At a glance
- Ziconotide is an FDA-approved drug, marketed as Prialt (first approval: December 28, 2004).
- PubMed lists 504 publications mentioning it, including 4 randomized controlled trials and 169 animal-only studies.
- ClinicalTrials.gov lists 14 registered studies testing it (4 active).
- FDA's adverse event system (FAERS) holds 2,717 reports mentioning it; 1,419 classified as serious. Reports do not prove causation.
Research topics
Most frequent MeSH subject headings in the latest PubMed records (English, as indexed).
Regulatory status
Drugs@FDA applications
| Application | Product | Status | First approval | Sponsor |
|---|---|---|---|---|
| NDA021060 | PRIALT | Approved, marketed | December 28, 2004 | ESTEVE |
Source: Drugs@FDA (openFDA) · verified October 30, 2026 · API query
FDA compounding safety list
Not on FDA's list of bulk drug substances that may present significant safety risks in compounding.
Source: FDA.gov — Category 2 bulk drug substances · verified October 30, 2026
Removal of a substance from a regulatory list does not mean it has been approved. A "research use only" label does not make a product safe or legal for human use.
Scientific publications
Counts are PubMed records that mention the peptide in the title or abstract. Categories overlap, and a mention is not the same as testing the peptide as a treatment. Each number opens the exact PubMed search. Effects seen in laboratory or animal studies may not occur in humans. A registered clinical trial does not show that a substance is effective or safe.
Latest publications
- Practical guide to intrathecal drug delivery: short-term and long-term management and complications.
- Resolving conformational polymorphism in disulfide-rich peptide drugs.
- From bench to bedside: experimental pharmacology approaches to overcome bioavailability, stability, and translational barriers of bioactive peptides from natural sources.
- Intrathecal Ziconotide Long-Term Management in Chronic Postamputation Pain.
- Pharmacological Inhibition of Cav2.2 Channels by Recombinant Phα1β Toxin (CTK01512-2).
- Targeting Cav2.2 channels for pain management: challenges, innovations, and future perspectives.
- Pharmaceutical Peptides: From Synthesis and Mechanistic Pharmacology to Future Biologic Therapeutics.
- A magnetic polymer adsorbent based on porous polystyrene microspheres for efficient extraction of conotoxins in biological fluids.
- A targeted partial reduction cyanylation strategy coupled with HRMS for accurate disulfide bridge mapping in disulfide rich cyclic peptides.
- Clinical Advances in Analgesic Drug Development from Ion Channel Modulators.
Source: PubMed (NCBI) · verified October 30, 2026
Clinical trials
- Registered
- 14
- Active
- 4
- With posted results
- 1
Conditions studied
| Study | Status | Phase | Start |
|---|---|---|---|
| Evaluating the Effectiveness of AIT in the Treatment of Pain Related to Pancreatic Cancer | Not yet recruiting | N/A | Sep 2026 |
| Intrathecal Ziconotide in Chemotherapy Induced Peripheral Neuropathy | Not yet recruiting | — | May 2, 2026 |
| Ziconotide for Non-cancer Pain by Intrathecal Administration | Recruiting | — | October 30, 2024 |
| OP2C : Prialt® Observatory in Clinical Practice | Recruiting | — | July 10, 2020 |
| Intrathecal Ziconotide Antalgic Efficacy for Severe Refractory Neuropathic | Unknown status | Phase 3 | June 20, 2019 |
| Ziconotide as First-Line IDT | Completed | Phase 4 | November 3, 2016 |
| Single Shot Intrathecal Ziconotide for Painful Neuropathy or Myelopathy | Withdrawn | Phase 4 | Jan 2014 |
| Patient Registry of Intrathecal Ziconotide Management(PRIZM) | Completed | — | Jul 2013 |
| Intrathecal Bolus Doses of Ziconotide | Completed | Phase 4 | Aug 2011 |
| Safety and Activity Study of Intrathecally Administered Ziconotide for Neuropathic Pain in Patients With Cancer | Unknown status | Phase 2 | Sep 2009 |
Show 4 more studies
| Study | Status | Phase | Start |
|---|---|---|---|
| Patient Registry of Intrathecal Pain Management in Europe for Prialt (Ziconotide Intrathecal Infusion) and Alternative Drugs for the Management of Severe, Chronic Pain. | Completed | — | Apr 2008 |
| Ziconotide Effectiveness and Safety Trial in Patients With Chronic Severe Pain | Completed | Phase 3 | Feb 2004 |
| Prialt (Ziconotide) In Severe Chronic Pain | Completed | Phase 3 | Aug 2002 |
| A Multicenter Phase II/III, Placebo-Controlled Study of SNX-111 Administered Intrathecally to Cancer and AIDS Patients With Chronic Pain | Completed | Phase 2 | — |
All 14 studies on ClinicalTrials.gov ↗
Source: ClinicalTrials.gov · verified October 30, 2026
Adverse event reports
- Reports
- 2,717
- Serious
- 1,419
- With death outcome
- 134
Most reported reactions
Adverse event reports do not prove that the substance caused these effects. Side effects not listed here may still occur. Reaction terms are MedDRA terms as reported to FAERS.
Source: FDA FAERS (FAERS data as of July 30, 2026) · verified October 30, 2026 · API query
FDA prescribing information
Official US prescribing information. Dosing sections are intentionally not shown.
Original FDA text (English) WARNING: NEUROPSYCHIATRIC ADVERSE REACTIONS PRIALT is contraindicated in patients with a preexisting history of psychosis. Severe psychiatric symptoms and neurological impairment may occur during treatment with PRIALT. Monitor all patients frequently for evidence of cognitive impairment, hallucinations, or changes in mood or consciousness. Discontinue PRIALT therapy in the event of serious neurological or psychiatric signs or symptoms. WARNING: NEUROPSYCHIATRIC ADVERSE REACTIONS See full prescribing information for complete boxed warning Severe psychiatric symptoms and neurological impairment may occur during treatment with PRIALT. Do not treat patients with a pre-existing history of psychosis with PRIALT Source: DailyMed / openFDA
Change history
No changes since monitoring began on October 30, 2026.