In a conversation with Pharmaceutical Executive, Jay Bregman, CEO and co-founder of Andel, discusses the potential impact of the FDA's increased scrutiny on non-FDA approved GLP-1 products, particularly on the competitive landscape for obesity and diabetes therapies
Understanding Tirzepatide: What It Is: Dual GIP/GLP-1 receptor agonist First-in-class medication combining two mechanisms Activates both GIP and GLP-1 receptors Produces superior weight loss to single-agonist medications Half-life of approximately 5 days (allows once-weekly dosing) Brand Names: Zepbound: Indication: Chronic weight management in adults with obesity or overweight with comorbidities FDA Approval: November 2023 Doses: 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, 15 mg (weekly) Manufacturer: Eli Lilly Cost: $1,069/month Mounjaro: Indication: Type 2 diabetes management FDA Approval: May 2022 Doses: 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, 15 mg (weekly) Manufacturer: Eli Lilly Cost: $1,069/month Note: Identical to Zepbound, prescribed off-label for weight loss Compounded Tirzepatide: Source: FDA-registered compounding pharmacies Indication: Prescribed for weight loss by licensed providers Doses: Custom concentrations available Cost: $349-$699/month Same active ingredient as Zepbound/Mounjaro Why Tirzepatide Is More Effective: Dual Mechanism: GLP-1 Effects (Same as Semaglutide): Appetite suppression through brain receptors Slowed gastric emptying Increased insulin secretion Decreased glucagon production Additional GIP Effects: Enhanced insulin response beyond GLP-1 alone Improved insulin sensitivity in tissues Effects on fat metabolism and energy expenditure Synergistic appetite reduction Additional weight loss mechanisms Result: The combination produces 5-7% more weight loss than GLP-1 agonists alone
Good choices include: Greek yogurt with berries and a drizzle of honey, protein pudding made from protein powder and Greek yogurt, cottage cheese with cinnamon and stevia, quality protein bars that taste like dessert, protein mug cakes, or small portions of high-protein ice cream brands
Calorie Deficit: What to Know Doherty, R., Madigan, S., Nevill, A., Warrington, G., & Ellis, J
