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ALX-0081

Phase 2

Unstable Angina | Small molecule | Cardiovascular |Sanofi|Last Updated: Apr 4, 2023

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment364

FDA Designations

No designations recorded

Clinical trial landscape

ALX-0081 · 1 trial · 3 indications

Phase 2 1
NCT01020383Comparative Study of ALX-0081 Versus GPIIb/IIIa Inhibitor in High Risk Percutaneous Coronary Intervention (PCI) PatientsUnstable Angina
COMPLETED364 Analytics
PHASE2COMPLETED
Comparative Study of ALX-0081 Versus GPIIb/IIIa Inhibitor in High Risk Percutaneous Coronary Intervention (PCI) Patients
Unstable AnginaUnlock trial analytics

Study Endpoints

Primary Endpoints

Incidence and severity of bleeding classified by the following criteria: TIMI major bleeding events, TIMI minor bleeding events, bleeding events requiring medical attention, defined as TIMI minimal bleeding events
30 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ALX-0081EXPERIMENTAL -
GPIIb/IIIa inhibitorACTIVE_COMPARATOR -

Interventions

NameTypeDescription
ALX-0081DRUG4 i.v. bolus injections, once every 6 hours; first dose of 6 mg, three subsequent doses of 4 mg
ReoPro®DRUG0.25 mg/kg i.v. bolus injection followed by continuous i.v. infusion of 0.125 µg/kg/min (to a max. of 10 µg/min) for 12 hours
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites39

Inclusion Criteria: * Have unstable angina or NSTEMI,or stable angina with at least 2 factors indicating a high risk PCI as follows: patient related: diabetic patients, renal failure (glomerular filtration rate \< 60), reduced left ventricular ejection fraction \< 35%, age \> 75 years, female gende...

Countries:AustriaBelgiumCzechiaGermanyIsraelPolandSwitzerland
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Frequently asked questions about ALX-0081

What is ALX-0081 used for?

ALX-0081 is an investigational small molecule being developed for unstable angina, a cardiovascular condition. It is also studied in patients with non-ST segment elevation myocardial infarction (NSTEMI) and stable angina associated with high-risk percutaneous coronary intervention (PCI). The drug is currently in Phase 2 clinical development.

Who makes ALX-0081?

ALX-0081 is being developed by Sanofi, a global biopharmaceutical company listed on the stock exchange under the ticker SNY. Sanofi is conducting clinical trials to evaluate the safety and efficacy of ALX-0081 in cardiovascular indications.

What phase is ALX-0081 in?

ALX-0081 is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials. The drug is being evaluated for use in unstable angina and related cardiovascular conditions.

What clinical trials is ALX-0081 in?

ALX-0081 has one completed Phase 2 clinical trial with the identifier NCT01020383. This study compared ALX-0081 versus a GPIIb/IIIa inhibitor in high-risk percutaneous coronary intervention (PCI) patients. The trial enrolled 364 participants and was conducted in multiple countries including Austria, Belgium, Czechia, Germany, Israel, Poland, and Switzerland.

Is ALX-0081 the same as any other drug?

ALX-0081 is not known to have any alternative names. It is a unique investigational compound being developed by Sanofi. The drug is being studied under its current name in clinical trials for cardiovascular conditions.