COX inhibitors(Cyclooxygenases inhibitors), P2Y12 receptor antagonists(Purinergic receptor P2Y12 antagonists), TBXA2R antagonists(Thromboxane A2 receptor antagonists)

Therapeutic Areas

Nervous System DiseasesCardiovascular Diseases

Active Indication

Angina, StableOld myocardial infarctionAngina, Unstable+ [8]

Inactive Indication

Atherosclerosis

Originator Organization

Sanofi

Active Organization

Mylan NVSanofi-Aventis Groupe SA

Sanofi Winthrop Industrie SA

+ [3]

Inactive Organization

Teva Pharmaceuticals Europe BV

Dong-A ST Co., Ltd.

Sanofi (China) Investment Co. Ltd.

+ [2]

Drug Highest PhaseApproved

First Approval Date

SG (01 Jan 2008),

Acute Coronary SyndromeAngina PectorisMyocardial Infarction+ [1]

Regulation-

Structure

Molecular FormulaC25H26ClNO10S2

InChIKeyUSKPQBRNXDJQGX-CKUXDGONSA-N

CAS Registry937818-61-6

Clinical Trials associated with Clopidogrel Bisulfate/Aspirin

CTIS2024-513665-40-00 / Not yet recruiting

Randomized, open-label, single dose, two-period, two-treatment, cross-over bioequivalence study comparing test product Rivaroxaban/Acetylsalicylic acid, tablet, 2.5 mg/50 mg (given as two tablets) to reference product Xarelto 2.5 mg film-coated tablets (given as two tablets) and Aspirin® N 100 mg tablet in healthy male and female subjects under fasting conditions.

Start Date29 Jul 2024

Sponsor / Collaborator-

CTR20242554 / CompletedNot Applicable

氯吡格雷阿司匹林片在健康人群中的生物等效性试验

[Translation] Bioequivalence study of clopidogrel and aspirin tablets in healthy people

研究空腹和餐后状态下单次口服受试制剂氯吡格雷阿司匹林片（北京福元医药股份有限公司生产）与参比制剂氯吡格雷阿司匹林片（商品名：多立维，Sanofi K.K.持证，Sanofi Winthrop Industrie, Ambares Plant生产）后在健康受试者体内的药代动力学，评价空腹和餐后状态下口服两种制剂的生物等效性。观察受试制剂氯吡格雷阿司匹林片和参比制剂氯吡格雷阿司匹林片在中国健康受试者中的安全性。

[Translation]

The pharmacokinetics of the test preparation clopidogrel aspirin tablets (produced by Beijing Fuyuan Pharmaceutical Co., Ltd.) and the reference preparation clopidogrel aspirin tablets (trade name: Duoliwei, licensed by Sanofi K.K., produced by Sanofi Winthrop Industrie, Ambares Plant) in healthy subjects after a single oral administration in the fasting and fed state were studied to evaluate the bioequivalence of the two preparations in the fasting and fed state. The safety of the test preparation clopidogrel aspirin tablets and the reference preparation clopidogrel aspirin tablets in healthy Chinese subjects was observed.

Start Date23 Jul 2024

Sponsor / Collaborator

Beijing Winsunny Pharmaceutical Co., Ltd.

CTR20241875 / CompletedNot Applicable

氯吡格雷阿司匹林片在健康人群中的生物等效性试验

[Translation] Bioequivalence study of clopidogrel and aspirin tablets in healthy people

空腹和餐后状态下单次口服受试制剂氯吡格雷阿司匹林片（北京福元医药股份有限公司生产）与参比制剂氯吡格雷阿司匹林片（Sanofi K.K.持证，Sanofi Winthrop Industrie, Ambares Plant生产）后，研究受试制剂和参比制剂的吸收速度和吸收程度，初步评估受试制剂和参比制剂是否具有生物等效性，估算参比制剂的个体内变异，为后续研究提供数据参考。观察受试制剂氯吡格雷阿司匹林片和参比制剂氯吡格雷阿司匹林片在中国健康受试者中的安全性。

[Translation]

After a single oral administration of the test preparation clopidogrel aspirin tablets (produced by Beijing Fuyuan Pharmaceutical Co., Ltd.) and the reference preparation clopidogrel aspirin tablets (licensed by Sanofi K.K., produced by Sanofi Winthrop Industrie, Ambares Plant) in the fasting and postprandial states, the absorption rate and extent of the test preparation and the reference preparation were studied, and the bioequivalence of the test preparation and the reference preparation was preliminarily evaluated. The intra-individual variation of the reference preparation was estimated to provide data reference for subsequent studies. The safety of the test preparation clopidogrel aspirin tablets and the reference preparation clopidogrel aspirin tablets in healthy Chinese subjects was observed.

