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EN3342

Phase 1

Schizophrenia | Small molecule | Psychiatry |BrainsWay Ltd.|Last Updated: Nov 3, 2014

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment35

FDA Designations

No designations recorded

Clinical trial landscape

EN3342 · 1 trial · 1 indication

Phase 1 1
NCT01774435Study in Stabilized Schizophrenic Patients to Evaluate the Pharmacokinetics of Risperidone and 9-Hydroxy (OH)-Risperidone When Risperidone is Administered From a Polyurethane ImplantSchizophrenia
COMPLETED35 Analytics
PHASE1COMPLETED
Study in Stabilized Schizophrenic Patients to Evaluate the Pharmacokinetics of Risperidone and 9-Hydroxy (OH)-Risperidone When Risperidone is Administered From a Polyurethane Implant
SchizophreniaUnlock trial analytics

Study Endpoints

Primary Endpoints

PK parameters (Cmax and AUC) for active moiety, 9-OH-risperidone and risperidone
6 months
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
EN3342EXPERIMENTALEN3342 (risperidone) subcutaneous implant

Interventions

NameTypeDescription
EN3342DRUG -
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Eligibility Criteria

Age Range18 Years to 60 Years
SexALL
Healthy VolunteersNo
Study Sites1

Subject Inclusion Criteria 1. Subject (and/or a subject's authorized legal representative) has provided written informed consent 2. Subject has identified a caregiver or personal contact with whom the subject has significant contact with at least once per week 3. Subject is male or female of non-ch...

Countries:United States
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Frequently asked questions about EN3342

What is EN3342 used for?

EN3342 is an investigational small molecule being developed for the treatment of schizophrenia. It is currently in Phase 1 clinical development and has not been approved by the FDA. The drug is being studied in stabilized schizophrenic patients to evaluate its pharmacokinetics.

Who makes EN3342?

EN3342 is being developed by BrainsWay Ltd., a company traded on the stock exchange under the ticker BWAY. The company is conducting clinical research on this investigational drug for schizophrenia, with the asset currently in Phase 1 development.

What phase is EN3342 in?

EN3342 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 study has been completed, and the drug remains under clinical investigation for schizophrenia.

What clinical trials is EN3342 in?

EN3342 has one completed clinical trial, identified as NCT01774435. This Phase 1 study evaluated the pharmacokinetics of risperidone and 9-hydroxy-risperidone when risperidone is administered from a polyurethane implant in stabilized schizophrenic patients. The trial enrolled 35 participants in the United States.

Is EN3342 the same as risperidone?

EN3342 is associated with the administration of risperidone from a polyurethane implant. The completed clinical trial for EN3342 evaluated the pharmacokinetics of risperidone and its metabolite 9-hydroxy-risperidone when delivered via this implant in patients with schizophrenia.