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Eli Lilly’s Oral Weight-Loss Pill Could Gain FDA Approval by 2026

by Daisy

Eli Lilly & Co. is making strides in developing an oral weight-loss medication as a viable alternative to its injectable products. The new oral medication, orforglipron, is a nonpeptide GLP-1 receptor agonist designed for once-daily use and could potentially be approved by the FDA as early as 2026, according to CEO Dave Ricks. This development comes as a solution for individuals hesitant about injectable treatments, which have gained significant popularity for weight management.

Orforglipron has shown promising results in clinical trials, with participants experiencing notable weight loss. In a Phase 2 trial published in 2023, adults with obesity or overweight lost an average of 8.6% to 12.6% of their body weight after 26 weeks of taking the medication, compared to only a 2% loss in the placebo group. Over a 36-week period, the weight loss was even more significant, with patients on orforglipron losing between 9.4% to 14.7% of their body weight.

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Additionally, orforglipron has demonstrated positive outcomes in managing Type 2 diabetes. In a separate Phase 2 trial, the medication helped reduce A1C levels by an average of 2.1%, compared to 0.4% for the placebo group. These results highlight orforglipron’s potential as both a weight-loss and diabetes management drug.

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The development of orforglipron is part of a broader competition among pharmaceutical companies to create effective oral weight-loss medications. Eli Lilly’s rival, Novo Nordisk, has already launched oral semaglutide (Rybelsus) for Type 2 diabetes and is conducting trials for its weight-loss application. Meanwhile, Pfizer is advancing its own oral GLP-1 receptor agonist, danuglipron, and other companies are exploring similar therapies.

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Ricks emphasized that the oral form of orforglipron could reach more patients globally, with the pill’s production potentially scaling more easily than injectables. While he did not discuss pricing, he noted that Lilly’s goal is to make the medication accessible to a broad audience.

As the obesity drug market continues to expand, with projections reaching over $100 billion by 2030, the race to develop effective, convenient oral treatments remains highly competitive.

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