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Eli Lilly Anticipates Orforglipron Approval for Weight Loss by Early 2026

• Eli Lilly projects its oral weight loss drug, orforglipron, could gain approval as early as 2026, according to CEO David Ricks. • Late-stage trial data for orforglipron is expected by mid-2025, potentially paving the way for regulatory clearance shortly thereafter. • Orforglipron, if approved, would provide a convenient pill alternative to injectable weight loss treatments like Zepbound and Wegovy. • Mid-stage trials demonstrated that orforglipron led to an average weight loss of 14.7% compared to 2.3% with placebo.

Eli Lilly anticipates its investigational oral weight loss drug, orforglipron, may receive regulatory approval as early as 2026. CEO David Ricks shared this projection during an interview with Bloomberg TV at the JPMorgan Healthcare Conference. The company expects to release pivotal late-stage trial data for orforglipron by mid-2025, potentially leading to an expedited approval process.

Potential Impact on Weight Management

Orforglipron is designed to compete with the increasingly popular injectable weight loss medications such as Eli Lilly's own Zepbound and Novo Nordisk's Wegovy. If approved, orforglipron would offer a more convenient oral administration route, potentially improving patient adherence and access. Ricks also noted that an oral formulation could alleviate some of the manufacturing challenges associated with injectable drugs, which have faced supply constraints due to high demand.

Promising Mid-Stage Trial Results

Data from mid-stage clinical trials have shown promising results for orforglipron. Participants taking the drug experienced an average weight loss of 14.7% of their body weight, compared to a 2.3% weight loss in the placebo group. These findings suggest that orforglipron could be a potent therapeutic option for individuals struggling with obesity or overweight.

The Obesity Treatment Landscape

The current treatment landscape for obesity is rapidly evolving, with GLP-1 receptor agonists leading the way. However, the availability of an effective oral therapy could significantly expand access to treatment and improve patient outcomes. The convenience of a daily pill may appeal to a broader range of individuals seeking medical weight management solutions.
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Reference News

[1]
Eli Lilly CEO tells Bloomberg TV company sees weight loss pill approval in 2026
markets.businessinsider.com · Jan 13, 2025

Eli Lilly anticipates its weight loss pill, orforglipron, could gain approval by early next year, with data expected by ...

[2]
New weight loss pill to be approved by early 2026: Eli Lilly
beckershospitalreview.com · Jan 14, 2025

Eli Lilly anticipates FDA approval for its weight loss pill, orforglipron, by next year, with late-stage trial data expe...

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