Reproductive & sexual health
Histrelin
A GnRH-agonist implant approved for central precocious puberty, releasing peptide continuously for about a year per implant.
- How settled this rating is:
- moderate confidence in the current evidence rating
- Routes studied:
- Implant
- Also known as:
- Supprelin LA, histrelin acetate
- Last reviewed:
- 2026-08-23
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Evidence passport
Histrelin
A one-screen evidence identity for this compound. These fields describe research maturity, confidence and legal status. They are not a safety guarantee, efficacy percentage or recommendation.
- Evidence level
- L4Good human trials
- Confidence
- Moderate confidence in rating
- Regulatory status
- Approved for a specific indication · See jurisdiction details
- Development status
- Approved
Evidence strength
Higher = more and better-quality human evidence. It does not mean the effect is bigger or that the compound works for you.
Higher = more mature, better-documented human safety data. It does not mean the compound is safer than one with a lower number.
The 0-100 values rate the strength and maturity of evidence, not how effective or safe the compound is.
- Evidence base
- Includes human studies
- Furthest established stage
- Approved
- Human research maturity
- Approved narrow paediatric indication
- Source curation
- Sources fully curated
Routes recorded
Overview
Higher = more and better-quality human evidence. It does not mean the effect is bigger or that the compound works for you.
Higher = more animal, tissue or cell research. Preclinical results are a starting point, not proof of a human benefit.
Higher = more mature, better-documented human safety data. It does not mean the compound is safer than one with a lower number.
How to read these scores
Every number here rates the evidence, not the compound. They are editorial 0-100 strength ratings, not percentages, and not a rating out of five stars.
- Human efficacy evidence strength — Higher = more and better-quality human evidence. It does not mean the effect is bigger or that the compound works for you.
- Preclinical evidence strength — Higher = more animal, tissue or cell research. Preclinical results are a starting point, not proof of a human benefit.
- Human safety evidence strength — Higher = more mature, better-documented human safety data. It does not mean the compound is safer than one with a lower number. A score of 80 does not mean “80% safe”.
- Evidence level (L0-L5) — the strongest type of study behind the compound, from anecdote (L0) to large replicated human trials (L5). It is a description of the study evidence, not a quality, safety or recommendation rating.
- Confidence — how likely we think it is that this rating changes as new research lands. Low confidence means the picture is unsettled, not that the compound is bad.
None of these ratings is medical advice, a safety guarantee, or a recommendation to use anything. How we grade evidence.
How far human research has progressed: 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.
Related evidence
Useful next reads based on this compound — not recommendations.
- Related compound
Leuprolide evidence profile
A GnRH agonist whose depot injections switch off sex-hormone production — used in prostate cancer, endometriosis and central precocious puberty depending on the product.
- Compare
Compare Histrelin vs Leuprolide evidence
Same questions, same fields, side by side — including how much human evidence exists.
- Context
Safety Centre
What approved, investigational and unapproved actually mean for documented human safety.
- Context
Research Desk
How to read animal, early-phase and controlled human studies without over-reading them.
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
This section covers questions raised by how the compound works in the body, plus anything regulators and trial teams keep an eye on. It is not a statement that this compound causes cancer — for most compounds here, no human data exist in either direction.
No concern identified
Regulatory status
Regulatory decisions apply to specific jurisdictions, products, formulations and indications. An approval elsewhere is not automatically an approval in your country.
Named regulators: FDA (US)
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
Completed, adequately informative controlled human trials supporting a specified outcome; replication and longer-term safety may remain uncertain.
What would change our rating?
- Longer-term outcome data into adulthood would deepen the evidence base.
References and sources
Source transparency
A provenance snapshot of this profile. Counts show what kinds of sources are cited, not how much scientific weight each source deserves.
- Last editorial review
- 2026-08-23
- Recently reviewed · 54 days ago
- Linked curated sources
- 2
- Sources still pending
- 0
- External specialist reviews
- 0
- None recorded for this profile
Review provenance
Registry editorial review: Colin Jackson-White, creator and editor, who is not a doctor or clinician. External specialist review is credited only when a named reviewer has completed a review of this exact profile.
Literature-discovery and AI tools may help locate or challenge candidate evidence, but they are not counted as evidence sources here. Registry judgements are tied to the underlying papers, trial records, regulator documents and official study records.
- 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
These entries record changes to our assessment of the published evidence — not changes to the compound itself.
No recorded changes yet. Baseline position set on 2026-08-23.