Foundayo Manufacturer: Who Discovered It, Who Makes It, and Why It Matters
- Clear, sourced facts on Eli Lilly's role as the UK licence holder and manufacturer of Foundayo
- The full story of how orforglipron was discovered by Chugai Pharmaceutical and licensed to Lilly in 2018
- Where UK packs are made, taken directly from the official UK patient leaflet
- Online consultation with UK-registered prescribers if you want to talk about treatment
Foundayo is an Eli Lilly medicine. Lilly holds the worldwide development and commercialisation rights to orforglipron and developed the medicine through clinical trials and regulatory submissions. In the UK, the marketing authorisation is held by Eli Lilly Nederland B.V., while the UK patient leaflet names manufacturing sites in Spain and Italy.
The fuller story begins before Lilly. Orforglipron was discovered by Chugai Pharmaceutical and was originally known as OWL833. In September 2018, Chugai licensed worldwide development and commercialisation rights to Lilly while the compound was preparing to enter Phase 1 clinical development.
Key things to know
- Eli Lilly develops, holds the licence for, and markets Foundayo in the UK.
- The active ingredient, orforglipron, was discovered by Chugai Pharmaceutical in Japan under the code name OWL833.
- Lilly licensed the compound from Chugai in September 2018 for a US$50 million upfront payment, plus milestones and royalties.
- Roche holds 59.89% of Chugai's outstanding shares.
- The UK leaflet names two manufacturing sites for UK packs, one in Spain and one in Italy.
- MHRA authorised Foundayo on 10 August 2026, making the UK the first country in Europe to do so.
Who Makes Foundayo? The Short Answer
If you want the company behind Foundayo, the answer is Eli Lilly. Lilly holds the worldwide development and commercialisation rights to orforglipron and markets Foundayo. In the UK, however, several Lilly entities have different legal roles: Eli Lilly Nederland B.V. is the marketing authorisation holder, Eli Lilly and Company Limited is the UK representative, and the UK leaflet names manufacturing sites operated by Lilly in Spain and Pfizer Italia in Italy.
Eli Lilly's Role: From Licensed Compound to Licensed Medicine
When Lilly licensed OWL833 from Chugai in 2018, the compound was preparing to enter Phase 1 clinical development. Lilly subsequently took responsibility for its clinical development and worldwide commercialisation. The company's development programme included studies in type 2 diabetes and obesity, followed by regulatory submissions in different markets.
The ACHIEVE programme evaluated orforglipron in adults with type 2 diabetes, while the ATTAIN programme evaluated it for weight management. These programmes generated clinical evidence that was subsequently assessed by regulators.
In the UK, MHRA authorised orforglipron on 10 August 2026 for weight management in eligible adults alongside a reduced-calorie diet and increased physical activity, and for improving glycaemic control in adults with insufficiently controlled type 2 diabetes.
Who holds the UK licence
The official UK patient information leaflet names the marketing authorisation holder as Eli Lilly Nederland B.V., based in Utrecht, the Netherlands. The marketing authorisation holder is the company legally responsible for the medicine: its quality, its safety monitoring, and the accuracy of its product information. For day-to-day enquiries, the leaflet names Eli Lilly and Company Limited as the local UK representative.
Where UK packs of Foundayo are manufactured
This is the question most online articles skip, and the UK leaflet answers it directly. It names two manufacturing sites responsible for UK supply:
- Lilly S.A., Alcobendas, Madrid, Spain
- Pfizer Italia S.r.l., Ascoli Piceno, Italy
The Spanish site is Lilly's own. The Italian site is operated by Pfizer Italia and is listed in the UK patient leaflet as a manufacturer of Foundayo. The marketing authorisation holder remains Eli Lilly Nederland B.V. Packs supplied in other countries may list different sites, so this information applies to UK packs specifically.
Company roles at a glance
| Company | Role in Foundayo's story |
|---|---|
| Chugai Pharmaceutical Co., Ltd. (Japan) | Discovered orforglipron (OWL833) and licensed it to Lilly in 2018 |
| Eli Lilly and Company (USA) | Worldwide development and commercialisation rights |
| Eli Lilly Nederland B.V. (Netherlands) | UK marketing authorisation holder |
| Lilly S.A. (Spain) | Manufacturing site named on the UK leaflet |
| Pfizer Italia S.r.l. (Italy) | Contract manufacturing site named on the UK leaflet |
| Eli Lilly and Company Limited (UK) | Local UK representative for enquiries |
Where Orforglipron Came From: Chugai Pharmaceutical
Orforglipron was discovered by Chugai Pharmaceutical Co., Ltd., a Tokyo-based company. During early research it was known as OWL833, and it was later given the development code LY3502970 once Lilly took it on. The name orforglipron is the international non-proprietary name for the active substance, and Foundayo is Lilly's brand name for the finished tablets.
