Ziconotide_Dosage, benefits & legal status
Also known as Prialt, SNX-111, omega-conotoxin MVIIA, ω-conotoxin MVIIA, CI-1009, ziconotide intrathecal
The FDA-approved cone-snail peptide for severe chronic pain, delivered only into the spinal fluid.
Common vial size is what vendors typically sell, not a recommendation. Enter your own vial in the calculator.
What is Ziconotide?
Plain language first. The technical label stays, but it never stands alone.Overview
A non-opioid painkiller approved in 2004 for people with severe chronic pain who have run out of other options, delivered by an implanted pump straight into the spinal fluid. It cannot be injected any other way, and it carries a boxed warning for severe psychiatric and neurological effects.
Ziconotide (Prialt) is a synthetic copy of omega-conotoxin MVIIA, a 25-amino-acid peptide from the venom of the cone snail Conus magus. It blocks N-type calcium channels on pain nerves in the spinal cord.
What it's used for
An approved treatment for severe chronic pain in people who need and cannot tolerate other intrathecal therapy. It is not an opioid, causes no tolerance or withdrawal, and has nothing to do with gray-market peptide use.
How does Ziconotide work?
What it does in the body, and where.Ziconotide plugs a calcium channel on the nerve endings that hand pain signals from the body to the spinal cord.
- 01N-type calcium channelThe Cav2.2 channel on A-delta and C fibres in the top layers of the dorsal horn. Blocking it stops calcium entering the nerve ending.
- 02Less transmitter releasedWithout the calcium pulse, the nerve ending releases less of the chemicals that pass the pain signal on, including substance P. The label notes this mechanism is established in animals.
- 03Not an opioidIt does not touch opioid receptors, opioid antagonists do not reverse it, and it neither causes nor relieves opioid withdrawal. That is why it has no tolerance or dependence, and why it does nothing for people who cannot reach a pump.
A schematic of the compound's mechanism, not a diagnostic image.
What else is it used for?
Each group carries its own evidence level.Approved means regulators have cleared it for that purpose. Investigational means it is in trials. Early research means it is being studied and is not established.
Severe chronic pain
FDA-approved- Human trialSlow-titration trial, 220 adults, three weeks: pain score improved 12% against 5% on placebo (p=0.04). Responders at 30% improvement, 16% versus 12%, not significant. This is the regimen approved.
- Human trialTwo fast-titration trials in cancer or AIDS pain (111 adults) and non-malignant pain (255 adults): pain improved 51% versus 18% and 31% versus 6%. The fast titration caused unacceptable neuropsychiatric effects and is no longer used.
- RegulatoryAcross 1,254 patients and 662 patient-years, about half discontinued at some point for adverse events, against 7% on placebo.
Safety record
FDA-approved- RegulatoryBoxed warning since 2004: severe psychiatric symptoms and neurological impairment. Hallucinations in 12%, paranoid reactions in 3%, psychosis in 1%. Suicide, attempt or ideation at 0.27 per patient-year against 0.10 on placebo.
- RegulatoryCreatine kinase above normal in 40% of patients and above three times normal in 11%, with cases of symptomatic muscle breakdown and kidney failure. The label asks for CK checks every two weeks for the first month.
- RegulatoryNo opioid activity, no tolerance, no dependence, no withdrawal and no respiratory depression. Not a controlled substance.
"A thousand times more potent than morphine" traces to intrathecal potency in a rat pain model, where the molar dose needed was far smaller than morphine's; it says nothing about clinical analgesia and appears in no label or regulatory document. Any suggestion it can be injected under the skin or into a vein is wrong and dangerous: the label states it is not for intravenous use, its blood half-life is about 1.3 hours, peptidases destroy it, and it only works where the spinal fluid carries it. "Non-addictive painkiller" is true as far as it goes, but the drug is restricted for its boxed psychiatric warning and narrow dosing window, not for abuse potential. Research-reagent catalogues sell omega-conotoxin MVIIA with acute-toxicity hazard labels; that is a laboratory tool, not a product anyone should handle at home.
The published record
Papers and trials about Ziconotide
223 papers tagged human · 107 not reviews or lab · 16 clinical trial publications
14 registered trials · 1 with posted results
Counted from Europe PMC indexing, not read by a person; a human tag can land on reviews, commentary or lab papers; clinical trial publications is the narrower count. 405 papers and 14 trials indexed in detail.
At a glance
Four things to know about Ziconotide
Evidence
FDA-approved
Category
Brain, mood and sleep
Common vial
Varies
Half-life
About 4.6 hours in spinal fluid
How much, and do you cycle it?
