RIYADH — The Food and Drug Authority (SFDA) has approved the registration of Foundaio, a once-daily oral medication to support long-term weight loss and weight maintenance in adults with obesity or overweight accompanied by at least one weight-related medical condition.
The drug contains the active ingredient orforglipron and is intended to be used alongside a healthy diet and regular physical activity.
According to the SFDA, Foundaio works by activating glucagon-like peptide-1 (GLP-1) receptors, helping regulate appetite and blood sugar levels, reducing food intake and supporting sustained weight loss. Unlike many GLP-1 therapies, the medication is taken orally once a day.
The authority said the approval followed a comprehensive assessment of the drug’s safety, efficacy and quality, supported by evidence from two pivotal Phase 3 clinical trials conducted over 72 weeks.
The first trial involved 3,127 adults with obesity who did not have diabetes. Participants receiving the highest evaluated dose of 36 mg achieved an average body weight reduction of 11.2%, compared with 2.1% in the placebo group.
The second trial enrolled 1,613 adults with obesity and Type 2 diabetes. Patients receiving the 36 mg dose recorded an average weight reduction of 9.6%, compared with 2.5% in the placebo group.
The SFDA said the most common side effects observed during clinical trials were gastrointestinal symptoms, including nausea, constipation, diarrhea, vomiting, indigestion and abdominal pain. Other reported side effects included abdominal bloating, hair loss and fatigue. Most gastrointestinal effects were mild to moderate and occurred during dose escalation before gradually subsiding.
The authority advised that the medication must not be used by patients with a personal or family history of certain thyroid cancers or related hereditary syndromes and stressed that treatment should only be undertaken under medical supervision with regular follow-up.
Source: Saudi Gazette