Foundayo (orforglipron) is a new oral GLP-1 medication not yet approved in Japan.
We will notify you via our official LINE account when we begin handling it. If you wish to start immediately, we can guide you to currently available GLP-1 medications.
What is Foundayo (Orforglipron)?
Foundayo is an oral small-molecule GLP-1 receptor agonist developed by Eli Lilly and Company. It is said to have originated from a compound in which Japan's Chugai Pharmaceutical was involved in the early stages of development, after which global development and approval were pursued. On April 1, 2026, the US FDA approved it as an obesity treatment, marketed under the brand name "Foundayo."
The key is "small-molecule, non-peptide type"
Conventional oral GLP-1 medication Rybelsus (semaglutide) has a peptide structure, making it difficult to absorb. This necessitated strict rules for taking it: immediately after waking, on an empty stomach, and with only a small amount of water. Foundayo, being a "small-molecule" compound without a peptide structure, can be taken at any time of day without concern for meal timing or water intake. This is its biggest feature.
Differences from Rybelsus
| Rybelsus (semaglutide) | Foundayo (orforglipron) | |
|---|---|---|
| Structure | Peptide type | Non-peptide type (small molecule) |
| Dosing rules | Immediately after waking, on an empty stomach, with only a small amount of water; no food or drink for 30 minutes after taking | Can be taken regardless of meal timing or water intake |
| Approval status | Approved in Japan (as a type 2 diabetes treatment) | Approved in the US (April 2026). Not yet approved in Japan |
| Renal/hepatic function | Careful consideration required depending on condition | No dose adjustment needed even with impaired renal function |
Effects known from clinical trials
The efficacy of Foundayo has been confirmed in two Phase 3 clinical trial programs: the "ATTAIN" study for obesity and the "ACHIEVE" study for type 2 diabetes.
| Study | Target population | Duration | Weight loss rate (maximum dose) |
|---|---|---|---|
| ATTAIN-1 | Adults with obesity/overweight without diabetes | 72 weeks | Average approx. -12.4% |
| ATTAIN-2 | Adults with obesity/overweight and type 2 diabetes | 72 weeks | Average approx. -10.5% |
While individuals with type 2 diabetes (ATTAIN-2) showed a slightly smaller weight loss compared to those without diabetes (ATTAIN-1), both groups demonstrated statistically significant weight loss compared to the placebo group. In addition to weight, reductions in waist circumference, non-HDL cholesterol, triglycerides, and systolic blood pressure were reported. Individual results may vary.
We will promptly notify you when we begin handling this medication.
How to take and increase dosage
How to take
- Take one tablet once daily, regardless of meal timing or water intake.
- Do not break, crush, or chew the tablet; swallow it whole.
- Do not take more than one tablet per day.
How to increase dosage
The dosage is designed to be gradually increased from a small amount to minimize gastrointestinal symptoms. Continue at each dose for at least 30 days before moving to the next dose.
| Stage | Dosage | Duration |
|---|---|---|
| Initial | 0.8mg | 30 days or more |
| 2nd stage | 2.5mg | 30 days or more |
| 3rd stage | 5.5mg | 30 days or more |
| Subsequent | 9mg → 14.5mg → 17.2mg (maximum) | Adjust every 30 days or more, observing effects and side effects |
The timing of dosage increases will be determined by the physician based on changes in weight and the presence of gastrointestinal symptoms. Do not increase the dosage on your own.
If you miss a dose
If you miss about one dose, return to your usual schedule the next day. However, if you miss doses for 7 consecutive days or more, you will need to restart the dosage increase from a lower dose to avoid gastrointestinal symptoms. Do not return to your original dose on your own; please consult us.
Side effects and precautions
Main side effects
- Gastrointestinal symptoms such as nausea, diarrhea, constipation, and abdominal pain (common during the initial phase of dose escalation, similar to other GLP-1 medications)
- Hypoglycemia (caution if combining with other diabetes medications)
- While serious side effects are considered infrequent, some cases of treatment discontinuation due to side effects have been reported.
Symptoms that require immediate contact
- Acute pancreatitis: Severe pain from the pit of the stomach to the back, persistent nausea/vomiting
- Gallbladder disease: Upper right abdominal pain, fever, yellowing of skin or whites of eyes
- Severe gastrointestinal symptoms: Severe nausea, vomiting, or diarrhea preventing fluid intake (can lead to kidney dysfunction from dehydration)
- Lump or swelling in the neck, hoarseness, difficulty swallowing, shortness of breath
Who should not use this medication
- Individuals with a history of medullary thyroid carcinoma or a family history of it
- Individuals with Multiple Endocrine Neoplasia type 2
- Individuals who have experienced severe allergic reactions to the ingredients
- Pregnant individuals (discontinue at the time of confirmed pregnancy) or those planning pregnancy
Drug interactions
- Concurrent use with other GLP-1 receptor agonists is not recommended. If switching from Mounjaro or Ozempic, discontinue the injection before transitioning.
