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Ziconotide regulatory status

Current status of Ziconotide in the United States: FDA approved. In sport: Not WADA prohibited. Details, sources, and the dated timeline follow.

By the PeptideAgent Editorial Team. Draft, pending editorial review.  Last verified

What is the current status of Ziconotide?

Regulatory: FDA approvedWADA: Not WADA prohibitedVerified: Verified Sep 23, 2026
FDA and compounding
FDA approved prescription drug (Prialt, approved December 28, 2004) for severe chronic pain in patients who need intrathecal therapy and are intolerant of or refractory to other treatments. Supplied as sterile solution for intrathecal pumps; hospital pharmacies may dilute it for pump filling. Not on any 503A bulks list and not sold as a research chemical for human use.
WADA
Not WADA prohibited
Access path
  1. Prescription and management by a pain specialist at a clinic or hospital that implants and refills intrathecal pumps.
  2. Not available through retail pharmacies, compounding pharmacies, or telehealth.

Full Ziconotide page: evidence, dosing in the literature, and sources

How has the status of Ziconotide changed over time?

  1. FDA

    FDA approves Prialt (ziconotide) for severe chronic pain

    FDA approved intrathecal ziconotide (Prialt), a synthetic cone snail peptide that blocks N-type calcium channels, for severe chronic pain in patients who need intrathecal therapy.

    Regulatory: FDA approvedSource: Drugs@FDA: Prialt (ziconotide) NDA 021060

Sources

Numbered citations in the answers above point here, followed by the regulatory sources on record for Ziconotide and the source of each dated event.

  1. [1]FDA prescribing information for Prialt (ziconotide) intrathecal infusion, via DailyMedFDA, 2025
  2. [2]WADA Prohibited ListWADA, 2026
  3. [3]Drugs@FDA: Prialt (ziconotide) NDA 021060FDA, 2004