Start Date27 May 2024

Sponsor / Collaborator

Beijing Winsunny Pharmaceutical Co., Ltd.

100 Clinical Results associated with Clopidogrel Bisulfate/Aspirin

100 Translational Medicine associated with Clopidogrel Bisulfate/Aspirin

100 Patents (Medical) associated with Clopidogrel Bisulfate/Aspirin

Literatures (Medical) associated with Clopidogrel Bisulfate/Aspirin

01 Jun 2020·Advances in therapyQ3 · MEDICINE

Implementation of a Reference-Scaled Average Bioequivalence Approach for Highly Variable Acetylsalicylic Acid in Fixed-Dose Combination with Clopidogrel Versus Enteric Aspirin in Chinese Subjects Under Fasting Conditions: A Phase 1, Open-Label, Randomized, Crossover Study

Q3 · MEDICINE

Article

Author: Xie, Fang ; Wang, Lu ; Ming, Jeffrey E ; Zhang, Linlin ; Di, Yujing ; Ping, Chuan ; Yin, Huiqiu ; Li, Yi ; Yang, Na ; Kong, Fangyuan ; Hou, Jie ; Guo, Tingting

INTRODUCTION:

Dual antiplatelet therapy, aspirin and a P2Y₁₂ inhibitor, is recommended to prevent thrombotic complications of acute coronary syndrome. Clopidogrel plus acetylsalicylic acid combination is the most commonly used dual antiplatelet therapy recommended by international guidelines and in Chinese clinical practice. Poor adherence to dual antiplatelet therapy or premature interruption of dual antiplatelet therapy is an important contributor to cardiovascular mortality and lethal cardiovascular events. Clopidogrel + acetylsalicylic acid fixed-dose combination enhances adherence to dual antiplatelet therapy. Herein, we aimed to evaluate bioequivalence of acetylsalicylic acid and clopidogrel in fixed-dose combination compared with simultaneous administration of their individual formulations in healthy Chinese subjects under fasting conditions.

METHODS:

This was a randomized, single-center, open-label, three-sequence, three-period, two-treatment, crossover study with a washout period of 10 days conducted in healthy Chinese volunteers. Subjects were randomized to receive Co-Plavix^® (test formulation- fixed-dose combination of 100 mg acetylsalicylic acid and 75 mg clopidogrel) once and reference formulations (coadministration of individual formulations of 100 mg acetylsalicylic acid and 75 mg clopidogrel) twice during the study period. Pharmacokinetic parameters were analyzed for acetylsalicylic acid, its metabolite salicylic acid, clopidogrel, and its metabolite SR26334. As acetylsalicylic acid shows high intrasubject variability, the reference-scaled average bioequivalence (RSABE) approach was implemented for acetylsalicylic acid analysis, while bioequivalence of clopidogrel was assessed using the average bioequivalence method. Point ratios and confidence intervals (CIs) for AUC, AUC_last, and C_max for acetylsalicylic acid and clopidogrel were calculated.

RESULTS:

In total, 171 healthy subjects were enrolled in this study. Subjects were randomized and 170 subjects were treated with test or reference formulation; 164 subjects completed the study. Regarding acetylsalicylic acid exposure, as reference within-subject standard deviation (SD_W) was at least 0.294 for acetylsalicylic acid C_max, AUC_last, and AUC, the RSABE analysis method was used to assess bioequivalence for all three parameters. The point estimates were within the 0.80-1.25 range (1.19, 1.09, and 1.04, respectively), and upper one-sided 95% CIs of scaled average bioequivalence metric were at most 0 (- 0.30, - 0.14, and - 0.10, respectively). Thus, bioequivalence was demonstrated with acetylsalicylic acid. Bioequivalence was also achieved with clopidogrel as the 90% CIs for geometric mean ratios of clopidogrel C_max, AUC_last, and AUC were within the bioequivalence range (0.80-1.25).

