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Clopidogrel Bisulfate

Phase 1FDA approved

Undisclosed | Small molecule | Other |Viatris Inc.|Trials Updated: Apr 24, 2024

Clopidogrel Bisulfate development status

FDA approval on record Feb 27, 2002 as Plavix
Approval holderSanofi Aventis Us
ApplicationNDA020839
Highest phase Phase 1

Label indication Plavix is a P2Y 12 platelet inhibitor indicated for: Acute coronary syndrome – For patients with non–ST-segment elevation ACS (unstable angina [UA]/non–ST-elevation myocardial infarction [NSTEMI]), Plavix has been shown to reduce the rate of myocardial infarction (MI) and stroke. ( 1.1 ) – For patients with ST-elevation myocardial infarction (STEMI), Plavix has been shown to reduce the rate of MI and stroke. FDA label

Clopidogrel Bisulfate target and mechanism

Molecular targetP2RY12
Target classAntagonist
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials2
Total Enrollment93

FDA Designations

No designations recorded

Clopidogrel Bisulfate clinical trials

Clopidogrel Bisulfate · 2 trials · 1 indication

Phase 1 2
NCT00648947Fasting Study of Clopidogrel Bisulfate Tablets 75 mg to Plavix® Tablets 75 mgHealthy
COMPLETED46 Analytics
NCT00650169Food Study of Clopidogrel Bisulfate Tablets 75 mg to Plavix® Tablets 75 mgHealthy
COMPLETED47 Analytics
PHASE1COMPLETED
Fasting Study of Clopidogrel Bisulfate Tablets 75 mg to Plavix® Tablets 75 mg
HealthyUnlock trial analytics
PHASE1COMPLETED
Food Study of Clopidogrel Bisulfate Tablets 75 mg to Plavix® Tablets 75 mg
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

Bioequivalence
within 30 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeOTHER

Treatment Arms

ArmTypeDescription
1EXPERIMENTALClopidogrel Bisulfate Tablets 75 mg
2ACTIVE_COMPARATORPlavix® Tablets 75 mg

Interventions

NameTypeDescription
Clopidogrel Bisulfate Tablets 75 mgDRUG75mg, single dose fasting
Plavix® Tablets 75 mgDRUG75mg, single dose fasting
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Age: 18 years and older. 2. Sex: Male and/or non-pregnant, non-lactating female. 1. Women of childbearing potential must have a negative serum (Beta HCG) pregnancy test performed within 14 days prior to the start of the study and on the evening prior to each dose administ...

Countries:United States
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Frequently asked questions about Clopidogrel Bisulfate

What is Clopidogrel Bisulfate?

Clopidogrel Bisulfate is a small molecule drug developed by Viatris Inc. (ticker VTRS). It is being studied in Phase 1 clinical development. The specific therapeutic indication for this program is undisclosed. It is also known as Clopidogrel Bisulfate Tablets 75 mg.

What does Clopidogrel Bisulfate target?

Clopidogrel Bisulfate targets P2RY12, a receptor that is classified as an antagonist target. By acting as an antagonist at P2RY12, the small molecule modulates the activity of this receptor. This mechanism defines how the drug is designed to work at the molecular level.

Who makes Clopidogrel Bisulfate?

Clopidogrel Bisulfate is developed by Viatris Inc., which trades under the ticker symbol VTRS. Viatris is the sponsor responsible for the clinical development program of this small molecule drug candidate.

What phase is Clopidogrel Bisulfate in?

Clopidogrel Bisulfate is in Phase 1 clinical development. It is an investigational drug and is not approved. The program has completed two Phase 1 trials with a total enrollment of 93 participants. No active trials are currently listed for this drug.

What clinical trials is Clopidogrel Bisulfate in?

Clopidogrel Bisulfate has been studied in two completed Phase 1 trials. NCT00650169 was a food study of Clopidogrel Bisulfate Tablets 75 mg versus Plavix Tablets 75 mg with 47 healthy volunteers. NCT00648947 was a fasting study of the same comparison with 46 healthy volunteers. Both were conducted in the United States.