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Medication Information

Orforglipron Tablets

Everything about its effects, use, clinical evidence and current approval status

GLP-1 Tablet Once Daily Approved in US & UK Not Approved in EU
This page was reviewed by Dr. Nicolette Lammers.
Orforglipron is currently not available at The Body Clinic.
At a Glance

Orforglipron at a Glance

What Is Orforglipron?

Orforglipron is a non-peptide, orally administered GLP-1 receptor agonist developed by Eli Lilly.

Unlike many established GLP-1 medicines, the active ingredient is not injected but taken as a once-daily tablet.

Orforglipron has been studied particularly for the treatment of obesity, overweight with weight-related comorbidities and type 2 diabetes.

You can learn more about the active ingredient on our orforglipron active ingredient page.

Approval Status 2026

Approval Varies Internationally

United States

Approved as Foundayo since April 2026 for long-term weight management.

United Kingdom

Approved since August 2026 for weight management and type 2 diabetes.

Germany / EU

Currently no regular EU marketing authorisation or routine availability.
Orforglipron is currently not available at The Body Clinic.

This page is provided solely for factual information about the active ingredient, international approvals, study results and the current status in Germany.

Is Orforglipron Approved in Germany?

No. Orforglipron currently has no regular EU marketing authorisation for Germany or the European Union.

Its approval status now differs internationally: in the United States, orforglipron was approved under the brand name Foundayo in April 2026 for long-term weight management. The United Kingdom followed in August 2026.

US Since April 2026

FDA-approved for adults with obesity or overweight plus at least one weight-related comorbidity.

UK Since August 2026

Approved for weight management and type 2 diabetes.

Germany / EU

Currently no regular EU marketing authorisation or routine availability.

What Is Special About Orforglipron?

Orforglipron is a small, non-peptide molecule. This allows the active ingredient to be taken orally without the strict food or water requirements needed for some other oral GLP-1 medicines.

In markets where it is already approved, Foundayo is taken once daily and can be used without regard to meals.

Administration & Dosage

How Is Orforglipron Taken?

In markets where it is already approved, orforglipron is taken under the brand name Foundayo as a once-daily tablet.

Unlike oral semaglutide, no special requirements regarding meals or the amount of water are necessary.

Administration in Approved Markets

Once Daily

Orforglipron is taken as a daily tablet.

With or Without Food

It can be taken regardless of meals.

No Fixed Water Amount

There are no comparable water restrictions as with some other oral GLP-1 medicines.

Which Doses Are Approved in the United States?

The US prescribing information recommends gradual dose escalation. Each dose should be taken for at least 30 days before moving to the next level.

0.8 mg Approved starting dose.
2.5 mg Next step after at least 30 days.
5.5 mg Next step in dose escalation.
9 mg Possible higher dose depending on response and tolerability.
14.5 mg Higher possible maintenance dose.
17.2 mg Maximum approved daily dose in the US.

Why Do Older Orforglipron Studies Use Different Doses?

ATTAIN-1 used an investigational capsule formulation at doses of 6 mg, 12 mg and 36 mg. These correspond to the later approved tablet doses of 5.5 mg, 9 mg and 17.2 mg respectively.

These doses are not an approved treatment regimen for Germany.

Orforglipron is currently not routinely approved or available in Germany and is not offered by The Body Clinic.

Your Journey to Sustainable Weight Loss Starts Here.

Effects & Studies

How Does Orforglipron Work and What Do Studies Show?

Orforglipron activates the GLP-1 receptor. This can influence satiety, appetite, food intake and glucose-dependent metabolic processes, among other effects.

The active ingredient is non-peptide and therefore differs structurally from many established GLP-1 receptor agonists.

Which Areas Does Orforglipron Affect?

Appetite

GLP-1 signalling can influence hunger and food intake.

Satiety

Increased feelings of fullness can reduce energy intake.

Blood Sugar

GLP-1 influences glucose-dependent processes involved in insulin regulation.

What Did the ATTAIN-1 Trial Show for Orforglipron?

ATTAIN-1 studied 3,127 adults with obesity without diabetes over 72 weeks.

Phase 3 · 72 Weeks

Mean Change in Body Weight

Orforglipron 36 mg −11.2% mean change in body weight in the primary treatment-regimen estimand.
Placebo −2.1% mean change in body weight over the same period.

