Foundayo prescribing information revised in July 2026
Foundayo's label now carries a July 2026 revision date setting out its dosing, boxed warning and drug interactions; the specific changes from the earlier version were not disclosed.
The U.S. prescribing information for Foundayo (orforglipron) was revised in July 2026, and the current label carries the revision date 7/2026 [1][2]. A supplement label, numbered 220934s003, was posted alongside the original approval label [2]. The labeling lists an initial U.S. approval of 2026 [1][2].
Foundayo is an oral GLP-1 receptor agonist taken as a tablet once daily, with or without food. It is indicated for use along with a reduced-calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long term in adults with obesity, or in adults with overweight who also have at least one weight-related condition [1][2]. The label says tablets must be swallowed whole and that no more than one tablet should be taken per day [1][2]. Available strengths are 0.8 mg, 2.5 mg, 5.5 mg, 9 mg, 14.5 mg and 17.2 mg [1][2].
Dosing in the label starts at 0.8 mg once daily. After at least 30 days the dose increases to 2.5 mg, and after at least another 30 days to 5.5 mg. Further increases to 9 mg, 14.5 mg or 17.2 mg may follow after at least 30 days at the current dose, based on response and tolerability, with 17.2 mg once daily as the maximum [1][2]. If seven or more consecutive doses are missed, the label says to restart dose escalation at a lower dose [2]. Combining Foundayo with another GLP-1 receptor agonist is not recommended [1][2].
The label carries a boxed warning about thyroid C-cell tumors. It notes that orforglipron is not pharmacologically active in rats or mice and did not produce tumors in rodents, and that the human relevance of GLP-1 receptor-dependent thyroid C-cell tumors seen in rodents has not been determined [1][2]. Foundayo is contraindicated in people with a personal or family history of medullary thyroid carcinoma or with Multiple Endocrine Neoplasia syndrome type 2, and in people with a known serious hypersensitivity to orforglipron or the tablets' inactive ingredients [1][2].
Adverse reactions reported in at least 5% of patients include nausea, constipation, diarrhea, vomiting, dyspepsia, abdominal pain, headache, abdominal distension, fatigue, eructation, gastroesophageal reflux disease, flatulence and hair loss [1][2]. The label also lists warnings for acute pancreatitis, severe gastrointestinal reactions, acute kidney injury from volume depletion, hypoglycemia when used with insulin or an insulin secretagogue, serious hypersensitivity reactions, diabetic retinopathy complications in people with type 2 diabetes, acute gallbladder disease, and pulmonary aspiration during general anesthesia or deep sedation [1][2].
Among drug interactions, the maximum Foundayo dose is 9 mg once daily when used with a strong CYP3A4 inhibitor, and use with strong CYP3A4 inhibitors that also inhibit OATP1B should be avoided. Simvastatin should not exceed 20 mg once daily with Foundayo, and Foundayo delays gastric emptying, which can affect how oral medicines are absorbed [1][2]. The label says Foundayo may cause fetal harm and should be discontinued when pregnancy is recognized, and that women using oral contraceptives should switch to a non-oral method or add a barrier method for 30 days after starting and for 30 days after each dose increase [1][2]. It is not recommended in patients with severe hepatic impairment or severe gastroparesis [1][2].
The labeling documents do not describe which sections changed or what was added or removed in the July 2026 revision, and that has not been disclosed [1][2].
Why it matters for patients
Prescribing information is the document clinicians and pharmacists rely on for dosing, warnings and interactions, so a revised label is the version now being consulted [1][2]. For anyone taking or considering Foundayo, the label confirms it is a once-daily oral tablet with a stepwise 30-day escalation schedule and a 17.2 mg maximum dose, and that it is intended for use with diet and physical activity rather than on its own [1][2]. The interaction sections describe dose limits for people taking certain other medicines, including a 9 mg Foundayo cap with strong CYP3A4 inhibitors and a 20 mg cap on simvastatin [1][2]. The label also advises people who use oral contraceptives to add or switch to a non-oral method for 30 days after starting and after each dose increase, and it says to tell healthcare providers about planned surgeries or procedures because of reports of pulmonary aspiration during anesthesia and deep sedation in patients receiving GLP-1 receptor agonists [1][2]. The boxed warning and contraindications regarding medullary thyroid carcinoma and MEN 2 remain in place [1][2].
What happens next
No further dated milestones, such as additional label updates or new FDA actions, have been reported [1][2]. The label directs patients to report suspected side effects to Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979) or to FDA at 1-800-FDA-1088 or through MedWatch [1][2].
Sources
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