● TIER 1 — FDA-approved / recognizedGRADE AGH secretagogues & GH axis
Somatropin (recombinant HGH)
Growth hormone. Research verification: Yes (TGA pending). Origin: China, Russia. Citations verified: yes. 5 human study record(s) in the FitClinicMD studies database.
GOALS · Muscle / body composition
FDA status
Approved for pediatric/adult GHD and others.
Compounding (503A/503B)
Biologic (deemed BLA Mar 2020) — not compoundable
DEA
Not DEA-scheduled, but distribution for non-approved uses is a federal crime (21 USC 333(e)).
WADA (sport)
S2.2.3 Growth hormone, analogues and fragments (incl. AOD-9604, hGH 176-191)
Mechanism
GH receptor agonist.
Human evidence · 5
Endocrine Society adult GHD guideline. Evaluation and treatment of adult growth hormone deficiency: an Endocrine Society clinical practice guideline.
Recreational athletes n=96: improved sprint capacity. The effects of growth hormone on body composition and physical performance in recreational athletes: a randomized trial.
Systematic review: GH ↑lean mass, not strength/exercise capacity. Systematic review: the effects of growth hormone on athletic performance.
Trial Effects of human growth hormone in men over 60 years old.
Dedov et al., Rastan in GHD and Turner syndrome.
other/unspecified
Reference only. This page summarizes publicly available regulatory and research information about Somatropin (recombinant HGH). 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.