54.6% of participants receiving 36 mg achieved at least 10% weight loss, 36.0% at least 15% and 18.4% at least 20%. The trial used an earlier formulation with different dose labels from the subsequently approved Foundayo tablets.

What Did ATTAIN-2 Show in Type 2 Diabetes?

ATTAIN-2 studied adults with overweight or obesity and type 2 diabetes.

Phase 3 · 72 Weeks
Orforglipron 36 mg −9.6% mean change in body weight after 72 weeks.
Placebo −2.5% mean change in body weight in the same trial.

How Did Orforglipron Compare With Oral Semaglutide?

ACHIEVE-3 compared orforglipron with oral semaglutide in adults with type 2 diabetes.

Phase 3 · Head-to-Head
Orforglipron 36 mg −2.2% HbA1c plus an average −9.2% change in body weight.
Oral Semaglutide 14 mg −1.4% HbA1c plus an average −5.3% change in body weight.

These results relate to adults with type 2 diabetes and to the formulations used in the trial. They are not an individual prediction of treatment outcomes.

Side Effects & Safety

What Side Effects Can Orforglipron Cause?

The approval data now available show a side-effect profile that is similar in many respects to other GLP-1 receptor agonists.

What Are the Common Side Effects of Orforglipron?

Nausea

One of the most commonly reported adverse effects.

Constipation

Is also commonly observed with orforglipron.

Diarrhea

Particularly during dose escalation, this is a typical gastrointestinal adverse effect.

Vomiting

Can also occur and is more frequent at higher doses.

What Risks and Warnings Apply to Orforglipron?

What Is the Warning About Thyroid C-Cell Tumors?

The US prescribing information carries a boxed warning concerning the potential risk of thyroid C-cell tumors associated with GLP-1 receptor activity. The relevance of this risk to humans is unknown.

Foundayo is contraindicated in people with a personal or family history of medullary thyroid carcinoma or with Multiple Endocrine Neoplasia syndrome type 2.

Can Orforglipron Cause Pancreatitis?

Acute pancreatitis has been observed with orforglipron and other GLP-1 receptor agonists. Severe or persistent abdominal pain should be medically assessed.

What Gastrointestinal Problems Can Occur With Orforglipron?

Gastrointestinal adverse reactions can sometimes be severe. The US prescribing information does not recommend use in people with severe gastroparesis.

Can Orforglipron Cause Gallbladder Problems?

Acute gallbladder disease was observed in clinical trials and is included among the relevant warnings and precautions.

Can Vomiting and Diarrhea Affect the Kidneys?

Persistent vomiting or diarrhea can cause dehydration and may consequently impair kidney function.

What Should Be Considered Before Surgery or Deep Sedation?

GLP-1 receptor agonists can delay gastric emptying. Before procedures involving general anesthesia or deep sedation, the treatment team should therefore be informed that orforglipron is being taken.

Orforglipron During Pregnancy and Breastfeeding

Special restrictions apply during pregnancy and breastfeeding.

The US prescribing information indicates a potential risk to the fetus. If pregnancy occurs, treatment should be discontinued.

Foundayo is not recommended during breastfeeding according to the US prescribing information.

Is There Already German Prescribing Information for Orforglipron?

No. There is currently no regularly approved German prescribing information for orforglipron. The information provided here is therefore based on international regulatory documents and published studies.

Medical Weight Loss – In-Person or Online.

Context & Differences

How Does Orforglipron Differ From Other Medications?

Like semaglutide, orforglipron is a GLP-1 receptor agonist. However, the two differ in molecular structure, administration, approval and dosage.

Key Differences With Orforglipron

Non-Peptide Active Ingredient

Orforglipron is a small molecule rather than a peptide-based GLP-1 active ingredient.

Flexible Oral Administration

The tablet can be taken regardless of meals and without a fixed amount of water.

Different Approval Status

Approved in the US and UK, but currently not routinely approved in Germany or the EU.

Orforglipron in Comparison

Orforglipron vs. Wegovy Pill

oral GLP-1 · different molecular structure

Both medications act through the GLP-1 receptor and are taken as tablets.

The Wegovy pill contains semaglutide, a peptide-based active ingredient. Orforglipron, by contrast, is a non-peptide small molecule.

