Tolperisone

Overview

Tolperisone is an oral, centrally acting muscle relaxant. Its precise mechanism is not completely understood, though it blocks sodium and calcium channels. It possesses a high affinity for nervous system tissue, reaching highest concentrations in brain stem, spinal cord and peripheral nerves. Based on existing clinical data, Tolperisone is not sedating and does not interact with alcohol.

Indication

Investigated for use/treatment in neurologic disorders, spinal cord injuries, muscle spasm, back pain, and multiple sclerosis.

Associated Conditions

Spasticity

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
The Prognostic Value of Biomarkers and the Effect of Tolperisone in Acute Low Back Pain and Sciatic Pain "BETA"	2022/09/16	NCT05544656	Phase 3	Active, not recruiting	Semmelweis University
Efficacy and Safety of Tolperisone in Subjects With Pain Due to Acute Back Muscle Spasm	2020/12/17	NCT04671082	Phase 3	Completed	Neurana Pharmaceuticals, Inc.
A Phase 1 PK Study of Tolperisone in Healthy Subjects	2020/07/10	NCT04465266	Phase 1	Completed	Neurana Pharmaceuticals, Inc.
Effects of Tolperisone on Measures of Drowsiness and Cognitive Function	2020/05/29	NCT04407377	Phase 1	Completed	Neurana Pharmaceuticals, Inc.
Tolperisone in Acute Muscle Spasm of the Back	2019/01/14	NCT03802565	Phase 2	Completed	Neurana Pharmaceuticals, Inc.
Safety and Preliminary Effectiveness of AV650 in Patients With Spasticity Associated With Multiple Sclerosis	2007/09/20	NCT00532532	Phase 2	Terminated	Avigen
Safety and Preliminary Effectiveness of AV650 in Patients With Spasticity Due to Spinal Cord Injury	2007/09/18	NCT00531466	Phase 2	Terminated	Avigen
AV650 Drug-Drug Interaction Study	2007/04/05	NCT00456560	Phase 1	Completed	Avigen
Study to Examine the Safety, Tolerability, and Pharmacokinetics of AV650	2006/08/15	NCT00364039	Phase 1	Completed	Avigen

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
No EMA approvals found for this drug.

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
Tolperisone Hydrochloride Tablets	赤峰蒙欣药业有限公司	国药准字H15021272	化学药品	片剂(糖衣)	5/7/2020
Tolperisone Hydrochloride Tablets	哈尔滨泰华药业股份有限公司	国药准字H23023084	化学药品	片剂	7/2/2024
Tolperisone Hydrochloride Tablets	山西太原药业有限公司	国药准字H14022897	化学药品	片剂	4/20/2020
Tolperisone Hydrochloride Tablets	黑龙江诺捷制药有限责任公司	国药准字H23022632	化学药品	片剂(糖衣)	4/20/2020
Tolperisone Hydrochloride Tablets	天方药业有限公司	国药准字H41024965	化学药品	片剂	4/7/2024
Tolperisone Hydrochloride Tablets	华润紫竹药业有限公司	国药准字H11022135	化学药品	片剂(糖衣)	12/8/2020
Tolperisone Hydrochloride Tablets	河南润弘制药股份有限公司	国药准字H41024794	化学药品	片剂	5/18/2020
Tolperisone Hydrochloride Tablets	中山可可康制药有限公司	国药准字H44024425	化学药品	片剂	9/28/2020
Tolperisone Hydrochloride Tablets	南京白敬宇制药厂	国药准字H32026625	化学药品	片剂	7/14/2020
Tolperisone Hydrochloride Tablets	广西南宁百会药业集团有限公司	国药准字H45021451	化学药品	片剂	9/13/2020

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.

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