# Foundayo gets an EMA green light, but what comes next - facts

Canonical page: https://www.preppinpeppers.com/blogs/the-lab/foundayo-gets-an-ema-green-light-but-comes-next
Type: Lab article

## TL;DR

On 15 October 2026 EMA's medicines committee (the CHMP) recommended authorising Foundayo (orforglipron) for type 2 diabetes and weight management; the

## Facts Index

| Fact ID | Category | Entity | Attribute | Value | Source | Evidence |
|---|---|---|---|---|---|---|
| foundayo-gets-an-ema-green-light-but-comes-next:title | identity | Foundayo gets an EMA green light, but what comes next | title | Foundayo gets an EMA green light, but what comes next | Lab article (https://www.preppinpeppers.com/blogs/the-lab/foundayo-gets-an-ema-green-light-but-comes-next) | https://www.preppinpeppers.com/blogs/the-lab/foundayo-gets-an-ema-green-light-but-comes-next |
| foundayo-gets-an-ema-green-light-but-comes-next:published | identity | Foundayo gets an EMA green light, but what comes next | published | 2026-10-19 | Lab article (https://www.preppinpeppers.com/blogs/the-lab/foundayo-gets-an-ema-green-light-but-comes-next) | https://www.preppinpeppers.com/blogs/the-lab/foundayo-gets-an-ema-green-light-but-comes-next |
| foundayo-gets-an-ema-green-light-but-comes-next:author | identity | Foundayo gets an EMA green light, but what comes next | author | PreppinPeppers Editorial Team | Lab article (https://www.preppinpeppers.com/blogs/the-lab/foundayo-gets-an-ema-green-light-but-comes-next) | https://www.preppinpeppers.com/blogs/the-lab/foundayo-gets-an-ema-green-light-but-comes-next |
| foundayo-gets-an-ema-green-light-but-comes-next:topics | identity | Foundayo gets an EMA green light, but what comes next | topics | News, peptide news, research news | Lab article (https://www.preppinpeppers.com/blogs/the-lab/foundayo-gets-an-ema-green-light-but-comes-next) | https://www.preppinpeppers.com/blogs/the-lab/foundayo-gets-an-ema-green-light-but-comes-next |
| foundayo-gets-an-ema-green-light-but-comes-next:summary | content | Foundayo gets an EMA green light, but what comes next | summary | On 15 October 2026 EMA's medicines committee (the CHMP) recommended authorising Foundayo (orforglipron) for type 2 diabetes and weight management; the | Lab article (https://www.preppinpeppers.com/blogs/the-lab/foundayo-gets-an-ema-green-light-but-comes-next) | https://www.preppinpeppers.com/blogs/the-lab/foundayo-gets-an-ema-green-light-but-comes-next |
| foundayo-gets-an-ema-green-light-but-comes-next:section-1 | content | Foundayo gets an EMA green light, but what comes next | section | What did EMA's medicines committee recommend for Foundayo? | Lab article (https://www.preppinpeppers.com/blogs/the-lab/foundayo-gets-an-ema-green-light-but-comes-next) | https://www.preppinpeppers.com/blogs/the-lab/foundayo-gets-an-ema-green-light-but-comes-next |
| foundayo-gets-an-ema-green-light-but-comes-next:section-2 | content | Foundayo gets an EMA green light, but what comes next | section | What is confirmed, and what is still open? | Lab article (https://www.preppinpeppers.com/blogs/the-lab/foundayo-gets-an-ema-green-light-but-comes-next) | https://www.preppinpeppers.com/blogs/the-lab/foundayo-gets-an-ema-green-light-but-comes-next |
| foundayo-gets-an-ema-green-light-but-comes-next:section-3 | content | Foundayo gets an EMA green light, but what comes next | section | What does the published trial data show? | Lab article (https://www.preppinpeppers.com/blogs/the-lab/foundayo-gets-an-ema-green-light-but-comes-next) | https://www.preppinpeppers.com/blogs/the-lab/foundayo-gets-an-ema-green-light-but-comes-next |
| foundayo-gets-an-ema-green-light-but-comes-next:section-4 | content | Foundayo gets an EMA green light, but what comes next | section | What do people get wrong about this news, and what are the documented risks of untested product? | Lab article (https://www.preppinpeppers.com/blogs/the-lab/foundayo-gets-an-ema-green-light-but-comes-next) | https://www.preppinpeppers.com/blogs/the-lab/foundayo-gets-an-ema-green-light-but-comes-next |
| foundayo-gets-an-ema-green-light-but-comes-next:product-gansulin-metal-peptide-pen | products | Foundayo gets an EMA green light, but what comes next | references product | Gansulin Pen · Reusable Click-Dial, 3 ml (1-60 Units) | Lab article (https://www.preppinpeppers.com/blogs/the-lab/foundayo-gets-an-ema-green-light-but-comes-next) | https://www.preppinpeppers.com/products/gansulin-metal-peptide-pen |
| foundayo-gets-an-ema-green-light-but-comes-next:product-gansulin-3ml-cartridge | products | Foundayo gets an EMA green light, but what comes next | references product | Gansulin-Compatible 3 ml Glass Cartridge for Pens (10-Pack) | Lab article (https://www.preppinpeppers.com/blogs/the-lab/foundayo-gets-an-ema-green-light-but-comes-next) | https://www.preppinpeppers.com/products/gansulin-3ml-cartridge |
| foundayo-gets-an-ema-green-light-but-comes-next:product-bacteriostatic-water-30ml | products | Foundayo gets an EMA green light, but what comes next | references product | Bacteriostatic Water 30 ml Multi-Dose Vial (Pfizer Hospira, USP) | Lab article (https://www.preppinpeppers.com/blogs/the-lab/foundayo-gets-an-ema-green-light-but-comes-next) | https://www.preppinpeppers.com/products/bacteriostatic-water-30ml |
| foundayo-gets-an-ema-green-light-but-comes-next:source-pubmed-ncbi-nlm-nih-gov | source | Foundayo gets an EMA green light, but what comes next | cites | Liu et al., Am J Manag Care 2025: Navigating compounded semaglutide: what health care providers need to know - pubmed.ncbi.nlm.nih.gov | Lab article (https://www.preppinpeppers.com/blogs/the-lab/foundayo-gets-an-ema-green-light-but-comes-next) | https://pubmed.ncbi.nlm.nih.gov/40966636/ |
| foundayo-gets-an-ema-green-light-but-comes-next:source-pubmed-ncbi-nlm-nih-gov-2 | source | Foundayo gets an EMA green light, but what comes next | cites | Wharton et al., N Engl J Med 2025: Orforglipron, an Oral Small-Molecule GLP-1 Receptor Agonist for Obesity Treatment - pubmed.ncbi.nlm.nih.gov | Lab article (https://www.preppinpeppers.com/blogs/the-lab/foundayo-gets-an-ema-green-light-but-comes-next) | https://pubmed.ncbi.nlm.nih.gov/40960239/ |
| foundayo-gets-an-ema-green-light-but-comes-next:source-pubmed-ncbi-nlm-nih-gov-3 | source | Foundayo gets an EMA green light, but what comes next | cites | McCall et al., Expert Opin Drug Saf 2026: Safety analysis of compounded GLP-1 receptor agonists: a pharmacovigilance study using the FDA adverse event reporting system - pubmed.ncbi.nlm.nih.gov | Lab article (https://www.preppinpeppers.com/blogs/the-lab/foundayo-gets-an-ema-green-light-but-comes-next) | https://pubmed.ncbi.nlm.nih.gov/40285721/ |
| foundayo-gets-an-ema-green-light-but-comes-next:source-pubchem-ncbi-nlm-nih-gov | source | Foundayo gets an EMA green light, but what comes next | cites | NCBI PubChem CID 137319706: Orforglipron (C48H48F2N10O5) - pubchem.ncbi.nlm.nih.gov | Lab article (https://www.preppinpeppers.com/blogs/the-lab/foundayo-gets-an-ema-green-light-but-comes-next) | https://pubchem.ncbi.nlm.nih.gov/compound/137319706 |
| foundayo-gets-an-ema-green-light-but-comes-next:source-www-ema-europa-eu | source | Foundayo gets an EMA green light, but what comes next | cites | European Medicines Agency (EMA): Foundayo - medicine overview (CHMP opinion) (retrieved 2026-10-19) - www.ema.europa.eu | Lab article (https://www.preppinpeppers.com/blogs/the-lab/foundayo-gets-an-ema-green-light-but-comes-next) | https://www.ema.europa.eu/en/medicines/human/EPAR/foundayo |
| foundayo-gets-an-ema-green-light-but-comes-next:source-www-ema-europa-eu-2 | source | Foundayo gets an EMA green light, but what comes next | cites | European Medicines Agency (EMA): New oral GLP-1 medicine for weight management and type 2 diabetes (retrieved 2026-10-19) - www.ema.europa.eu | Lab article (https://www.preppinpeppers.com/blogs/the-lab/foundayo-gets-an-ema-green-light-but-comes-next) | https://www.ema.europa.eu/en/news/new-oral-glp-1-medicine-weight-management-type-2-diabetes |

