offered by companies that sell supplements and other untested products claiming to help you shed a few pounds and look and feel better. That includes all the companies selling a synthetic peptide that promises to deliver results similar to a weight-loss drug called retatrutide that’s showing promising results in clinical trials.

For now, retatrutide, which is in development by Eli Lilly and Company, is still not available to the public. But that could all change in 2027 when the company plans to file an application for approval from the U.S. Food and Drug Administration (FDA). Here’s what you need to know about the options that are available to you now for weight loss and what you can expect in the future.

Is retatrutide FDA approved?

No, retatrutide is not FDA approved. It’s still classified as an investigational drug, which means it’s not legally available in U.S. pharmacies, and you can’t ask your doctor for a prescription. Until the FDA gives the green light, retatrutide is off-limits to anyone not participating in a clinical trial, with one exception: Eli Lilly recently announced it would allow certain people to apply for special early access.

That hasn’t stopped it from generating buzz. When injectable drugs like the GLP-1 receptor agonist Ozempic (semaglutide) and the dual GIP/GLP-1 receptor agonist Mounjaro (tirzepatide) hit the market, many experts declared them gamechangers. Suddenly, people had new options for helping manage Type 2 diabetes and other conditions while also helping them lose significant amounts of weight.

The market expanded to encompass versions specifically designed to help people shed weight: Wegovy (semaglutide) and Zepbound (tirzepatide). Eli Lilly and Company, which manufactures Zepbound, also introduced a new oral weight-loss medication, the GLP drug called Foundayo (orforglipron) earlier this year. The manufacturer of Wegovy and Ozempic, Novo Nordisk, offers an oral version of each as well.

Now, retatrutide looms on the horizon. It has completed multiple clinical trials and produced positive results. The results of the TRIUMPH-2 and TRIUMPH-3 Phase 3 trials, according to the manufacturer, showed that retatrutide could help people achieve significant weight loss and reduce their risk of cardiovascular disease, while also helping people with Type 2 diabetes improve their glycemic control. Research also suggests that it could help improve insulin sensitivity and improve liver health in people with metabolic dysfunction-associated steatotic liver disease (MASLD).

When it becomes available, “all evidence suggests that it’s going to be the most effective weight-loss medication that we’ve ever seen,” predicts Adam Wolfberg, MD, MPH, chief medical officer of Virta Health.

When will retatrutide be available?

You may not have to wait much longer. The drug manufacturer Eli Lilly and Company plans to file an application for FDA approval for retatrutide in the first quarter of 2027. Typically, the FDA takes about 10 months to review a new drug application (NDA) and take action on it. (The exception is a request for priority review designation, which usually takes about six months.) That would mean that the most realistic window for pharmacy availability in the U.S. would be late 2027 to early 2028.

How is retatrutide different from the GLP-1s already on the market?

The key difference is mechanism: retatrutide is a “triple agonist,” hitting three metabolic pathways instead of one or two. Ozempic and Wegovy act on a single target (GLP-1), while Mounjaro and Zepbound act on two (GIP and GLP-1). Retatrutide adds a third target, the glucagon receptor, on top of GIP and GLP-1.

That broader mechanism appears to translate into stronger results. A recent meta-analysis of numerous clinical trials found that retatrutide produced better weight loss than tirzepatide, though the researchers noted a higher rate of adverse effects.

“If retatrutide is approved, I expect it to reshape the ceiling of what is possible with medication alone,” says Nicole Gendron-Trainer, DNP, RN, assistant professor at the GW School of Nursing in Washington, D.C. “As a triple agonist hitting GIP, GLP-1, and glucagon receptors, it has shown weight loss approaching what we have historically only seen with bariatric surgery, up to roughly 30% of body weight in its pivotal obesity trial.”

Like semaglutide and tirzepatide, retatrutide’s weight-loss effects can help improve obesity-related health conditions, but it hasn’t yet been proven to be more effective in humans outside of trial settings.

Retatrutide vs. Zepbound and Wegovy at a glance

These are not head-to-head trials that directly compared the medications, but this information can show you how these medications would likely compare. Note: Results vary by individual.

Can you get retatrutide through a clinical trial?

The only way to access retatrutide prior to the FDA’s approval is through eligibility for a clinical trial.

