Not a sign-up pageThere is no form for patients. Only a treating physician can ask Lilly for early access, and only for one patient at a time.[1] Retatrutide remains investigational and is not approved anywhere.[6]
What Eli Lilly announced
On Monday, August 3, 2026, Lilly said it would let a limited number of patients receive retatrutide before FDA approval. A company spokesperson told Reuters this was "medically appropriate" for patients who cannot take part in a clinical trial, and that Lilly was reviewing requests from health care providers. Lilly did not give a price or say how many patients it would accept.[2]
Headlines such as "Eli Lilly offers early access to experimental drug retatrutide" refer to this program. Its formal record, "Pre-approval Expanded Access of Retatrutide (LY3437943)", had been posted on ClinicalTrials.gov on June 5, 2026 and was last updated on August 6, 2026.[1] Before that, Reuters reported, Lilly had granted special access to a single 79-year-old patient in April 2026.[2]
Who qualifies: the official criteria
The ClinicalTrials.gov record lists five requirements, and a patient must meet all of them.[1]
| Requirement | What the record says |
|---|---|
| Age | 18 or older |
| Body mass index | BMI of 35 or more, despite sticking to and tolerating the highest available dose of a chronic weight-management medicine |
| Complications | Two or more serious or life-threatening obesity-related complications, already under standard care |
| Clinical trials | Cannot join an ongoing retatrutide trial or a comparable investigational study, because of eligibility rules or because no site is reasonably close |
| Options discussed | A shared decision-making discussion of all standard options, including bariatric surgery |
| Exclusion | Any medical reason retatrutide should not be used |
In practice this is a narrow group: people with severe obesity whose condition has not responded to the strongest approved treatment. Most people who search for retatrutide will not qualify. The Reuters report described the same core criteria from Lilly's spokesperson.[2]
How a request works
- The physician contacts Lilly. Requests must come from the treating physician, not the patient or a caregiver. The record lists the Lilly Answers Center, 1-800-LillyRx (1-800-545-5979), and ClinicalTrials@lilly.com for physician inquiries.[1]
- Lilly reviews the individual case. Access depends on the patient's country, the available supply of the drug and a detailed eligibility review.[1]
- The regulator signs off. Under Lilly's expanded-access policy, if Lilly agrees, the regulatory authority of the country the request came from must also approve before the drug is shipped to the physician.[3]
- Treatment is supervised. The physician who made the request manages treatment and follow-up.
The record lists no study sites, no waiting list and no fee.[1] Anyone offering to "enroll" you in Lilly's early access for a payment is not part of this program.
Retatrutide expanded access: what it is, and what it is not
Expanded access, sometimes called "compassionate use", is the FDA's pathway for a patient with a serious or immediately life-threatening condition to get an investigational product outside a clinical trial.[4] The FDA lists five conditions that should all apply:
- The disease or condition is serious or immediately life-threatening.
- No comparable or satisfactory approved alternative is available.
- Enrolling in a clinical trial is not possible.
- The potential benefit justifies the potential risks.
- Providing the product will not interfere with trials that could support its approval.
Expanded access is not approval. The FDA notes that these products have not been approved and may not work, or may cause unexpected serious side effects.[4] The known side effects of retatrutide in trials are on the retatrutide side effects page.
Early access timeline
| Date | Event |
|---|---|
| April 2026 | Lilly grants special access to one 79-year-old patient (reported later)[2] |
| June 5, 2026 | Expanded-access record NCT07629401 posted on ClinicalTrials.gov[1] |
| August 3, 2026 | Lilly confirms limited early access and says it is reviewing doctors' requests[2] |
| August 6, 2026 | Record last updated[1] |
| Q1 2027 | Lilly's planned U.S. submission for approval[5] |
When will retatrutide be on the market?
Not before an FDA approval decision. Lilly plans to submit its application in the first quarter of 2027.[5] The FDA's review goals put a decision roughly 8 to 12 months after submission; the arithmetic is on the retatrutide FDA approval page. Until then, early access and clinical trials are the only routes.
Eli Lilly retatrutide: where the drug stands
Retatrutide (development code LY3437943) is Eli Lilly's investigational once-weekly injection that acts on GIP, GLP-1 and glucagon receptors. In October 2026 Lilly wrote that it "has not been approved by FDA or any regulatory organization anywhere in the world" and that anyone selling it to consumers is breaking the law.[6] Lilly plans to submit it for U.S. approval in the first quarter of 2027.[5] ClinicalTrials.gov lists the expanded-access program as "Available".[7]
For the broader picture, see how to get retatrutide legally, the FDA approval timeline, and Lilly's lawsuits against sellers.
Early access is not sold onlineLilly supplies retatrutide only to trial sites and approved expanded-access requests. Products sold online as "research use only" are not Lilly's drug. Read what the FDA says about these products.
Related
- How to get retatrutideTrials, early access and approval
- FDA approval statusFiling planned for Q1 2027
- What is retatrutide?The triple agonist, explained
Frequently asked questions
Can I sign up for Eli Lilly retatrutide early access myself?
No. The program accepts requests only from a treating physician, for one patient at a time. Patients and caregivers cannot apply directly.[1]
Who qualifies for retatrutide early access?
Adults aged 18 or older with a BMI of 35 or more despite the highest available dose of a weight-management medicine, at least two serious or life-threatening obesity complications, and no way to join a trial. All standard options, including bariatric surgery, must have been discussed.[1]
How much does retatrutide early access cost?
Lilly has not said. Neither the ClinicalTrials.gov record nor Lilly's August 2026 statement gave a price.[1][2] There is no approved price for retatrutide; see retatrutide cost.
Is retatrutide available through compassionate use?
Is early access the same as FDA approval?
No. Expanded access lets a small number of patients receive an investigational drug before approval. The drug has not been found safe and effective by the FDA.[4]
Sources
- Pre-approval expanded access of retatrutide (LY3437943), NCT07629401
- Eli Lilly to offer early access to next-gen obesity drug to some patients
- Lilly expanded access policy
- Expanded access
- Lilly: retatrutide successful in two additional phase 3 obesity trials (TRIUMPH-2, TRIUMPH-3)
- Lilly: retatrutide vs semaglutide 2 mg in TRANSCEND-T2D-2
- Retatrutide studies (NCT04881760, NCT05929066, NCT05931367, NCT06662383, NCT07629401 and others)