Clinical Trials

Ziconotide acetate has been evaluated in multiple clinical trials investigating its therapeutic potential across various pain conditions, including neuropathic pain, severe refractory chronic pain, peripheral neuropathy, and pain associated with cancer or HIV infections. These studies span Phase 2, Phase 3, and Phase 4 clinical evaluations, supported by pharmaceutical sponsors such as Elan Pharmaceuticals and Neurex alongside academic research institutions like Albany Medical College and Hospices Civils de Lyon. Specific trials, including NCT00076544, NCT03321955, and NCT03942848, have evaluated intrathecal delivery methods across protocols with recruitment statuses listed as completed, withdrawn, or unknown. Overall, these clinical research efforts emphasize assessing the antalgic efficacy, dosing safety, and administration algorithms of the compound for managing intractable pain syndromes.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT00996983 UNKNOWN
Pain; Neuropathic Pain; Intractable Pain; Cancer
National Cancer Institute, Naples
 2009-09 PHASE2
NCT03321955 COMPLETED
Neuropathic Pain
Albany Medical College
 2016-11-03 PHASE4
NCT03942848 UNKNOWN
Severe Refractory Neuropathic Pain; Spinal Cord Lesions
Hospices Civils de Lyon
 2019-06-20 PHASE3
NCT01992562 WITHDRAWN
Painful Myelopathy; Painful Neuropathy
Aaron Boster
 2014-01 PHASE4
NCT01373983 COMPLETED
Peripheral Neuropathy
University Hospital, Linkoeping
 2011-08 PHASE4
NCT00076544 COMPLETED
Pain
Elan Pharmaceuticals
 2004-02 PHASE3
NCT00002160 COMPLETED
HIV Infections; Cancer; Pain
Neurex
 PHASE2
NCT00047749 COMPLETED
Pain
Elan Pharmaceuticals
 2002-08 PHASE3

(data from https://clinicaltrials.gov, updated on 2023-03-24)

Check the Ziconotide Acetate product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Ziconotide acetate acts as a potent and selective antagonist of N-type voltage-gated calcium channels, blocking calcium influx into presynaptic nerve terminals and suppressing excitatory neurotransmitter release. This inhibition reduces central synaptic transmission and attenuates nociceptive signal propagation, addressing the pathophysiology of severe chronic and neuropathic pain conditions investigated in clinical trials.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

Jump to

Note: Technical data last updated: Sep 1, 2026.