CONCLUSION:

Application of the reference-scaled average bioequivalence approach to evaluate bioequivalence of acetylsalicylic acid in Chinese male and female healthy volunteers under fasting conditions demonstrated bioequivalence of test and reference formulations.

TRIAL REGISTRATION:

CTR20181695.

17 Feb 2017·PlateletsQ3 · MEDICINE

Pharmacodynamic effects of a new fixed-dose clopidogrel–aspirin combination compared with separate administration of clopidogrel and aspirin in patients treated with coronary stents: The ACCEL-COMBO trial

Q3 · MEDICINE

Article

Author: Ahn, Jong-Hwa ; Kwak, Choong Hwan ; Hwang, Jin-Yong ; Tantry, Udaya S. ; Kim, Kyehwan ; Kang, Min Gyu ; Park, Jeong Rang ; Park, Yongwhi ; Gurbel, Paul A. ; Jeong, Young-Hoon ; Koh, Jin-Sin ; Park, Hyun Woong ; Jang, Jeong Yoon ; Hwang, Seok-Jae

Dual antiplatelet therapy (DAPT) with clopidogrel and aspirin is a widely prescribed regimen to prevent ischemic events in patients undergoing percutaneous coronary intervention (PCI). A fixed-dose combination (FDC) capsule (HCP0911) has been developed to provide dosing convenience and improve adherence. We compared the antiplatelet effects of single daily dose HCP0911 with separate treatment with daily 75 mg clopidogrel plus 100 mg aspirin. This was a randomized, open-label, two-period, crossover, non-inferiority study conducted in stented patients who had been treated for at least 6 months with clopidogrel and aspirin. Thirty patients were randomly assigned to receive either daily 75 mg clopidogrel plus 100 mg aspirin treatment or HCP0911 for 2 weeks and then were crossed over to the other treatment for 2 weeks. Pharmacodynamic effects were measured with VerifyNow, light transmittance aggregometry (LTA), and thromboelastography (TEG^®). The primary endpoint was P2Y12 Reaction Units (PRU) measured by VerifyNow. PRUs during treatment with HCP0911 were not inferior to those during separate treatment (202 ± 52 vs. 207 ± 60 PRU; mean difference, -5 PRU; 90% confidence interval of difference, -23 to 13 PRU; P for non-inferiority = 0.015 for predetermined limit). "BASE" and Aspirin Reaction Units by VerifyNow did not differ between the two treatments. During each treatment, there were no differences in maximal and final platelet aggregations by LTA (all P values ≥0.822) and TEG^® measurements. In conclusion, in stented patients, the antiplatelet effect of a fixed-dose clopidogrel-aspirin combination, HCP0911, was not inferior to separate administration of clopidogrel and aspirin.