Why Chugai's molecule was different
Many GLP-1 medicines, including injectable medicines such as Mounjaro and Wegovy, are peptide-based medicines. Peptides are made from chains of amino acids and are generally difficult to deliver effectively by mouth because they can be broken down in the digestive system and have limited absorption through the gut.
Chugai developed OWL833 as a small-molecule, non-peptide GLP-1 receptor agonist that could be administered orally. This was an important feature of the compound from the beginning: when Chugai and Lilly announced their 2018 licensing agreement, they specifically described OWL833 as an oral, non-peptide GLP-1 receptor agonist.
That is what distinguishes orforglipron from many injectable GLP-1 medicines. Foundayo is taken as a once-daily tablet. According to the UK patient leaflet, it can be taken at any time of day, with or without food, and swallowed with water. It does not require the fasting and post-dose waiting instructions associated with some other oral medicines.
The important point is not simply that orforglipron is “not a peptide”, but that it is a small-molecule GLP-1 receptor agonist specifically developed for oral use.
The 2018 Licensing Agreement Explained
Chugai and Lilly announced the agreement on 27 September 2018. Under its terms, Lilly received worldwide rights to develop and commercialise OWL833. At that stage the compound had not yet been tested in people; it was described as ready to enter phase 1 studies.
What Lilly paid, and what Chugai can still earn
Lilly's quarterly and annual filings with the US Securities and Exchange Commission set out the financial terms in more detail than the original press release.
| Element | Detail (from Eli Lilly's public filings) |
|---|---|
| Upfront payment | US$50 million, paid in 2018 |
| Regulatory milestones | Up to US$140 million, contingent on regulatory success |
| Sales milestones | Up to US$250 million, contingent on commercial success |
| Royalties | Tiered, from mid single digits to low teens as a percentage of worldwide net sales |
Two points are worth being precise about. The milestone figures are maximum potential payments tied to specified achievements; they should not be interpreted as amounts that Chugai has necessarily received. Lilly's June 2026 filing continues to describe the milestone payment rights as not material and confirms that Chugai receives tiered royalties on worldwide net sales.
Why the deal attracted attention
Chugai's relationship with Roche is an important context. Roche holds 59.89% of Chugai's shares, while Chugai retains management autonomy within the Roche Group. Orforglipron was licensed to Lilly rather than Roche in 2018. The published agreement provided for a $50 million upfront payment plus potential milestones and royalties.
Who Is Chugai Pharmaceutical?
Chugai is one of Japan's longest-established pharmaceutical companies. It was founded in Tokyo in 1925 by Juzo Ueno as Chugai Shinyaku, and took the name Chugai Pharmaceutical in 1943. Today it is known particularly for antibody engineering and for medicines in immunology and other specialist areas.
The Roche relationship
In 2002 Chugai entered a strategic alliance with Roche, and Roche now holds 59.89% of Chugai's shares. Despite that majority stake, Chugai remains listed on the Tokyo Stock Exchange and runs as an independently managed company within the Roche Group. The alliance gives Chugai rights to Roche medicines in Japan, while Roche has typically taken on Chugai's own discoveries internationally. Orforglipron stands out as a Chugai compound that went to a different global partner.
Who Is Eli Lilly?
Eli Lilly and Company was founded in 1876 in Indianapolis, Indiana, by Colonel Eli Lilly, a pharmacist and Civil War veteran. It remains headquartered in Indianapolis and is one of the largest pharmaceutical companies in the world.
A century of work in type 2 diabetes
Lilly's connection with diabetes and metabolic medicine goes back more than a hundred years. In 1923 it launched Iletin, the world's first commercially available insulin, after working with the University of Toronto researchers who had first isolated insulin. Lilly already had a substantial diabetes portfolio when it entered the 2018 agreement with Chugai. The agreement gave Lilly worldwide development and commercialisation rights to an oral GLP-1 receptor agonist that was then preparing to enter Phase 1 development.
Lilly's history also includes humanitarian work, such as funding and staffing a US Army base hospital in France with the American Red Cross during the First World War.
Lilly's wider portfolio today
Foundayo sits alongside Mounjaro (tirzepatide), Lilly's once-weekly injection for weight management and type 2 diabetes. Beyond metabolic medicine, Lilly markets treatments in immunology, migraine prevention and Alzheimer's disease, among other areas. Foundayo is therefore one product within a large and diversified company, not the output of a single-product business.