- For individuals using oral contraceptives (e.g., low-dose birth control pills): Foundayo may slow gastric emptying, potentially affecting the absorption of oral medications. It is recommended to switch to a non-oral contraceptive method or use condoms in conjunction for 30 days after starting the medication and for 30 days each time the dose is increased.
- When used concurrently with certain medications (strong CYP3A4 inhibitors), the maximum dose is limited to 9mg. Please always inform us of any medications you are taking.
Regarding kidney and liver function
Foundayo has been reported to have unchanged pharmacokinetics in individuals with impaired kidney function, and dose adjustment is not required even for those with end-stage renal disease. No adjustment is needed for mild to moderate liver impairment. This medication may be an option for individuals who found other diet medications difficult to use due to kidney function concerns.
Recommended for
- Those who are resistant to injections
- Those who find it difficult to adhere to Rybelsus's dosing rules (upon waking, on an empty stomach, with a small amount of water)
- Those who frequently eat out or have irregular meal times and desire flexibility in dosing timing
- Those who have lost weight with injectables like Mounjaro or Ozempic and wish to switch to oral medication to maintain weight
- Those who found other medications difficult to use due to kidney function concerns
Comparison with other GLP-1 preparations
| Medication (component) | Usage | Features |
|---|---|---|
| Foundayo (orforglipron) | Once daily oral | No food/water restrictions. Not yet approved in Japan. |
| Rybelsus (semaglutide) | Once daily oral | Take upon waking, on an empty stomach. Approved in Japan. |
| Ozempic (semaglutide) | Once weekly subcutaneous injection | Once a week, no dosing restrictions. |
| Mounjaro (tirzepatide) | Once weekly subcutaneous injection | Acts on GLP-1 and GIP, tends to have greater weight loss effects. |
While you wait for Foundayo to become available, you can receive online medical consultations for the medications listed above.
Prospects for approval in Japan
As of September 2026, Foundayo (orforglipron) is not approved in Japan. Following its approval in the U.S., marketing authorization applications are underway in over 40 countries, with reports indicating a sequential launch expected in China, Europe, and the UK. However, the approval date in Japan is not yet clear.
Our clinic is considering handling this medication through self-pay medical care and import procedures during the period before domestic approval. We will announce the official start date on our official LINE account.
Precautions regarding unapproved medicines
- Unapproved drug: Foundayo (orforglipron) is a drug not approved in Japan.
- Acquisition route: If handling begins, we will use medication imported by a physician after completing personal import procedures (obtaining a Yakkan Shomei from the Regional Bureau of Health and Welfare).
- Availability of domestically approved drugs: There are no domestically approved drugs with the same active ingredient. However, other GLP-1 receptor agonists such as Rybelsus, Ozempic, and Mounjaro are approved in Japan.
- Safety information in other countries: It was approved in the US in April 2026 as an obesity treatment. The package insert contains a warning regarding the risk of thyroid C-cell tumors, and it is contraindicated in individuals with a history of medullary thyroid carcinoma, a family history of it, or Multiple Endocrine Neoplasia Type 2. Other reported adverse events include acute pancreatitis, gallbladder disease, severe gastrointestinal symptoms, and renal impairment.
- Health Damage Relief System: Health damage caused by the use of unapproved drugs is not covered by the Pharmaceutical Side Effect Relief System.
- Cost/Effectiveness: As this is self-pay medical care, health insurance does not apply, and the full cost is borne by the patient. The degree of effectiveness varies among individuals.
Online Consultation Process
| STEP | Content |
|---|---|
| 1. Order and pre-consultation | Select your desired plan and place an order. You will then be asked to complete a questionnaire. Please be sure to inform us of any medications you are currently taking (especially low-dose birth control pills) and any pre-existing medical conditions. |
| 2. Online consultation | A doctor will determine whether a prescription is appropriate via video call. |
| 3. Shipping | Ships as early as the same day. Delivered in discreet packaging. |
While you wait, you can start with existing GLP-1 medications.
Frequently Asked Questions
Related Pages
- About Rybelsus/Ozempic (GLP-1)
- About Mounjaro (GLP-1/GIP injection)
- Metformin (supports sugar metabolism)
- SGLT2 Inhibitors (sugar cutting)
- About Online Consultation / About Fees
References
FOUNDAYO (orforglipron) tablets, for oral use — US Prescribing Information (Eli Lilly and Company, 2026)
Wharton S, et al. Orforglipron, an oral small-molecule GLP-1 receptor agonist for obesity treatment (ATTAIN-1). N Engl J Med. 2025;393(18):1796-1806.
Jastreboff AM, et al. Oral orforglipron for the treatment of obesity and type 2 diabetes (ATTAIN-2). N Engl J Med. 2025.
Frias JP, et al. Daily oral GLP-1 receptor agonist orforglipron for adults with obesity. N Engl J Med. 2023;389:877-888.
