MEDISEARCHER NEWS
European Union · Weight management and type 2 diabetes · 17 October 2026
In brief
- The European Medicines Agency’s human medicines committee has recommended EU marketing authorisation for Foundayo (orforglipron), a once-daily oral GLP-1 medicine for weight management and type 2 diabetes.
- Foundayo is a tablet rather than an injection and can be taken at any time of day, with or without food.
- In weight-management studies, people taking Foundayo lost around 5% to 11% of their body weight after 72 weeks, depending on the dose, compared with around 2% to 2.5% with placebo.
- Across four main type 2 diabetes studies, Foundayo reduced HbA1c by around 1.2 to 1.9 percentage points, depending on dose.
- The positive CHMP opinion is not yet an EU marketing authorisation. The European Commission must make the final authorisation decision.
- Even after EU authorisation, pricing, reimbursement and routine access will be decided separately by individual EU member states.
A once-daily oral GLP-1 medicine for both weight management and type 2 diabetes has moved a major step closer to becoming available across the European Union.
On 15 October 2026, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending marketing authorisation for Foundayo (orforglipron).
Unlike many of the GLP-1 medicines that have transformed obesity and diabetes treatment, Foundayo is taken as a tablet rather than an injection.
The medicine can be taken once daily at any time of day, with or without food, according to the EMA. If authorised, it would provide another oral option within a treatment area currently dominated by injectable medicines.
However, the regulatory process is not complete. The CHMP recommendation will now be sent to the European Commission, which must decide whether to grant an EU-wide marketing authorisation.
What is Foundayo?
Foundayo is the proposed European brand name for orforglipron, a glucagon-like peptide-1 receptor agonist, commonly known as a GLP-1 receptor agonist.
Orforglipron differs structurally from peptide-based GLP-1 medicines. It is a small, non-peptide molecule designed to activate the GLP-1 receptor while being suitable for oral administration.
GLP-1 is a naturally occurring hormone involved in appetite and blood-glucose regulation.
By activating GLP-1 receptors, orforglipron can reduce appetite and increase feelings of fullness, helping people consume less food and lose weight. It also affects blood-glucose regulation by increasing insulin release when glucose levels are elevated, reducing glucagon and improving the body’s response to insulin.
The EMA says Foundayo will be available in several tablet strengths if authorised, with treatment beginning at a low dose and gradually increasing according to response and tolerability.
What has the EMA recommended Foundayo for?
The CHMP has recommended Foundayo for two major indications: weight management and type 2 diabetes.
For weight management, the proposed indication covers adults with:
- a body mass index (BMI) of 30 kg/m² or higher, classified as obesity; or
- a BMI of 27 kg/m² to below 30 kg/m², classified as overweight, together with at least one weight-related health condition.
Examples of weight-related conditions listed by the EMA include prediabetes or type 2 diabetes, high blood pressure, abnormal blood lipid levels, obstructive sleep apnoea and cardiovascular disease.
Foundayo would be used alongside a healthy diet and physical activity for weight loss and weight maintenance.
For type 2 diabetes, the proposed indication covers adults whose blood glucose is not adequately controlled through diet and physical activity.
The medicine could be used alone when metformin is considered inappropriate or together with other diabetes medicines.
How effective is Foundayo for weight loss?
The EMA’s recommendation for weight management is based on two studies involving approximately 4,740 adults with obesity or overweight.
One study involved adults without type 2 diabetes who had another weight-related health condition, while the second involved people with type 2 diabetes.
After 72 weeks, people treated with Foundayo lost approximately 5% to 11% of their body weight, depending on the dose they received.
Participants receiving placebo lost approximately 2% to 2.5% over the same period.
One of the pivotal Phase 3 studies, ATTAIN-1, enrolled more than 3,100 adults with obesity but without diabetes. Results published in the New England Journal of Medicine showed average weight reductions of 7.5%, 8.4% and 11.2% with the three studied orforglipron doses after 72 weeks, compared with 2.1% with placebo.
At the highest dose in that trial, more than half of participants lost at least 10% of their body weight, while more than one-third lost at least 15%.
How effective is Foundayo for type 2 diabetes?
For type 2 diabetes, Foundayo was evaluated in four main studies involving approximately 3,765 adults whose blood glucose was not adequately controlled through diet and physical activity alone or together with other diabetes medicines.
The studies evaluated orforglipron alone or in combination with other treatments and compared it with placebo, dapagliflozin or oral semaglutide.
The principal measure was the change in HbA1c, which reflects average blood-glucose levels over time.
Across the studies, Foundayo reduced HbA1c by approximately 1.2 to 1.9 percentage points, depending on dose.
For comparison, the EMA reports reductions of approximately 0.4 to 0.8 percentage points with placebo, 0.8 percentage points with dapagliflozin 10 mg and 1.2 to 1.5 percentage points with the studied doses of oral semaglutide.
Why is an oral GLP-1 important?
The rapid expansion of GLP-1-based treatment has been driven largely by injectable medicines used for type 2 diabetes and, increasingly, obesity.
A once-daily tablet could offer another option for patients who prefer not to use injections or for whom an oral medicine is otherwise more practical.
Foundayo also differs from peptide-based oral GLP-1 medicines because orforglipron is a small, non-peptide molecule.
According to the EMA, Foundayo can be taken at any time of day, with or without food.
That convenience could become an important factor in how oral GLP-1 medicines compete with established injectable treatments, although treatment choice will ultimately depend on factors including effectiveness, side effects, individual medical circumstances, availability and cost.
What are the side effects of Foundayo?
The most commonly reported side effects with Foundayo are gastrointestinal, particularly:
- nausea;
- vomiting; and
- diarrhoea.
