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The Saudi Food and Drug Authority registered Foundaio for long-term weight management in adults with obesity or overweight plus at least one weight-related condition when combined with diet and physical activity. The medication contains orforglipron as its active ingredient and received the regulator’s green light following a full review of its quality, safety and efficacy data. Eli Lilly and Company developed the treatment which first secured approval from the US Food and Drug Administration in April according to a company press release issued at the time.
Foundaio activates glucagon-like peptide-1 receptors to regulate appetite and blood sugar while reducing food intake the SFDA explained. The authority highlighted that the drug is taken orally once daily unlike many other GLP-1 therapies that require injections. Regulators in the kingdom assessed evidence from two major Phase 3 clinical studies that ran for 72 weeks each before granting approval.
One trial enrolled 3,127 adults with obesity but without diabetes and found that the 36-milligram dose delivered an average weight reduction of 11.2 percent compared with 2.1 percent in the placebo group the SFDA reported. A parallel study of 1,613 adults who had both obesity and Type 2 diabetes showed average weight loss of 9.6 percent at the highest dose versus 2.5 percent for placebo. The authority said these results supported its conclusion that the benefits justified approval for the Saudi market.
Gastrointestinal symptoms including nausea constipation diarrhea vomiting indigestion and abdominal pain emerged as the most frequent side effects during the trials according to the SFDA. Most of those reactions remained mild to moderate and eased after the dose-escalation phase although the regulator also noted instances of fatigue hair loss and abdominal bloating. Patients with a personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia syndrome type 2 must avoid the medication the authority warned.
The SFDA stressed that Foundaio should only be prescribed under medical supervision with ongoing follow-up to track patient response and any adverse events. This Saudi decision follows the US clearance earlier this year during which Eli Lilly described the pill as the only GLP-1 treatment that can be taken at any time without food or water restrictions in its announcement. The availability of an oral daily option broadens treatment choices for clinicians addressing weight-related conditions in the kingdom.