Some clinical trials that are investigating retatrutide are still enrolling new participants. You can check the U.S. government’s Clinical Trials website to get more information and to look for active trials that are still recruiting qualified patients.

You can also check Eli Lilly and Company’s online trial information center to find clinical trials that could be a good fit for you. For example, Lilly’s TRIUMPH phase 3 trials, which have been researching retatrutide, may still have some extension openings.

However, Gendron-Trainer says people already have access to some very successful medications to help them lose weight. “For the great majority of patients, an already-approved medication like tirzepatide is the right call today,” she says. “Starting it now does not close the door on retatrutide later. If it’s approved and clinically appropriate, a patient can transition at that point.”

Who’s eligible for a retatrutide clinical trial?

When searching for retatrutide clinical trials, look at the participation criteria. Every clinical trial has its own unique criteria for enrollment. For example, the eligibility criteria for one retatrutide clinical trial as listed on ClinicalTrials.gov included having a body mass index (BMI) greater than or equal to 35.0 and established cardiovascular (CV) disease with at least one unsuccessful dietary attempt to lose weight.

Clinical trials also list criteria that can exclude someone from being eligible. For example, one study excluded people who have a personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome Type 2 (MEN-2).

Is it safe to buy retatrutide online right now?

Experts recommend caution purchasing anything that claims to be retatrutide (or identical to retatrutide) before the FDA grants approval. That includes supplements sold as a “research peptide” that’s not part of the manufacturer’s trials, as well as any unauthorized products from compounding pharmacies. You don’t know for sure what you may be getting, and the product may not contain the correct amount of active ingredient. There’s also a possibility that you may buy a mislabeled or contaminated product.

In fact, the FDA has released numerous statements warning about the possible dangers of unapproved versions of GLP-1 and GIP/GLP-1 drugs, including semaglutide and tirzepatide, as an option for weight loss. The FDA also issued warning letters to dozens of telehealth companies earlier this year about false and misleading claims about compounded GLP-1 products.

Dr. Wolfberg has concerns about people turning to compounding pharmacies. “I don’t condone that,” Dr. Wolfberg says. “I don’t think that’s necessarily safe.”

What might retatrutide cost once it’s approved?

Because the drug has not yet been approved by the FDA, the manufacturer has not yet set a price for retatrutide. In the meantime, consider the current costs of other weight-loss medications on the market.

For example, the list price for one month’s supply of Wegovy is about $1,820 and one month’s supply of a starting dose of Zepbound is approximately $655. However, those are the prices for people without insurance coverage or other discounts.

The cost can be substantially less with certain insurance plans or savings programs. SingleCare offers coupons for other weight-management medications and will offer a coupon for retatrutide when it receives FDA approval. Copay and savings programs may eventually emerge for retatrutide, similar to Zepbound’s patient assistance program.

Frequently asked questions

Here are some answers to some questions that people often have about retatrutide:

What is retatrutide?

Retatrutide is an investigational triple-hormone receptor agonist under development for weight loss. It’s a once-weekly injection.

Is retatrutide a ‘GLP-3’ drug?

‘GLP-3’ is a colloquial nickname for retatrutide, not a real name for the drug class, because it targets GLP-1, GIP, and glucagon receptors.

Is retatrutide the same as tirzepatide?

No, but they are related. Tirzepatide (brand names: Mounjaro, Zepbound) is a dual agonist while retatrutide adds a third receptor target.

How much weight can you lose on retatrutide?

Participants in the TRIUMPH-1 clinical trial who took the highest dose of retatrutide (12 mg) for 104 weeks achieved a total body weight reduction of about 30%. However, the drug is still under investigation, and individual results can vary.

What are the side effects of retatrutide?

The most commonly reported side effects are similar to the GI side effects associated with GLP-1 drugs, such as nausea, vomiting, constipation, and diarrhea. A full safety profile still awaits FDA review.

Bottom line

Because retatrutide isn’t available yet, the only legitimate access point to this particular medication is a clinical trial. However, the manufacturer announced it plans to file for FDA approval in early 2027, so it may be available later next year. SingleCare can help patients save on the cost as soon as retatrutide hits pharmacy shelves.