Saudi Arabia’s Saudi Food and Drug Authority (SFDA) has approved the registration of Orforglipron (Foundaio), a new oral medication designed to help adults with obesity or overweight conditions lose weight and maintain long-term weight reduction.
The approval follows a comprehensive scientific review of the drug’s quality, safety, and effectiveness, based on clinical data and extensive regulatory evaluation.
Who Can Use the Medication?
The treatment is intended for:
- Adults diagnosed with obesity.
- Adults who are overweight and have at least one weight-related medical condition, such as diabetes, hypertension, or cardiovascular disease.
The SFDA emphasized that the medication should be used alongside a healthy diet and regular physical activity, rather than as a standalone treatment.
Unlike several other GLP-1 therapies, Orforglipron is administered orally once daily, providing patients with an alternative to injectable medications.
How Does It Work?
Orforglipron targets GLP-1 receptors, which play an important role in regulating appetite and blood sugar levels.
By activating these receptors, the medication helps:
- Reduce hunger.
- Increase feelings of fullness.
- Lower food intake.
- Support sustained weight loss when combined with lifestyle changes.
Clinical Trial Results
The approval was supported by two Phase III clinical trials lasting 72 weeks.
The first study involved 3,127 adults with obesity but without diabetes, where participants taking the 36 mg dose achieved an average weight reduction of 11.2%, compared with 2.1% in the placebo group.
The second study included 1,613 adults with obesity and Type 2 diabetes, with participants receiving the same dosage achieving an average 9.6% weight loss, compared to 2.5% for placebo recipients.
Possible Side Effects
According to the SFDA, the most commonly reported adverse effects involved the digestive system, including:
- Nausea
- Diarrhea
- Constipation
- Vomiting
- Indigestion
- Abdominal pain and bloating
- Fatigue
- Hair loss
Most side effects were mild to moderate and generally occurred during dose escalation before gradually improving over time.
Important Safety Warnings
The SFDA warned that the medication is not suitable for individuals with a personal or family history of certain thyroid cancers or specific inherited endocrine disorders.
The authority stressed that treatment should only be used under medical supervision, with regular follow-up to ensure safety and effectiveness.
Supporting Saudi Vision 2030
The approval of Orforglipron expands Saudi Arabia’s portfolio of advanced obesity treatments and supports the Kingdom’s healthcare transformation by improving access to innovative therapies for chronic diseases associated with obesity.
The move aligns with Saudi Vision 2030, which seeks to enhance healthcare quality, promote disease prevention, and improve overall public health outcomes.