News (Medical) associated with Clopidogrel Bisulfate/Aspirin

11 Nov 2022

·www.ema.europa.eu

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 7-10 November 2022

Four new medicines recommended for approval EMA’s human medicines committee ( CHMP ) recommended four medicines for approval at its November 2022 meeting. The CHMP recommended authorising the COVID-19 vaccine VidPrevtynBeta (COVID-19 vaccine (recombinant, adjuvanted)) as a booster in adults previously vaccinated with an mRNA or adenoviral vector COVID-19 vaccine. It is the seventh vaccine recommended in the European Union (EU) for protecting against COVID-19 and, together with the vaccines already authorised, will support vaccination campaigns in EU Member States during the pandemic. See more information in the news announcement in the grid below. The committee adopted a positive opinion for a biosimilar medicine , Kauliv (teriparatide), for the treatment of osteoporosis, a health condition that weakens bones, making them fragile and more likely to break. A generic medicine , Pirfenidone Viatris (pirfenidone), received a positive opinion for the treatment of idiopathic pulmonary fibrosis, a chronic and progressive condition in which the lungs become scarred and breathing becomes increasingly difficult. The CHMP adopted a positive opinion for a generic medicine , Sugammadex Amomed (sugammadex), intended for the reversal of neuromuscular blockade induced by rocuronium in adults and children or vecuronium in adults. Rocuronium and vecuronium are muscle relaxants used during some types of surgeries. Sugammadex is used to speed up the recovery from the effects of the muscle relaxant. Recommendations on extensions of therapeutic indication for 11 medicines The committee recommended 11 extensions of indication for medicines that are already authorised in the EU: Ceprotin , Comirnaty , DuoPlavin , Dupixent , Enhertu , Eylea , Imfinzi , Iscover , Lynparza , Plavix and Xofluza . Withdrawals of applications Two applications for marketing authorisation were withdrawn: Orepaxam * for the treatment of pulmonary arterial hypertension, and Febseltiq * for the treatment of cholangiocarcinoma (cancer of the bile ducts). Two applications for extensions of therapeutic indications were withdrawn: Gavreto for the treatment of certain types of thyroid cancer, and Ilaris for the treatment of Schnitzler syndrome, a rare inflammatory disease causing long-term urticaria, recurrent fever, bone and joint pain, and swollen lymph nodes. Question-and-answer documents on the withdrawals are available in the grid below. COVID-19 update The committee recommended extending the use of COVID-19 vaccine Comirnaty targeting the original strain and Omicron subvariants BA.4 and BA.5 in children between 5 to 11 years of age. An overview of all the COVID-19 vaccines authorised in the EU is available on EMA’s website. Safety update The CHMP endorsed the measures recommended by the Pharmacovigilance Risk Assessment Committee ( PRAC ) to minimise the risk of serious side effects with Janus kinase (JAK) inhibitors used to treat several chronic inflammatory disorders. These side effects include cardiovascular conditions, blood clots, cancer and serious infections. This recommendation is the outcome of an article 20 referral procedure, which is triggered for medicines that have been authorised via the centralised procedure in case ofquality, safety or efficacy issues. A public health communication on this referral is available in the grid below. Agenda and minutes The agenda of the November 2022 CHMP meeting is published on EMA's website. Minutes of the October 2022 CHMP meeting will be published in the coming weeks. CHMP statistics Key figures from the November 2022 CHMP meeting are represented in the graphic below. *This product was designated as an orphan medicine during its development. Orphan designations are reviewed by EMA's Committee for Orphan Medicinal Products ( COMP ) at the time of approval to determine whether the information available to date allows maintaining the medicine’s orphan status and granting the medicine ten years of market exclusivity . Positive recommendation on new medicines Name of medicine VidPrevtyn Beta International non-proprietary name (INN) COVID-19 vaccine (recombinant, adjuvanted) Marketing-authorisation applicant Sanofi Pasteur Therapeutic indication VidPrevtyn Beta is indicated as a booster for active immunisation to prevent COVID-19 in adults who have previously received a mRNA or adenoviral vector COVID-19 vaccine More information VidPrevtyn Beta: Pending EC decision News announcement: EMA recommends approval of VidPrevtyn Beta as a COVID 19 booster vaccine Positive recommendation on new biosimilar medicine Name of medicine Kauliv INN teriparatide Marketing-authorisation applicant Strides Pharma Cyprus Therapeutic indication Treatment of osteoporosis More information Kauliv: Pending EC decision Positive recommendations on new generic medicines Name of medicine Pirfenidone Viatris INN pirfenidone Marketing-authorisation applicant Viatris Limited Therapeutic indication Treatment of idiopathic pulmonary fibrosis More information Pirfenidone Viatris: Pending EC decision Name of medicine Sugammadex Amomed INN sugammadex Marketing-authorisation applicant AOP Orphan Pharmaceuticals GmbH Therapeutic indication Reversal of neuromuscular blockade induced by rocuronium or vecuronium More information Sugammadex Amomed: Pending EC decision Positive recommendations on extensions of indications Name of medicine Ceprotin INN human protein C Marketing-authorisation holder Takeda Manufacturing Austria AG More information Ceprotin: Pending EC decision Name of medicine Comirnaty INN tozinameran Marketing-authorisation holder BioNTech Manufacturing GmbH More information Comirnaty: Pending EC decision Name of medicine DuoPlavin INN clopidogrel / acetylsalicylic acid Marketing-authorisationholder Sanofi-aventis groupe More information DuoPlavin: Pending EC decision Name of medicine Dupixent INN dupilumab Marketing-authorisation holder Sanofi-aventis groupe More information Dupixent: Pending EC decision Name of medicine Enhertu INN trastuzumab deruxtecan Marketing-authorisation holder Daiichi Sankyo Europe GmbH More information Enhertu: Pending EC decision Name of medicine Eylea INN aflibercept Marketing-authorisation holder Bayer AG More information Eylea: Pending EC decision Name of medicine Imfinzi INN durvalumab Marketing-authorisation holder AstraZeneca AB More information Imfinzi: Pending EC decision Name of medicine Iscover INN clopidogrel Marketing-authorisationholder Sanofi-aventis groupe More information Iscover: Pending EC decision Name of medicine Lynparza INN olaparib Marketing-authorisationholder AstraZeneca AB More information Lynparza: Pending EC decision Name of medicine Plavix INN clopidogrel Marketing-authorisationholder Sanofi-aventis groupe More information Plavix: Pending EC decision Name of medicine Xofluza INN baloxavir marboxil Marketing-authorisationholder Roche Registration GmbH More information Xofluza: Pending EC decision Withdrawal of initial marketing authorisation application Name of medicine Febseltiq INN infigratinib Marketing-authorisation applicant Helsinn Birex Pharmaceuticals Limited More information Febseltiq: Withdrawn application Name of medicine Orepaxam INN treprostinil diolamine Marketing-authorisationapplicant Ferrer Internacional S.A. More information Orepaxam: Withdrawn application Withdrawals of post-authorisation marketing authorisation applications Name of medicine Gavreto INN pralsetinib More information Gavreto: Withdrawn application Name of medicine Ilaris INN canakinumab More information Ilaris: Withdrawn application Conclusion of referral Name of medicine Janus kinase (JAK) inhibitors More information Janus Kinase inhibitors (JAKi) Other updates List item Scientific advice and protocol assistance adopted during the CHMP meeting 7-10 November 2022 (PDF/246.92 KB) (new) Adopted First published: 11/11/2022 EMA/CHMP/SAWP/872304/2022 List item Start of Union reviews adopted during the CHMP meeting of 7-10 November 2022 (PDF/106.5 KB) (new) Adopted First published: 11/11/2022 EMA/846051/2022

