Ziconotide

Overview

Ziconotide (also known as SNX-111) is a neurotoxic peptide derived from the cone snail Conus magus comprising 25 amino acids with three disulphide bonds. Other such peptides, collectively termed conotoxins, exist, and some have shown efficacy in binding specific subsets of calcium channels; ziconotide is used in part because it can be synthesized without loss of proper bond formation or structural elements. Ziconotide is used to manage severe chronic pain refractory to other methods, through its ability to inhibit N-type calcium channels involved in nociceptive signalling. Ziconotide was granted FDA approval on December 28, 2004 for marketing by TerSera therapeutics LLC. under the name Prialt. To date, ziconotide is the only calcium channel blocking peptide approved for use by the FDA.

Indication

用于需要鞘内治疗且对其他镇痛治疗（如应用全身性镇痛药或鞘内注射吗啡等）不耐受或疗效差的严重慢性疼痛患者。

Associated Conditions

Severe, Chronic Pain

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Ziconotide for Non-cancer Pain by Intrathecal Administration	2024/08/07	NCT06541184	N/A	Recruiting	ESTEVE Pharmaceuticals SAS
OP2C : Prialt® Observatory in Clinical Practice	2020/03/25	NCT04321408	N/A	Recruiting	Institut Cancerologie de l'Ouest
Ziconotide as First-Line IDT	2017/10/26	NCT03321955	Phase 4	Completed	Albany Medical College
Single Shot Intrathecal Ziconotide for Painful Neuropathy or Myelopathy	2013/11/25	NCT01992562	Phase 4	Withdrawn	Aaron Boster
Patient Registry of Intrathecal Ziconotide Management(PRIZM)	2013/06/27	NCT01888120	N/A	Completed	Jazz Pharmaceuticals
Intrathecal Bolus Doses of Ziconotide	2011/06/15	NCT01373983	Phase 4	Completed	University Hospital, Linkoeping
Safety and Activity Study of Intrathecally Administered Ziconotide for Neuropathic Pain in Patients With Cancer	2009/10/16	NCT00996983	Phase 2	Active, not recruiting	National Cancer Institute, Naples
Ziconotide Effectiveness and Safety Trial in Patients With Chronic Severe Pain	2004/02/04	NCT00076544	Phase 3	Completed	Elan Pharmaceuticals
Prialt (Ziconotide) In Severe Chronic Pain	2002/10/17	NCT00047749	Phase 3	Completed	Elan Pharmaceuticals
A Multicenter Phase II/III, Placebo-Controlled Study of SNX-111 Administered Intrathecally to Cancer and AIDS Patients With Chronic Pain	2001/08/31	NCT00002160	Phase 2	Completed	Neurex

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
Prialt	Esteve Pharmaceuticals GmbH,Hohenzollerndamm 150-151,14199 Berlin,Germany	Authorised	2/21/2005

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
PRIALT 100 MICROGRAMOS/ML SOLUCION PARA PERFUSION	Esteve Pharmaceuticals Gmbh	04302003	SOLUCIÓN PARA PERFUSIÓN	Uso Hospitalario	Commercialized
PRIALT 100 MICROGRAMOS/ML SOLUCION PARA PERFUSION	Esteve Pharmaceuticals Gmbh	04302001	SOLUCIÓN PARA PERFUSIÓN	Uso Hospitalario	Commercialized

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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