Ticlopidine

Overview

Ticlopidine is an effective inhibitor of platelet aggregation. It is a prodrug that is metabolised to an active form, which blocks the ADP receptor that is involved in GPIIb/IIIa receptor activation leading to platelet aggregation. Ticlopidine is marketed under the brand name Ticlid and is indicated for patients who cannot take aspirin or in whom aspirin has not worked to prevent a thrombotic stroke. The FDA label includes a black-box warning of neutropenia, aplastic anemia, thrombotic thrombocytopenia purpura, and agranulocytosis, so it is necessary to monitor patients' WBC and platelets when they are taking ticlopidine.

Background

Indication

Used in patients, who have had a stroke or stroke precursors and who cannot take aspirin or aspirin has not worked, to try to prevent another thrombotic stroke.

Associated Conditions

Stroke
Thrombosis (Stent Thrombosis)
Thrombotic Stroke
Subacute stent thrombosis

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
A Study to Assess the Effect of Ticlopidine on the Pharmacokinetics, Safety, and Tolerability of Intranasally Administered Esketamine in Healthy Participants	2017/10/02	NCT03298906	Phase 1	Completed	Janssen Research & Development, LLC
Clopidogrel Resistance and Embolism in Carotid Artery Stenting	2014/05/08	NCT02133989	Phase 3	UNKNOWN	Samsung Medical Center
Effect of Itraconazole and Ticlopidine on the Pharmacokinetics and Pharmacodynamics of Oral Tramadol	2010/10/05	NCT01214941	Phase 4	Completed	Turku University Hospital
Safety Evaluation of Clopidogrel Sulfate in Patients With Peripheral Arterial Disease	2009/03/16	NCT00862420	Phase 3	Completed	Sanofi
Safety Evaluation of Clopidogrel Sulfate in Patients With Stable Angina/Old Myocardial Infarction to Whom Percutaneous Coronary Intervention is Being Planned	2009/01/14	NCT00821834	Phase 3	Completed	Sanofi
Antiplatelet Therapy to Prevent Stroke in African Americans	2000/02/28	NCT00004727	Phase 4	Completed	National Institute of Neurological Disorders and Stroke (NINDS)

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Ticlopidine Hydrochloride	Carilion Materials Management	68151-0079	ORAL	250 mg in 1 1	7/8/2009

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
TIPIDIN TABLET 250 mg	PT. ACTAVIS INDONESIA	SIN10054P	TABLET, FILM COATED	250 mg/tablet	9/23/1998
TIODIN TABLET 250 mg	T O PHARMA CO LTD	SIN10367P	TABLET, FILM COATED	250 mg	11/3/1998
APO-TICLOPIDINE TABLET 250 mg	APOTEX INC	SIN11692P	TABLET, FILM COATED	250 mg	10/5/2001

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
Ticlopidine Hydrochloride Tablets	远大医药（中国）有限公司	国药准字H20066569	化学药品	片剂	12/29/2020
Ticlopidine Hydrochloride Tablets	津药达仁堂集团股份有限公司新新制药厂	国药准字H10950091	化学药品	片剂	4/26/2020
Ticlopidine Hydrochloride Tablets	白云山东泰商丘药业有限公司	国药准字H10970142	化学药品	片剂	8/14/2020
Ticlopidine Hydrochloride Tablets	成都恒瑞制药有限公司	国药准字H20094082	化学药品	片剂	4/24/2024
Ticlopidine Hydrochloride Tablets	苏州弘森药业股份有限公司	国药准字H10970289	化学药品	片剂	6/24/2020
Ticlopidine Hydrochloride Tablets	江苏恒瑞医药股份有限公司	国药准字H10970031	化学药品	片剂	8/31/2020
Ticlopidine Hydrochloride Tablets	津药达仁堂集团股份有限公司新新制药厂	国药准字H20010591	化学药品	片剂	4/26/2020
Ticlopidine Hydrochloride Tablets	山东齐鲁制药有限公司	国药准字H10960037	化学药品	片剂	4/10/2024
Ticlopidine Hydrochloride Capsules	河北长天药业有限公司	国药准字H10980073	化学药品	胶囊剂	5/27/2020
Ticlopidine Hydrochloride Capsules	山西丕康药业有限公司	国药准字H10980258	化学药品	胶囊剂	4/20/2020

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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