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NXY-059

Phase 3

Cerebral Stroke | Small molecule | Neurology |AstraZeneca PLC|Last Updated: Jan 4, 2013

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials2
Total Enrollment4,900

FDA Designations

No designations recorded

Clinical trial landscape

NXY-059 · 3 trials · 5 indications

Phase 3 2Phase 2 1
NCT00119626Safety and Effectiveness of NXY-059 for the Treatment of Patients Who Have Suffered From a StrokeCerebral Stroke
COMPLETED1,700 Analytics
NCT00061022Safety and Effectiveness of NXY-059 for the Treatment of Patients Who Have Suffered From a StrokeCerebral Stroke
COMPLETED3,200 Analytics
PHASE3COMPLETED
Safety and Effectiveness of NXY-059 for the Treatment of Patients Who Have Suffered From a Stroke
Cerebral StrokeUnlock trial analytics
PHASE3COMPLETED
Safety and Effectiveness of NXY-059 for the Treatment of Patients Who Have Suffered From a Stroke
Cerebral StrokeUnlock trial analytics

Study Endpoints

Primary Endpoints

Global disability on modified Rankin scale at 90 days.
Global disability on modified Rankin scale at 90 days

Secondary Endpoints

NIH stroke scale (termed "co-primary" in study protocol), Barthel Index, Stroke Impact Scale, EQ-5D all at 90 days, Safety outcomes.
NIH stroke scale
Barthel Index
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
NXY-059DRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Males and females * Acute ischemic stroke with limb weakness, onset of symptoms within 6 hours * Full functional independence prior to the present stroke Exclusion Criteria: * Unconsciousness * Subjects who are unlikely to complete the infusion of investigational product and...

Countries:SwedenUnited KingdomUnited StatesArgentinaAustraliaAustriaBelgiumBrazilBulgariaCanadaChileChinaCzechiaFranceGermanyGreeceHong KongHungaryIsraelMexicoNew ZealandPhilippinesPolandPortugalRussiaSlovakiaSouth AfricaSouth KoreaSpainSwitzerlandTaiwan
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Frequently asked questions about NXY-059

What is NXY-059 used for?

NXY-059 is an investigational small molecule being developed for cerebral stroke and intracerebral hemorrhage. It has been studied in patients who have suffered a stroke, including acute ischemic stroke and transient ischemic attack. The drug is in Phase 3 clinical development but is not approved by the FDA.

What does NXY-059 target?

NXY-059 is a free radical trapping agent, also known as a nitrone, that is designed to protect the brain from damage after a stroke. It works by trapping free radicals that are generated during ischemia and reperfusion, thereby reducing oxidative stress and neuronal injury.

Who makes NXY-059?

NXY-059 is being developed by AstraZeneca PLC, a multinational pharmaceutical company listed on the stock exchange under the ticker symbol AZN. AstraZeneca has conducted clinical trials to evaluate the safety and effectiveness of NXY-059 in stroke patients.

What phase is NXY-059 in?

NXY-059 is in Phase 3 clinical development. It has completed two Phase 3 trials and one Phase 2 trial, with a total enrollment of approximately 4,900 patients. However, it remains investigational and has not received FDA approval.

What clinical trials is NXY-059 in?

NXY-059 has been studied in three completed clinical trials. NCT00061022 was a Phase 3 trial with 3,200 patients for cerebral stroke. NCT00075959 was a Phase 2 trial with 600 patients for intracerebral hemorrhage. NCT00119626 was a Phase 3 trial with 1,700 patients for cerebral stroke.

Is NXY-059 the same as cerovive?

NXY-059 is also known as cerovive, a name that was used in earlier research and development. The drug is a nitrone-based free radical scavenger developed by AstraZeneca for the treatment of stroke. Both names refer to the same investigational compound.