VaccineDrug ApprovalOrphan Drug

100 Deals associated with Clopidogrel Bisulfate/Aspirin

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	B01AC30	-

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Angina, Stable	JP	Sanofi KK	20 Sep 2013
Old myocardial infarction	JP	Sanofi KK	20 Sep 2013
Angina, Unstable	EU	Sanofi Winthrop Industrie SA	14 Mar 2010
Angina, Unstable	IS	Sanofi Winthrop Industrie SA	14 Mar 2010
Angina, Unstable	LI	Sanofi Winthrop Industrie SA	14 Mar 2010
Angina, Unstable	NO	Sanofi Winthrop Industrie SA	14 Mar 2010
Non ST segment elevation acute coronary syndrome	EU	Sanofi Winthrop Industrie SA	14 Mar 2010
Non ST segment elevation acute coronary syndrome	IS	Sanofi Winthrop Industrie SA	14 Mar 2010
Non ST segment elevation acute coronary syndrome	LI	Sanofi Winthrop Industrie SA	14 Mar 2010
Non ST segment elevation acute coronary syndrome	NO	Sanofi Winthrop Industrie SA	14 Mar 2010
Non-Q wave myocardial infarction	EU	Sanofi Winthrop Industrie SA	14 Mar 2010
Non-Q wave myocardial infarction	IS	Sanofi Winthrop Industrie SA	14 Mar 2010
Non-Q wave myocardial infarction	LI	Sanofi Winthrop Industrie SA	14 Mar 2010
Non-Q wave myocardial infarction	NO	Sanofi Winthrop Industrie SA	14 Mar 2010
ST Elevation Myocardial Infarction	EU	Sanofi Winthrop Industrie SA	14 Mar 2010
ST Elevation Myocardial Infarction	IS	Sanofi Winthrop Industrie SA	14 Mar 2010
ST Elevation Myocardial Infarction	LI	Sanofi Winthrop Industrie SA	14 Mar 2010
ST Elevation Myocardial Infarction	NO	Sanofi Winthrop Industrie SA	14 Mar 2010
Thromboembolism	AU	Bristol Myers Squibb Co.	31 Dec 2009
Acute Coronary Syndrome	SG	Sanofi	01 Jan 2008

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Atherosclerosis	Phase 1	-	Dong-A ST Co., Ltd.	01 Sep 2011

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