Peptide

Ziconotide (Prialt)

FDA-approved product exists
Not yet scored

BioHarmony verdict

Awaiting review

No BioHarmony report yet. It is queued for review; until then, rely on the status and sources below.

What is Ziconotide (Prialt)?

FDA-approved ziconotide is marketed as Prialt for severe chronic pain in patients for whom intrathecal therapy is warranted and who are intolerant of or refractory to other treatment.

Dosing as published

Approved labelPRIALT prescribing information for severe chronic pain requiring intrathecal therapy
PopulationAdults covered by the approved PRIALT indication under specialist care
DoseStart at no more than 2.4 mcg/day (0.1 mcg/hour). The label permits increases of up to 2.4 mcg/day no more than 2-3 times weekly, up to a recommended maximum of 19.2 mcg/day by day 21.
RouteContinuous intrathecal infusion using a compatible implanted or external microinfusion device
FrequencyContinuous infusion with specialist-directed titration
DurationLong-term specialist-managed use within the approved indication
PreparationUse 25 mcg/mL undiluted; dilute the 100 mcg/mL formulation with preservative-free 0.9% sodium chloride until an appropriate dose is established. Refrigerate prepared solutions, do not freeze, and begin infusion within 24 hours.
Source: Dosage and Administration sections 2.1-2.4; Dosage Forms and Strengths section 3

More reported protocols

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Members can compare additional reported doses, schedules, and preparation notes.

Trust & sourcing

US approvalFDA-approved product exists
CompoundingFDA-approved product exists; compounded copies are not FDA approved
Last checked2026-07-13
Next review2026-10-11

Primary sources

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