The range, and whether you take breaks.2.4 up to 19.2 mcg per day by continuous pump (label), continuous infusion. Continuous infusion FDA label
Delivered around the clock by an implanted pump, titrated slowly upward over three weeks. There is no cycle; stopping for side effects is the only interruption the label describes, and it can be done abruptly without withdrawal.
How long does it stay in the body?
The half-life, and where the figure comes from.About 4.6 hours in spinal fluidFDA label
Elimination half-life in cerebrospinal fluid 4.6 hours (range 2.9 to 6.5) in 23 patients, matching the rate the fluid itself turns over. In blood after an intravenous dose the half-life is about 1.3 hours, and after intrathecal infusion blood levels were unmeasurable in most patients. Cleared by peptidases to amino acids.
Source: Prialt prescribing information section 12.3, DailyMed setid b025d8ed-937d-4597-9ad1-0b2f6e0ee5b1
You can compare this against the whole library to see where it sits.
How do I dose and price it?
Enter your vial and your dose. Pick a mix. We show the draw and the cost.The vial holds a fixed amount of drug. Adding more water does not make more drug, it just spreads it thinner, so you draw a bigger number on the syringe for the same dose.
Start at no more than 2.4 mcg per day (0.1 mcg per hour) by continuous intrathecal infusion, raising by up to 2.4 mcg per day no more than two or three times a week, to a maximum of 19.2 mcg per day (0.8 mcg per hour) by day 21. Delivered by an implanted Medtronic SynchroMed pump or an external microinfusion device, in a hospital setting. Given by continuous infusion into the spinal fluid, so no vial draw can be shown and the calculator does not apply.
How do you store it?
Before mixing, and after.Dry powder in the freezer or fridge. Once mixed, fridge, and use within about a month.
Unmixed lyophilized Ziconotide keeps for a long time cold. Once you add water the clock starts: most reconstituted vials hold up for roughly 28 to 30 days at fridge temperature. Keep it out of light, and do not freeze it after mixing.
What are the side effects and cautions?
Known cautions and warnings for this compound.Solubility, computed: 36% charged residues, 36% hydrophobic. Water usually sufficient.
A first-pass rule from peptide manufacturers' guidance. It does not account for disulfide bridges, salt form or how the powder was dried, and it predicts what should be easy rather than what will happen in your vial.
Who should avoid it
- A pre-existing history of psychosis, the boxed contraindication
- Infection at the pump or injection site, uncontrolled bleeding, or a blockage of the spinal canal
- Any route other than an intrathecal pump. The label states it is not for intravenous use; into a vein it could cause severe hypotension
- Depression or suicidal thoughts, where the label calls for great caution because the drug can worsen both
Stop and get help
- Hallucinations, paranoia, confusion that is new or worsening, or any change in mood or consciousness
- Thoughts of suicide
- Muscle pain or weakness with dark urine, a sign of muscle breakdown; creatine kinase rose in 40% of patients
- Fever, stiff neck and headache, since meningitis occurred in 93% of patients using an external pump
- Becoming unresponsive or very hard to rouse
Common effects
- Dizziness in 46% against 13% on placebo, nausea 40% against 29%, confusion 15% against 5%
- Unsteady walking in 14%, abnormal eye movements in 8%, memory problems in 7%, blurred vision in 12%
- Across the whole programme, confusion affected 33% and memory impairment 22%, mostly reversible within about two weeks of stopping
- No respiratory depression, no tolerance, no physical dependence and no withdrawal on stopping
Where this page says nothing is established, that means nobody has studied it, not that a compound is safe.
Is Ziconotide approved?
And where the numbers on this page come from.Yes. Ziconotide is FDA approved and available on prescription in the United States. It is approved in European Union, but not in the United States.
- Approval statusFDA-approved
- RouteInto the spinal fluid by pump (intrathecal only)
- Checked10 October 2026
- Approved outside the USEuropean Union: Authorised in the EU on 21 February 2005 (EMEA/H/C/000551) for severe chronic pain in adults who need intrathecal analgesia; current holder Esteve Pharmaceuticals GmbH. Also approved in the US.This does not change the United States position above.
- DoseFrom the drug label. The manufacturer tested this range and a regulator reviewed it.
- Vial sizeFrom what vendors typically list; not a recommendation.
