Pain & neurology
Ziconotide
A cone-snail-venom-derived peptide painkiller given directly into spinal fluid for severe chronic pain.
- How settled this rating is:
- high confidence in the current evidence rating
- Routes studied:
- Intrathecal
- Also known as:
- Prialt, SNX-111
- Last reviewed:
- 2026-08-23
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Evidence passport
Ziconotide
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
- L5Repeated human trials
- Confidence
- High 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 specialist pain medicine
- 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 specialist pain medicine
Routes & formulations
Studied / approved routes
The approved product is delivered by intrathecal infusion from an implanted or external pump directly into the spinal fluid — the only approved route, and a clinical procedure managed by specialists. This registry provides no pump or dosing information.
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 synthetic version of a peptide from cone-snail venom that blocks pain signalling in the spinal cord by closing N-type calcium channels.
What people claim
- Relieves severe chronic pain in selected patients when other options fail
What the evidence actually says
Randomised controlled trials supported approval for its narrow intrathecal indication. It is also the clearest example in this registry of why route is part of the evidence: the same molecule is unmanageable systemically, and only works as a medicine because of where and how it is delivered.
Related evidence
Useful next reads based on this compound — not recommendations.
- Related compound
Enfuvirtide evidence profile
The first HIV entry inhibitor — a 36-amino-acid peptide that blocks viral fusion.
- Compare
Compare Ziconotide vs Enfuvirtide 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
- Randomised, placebo-controlled intrathecal trials in severe chronic pain populations.
Preclinical evidence
- Cone-snail conotoxin pharmacology and spinal analgesia models.
Animal and cell findings are Level 1–2 evidence.
Mechanism and pathways
- Selective blockade of N-type calcium channels in dorsal-horn neurons interrupts pain transmission.
Safety and unknowns
- Serious neuropsychiatric and neurological adverse effects are labelled; use is restricted to specialist intrathecal therapy with careful titration.
- Systemic exposure is not the approved use and carries a different risk profile.
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 (Prialt) for management of severe chronic pain in patients for whom intrathecal therapy is warranted and other treatments are inadequate or intolerable. Approval is specific to that intrathecal use in selected patients.
Evidence grade
Substantial, consistent controlled human evidence supporting a specified outcome, preferably independently replicated. Approval is reported separately.
What would change our rating?
- Not applicable at this evidence tier.
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
- 1
- 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 via DailyMed: Prialt (ziconotide) intrathecal infusion — initial U.S. approval 2004
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.