What peptides can physicians prescribe?

Physicians can prescribe both FDA-approved peptides (like tesamorelin and semaglutide) and compounded peptides through 503A and 503B pharmacies. The specific peptides available depend on current FDA regulations, drug shortage status, and state-level compounding laws. Our peptide guides provide detailed information on each peptide's regulatory status and prescribing considerations.

Are peptides FDA approved?

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

How are peptides regulated by the FDA?

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 from compounding, and Category 3 substances cannot be compounded. Regulations change frequently, so prescribers should verify current status through official FDA sources.

What is the difference between FDA-approved and compounded peptides?

FDA-approved peptides have undergone rigorous clinical trials demonstrating safety and efficacy for specific indications. Compounded peptides are prepared by pharmacies (503A or 503B facilities) from bulk ingredients, typically for uses not covered by commercially available products. Compounded preparations have not undergone the same level of regulatory review as FDA-approved drugs.

Clinical Monographs

Peptide Guides

Comprehensive clinical monographs for prescribing professionals. Each guide covers mechanisms, dosing, safety, and practical considerations.

MetabolicStrong EvidenceapprovedSubcutaneous injection

Tesamorelin

GHRH Analog - FDA-Approved Growth Hormone Secretagogue

Primary indication: Reduction of excess abdominal fat in HIV-infected patients with lipodystrophy (FDA-approved)

Tesamorelin (Egrifta/Egrifta SV) is an FDA-approved synthetic growth hormone-releasing hormone (GHRH) analog indicated for the reduction of excess abdominal fat in HIV-infected patients with lipodystrophy, with emerging evidence for cognitive enhancement and hepatic steatosis.

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Weight LossModerate EvidenceavailableSubcutaneous injection (oral formulation was also investigated)

AOD-9604

Growth Hormone Fragment - Fat Metabolism Guide

Primary indication: Fat reduction and body composition improvement (investigational; no regulatory approval for therapeutic use)

AOD-9604 is a modified fragment of human growth hormone (hGH fragment 177-191) studied for its fat-reducing properties without the diabetogenic or growth-promoting effects of full GH.

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Tissue RepairPreclinicalcategory2Multiple (SC, IM, IV, oral, intra-articular, topical)

BPC-157

Body Protection Compound - Complete Clinical Guide

Primary indication: Gastrointestinal cytoprotection and mucosal healing (investigational)

BPC-157 is a 15-amino acid peptide derived from human gastric juice that has demonstrated tissue-protective and healing properties across multiple organ systems.

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Growth HormoneLimited EvidenceavailableSubcutaneous injection (SC)

CJC-1295/Ipamorelin

Growth Hormone Secretagogue Combination - Prescriber Guide

Primary indication: Growth hormone deficiency and age-related GH decline (investigational combination)

CJC-1295/Ipamorelin is a synergistic combination of a growth hormone-releasing hormone (GHRH) analog and a growth hormone secretagogue used to stimulate natural growth hormone production.

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LongevityPreclinicalavailableSubcutaneous injection (SC), intramuscular injection (IM), intranasal (investigational)

Epithalon

Telomerase Activator Peptide - Anti-Aging Guide

Primary indication: Telomerase activation and telomere maintenance (investigational anti-aging peptide)

Epithalon (Epitalon) is a synthetic tetrapeptide based on the natural epithalamin produced by the pineal gland, studied for its effects on telomerase activation and potential anti-aging properties.

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Skin/HealingModerate EvidenceavailableTopical (most common), subcutaneous injection (SC), mesotherapy/microneedling delivery

GHK-Cu

Copper Peptide Complex - Regenerative Medicine Guide

Primary indication: Wound healing and tissue repair (topical and injectable formulations)

GHK-Cu (Glycyl-L-Histidyl-L-Lysine Copper) is a naturally occurring copper-binding peptide with demonstrated wound healing, anti-aging, and tissue remodeling properties.

