Reproductive & sexual health
Histrelin
A GnRH-agonist implant approved for central precocious puberty, releasing peptide continuously for about a year per implant.
Also known as: Supprelin LA, histrelin acetate
Evidence passport
Last reviewed 2026-08-23
- Evidence level
- L4Strong human
- Confidence
- Moderate confidence
- Human efficacy
- 68/100
- Human safety
- 65/100
- Regulatory status
- Approved — narrow indication
- Development
- Approved
- Routes
- Implant
- Evidence base
- Includes human data
- Furthest stage
- Approved
- Source curation
- Sources fully curated
- Clinical maturity
- Approved narrow paediatric indication
Overview
Clinical maturity: Approved narrow paediatric indication
Routes & formulations
Studied / approved routes
A small implant placed under the skin of the upper arm, replaced roughly annually under specialist care.
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
Discovery
Preclinical
Phase I
Phase II
Phase III
Approved
What it is
A potent GnRH-agonist peptide in a long-acting implant that suppresses premature activation of the reproductive hormone axis.
What people claim
- Halts progression of central precocious puberty while implanted
What the evidence actually says
Clinical studies in children with central precocious puberty supported approval of the implant; suppression of puberty reverses after removal, which is part of its labelled use profile.
Human evidence
- Open-label and supportive clinical studies in children with CPP underpinning approval.
Preclinical evidence
- GnRH-agonist pharmacology and implant-release characterisation.
Animal and cell findings are Level 1–2 evidence.
Mechanism and pathways
- Sustained GnRH-receptor agonism desensitises the pituitary, suppressing LH/FSH and sex-steroid production.
Safety and unknowns
- Labelled considerations include implant-site reactions and the expected transient hormone rise at initiation.
- Long-term specialist monitoring accompanies use.
Cancer relevance
No concern identified
Regulatory status
FDA-approved (Supprelin LA) as a subcutaneous implant for treatment of children with central precocious puberty. Approval is specific to that paediatric indication and product.
Evidence grade
Solid controlled human trials, though not yet definitive or fully replicated.
What would change our rating?
- Longer-term outcome data into adulthood would deepen the evidence base.
References and sources
- Regulatory / labelFDA label: Supprelin LA (histrelin acetate) subcutaneous implant
- Regulatory / labelFDA review summary: Supprelin LA (NDA 022058)
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.