● TIER 2 — Compoundable · emerging dataGRADE B (DHEA) / C (pregnenolone)Adrenal / neurosteroids
DHEA / Pregnenolone
Adrenal steroid precursors. Research verification: Yes (TGA pending). 3 human study record(s) in the FitClinicMD studies database.
GOALS · Hormone optimization / menopause / low T · Longevity
FDA status
Dietary supplements in US (not drugs); prasterone vaginal insert (Intrarosa) approved.
Compounding (503A/503B)
DHEA: dietary supplement; 7-keto-DHEA and pregnenolone are 503A Category 1
DEA
DHEA expressly excluded from 'anabolic steroid' definition by Anabolic Steroid Control Act of 2004 (21 USC 802(41)(A)) — not scheduled
WADA (sport)
S1 Anabolic agents
Mechanism
Precursors to androgens/estrogens/neurosteroids.
Human evidence · 3
Pregnenolone small RCT (craving/anxiety). Pregnenolone Reduces Stress-Induced Craving, Anxiety, and Autonomic Arousal in Individuals with Cocaine Use Disorder.
Meta-analysis of DHEA RCTs. A systematic review and meta-analysis of randomized placebo-controlled trials of DHEA supplementation of bone mineral density in healthy adults.
Nair NEJM 2006, n=87 men, 57 women, 2 y: no meaningful benefit. DHEA in elderly women and DHEA or testosterone in elderly men.
Reference only. This page summarizes publicly available regulatory and research information about DHEA / Pregnenolone. 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.