## FAQ

### What did EMA recommend for Foundayo?

EMA said the CHMP adopted a positive opinion on 15 October 2026, recommending a marketing authorisation for Foundayo (orforglipron) for type 2 diabetes and for weight management.

### Is Foundayo approved in the EU yet?

EMA's overview says the summary of product characteristics will be published after the European Commission grants the marketing authorisation. The committee opinion is a recommendation, not the grant.

### What is orforglipron?

EMA describes the active substance as a small, non-peptide molecule that activates the GLP-1 receptor. PubChem lists its formula as C48H48F2N10O5 and its molecular weight as 883.0.

### Who is the applicant for Foundayo?

According to EMA's medicine overview, the applicant is Eli Lilly Nederland B.V.

### What side effects does EMA list for Foundayo?

EMA's overview says the most common side effects are gastrointestinal, such as nausea, vomiting and diarrhoea.

### What did the phase 3 orforglipron trial examine?

Wharton and colleagues (NEJM, 2025) ran a randomized, double-blind trial over 72 weeks in adults with obesity without diabetes. The primary end point was percent change in body weight from baseline.

### Do adverse-event reports show a product caused harm?

No. A report records that an event was mentioned alongside a product. It does not prove the product caused the event.

### Is orforglipron a peptide?

No. EMA calls it a small, non-peptide molecule, and the 2025 NEJM abstract describes it as nonpeptide.

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