● TIER 1 — FDA-approved / recognizedGRADE AReproductive hormones
Gonadorelin & GnRH analogs
GnRH agonists/antagonists. Research verification: Yes (TGA pending). 5 human study record(s) in the FitClinicMD studies database.
GOALS · Hormone optimization / menopause / low T
FDA status
Approved: Lupron/Eligard/Fensolvi (leuprolide), degarelix (Firmagon), relugolix (Orgovyx), elagolix (Orilissa). Gonadorelin (Factrel) discontinued in US.
Compounding (503A/503B)
Gonadorelin acetate has a USP monograph → eligible 503A bulk substance (subject to COA/registered source) —;
DEA
Not controlled.
WADA (sport)
S2.2.1 Testosterone-stimulating peptides in males (CG, LH, GnRH/gonadorelin & agonist analogues, kisspeptin & agonist analogues)
Mechanism
GnRH agonists (leuprolide, triptorelin, goserelin) cause downregulation; antagonists (degarelix, relugolix, elagolix) block directly.
Human evidence · 5
Fensolvi for central precocious puberty. Leuprolide acetate (Fensolvi) for central precocious puberty.
oral relugolix vs leuprolide. Oral Relugolix for Androgen-Deprivation Therapy in Advanced Prostate Cancer.
Pulsatile GnRH ovulation induction review. Ovulation induction with pulsatile gonadotropin releasing hormone: missing in action.
Elagolix endometriosis pain, two phase 3 RCTs. Treatment of Endometriosis-Associated Pain with Elagolix, an Oral GnRH Antagonist.
Degarelix phase 3, n=610. The efficacy and safety of degarelix: a 12-month, comparative, randomized, open-label, parallel-group phase III study in patients with prostate cancer.
Reference only. This page summarizes publicly available regulatory and research information about Gonadorelin & GnRH analogs. It is not a prescription, an endorsement, or an offer to dispense, and regulatory status can change. Clinicians should verify current status before prescribing or compounding.