Home/Compounds/hCG
● TIER 1 — FDA-approved / recognizedGRADE AReproductive hormones

hCG

Gonadotropin. Research verification: Yes (TGA pending). 1 human study record(s) in the FitClinicMD studies database.

GOALS · Hormone optimization / menopause / low T · Sexual function

FDA status
Approved (Novarel, Pregnyl) for hypogonadotropic hypogonadism, ovulation induction; not for weight loss (label disclaimer).
Compounding (503A/503B)
Biologic since Mar 23 2020 BPCI Act transition — NOT eligible for 503A/503B compounding (only mixing/diluting/repackaging of approved product per 2018 guidance)
DEA
Not controlled federally.
WADA (sport)
S2.2.1 Testosterone-stimulating peptides in males (CG, LH, GnRH/gonadorelin & agonist analogues, kisspeptin & agonist analogues)

Mechanism

LH-receptor agonist.

Human evidence · 1

Review: TRT and spermatogenesis (hCG for preservation). Testosterone replacement therapy and spermatogenesis in reproductive age men.
2025review (narrative)PMID 40346275 →
Reference only. This page summarizes publicly available regulatory and research information about hCG. 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.

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