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Reproductive & sexual health

Leuprolide

A GnRH agonist whose depot injections switch off sex-hormone production — used in prostate cancer, endometriosis and central precocious puberty depending on the product.

L5Practice-changingApproved medicineApprovedHigh confidenceLast reviewed 2026-08-23
IMSC injection

Also known as: leuprolide acetate, Lupron Depot, Lupron, Eligard

Evidence passport

Last reviewed 2026-08-23

Evidence level
L5Practice-changing
Confidence
High confidence
Human efficacy
85/100
Human safety
80/100
Regulatory status
Approved medicine
Development
Approved
Routes
IMSC injection
Evidence base
Includes human data
Furthest stage
Approved
Source curation
Sources fully curated
Clinical maturity
Established hormone-suppression medicine family

Overview

Human evidence85/100
Preclinical evidence75/100
Human safety evidence80/100

Clinical maturity: Established hormone-suppression medicine family

Routes & formulations

Studied / approved routes

IMSC injection

Depot products are given IM or SC depending on the specific product; formulations are not interchangeable and dosing intervals differ by product.

Route availability is not evidence of efficacy, and evidence from one route does not transfer to another. The Registry never provides dosing or sourcing information.

Peptide lifecycle

  1. Discovery

  2. Preclinical

  3. Phase I

  4. Phase II

  5. Phase III

  6. Approved

Approved

What it is

A synthetic super-agonist of the GnRH receptor: after a brief stimulation phase, continuous exposure desensitises the pituitary and shuts down LH/FSH-driven sex-hormone production.

What people claim

  • Suppresses testosterone in advanced prostate cancer
  • Suppresses oestrogen in endometriosis
  • Pauses central precocious puberty

What the evidence actually says

Decades of controlled trials and clinical use underpin its hormone-suppression indications. The initial flare of hormone release is a predictable pharmacological effect reflected in labelling.

Human evidence

  • Randomised trials and a long clinical history across prostate cancer, endometriosis and central precocious puberty indications.

Preclinical evidence

  • GnRH-receptor pharmacology demonstrating desensitisation with continuous agonism.

Animal and cell findings are Level 1–2 evidence.

Mechanism and pathways

  • Continuous GnRH-receptor stimulation down-regulates pituitary gonadotroph signalling, collapsing LH/FSH output and gonadal hormone production.

Safety and unknowns

  • Labelled class effects include hot flushes, bone-density effects with long-term use and the initial hormone flare.
  • Cardiovascular and metabolic considerations are labelled for prostate-cancer use.

Cancer relevance

No concern identified

Used deliberately as a treatment in hormone-sensitive prostate cancer; no cancer-promotion signal within approved use.

Regulatory status

Multiple FDA-approved depot products exist with different indications — advanced prostate cancer, endometriosis, preoperative management of uterine fibroids and central precocious puberty among them. Each formulation and dosing interval is approved for specific uses.

Evidence grade

L5Practice-changingHigh confidence

Replicated large randomised trials, pivotal Phase 3 programmes, or a major regulatory decision.

What would change our rating?

  • Not applicable at this evidence tier.

References and sources

Sources fully curated

Source hierarchy: regulatory documents and trial registries first, peer-reviewed work next, sponsor material flagged as non-independent. We never use supplier or clinic marketing as evidence, and where a verified source has not yet been curated we say so rather than inventing one.

Evidence change history

No recorded changes yet. Baseline position set on 2026-08-23.