The EMA says these effects occurred more frequently while doses were being increased and generally became less frequent over time.
Gastrointestinal adverse effects are also commonly associated with other medicines that activate GLP-1 receptors.
If Foundayo receives EU marketing authorisation, detailed prescribing information, contraindications, warnings and precautions will be published in the medicine’s official European product information.
Is Foundayo approved in the European Union?
Not yet.
The CHMP adopted a positive opinion for Foundayo on 15 October 2026, recommending that the medicine receive an EU marketing authorisation.
A positive CHMP opinion is one of the final major scientific steps in the European Union’s centralised medicine approval process, but it is not itself a marketing authorisation.
The recommendation now goes to the European Commission, which will decide whether to grant an authorisation valid across EU member states.
MediSearcher’s EU medicine access guide explains the wider European framework for medicine regulation, prescriptions and access across member states.
When could Foundayo become available in Europe?
There are two different questions involved: when Foundayo receives EU regulatory authorisation and when patients can actually obtain it within individual countries.
The first step is the European Commission decision on marketing authorisation.
If the Commission grants authorisation, Foundayo can then legally be marketed for its authorised indications across the European Union.
That does not mean that the medicine will immediately become routinely available or reimbursed in every EU country.
Pricing and reimbursement decisions are generally made nationally. Individual countries may conduct their own health-technology assessments, price negotiations and reimbursement decisions before a new medicine becomes widely available through public healthcare systems.
MediSearcher’s guide to prescription costs and reimbursement across the EU explains why access and patient costs can differ between member states even after a medicine receives EU-wide marketing authorisation.
Will Foundayo be available in Germany, France, Italy, Spain and other EU countries?
If the European Commission grants a centralised marketing authorisation, that authorisation will apply across EU member states.
Actual patient access can nevertheless develop at different speeds.
Countries including Germany, France, Italy, Spain, the Netherlands, Ireland, Sweden, Poland and Malta operate different systems for medicine pricing, reimbursement and health-technology assessment.
A medicine may therefore be authorised at EU level while reimbursement negotiations are complete in one country, still under assessment in another, or initially available only through private prescriptions elsewhere.
The timing of commercial launches can also differ between countries.
For patients, the European Commission’s eventual authorisation decision will therefore be an important milestone, but national pricing and reimbursement announcements will provide a better indication of when Foundayo becomes routinely accessible in a particular country.
How does Foundayo compare with injectable GLP-1 medicines?
Foundayo belongs to the same broad GLP-1 treatment class as several established medicines but should not be assumed to be directly interchangeable with them.
Different GLP-1 medicines use different active substances, doses, dosing schedules and delivery methods, and some have different authorised indications.
Orforglipron’s most obvious practical difference is that it is a once-daily tablet.
The weight loss observed in the Foundayo clinical programme is clinically significant, but headline percentages from separate trials should not be treated as direct comparisons between medicines because study populations and trial designs can differ.
Treatment decisions should therefore be based on the authorised product information and individual clinical circumstances rather than comparisons of isolated trial results.
Can Foundayo be bought online in the EU yet?
No legitimate EU pharmacy should currently be selling Foundayo as an EU-authorised prescription medicine on the basis of the CHMP recommendation alone.
The European Commission has not yet granted the EU marketing authorisation.
Even after authorisation, Foundayo will be a prescription medicine and will remain subject to national prescribing, pharmacy and reimbursement rules.
Consumers should be particularly cautious about websites or social-media sellers claiming to provide medicines before they have become legitimately available in the relevant country.
MediSearcher’s guide to checking online pharmacies in the EU explains how European pharmacy verification systems work and what consumers should check before ordering medicines online.
What happens next for Foundayo in Europe?
The immediate next step is a decision from the European Commission on whether to grant Foundayo an EU-wide marketing authorisation.
If authorisation is granted, attention will then shift toward commercial launch plans and national decisions concerning pricing and reimbursement.
Those national decisions will ultimately determine how quickly patients can routinely obtain Foundayo and how much they may have to pay.
The arrival of another oral GLP-1 option could also affect an increasingly competitive European market for obesity and diabetes medicines, particularly if oral treatment expands the number of patients willing or able to use GLP-1 therapy.
MediSearcher will update this article when the European Commission announces its decision and as significant pricing, reimbursement or launch decisions emerge across EU member states.
Reviewed by: Dr Mattias Hagman, PhD
Editorial review: This article was reviewed for source accuracy, medicine-regulation context and consistency with MediSearcher’s editorial standards. Information about Foundayo’s regulatory status, proposed indications, clinical evidence, dosing and side effects was checked against European Medicines Agency information and published Phase 3 clinical-trial evidence. The distinction between a positive CHMP opinion, European Commission marketing authorisation and subsequent national pricing and reimbursement decisions has been preserved throughout.
Last reviewed: 17 October 2026
Sources and verification
MediSearcher reviewed the following primary and authoritative sources when preparing this article:
- European Medicines Agency: new oral GLP-1 medicine for weight management and type 2 diabetes, published 16 October 2026
- European Medicines Agency: Foundayo (orforglipron) European Public Assessment Report and CHMP positive opinion
- European Medicines Agency: CHMP meeting highlights, 12–15 October 2026
- New England Journal of Medicine: Phase 3 ATTAIN-1 trial of oral orforglipron in adults with obesity
MediSearcher provides general information about medicines, medicine regulation and healthcare access. Foundayo (orforglipron) has received a positive opinion from the EMA’s Committee for Medicinal Products for Human Use but, as of 17 October 2026, has not yet received an EU marketing authorisation from the European Commission. Availability, pricing and reimbursement may differ between countries following authorisation. This article does not provide personal medical advice. Decisions about treatment should be made with an appropriately qualified healthcare professional.