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Orforglipron: First Approval

delete2026-07-21
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Matt Shirley *
DOI:10.1007/s40265-026-02363-5delete
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Abstract

Abstract

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Orforglipron (Foundayo™) is an orally administered, non-peptide glucagon-like peptide-1 (GLP-1) receptor agonist being developed by Eli Lilly and Co. for use in long-term weight management and for the treatment of type 2 diabetes (T2D) among other indications. In April 2026, orforglipron received its first approval, in the USA, for use in combination with a reduced-calorie diet and increased physical activity for long-term weight management in adults with obesity or adults with overweight in the presence of one or more weight-related comorbid condition. Orforglipron has also been submitted for regulatory review in the EU for long-term weight management and T2D, in Japan for long-term weight management, and in Canada for T2D. In addition to long-term weight management and T2D treatment, orforglipron is currently under phase III clinical evaluation for use in the treatment of obstructive sleep apnoea, hypertension, stress urinary incontinence in females, osteoarthritis pain and peripheral arterial disease. This article summarises the milestones in the development of orforglipron leading to this first approval for long-term weight management in adults with obesity or overweight.

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