Glossary
FDA-Approved
Cleared by regulators for specific uses
FDA-approved means the U.S. Food and Drug Administration has reviewed submitted data and determined that a product meets standards for safety and effectiveness for one or more stated uses. Approval applies only to the exact product, dose, and indication evaluated. The designation does not extend to substances that have not completed this review process.
Used in 22 research peptides
- CosmeticMelanotan IEnhances melanin production for protective tanning without UV exposure.
- CosmeticPT-141 (Bremelanotide)Melanocortin agonist FDA-approved (Vyleesi) for HSDD; libido enhancement.
- MetabolicTesofensineTriple monoamine reuptake inhibitor with strong weight-loss data; not FDA-approved.
- PerformanceCapromorelinOral non-peptide ghrelin-receptor agonist; FDA-approved as a veterinary appetite stimulant.
- MetabolicLiraglutideDaily GLP-1 analog; FDA-approved for diabetes (Victoza) and obesity (Saxenda®).
- MetabolicDulaglutideWeekly GLP-1 receptor agonist fused to an IgG4 Fc fragment; sold as Trulicity by Eli Lilly.
- CognitiveN-Acetyl SemaxAcetylated, more stable analog of Semax; longer-acting nootropic via BDNF/NGF upregulation.
- MetabolicExenatideFirst-in-class GLP-1 mimetic derived from Gila monster venom; sold as Byetta/Bydureon.
- MetabolicAlbiglutideWeekly GLP-1 agonist fused to albumin; discontinued GSK product (Tanzeum/Eperzan).
- PerformanceIpamorelin + Tesamorelin BlendInvestigational blend pairing a clean GHRP (ipamorelin) with a stable GHRH (tesamorelin).
- PerformanceGonadorelinSynthetic decapeptide identical to endogenous GnRH that stimulates the pituitary to release LH and FSH; used diagnostically and, off-label, to support the gonadal axis during testosterone therapy.
- PerformanceHCG (Human Chorionic Gonadotropin)Glycoprotein hormone with LH-mimetic activity that stimulates gonadal steroidogenesis; FDA-approved for cryptorchidism, select male hypogonadotropic hypogonadism, and ovulation induction.
- MetabolicTeduglutide (Gattex)FDA-approved GLP-2 analog that promotes intestinal mucosal growth and absorption, used for short bowel syndrome in patients dependent on parenteral support.
- OtherOxytocinNine-amino-acid neuropeptide hormone; FDA-approved as an injectable for obstetric use, and studied off-label as an intranasal agent for social, anxiety, and sexual-health applications with mixed results.
- TRTTestosterone CypionateTestosterone cypionate is a long-acting oil-soluble ester of the endogenous androgen testosterone, administered by intramuscular or subcutaneous injection. It is FDA-approved for testosterone replacement therapy in adult males diagnosed with primary or hypogonadotropic hypogonadism.
- TRTTestosterone EnanthateTestosterone enanthate is a long-acting ester of testosterone administered by intramuscular or subcutaneous injection. It is FDA-approved for testosterone replacement therapy in adult males with primary or hypogonadotropic hypogonadism.
- TRTTestosterone UndecanoateTestosterone undecanoate (Aveed) is a very long-acting ester of testosterone administered by deep intramuscular injection. FDA-approved for replacement therapy in adult males with primary or hypogonadotropic hypogonadism; the injectable formulation carries a boxed warning for pulmonary oil microembolism (POME) and anaphylaxis.
- TRTClomipheneClomiphene citrate is a nonsteroidal SERM consisting of a mixture of enclomiphene (trans) and zuclomiphene (cis) isomers. It is FDA-approved for ovulation induction in women; its use in males to raise endogenous testosterone is off-label.
- TRTAnastrozoleAnastrozole (Arimidex) is a potent, selective non-steroidal aromatase inhibitor. It is FDA-approved for breast cancer in postmenopausal women; its use in males to manage estradiol levels during testosterone therapy is off-label.
- TRTDHEA (Prasterone)DHEA (dehydroepiandrosterone; prasterone) is an endogenous adrenal steroid that serves as a precursor to androgens and estrogens. The vaginal insert formulation (Intrarosa) is FDA-approved for dyspareunia due to menopause; oral DHEA products are sold as dietary supplements and do not have an FDA drug approval for systemic hormone replacement.
- TRTPregnenolonePregnenolone is an endogenous neurosteroid and the first committed steroid produced from cholesterol. It is not FDA-approved as a drug and is available as a dietary supplement or through compounding.
- TRTTamoxifenTamoxifen (Nolvadex) is a nonsteroidal SERM and the primary approved endocrine therapy for hormone receptor-positive breast cancer. Its use in males during or after testosterone therapy to manage gynecomastia or restore the hypothalamic-pituitary axis is off-label.
See also
Educational use only
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