Peptides Available for Prescription After FDA Changes in November 2023
Following the FDA changes in November 2023, tirzepatide is the only peptide that is clearly available for prescription, having received FDA approval for obesity treatment in November 2023. 1
Available Peptides
Tirzepatide: A dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist that was FDA approved for treatment of obesity in November 2023. In clinical trials, it demonstrated significant weight loss of 20.9% at the 15 mg dose over 72 weeks. 1
GLP-1 Receptor Agonists: These peptides remain available for prescription:
- Semaglutide: Available in injectable and oral formulations for diabetes management and weight loss 1
- Dulaglutide: Weekly injectable peptide for diabetes management 1
- Liraglutide: Daily injectable peptide for diabetes and weight management 1
- Exenatide: Available in immediate and extended-release formulations 1
Regulatory Context
The FDA changes in November 2023 specifically included the approval of tirzepatide for obesity treatment, making it the newest peptide medication available by prescription. 1
Other peptides that remain available by prescription include GLP-1 receptor agonists which have established roles in diabetes management and, in some cases, weight management. 1
Clinical Considerations
Efficacy: Tirzepatide has demonstrated superior weight loss compared to other GLP-1 receptor agonists, with a mean difference of 5.1% greater weight loss than semaglutide and 13.0% greater than liraglutide. 1
Administration: Most of these peptides are administered subcutaneously:
Cost considerations: These peptides vary significantly in cost, with median Average Wholesale Prices ranging from approximately $990 to $1,340 for a month's supply. 1
Common Pitfalls to Avoid
Failure to consider contraindications: These peptides may be contraindicated in certain conditions such as personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia syndrome type 2. 1
Inappropriate use in heart failure: While SGLT2 inhibitors are preferred in patients with heart failure, GLP-1 receptor agonists should be used with caution in patients with recent heart failure decompensation. 1
Overlooking renal function: Dosage adjustments or avoidance may be necessary in patients with reduced renal function. 1
Not monitoring for gastrointestinal side effects: These are common with peptide therapies and may require dose titration or management strategies. 1
The FDA changes in November 2023 primarily affected the approval status of tirzepatide for obesity treatment, while other previously approved peptides remain available for their indicated uses.