- SourcesFDA, Prialt (ziconotide intrathecal infusion) prescribing information, DailyMedDrugs@FDA, NDA 021060Rauck RL et al., J Pain Symptom Manage 2006, slow-titration trial (Study 301, NCT00047749)Staats PS et al., JAMA 2004, cancer and AIDS painWallace MS et al., Neuromodulation 2006, non-malignant painEMA, Prialt European public assessment report and product informationFDA GSRS substance record, ziconotide (UNII 7I64C51O16)Deer TR et al., Pain Medicine 2019, review of morphine and ziconotide as first-line intrathecal optionsEsteve, announcement of the TerSera infusion therapies acquisition (13 Jan 2026)
What has happened recently
FDA-approved 28 December 2004 (NDA 021060) with a boxed warning for severe psychiatric symptoms and neurological impairment, present since the first label. EU authorisation 21 February 2005, originally under exceptional circumstances. Not a controlled substance: it has no opioid activity. US rights passed from Elan to Azur, Jazz and TerSera, and in early 2026 Esteve bought TerSera's unit, so one company now holds it worldwide. Label last revised May 2025 (TerSera) and June 2026 (Esteve).
You can compare this against the whole library, or read how to check a seller.
What else is like Ziconotide?
Others in Brain, mood and sleep, side by side.If you're weighing Ziconotide, it's worth reading Selank, Semax, and DSIP (Delta Sleep-Inducing Peptide) in the same class.
The FDA-approved cone-snail peptide for severe chronic pain, delivered only into the spinal fluid.
- Dose
- 2.4 up to 19.2 mcg per day by continuous pump (label)
- How often
- Continuous infusion
A peptide that eases anxiety while keeping you clear-headed.
- Dose
- 0.25 up to 0.5 mg per day
- How often
- 1-2x daily
A peptide used for sharper focus, memory, and mental clarity.
- Dose
- 0.2 up to 0.6 mg per day
- How often
- 1-2x daily
A before-bed peptide used to deepen sleep.
- Dose
- 0.1 up to 0.2 mg per dose (start low, increase slowly)
- How often
- Nightly
Guides for this compound
- How to Reconstitute a Peptide
Mix peptide powder with bacteriostatic water, step by step.
- How to Read an Insulin Syringe
Read the units, convert to millilitres, and draw the exact dose.
- mcg vs mg: The Peptide Dosing Mistake to Avoid
Your vial says mg and your protocol says mcg. Here is the conversion and how to check it.
Sources
- FDA, Prialt (ziconotide intrathecal infusion) prescribing information, DailyMed(2025)Boxed warning for severe psychiatric symptoms and neurological impairment; contraindicated with a history of psychosis. Start at 2.4 mcg/day, maximum 19.2 mcg/day by day 21. CSF half-life 4.6 hours. Adverse reactions in the slow-titration trial: dizziness 46% versus 13%, nausea 40% versus 29%, confusion 15% versus 5%. Creatine kinase above normal in 40%.
- Drugs@FDA, NDA 021060(2004)Approved 28 December 2004 as a new molecular entity. Label supplements through 2023 and 2025.
- Rauck RL et al., J Pain Symptom Manage 2006, slow-titration trial (Study 301, NCT00047749)(2006)220 adults with severe chronic pain, three weeks, slow titration. Pain score improved 14.7% on ziconotide against 7.2% on placebo (p=0.036; the FDA label reads 12% versus 5%, p=0.04). Responders (30% improvement) 16.1% versus 12.0%, not significant. This is the regimen in the label.
- Staats PS et al., JAMA 2004, cancer and AIDS pain(2004)111 adults, fast titration over five to six days. Pain score improved 51.4% against 18.1% on placebo (p<0.001). The fast titration was later abandoned on safety grounds.
- Wallace MS et al., Neuromodulation 2006, non-malignant pain(2006)255 adults, fast titration. Pain score improved 31.2% against 6.0% (p<0.001); responders 33.7% versus 12.8%.
- EMA, Prialt European public assessment report and product information(2026)Authorised 21 February 2005, originally under exceptional circumstances, with the regulator noting the slow-titration trial met its primary endpoint only marginally. Current holder Esteve Pharmaceuticals GmbH. EU maximum 21.6 mcg/day.
- FDA GSRS substance record, ziconotide (UNII 7I64C51O16)(2026)25-residue sequence CKGKGAKCSRLMYDCCTGSCRSGKC with disulfide bonds 1-16, 8-20 and 15-25 and a C-terminal amide; synonym omega-conotoxin MVIIA; molecular weight 2,639.
- Deer TR et al., Pain Medicine 2019, review of morphine and ziconotide as first-line intrathecal options(2019)Both are first-line intrathecal agents in the Polyanalgesic Consensus Conference framework. No adequately powered randomised head-to-head trial exists.
- Esteve, announcement of the TerSera infusion therapies acquisition (13 Jan 2026)(2026)Esteve acquired the US rights to Prialt, consolidating worldwide ownership; closed in the first quarter of 2026.
Beyond these, 419 records are indexed. Browse the records