The Saudi Food and Drug Authority (SFDA) has approved the registration of Foundayo (orforglipron) to help reduce excess body weight and maintain long-term weight loss in adults with obesity, or adults who are overweight accompanied by at least one weight-related comorbid condition. It is used as an adjunct to a healthy diet and physical activity.

Innovative Mechanism of Action

Foundayo works by activating natural receptors in the body called glucagon-like peptide-1 (GLP-1) receptors that help regulate appetite and blood sugar levels. As a result, it helps reduce appetite and food intake, supporting weight loss and long-term weight maintenance when used alongside a healthy diet and regular physical activity. Foundayo is taken orally once daily

Positive Results Demonstrated in Clinical Studies

The SFDA clarified that approval of the product followed a comprehensive evaluation of its efficacy, safety, and quality, based on the totality of evidence submitted in the registration dossier. Clinical studies demonstrated that Foundayo produced statistically significant and clinically meaningful reductions in body weight in adults with obesity, or adults who are overweight with at least one weight-related comorbid condition, across two pivotal Phase 3 clinical trials conducted over 72 weeks.

ATTAIN-1 trial included 3,127 adults with obesity without diabetes. The highest evaluated dose of Foundayo (36 mg) resulted in a mean body weight reduction of 11.2% from baseline, compared to 2.1% in the placebo group. Meanwhile, ATTAIN-2 trial included 1,613 adults with obesity and type 2 diabetes, where a Foundayo (36 mg) dose resulted in a mean body weight reduction of 9.6% from baseline, compared to 2.5% in the placebo group.

Most Common Side Effects

The SFDA noted that the most common adverse reactions observed in clinical studies included gastrointestinal disorders such as nausea, constipation, diarrhea, vomiting, dyspepsia, and abdominal pain, in addition to abdominal distension, hair loss, and fatigue. Most gastrointestinal disorders were mild to moderate in severity, occurring mostly during the dose escalation period and decreasing over time.

The SFDA emphasizes that the use of Foundayo is contraindicated in patients with a personal or family history of certain types of thyroid tumors or associated genetic syndromes, highlighting the necessity of using it under medical supervision with regular follow-up throughout the treatment period.

A New Step Toward Enhancing the Quality of Healthcare

This approval reflects the SFDA’s continued commitment to innovation and expanding access to advanced treatment options, thereby enhancing the quality of healthcare in alignment with the goals of the Health Sector Transformation Program, one of the key initiatives of Saudi Vision 2030.