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.

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
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
TICLOPIDINE	Apotex Inc	02237560	Tablet - Oral	250 MG	N/A
TICLID 250MG TABLETS	Hoffmann-La Roche Limited	02162776	Tablet - Oral	250 MG	12/31/1995
MYLAN-TICLOPIDINE	Mylan Pharmaceuticals ULC	02239744	Tablet - Oral	250 MG	3/4/1999
TICLOPIDINE-250	PRO DOC LIMITEE	02238208	Tablet - Oral	250 MG	11/18/1999
TICLOPIDINE	sanis health inc	02343045	Tablet - Oral	250 MG	2/16/2010
PMS-TICLOPIDINE	Pharmascience Inc	02243327	Tablet - Oral	250 MG	2/23/2001
TEVA-TICLOPIDINE	teva canada limited	02236848	Tablet - Oral	250 MG	7/30/2002
SANDOZ TICLOPIDINE	Sandoz Canada, Inc.	02243587	Tablet - Oral	250 MG	5/14/2001
TICLOPIDINE	aa pharma inc	02237701	Tablet - Oral	250 MG	3/30/1998
TICLID TAB 250MG	syntex inc.	01911759	Tablet - Oral	250 MG / TAB	12/31/1992

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

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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