Question 1

What are therapeutic peptides?

Accepted Answer

Therapeutic peptides are short chains of amino acids that act as signaling molecules in the body. They are used in regenerative medicine for tissue repair, hormone optimization, metabolic health, and anti-aging applications. Unlike proteins, peptides are smaller and can more easily penetrate tissues and enter the bloodstream.

Question 2

What peptides can physicians prescribe?

Accepted Answer

Physicians can prescribe both FDA-approved peptides (like tesamorelin for HIV-associated lipodystrophy and semaglutide for weight management) and compounded peptides through 503A and 503B pharmacies. Available peptides depend on current FDA regulations, drug shortage status, and state-level compounding laws.

Question 3

How do you reconstitute peptides for clinical use?

Accepted Answer

Peptides are reconstituted by adding bacteriostatic water to the lyophilized (freeze-dried) powder. The amount of water determines the concentration. For example, adding 2mL of water to a 5mg vial creates a concentration of 2.5mg/mL. Our reconstitution calculator helps determine the exact units to draw on an insulin syringe for any desired dose.

Question 4

What is the difference between semaglutide and tirzepatide?

Accepted Answer

Semaglutide (Ozempic, Wegovy) is a GLP-1 receptor agonist, while tirzepatide (Mounjaro, Zepbound) is a dual GLP-1/GIP agonist. Clinical trials show tirzepatide may produce greater weight loss, with patients achieving up to 20-25% body weight reduction compared to 15-17% with semaglutide. Both require subcutaneous injection.

Question 5

Are peptides FDA approved?

Accepted Answer

Some peptides are FDA-approved for specific indications—tesamorelin for HIV-associated lipodystrophy, semaglutide for weight management and type 2 diabetes. Many other peptides used clinically (such as BPC-157 and TB-500) are not FDA-approved and are available only through compounding pharmacies, subject to regulatory restrictions.

Question 6

How are peptides regulated by the FDA?

Accepted Answer

The FDA classifies bulk drug substances used in compounding into categories. Category 1 substances can be compounded, Category 2 substances have significant safety concerns and are generally prohibited, and Category 3 substances cannot be compounded. Regulations change frequently, and prescribers should verify current status through official FDA sources.

Clinical resources for peptide-prescribing professionals

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AOD-9604

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