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ORMD-0801 Treatment A

Phase 2

Type 1 Diabetes | Small molecule | Metabolic |Oramed Pharmaceuticals Inc.|Last Updated: Jun 1, 2022

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLED
Total Trials1
Total Enrollment30
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04150107A Study to Compare ORMD-0801 Once Daily to ORMD-0801 Three Times Daily in Subjects With Type 1 DiabetesPHASE2 COMPLETED 30Oct 1, 2019Mar 1, 2020Jun 1, 2022 -
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Study Design & Arms
Interventions
NameTypeDescription
ORMD-0801 Treatment ADRUGTreatment A: 24 mg (16 mg capsule + 8 mg capsule) Once Daily (QD) at bedtime
ORMD-0801 Treatment BDRUGTreatment B: 8 mg (8 mg capsule) three times a day (TID) 45-90 minutes before meals
PlaceboOTHERFish oil capsule
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