The Saudi Food and Drug Authority (SFDA) has approved the registration of Foundaio, a once-daily oral medication designed to help adults with obesity or overweight achieve and maintain long-term weight loss.
The medication is intended for adults who are overweight or obese and have at least one weight-related health condition. It should be used alongside a healthy diet and regular physical activity for the best results.
What Is Foundaio and How Does It Work?
Foundaio contains the active ingredient orforglipron, which works by activating the body's glucagon-like peptide-1 (GLP-1) receptors.
According to the SFDA, the medication helps to:
- Control appetite and blood sugar levels
- Reduce food intake
- Support long-term weight loss
Unlike many other GLP-1 therapies that require injections, Foundaio is taken orally once a day.
SFDA Approval Supported by Phase 3 Clinical Trials
The SFDA approved Foundaio after evaluating its safety, effectiveness, and quality. The decision was based on findings from two major Phase 3 clinical trials, each lasting 72 weeks.
Clinical Trial in Adults Without Diabetes
The first study 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% after 72 weeks, while those receiving a placebo recorded an average reduction of 2.1%.
Clinical Trial in Adults With Type 2 Diabetes
The second study included 1,613 adults living with obesity and Type 2 diabetes.
Participants taking the 36 mg dose experienced an average body weight reduction of 9.6% over 72 weeks, compared with an average reduction of 2.5% in the placebo group.
The trial results demonstrated that Foundaio effectively promoted weight loss in adults with obesity, including those with Type 2 diabetes.
Common Side Effects
The SFDA reported that the most frequently observed side effects during clinical trials were related to the digestive system.
- Nausea
- Constipation
- Diarrhea
- Vomiting
- Indigestion
- Abdominal pain
Other reported side effects included:
- Abdominal bloating
- Hair loss
- Fatigue
According to the SFDA, most gastrointestinal side effects were mild to moderate, occurred mainly during dose escalation, and generally became less severe over time.
Who Should Not Use Foundaio?
The SFDA advises that Foundaio should not be used by individuals with a personal or family history of certain thyroid cancers or hereditary syndromes associated with these cancers.
Treatment should only begin and continue under the supervision of a qualified healthcare professional. Patients are also advised to attend regular medical follow-up appointments to monitor treatment progress and overall health.
What the Approval Means
The approval of Foundaio introduces a new once-daily oral GLP-1 treatment option for adults with obesity or overweight who have at least one weight-related medical condition.
Containing orforglipron, the medication is intended to complement healthy eating habits and regular physical activity. Its approval follows the SFDA's review of clinical evidence demonstrating its safety, efficacy, and quality.
