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Reproductive & sexual health

Cetrorelix

The other widely used GnRH antagonist in assisted reproduction protocols.

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

Also known as: Cetrotide, cetrorelix 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

Approved as a subcutaneous injection within supervised fertility treatment.

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 decapeptide GnRH antagonist used to control timing of ovulation in assisted reproduction.

What people claim

  • Prevents premature LH surges in controlled ovarian stimulation

What the evidence actually says

Approved on controlled trial evidence and used routinely in fertility medicine for the same narrow purpose as ganirelix.

Human evidence

  • Controlled clinical trials in assisted reproduction supporting approval.

Preclinical evidence

  • GnRH antagonist pharmacology.

Animal and cell findings are Level 1–2 evidence.

Mechanism and pathways

  • Competitive GnRH-receptor blockade with immediate, reversible pituitary suppression.

Safety and unknowns

  • Labelled effects include injection-site reactions and nausea; clinical monitoring is standard.

Cancer relevance

No concern identified

No established human cancer signal within approved use.

Regulatory status

FDA-approved (Cetrotide) for inhibition of premature LH surges in women undergoing controlled ovarian stimulation. 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.