Evidence review: Open Peptide Project (verified against primary PubMed, ClinicalTrials.gov & FDA records) · Last checked 2026-10-27. ← Back to Evidence Library
Ziconotide (Prialt): what the evidence says
At a glance
What it is: an FDA-approved, 25-amino-acid synthetic copy of a cone-snail (Conus magus) toxin that blocks N-type calcium channels. R1, R2 Given only by intrathecal infusion.
What the evidence says: three placebo-controlled trials found pain relief, larger with fast titration but with more side effects. R3, R4, R5
Biggest risks: boxed warning for severe psychiatric symptoms and neurological impairment; contraindicated with a history of psychosis; meningitis risk from the pump. R1
Rating
| Human Human evidence | Moderate: 3 RCTs R3, R4, R5 |
| Animal Animal / lab evidence | Not reviewed here |
| Regulatory | FDA-approved, NDA 021060 · on FDA's 503B Category 1 list (under evaluation; component of an approved drug); not on 503A lists or the safety-risk page · not named on WADA's 2026 list R2, R6, R7, R8, R9 |
| Established human dose | Labeled intrathecal dosing only; see label R1 |
Evidence verdict: Severe chronic pain via intrathecal pump: Moderate (3 placebo-controlled RCTs, modest effect, frequent side effects) · Any other route or use: No human data
This page reports what studies used. It is not dosing advice.
Legend: HUMAN data · ANIMAL / LAB data · UNKNOWN · UNVERIFIED: not yet confirmed against a primary source
About the evidence: benefit is real but modest in the slow-titration trial (14.7% vs 7.2% at week 3). R5
What is it?
Ziconotide blocks pain signals in the spinal cord. It is not an opioid. R1 Related pages: Oxytocin, ARA-290.
Does it work?
- Human Cancer or AIDS pain (n = 108 randomized: 68 vs 40): pain scores improved 53.1% vs 18.1%. R3
- Human Non-cancer pain, fast titration: 31.2% vs 6.0%, with many side effects. R4
- Human Slow titration (n = 220: 112 vs 108): 14.7% vs 7.2%, better tolerated. R5
Is it safe?
- Caution Boxed warning: severe psychiatric symptoms and neurological impairment; stop if they occur. R1
- Human Dizziness, confusion, unsteady walking and memory problems in trials. R5
- Human Label: meningitis and reduced consciousness. R1
Gray-market products: extra risks
A gray-market vial has no quality control and no guarantee of identity, strength or sterility. We test retail vials blind under the Open Peptide Standard; see /tests/. A passing test covers one batch on one date and does not mean the compound is safe. A spinal-pump drug cannot be used safely outside a hospital setting.
Is it legal?
- US: prescription only (NDA 021060). R2 It appears on FDA's 503B Category 1 list. R6
- Sport: not named on WADA's 2026 list. R9
Study details
Study details
These are amounts researchers used, not recommendations.
| Study | People / model | Route | Amount used | Follow-up | Reported | Citation |
|---|---|---|---|---|---|---|
| Staats 2004 | 108 adults, cancer/AIDS pain | Intrathecal | Titrated (per study) | ~11 days | 53.1% vs 18.1% | PMID 14709577 |
| Wallace 2006 | Adults, non-cancer pain | Intrathecal | Fast titration | 6 days | 31.2% vs 6.0% | PMID 22151630 |
| Rauck 2006 | 220 adults | Intrathecal | Slow titration (per study) | 3 weeks | 14.7% vs 7.2% | PMID 16716870 |
Full reference list (PubMed, CT.gov, FDA and WADA checked Oct 26, 2026)
- R1 Prialt prescribing information, label published May 31, 2025 (DailyMed, checked Oct 26, 2026). https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b025d8ed-937d-4597-9ad1-0b2f6e0ee5b1
- R2 Drugs@FDA, Prialt (ziconotide), now Esteve, approved Dec 28, 2004, application NDA021060 (openFDA drugsfda record checked Oct 26, 2026). https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=NDA021060
- R3 Staats PS, et al. JAMA. 2004. PMID 14709577
- R4 Wallace MS, et al. Neuromodulation. 2006. PMID 22151630
- R5 Rauck RL, et al. J Pain Symptom Manage. 2006. PMID 16716870
- R6 FDA, 503B bulk drug substances categories list (updated Mar 21, 2025). https://www.fda.gov/media/94164/download
- R7 FDA, 503A bulk drug substances categories list (updated May 14, 2026). https://www.fda.gov/media/94155/download
- R8 FDA, Certain bulk drug substances for use in compounding that may present significant safety risks (content current Apr 22, 2026). https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks
- R9 WADA. The 2026 Prohibited List, full list checked; compound not named. https://www.wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf
Disclaimer
This page is for education and harm reduction, not medical advice or a recommendation to use Ziconotide (Prialt). Ziconotide is given only by an implanted spinal pump under specialist care. Never inject it any other way. Report problems to FDA MedWatch (https://www.fda.gov/safety/medwatch).