Last updated October 21, 2026. Approval line checked October 21, 2026. No compounding source date is assigned.
FDA status
Approved
Approved. Leuprolide is the active ingredient in FDA-approved products such as Lupron, for specific indications. Approval is specific to the product, indication, and route.
Drugs@FDA: Lupron (NDA 019010)By signing up you agree to get PeptideX update emails. Unsubscribe anytime. Educational only, not medical advice.
Evidence tier
Human RCT. The tier is the highest indexed study type. It is not a safety rating and it is not an FDA approval. Confidence score 5/5. 4,156 PubMed citations indexed.
Leuprolide acetate is a synthetic nonapeptide GnRH agonist that occupies and continuously stimulates pituitary GnRH receptors, producing an initial gonadotropin surge followed by receptor downregulati
What the literature studies
Metabolic Research
Evidence tier
Human RCT
Compounding record
Status not verified
Status not verified. No product-specific FDA primary source is recorded for this entry. FDA approval and compounding eligibility are not verified. Research information is not evidence of FDA approval. Approval, where applicable, is specific to a drug product, indication and route. Research information is not evidence of FDA approval. Approval, where applicable, is specific to a drug product, indication and route.
Regulatory source not verified; no checked date is assigned.
Long-term use causes significant bone density loss, cardiovascular risk, hot flashes, cognitive effects, and metabolic syndrome; bone densitometry monitoring and calcium/vitamin D
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Educational only. Not medical advice. This page does not give doses or sourcing. See the medical and editorial disclaimer.