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Sexual HealthStrong EvidenceapprovedSubcutaneous injection (SC); auto-injector available (Vyleesi)

PT-141 (Bremelanotide)

Melanocortin Receptor Agonist - Sexual Dysfunction Guide

Primary indication: Hypoactive sexual desire disorder (HSDD) in premenopausal women (FDA-approved as Vyleesi)

PT-141 (bremelanotide) is a melanocortin receptor agonist FDA-approved for hypoactive sexual desire disorder in premenopausal women, also used off-label for male sexual dysfunction.

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Nootropic & AnxiolyticLimited Evidenceavailableintranasal

Selank

Synthetic tuftsin-analog heptapeptide with anxiolytic, nootropic, and immunomodulatory properties

Primary indication: Generalized anxiety disorder and neurasthenia (approved in Russia as intranasal spray)

Selank (TP-7) is a synthetic heptapeptide analog of the endogenous immunomodulatory peptide tuftsin, developed at the Institute of Molecular Genetics of the Russian Academy of Sciences. Approved in Russia since 2009 as an intranasal anxiolytic and nootropic, Selank provides clinically meaningful anxiety reduction through GABAergic modulation without the sedation, tolerance, or dependence associated with benzodiazepines. Its tuftsin core also confers immunomodulatory properties, creating a unique dual anxiolytic-immunomodulatory pharmacological profile.

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MetabolicStrong EvidenceshortageSubcutaneous injection (Ozempic, Wegovy) or oral (Rybelsus)

Semaglutide

GLP-1 Receptor Agonist - Prescriber Reference

Primary indication: Type 2 diabetes mellitus (FDA-approved: Ozempic, Rybelsus) and chronic weight management (FDA-approved: Wegovy)

Semaglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist with FDA approval for type 2 diabetes and chronic weight management.

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Hormone OptimizationModerate Evidenceavailablesubcutaneous

Sermorelin

Synthetic GHRH(1-29) fragment for physiologic growth hormone optimization

Primary indication: Growth hormone optimization and anti-aging (off-label via compounding pharmacies)

Sermorelin acetate is a synthetic 29-amino-acid peptide corresponding to the biologically active N-terminal segment of endogenous growth hormone-releasing hormone (GHRH). Originally FDA-approved as Geref/Geref Diagnostic for diagnosing and treating GH deficiency, the commercial product was discontinued around 2008 due to manufacturing and business reasons — not safety concerns. Today, sermorelin is one of the most widely prescribed peptides in functional and regenerative medicine, stimulating the pituitary to release GH in a physiologic, pulsatile pattern that preserves natural feedback mechanisms.

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RegenerativePreclinicalavailableMultiple (SC, IM, IV, topical, ophthalmic)

TB-500

Thymosin Beta-4 Fragment - Tissue Repair Guide

Primary indication: Wound healing and tissue repair (investigational; pharmaceutical Tbeta4 in Phase II trials for epidermolysis bullosa and dry eye)

TB-500 is a synthetic peptide representing the active region of Thymosin Beta-4, studied for its roles in tissue repair, wound healing, and anti-inflammatory effects.

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Immune SupportModerate EvidenceavailableSubcutaneous injection

Thymosin Alpha-1

Immune-Modulating Peptide - Clinical Monograph

Primary indication: Chronic hepatitis B (approved in 35+ countries as Zadaxin); immune modulation (compounded use in US)

Thymosin Alpha-1 is a naturally occurring thymic peptide that modulates immune function and has been studied for various infectious and oncologic applications.

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Weight LossStrong EvidenceshortageSubcutaneous injection (once weekly)

Tirzepatide

Dual GIP/GLP-1 Receptor Agonist - Clinical Guide

Primary indication: Type 2 diabetes mellitus (FDA-approved: Mounjaro, 2022) and chronic weight management (FDA-approved: Zepbound, 2023; expanded in 2024 for moderate-to-severe obstructive sleep apnea in adults with obesity)

Tirzepatide is a first-in-class dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist with FDA approval for type 2 diabetes and chronic weight management.

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