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Pipelineorforglipron › Foundayo

Foundayo

Foundayo is a brand of orforglipron from Eli Lilly, first approved by the FDA on 2026-04-01 under application NDA220934, not separately authorised in the European Union under this name, with no open FDA supply records.

Foundayo is Eli Lilly's brand of orforglipron, approved under NDA220934. Its current FDA label, effective 2026-07-29, covers obesity. Nothing under this name is currently on the FDA shortage list.

Active ingredient
orforglipron
Sponsor
Eli Lilly
FDA applications
NDA220934
First FDA action
2026-04-01
Most recent FDA action
2026-08-04
FDA actions on file
2
EU authorisation
Not under this name
Active trials of orforglipron
19

Approved indications

Quoted from the current FDA label for each application. This is what the drug is approved to treat in the US — separate from the conditions it is being studied in.

Foundayo NDA220934
label effective 2026-07-29 · full label

FOUNDAYO TM is indicated in combination with a reduced-calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long term in adults with obesity or adults with overweight in the presence of at least one weight-related comorbid condition. FOUNDAYO™ is a GLP-1 receptor agonist indicated in combination with a reduced-calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long term in adults with obesity or adults with overweight in the presence of at least one weight-related comorbid condition. ( 1 ) Limitations of Use Concomitant use with another GLP-1 receptor agonist is not recommended. ( 1 ) Limitations of Use Concomitant use with another GLP-1 receptor agonist is not recommended.

FDA record

Every approved submission filed under this brand, newest first, from Drugs@FDA: original approval, efficacy supplements, labeling changes and manufacturing updates. New safety language usually arrives in a labeling supplement.

DateActionApplication
2026-08-04LabelingNDA220934 · label
2026-04-01Type 1 - New Molecular Entity originalNDA220934 · label

For the molecule behind this brand — every trial, every indication under study and the full research record — see orforglipron.