From Preclinical Compound to Approved Medicine: Clinical Trials Timeline
| Date | Milestone |
|---|---|
| September 2018 | Lilly licenses OWL833 from Chugai while it is still preclinical |
| From 2019 | Compound, now orforglipron, enters human studies under Lilly |
| 2023 to 2025 | ACHIEVE (type 2 diabetes) and ATTAIN (weight management) phase 3 programmes |
| 1 April 2026 | US approval for weight management, the first new molecular entity approved under the FDA's national priority voucher pilot, 50 days after filing |
| 10 August 2026 | MHRA grants UK marketing authorisation, the first in Europe, covering weight management and type 2 diabetes |
| August 2026 | UK Summary of Product Characteristics and patient leaflet published on the electronic medicines compendium |
| 18 November 2026 (expected) | NICE technology appraisal decision for orforglipron for managing overweight and obesity. |
The US and UK authorisations differ in their authorised uses. The initial US approval covered chronic weight management, while the UK authorisation also includes glycaemic control in adults with type 2 diabetes whose blood sugar is not adequately controlled.
In the UK, Foundayo was authorised by the Medicines and Healthcare products Regulatory Agency (MHRA) on 10 August 2026. The UK patient leaflet lists six tablet strengths: 0.8 mg, 2.5 mg, 5.5 mg, 9 mg, 14.5 mg and 17.2 mg.
Foundayo is taken once daily, and the dose is increased gradually according to the authorised dosing schedule. The UK product information specifies the minimum duration at each dose before an increase, so patients should follow the dosing schedule provided by their prescriber and the current patient information leaflet rather than changing the dose themselves.
Why Discovery and Commercialisation Often Split
The Chugai and Lilly arrangement is a very common pattern in the pharmaceutical industry. Discovering a promising molecule and turning it into a licensed medicine are very different jobs, with very different costs.
What matters for patients is the evidence generated during development and the regulator's assessment of the finished medicine, rather than whether the original molecule was discovered and developed by the same company.
Licensing lets each company play to its strengths. The discovering company receives a guaranteed upfront payment plus a share of future success, without carrying the full cost of failure. The licensing company gets access to science it did not invent, and takes on the risk in return for the larger share of the reward. Many well-known medicines reached patients this way; others, including Mounjaro, were discovered and developed within a single company. Neither route is safer or better than the other, because the evidence that matters to patients comes from the trials and the regulator's review, not from where the first molecule was made.
Does the Manufacturer Change Anything for You?
For most people, the answer is no. Your prescriber's decisions about whether Foundayo is suitable, which dose to start on, and how to increase it are based on the licensed product information and your own health, not on corporate history. That said, knowing who stands behind the medicine is genuinely useful in two practical ways.
Recognising a genuine UK pack
Because the UK leaflet describes each tablet in detail, you can check what you receive. Each strength has a specific colour, shape and marking: the three lower strengths are round tablets marked G1, G2 or G3 on one side and "L" on the other, and the three higher strengths are oval tablets marked G4, G5 or G6 on one side and "Lilly" on the other. Packs come in blister strips of 30 or 90 tablets, with an expiry date after "EXP" on both the carton and the blister, and should include the patient leaflet naming Eli Lilly Nederland B.V. as licence holder. Store the tablets in the original package, as the medicine is sensitive to light.
Foundayo is prescription-only in the UK. Products supplied outside a legitimate prescription and pharmacy pathway should be treated with caution.
Why the licence holder matters for safety reporting
Foundayo carries the black triangle because it is subject to additional monitoring. This means suspected adverse reactions are particularly important to report as regulators continue to gather safety information after authorisation. The marketing authorisation holder is responsible for collecting and assessing safety reports worldwide. You can help by reporting any suspected side effects through the MHRA Yellow Card scheme, online or through the Yellow Card app. With newly authorised medicines, the safety profile can continue to be characterised after launch. Every report adds to the picture regulators and Lilly use to keep the product information up to date.
Getting Foundayo Through a UK Pharmacy
Foundayo is prescription-only in the UK. A prescriber must assess whether it is appropriate for you, taking into account your medical history, other medicines and the authorised indication. Where remote prescribing is used, the service should operate through an appropriate UK regulatory framework and involve a suitably qualified prescriber.
EverydayMeds offers an online consultation for obesity care with UK-registered prescribers, giving you private, convenient access through remote prescribing without an in-person visit, which can be especially helpful for patients with mobility issues. Remote prescribing in the UK should be carried out through GPhC-regulated pharmacy services and UK-registered prescribers. They can explain whether Foundayo or another option is appropriate for you and answer questions about side effects, dosing and interactions.
