Skip to content

Reproductive & sexual health

Ganirelix

A GnRH antagonist used in assisted reproduction to time ovulation precisely.

L5Practice-changingApproved — narrow indicationApprovedHigh confidenceLast reviewed 2026-08-23
SC injection

Also known as: ganirelix acetate

Evidence passport

Last reviewed 2026-08-23

Evidence level
L5Practice-changing
Confidence
High confidence
Human efficacy
80/100
Human safety
80/100
Regulatory status
Approved — narrow indication
Development
Approved
Routes
SC injection
Evidence base
Includes human data
Furthest stage
Approved
Source curation
Sources fully curated
Clinical maturity
Approved medicine in assisted reproduction

Overview

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

Clinical maturity: Approved medicine in assisted reproduction

Routes & formulations

Studied / approved routes

SC injection

The approved product is a subcutaneous injection used within fertility treatment protocols under clinical supervision.

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 peptide GnRH antagonist that immediately blocks LH/FSH release, used to prevent premature ovulation during IVF-style stimulation cycles.

What people claim

  • Prevents premature LH surges in controlled ovarian stimulation

What the evidence actually says

Supported by the controlled trials behind its approval and by routine use in fertility medicine. A clean example of a peptide with a narrow, well-evidenced job.

Human evidence

  • Controlled clinical trials in assisted reproduction populations supporting approval.

Preclinical evidence

  • GnRH antagonist pharmacology in reproductive endocrinology models.

Animal and cell findings are Level 1–2 evidence.

Mechanism and pathways

  • Competitive GnRH-receptor blockade produces immediate, reversible suppression of LH and FSH.

Safety and unknowns

  • Labelled effects include injection-site reactions and headache; used under fertility-clinic monitoring.

Cancer relevance

No concern identified

No established human cancer signal within approved use.

Regulatory status

FDA-approved for inhibition of premature LH surges in women undergoing controlled ovarian hyperstimulation in fertility treatment. Indication-specific.

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.