Brand Name
Foundayo
Generic Name
Orforglipron
View Brand Information FDA approval date: April 01, 2026
Form: Tablet
What is Foundayo (Orforglipron)?
FOUNDAYO TM is indicated in combination 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 adults with overweight in the presence of at least one weight-related comorbid condition. FOUNDAYO™ is a GLP-1 receptor agonist indicated in combination 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 adults with overweight in the presence of at least one weight-related comorbid condition. Limitations of Use Concomitant use with another GLP-1 receptor agonist is not recommended. Limitations of Use Concomitant use with another GLP-1 receptor agonist is not recommended.
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Brand Information
FOUNDAYO (orforglipron)
WARNING: RISK OF THYROID C-CELL TUMORS
- In products with glucagon-like peptide-1 (GLP-1) receptor agonist activity that are pharmacologically active in rats and mice, rodent thyroid C-cell tumors (adenomas and carcinomas) have been observed at clinically relevant exposures and are considered GLP-1 receptor-dependent effects in rodents. Orforglipron is not pharmacologically active in rats or mice and did not produce tumors in rodents [see Nonclinical Toxicology (. While orforglipron is pharmacologically active at the human GLP-1 receptor, the human relevance of GLP-1 receptor-dependent thyroid C-cell tumors observed in rodents has not been determined [see Warnings and Precautions (.
- FOUNDAYO is contraindicated in patients with a personal or family history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) [see Contraindications (. Counsel patients regarding the potential risk for MTC with the use of FOUNDAYO and inform them of symptoms of thyroid tumors (e.g., a mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with FOUNDAYO [see Contraindications (.
1INDICATIONS AND USAGE
FOUNDAYO
2DOSAGE FORMS AND STRENGTHS
FOUNDAYO tablets are available as orforglipron:
- 0.8 mg: pink round tablet debossed with “L” on one side and “G1” on the other side
- 2.5 mg: light yellow round tablet debossed with “L” on one side and “G2” on the other side
- 5.5 mg: grayish purple round tablet debossed with “L” on one side and “G3” on the other side
- 9 mg: pink modified oval tablet debossed with “Lilly” on one side and “G4” on the other side
- 14.5 mg: light yellow modified oval tablet debossed with “Lilly” on one side and “G5” on the other side
- 17.2 mg: grayish purple modified oval tablet debossed with “Lilly” on one side and “G6” on the other side
3CONTRAINDICATIONS
FOUNDAYO is contraindicated in patients with:
- A personal or family history of MTC or in patients with MEN 2
- Known serious hypersensitivity to orforglipron or any of the excipients in FOUNDAYO. Serious hypersensitivity reactions, including anaphylaxis and angioedema, have been reported with GLP-1 receptor agonists
4ADVERSE REACTIONS
The following serious adverse reactions are described below or elsewhere in the prescribing information:
- Risk of Thyroid C-Cell Tumors
- Acute Pancreatitis
- Severe Gastrointestinal Reactions
- Acute Kidney Injury Due to Volume Depletion
- Hypoglycemia
- Hypersensitivity Reactions
- Diabetic Retinopathy Complications in Patients with Type 2 Diabetes
- Acute Gallbladder Disease
- Pulmonary Aspiration During General Anesthesia or Deep Sedation
4.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The safety of FOUNDAYO has been established in combination 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 adults with overweight in the presence of at least one weight-related comorbid condition based on adequate and well-controlled trials of an investigational orforglipron formulation (Trials 1 and 2), referred to in this section as FOUNDAYO
4.2Postmarketing Experience
The following adverse reactions have been reported during post-approval use of GLP-1 receptor agonists. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Gastrointestinal Disorders: acute pancreatitis, hemorrhagic and necrotizing pancreatitis sometimes resulting in death; ileus, intestinal obstruction, severe constipation including fecal impaction
Hypersensitivity: anaphylaxis, angioedema
Pulmonary: Pulmonary aspiration has occurred in patients receiving GLP-1 receptor agonists undergoing elective surgeries or procedures requiring general anesthesia or deep sedation
Renal and Urinary Disorders: acute renal failure or worsening of chronic renal failure, sometimes requiring hemodialysis
5OVERDOSAGE
In the event of an overdose, consider contacting Poison Control (1-800-222-1222) or a medical toxicologist for latest recommendations. Initiate appropriate supportive treatment according to the patient's clinical signs and symptoms. A period of observation and treatment for these symptoms may be necessary, considering the half-life of orforglipron
6DESCRIPTION
FOUNDAYO contains orforglipron, a GLP-1 receptor agonist. The molecular formula for orforglipron calcium is C
Orforglipron calcium is a white to practically white to light brown solid that is hygroscopic. Orforglipron calcium is insoluble in water.
FOUNDAYO tablets contain 0.8 mg, 2.5 mg, 5.5 mg, 9 mg, 14.5 mg, or 17.2 mg of orforglipron (equivalent to 0.817 mg, 2.554 mg, 5.619 mg, 9.194 mg, 14.81 mg, and 17.57 mg of orforglipron calcium, respectively) as film-coated, debossed tablets for oral use. Each tablet contains the following inactive ingredients: copovidone, crospovidone, magnesium stearate, microcrystalline cellulose, and sodium carbonate anhydrous. The tablet film-coating material contains polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. Additionally, the film coating of the:
- 0.8 mg and 9 mg tablets contain ferric oxide red and ferric oxide yellow
- 2.5 mg and 14.5 mg tablets contain ferric oxide yellow
- 5.5 mg and 17.2 mg tablets contain ferrosoferric oxide and ferric oxide red.
Each tablet contains 10 mg or less of sodium.
7PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Medication Guide).