Their administration requirements also differ: in approved markets, orforglipron can be taken without specific requirements regarding meals or the amount of water.

Orforglipron vs. Rybelsus

two oral GLP-1 medications

Rybelsus contains semaglutide and is approved for the treatment of type 2 diabetes.

Rybelsus has specific requirements regarding fasting and the amount of water used for administration. Orforglipron does not require these restrictions in its approved markets.

Orforglipron vs. Wegovy Injection

daily tablet vs. weekly injection

Wegovy as an injection contains semaglutide and is administered subcutaneously once weekly.

Orforglipron, by contrast, is taken orally once daily.

Orforglipron vs. Mounjaro

GLP-1 vs. GIP + GLP-1

Orforglipron activates the GLP-1 receptor. Mounjaro contains tirzepatide and activates both GIP and GLP-1 receptors.

Mounjaro is already approved in the EU for weight management. Orforglipron currently is not.

Frequently Asked Questions

More Questions About Orforglipron

Is Orforglipron Approved in Germany?

No. Orforglipron currently does not have regular EU marketing authorisation for Germany or the European Union.

Is Orforglipron Already Approved Anywhere?

Yes. In the United States, orforglipron was approved under the brand name Foundayo on April 1, 2026 for long-term weight management.

In the United Kingdom, it was approved on August 10, 2026 for weight management and type 2 diabetes.

Does The Body Clinic Offer Orforglipron?

No. Orforglipron is currently not available or offered by The Body Clinic.

Does Orforglipron Have to Be Taken on an Empty Stomach?

In approved markets, Foundayo can be taken once daily with or without food. There are no fixed requirements for the amount of water.

Is Orforglipron the Same as Rybelsus?

No. Both are oral GLP-1 receptor agonists, but they contain different active ingredients.

Rybelsus contains semaglutide. Orforglipron is a non-peptide active ingredient with a different molecular structure.

How Much Weight Loss Was Observed With Orforglipron?

In the Phase 3 ATTAIN-1 trial, mean body-weight change after 72 weeks was −11.2% at the highest dose studied, compared with −2.1% with placebo.

Study results are averages from defined patient populations and are not an individual prediction of treatment outcomes.

Medical Sources

Sources on Orforglipron

  1. U.S. Food and Drug Administration (FDA). FDA Approves First New Molecular Entity Under National Priority Voucher Program. Official FDA announcement on the approval of Foundayo (orforglipron) dated April 1, 2026. View the FDA approval announcement.
  2. U.S. Food and Drug Administration. Foundayo (orforglipron) – Prescribing Information. Official US prescribing information covering indication, dosage, adverse reactions, warnings, drug interactions and pregnancy. View the FDA prescribing information.
  3. Medicines and Healthcare products Regulatory Agency (MHRA). UK first in Europe to authorise orforglipron for weight management and type 2 diabetes. Official UK approval announcement dated August 10, 2026. View the MHRA approval announcement.
  4. Wharton S., Blevins T., Connery L. et al. Daily Oral GLP-1 Receptor Agonist Orforglipron for Adults with Obesity. New England Journal of Medicine. 2023;389:877–888. DOI: 10.1056/NEJMoa2302392. Peer-reviewed Phase 2 trial. View the Phase 2 trial.
  5. Wharton S. et al. Orforglipron, an Oral Small-Molecule GLP-1 Receptor Agonist for Obesity Treatment. New England Journal of Medicine. 2025;393:1796–1806. DOI: 10.1056/NEJMoa2511774. Peer-reviewed Phase 3 ATTAIN-1 trial. View ATTAIN-1.
  6. Horn D. B., Ryan D. H., Giljanovic Kis S. et al. Orforglipron, an oral small-molecule GLP-1 receptor agonist, for the treatment of obesity in people with type 2 diabetes (ATTAIN-2): a phase 3, double-blind, randomised, multicentre, placebo-controlled trial. The Lancet. DOI: 10.1016/S0140-6736(25)02165-8. Peer-reviewed Phase 3 trial in adults with type 2 diabetes. View ATTAIN-2.
  7. European Commission. Union Register of medicinal products. Official register of medicinal products authorised through the European Union's centralised procedure. View the EU Union Register.
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