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ODSH

Phase 1

Acute Myeloid Leukemia | Small molecule | Oncology |Jazz Pharmaceuticals plc|Last Updated: Nov 10, 2021

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
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment10
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01843634Ph I Safety and Efficacy of ODSH in Patients Receiving Induction or Consolidation Therapy for Acute Myeloid LeukemiaEARLY_PHASE1 COMPLETED 10Aug 1, 2013Apr 1, 2015Nov 10, 20211 United States
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Study Endpoints
Primary Endpoints
Safety by incidence of serious events
12 months
Efficacy by time to platelet recovery
12 months
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ODSHEXPERIMENTAL -
Interventions
NameTypeDescription
ODSHDRUG -
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Eligibility Criteria
Age Range18 Years — 70 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Newly diagnosed, previously untreated acute myeloid leukemia. Acute promyelocytic leukemia is excluded. * No prior chemotherapy for acute myeloid leukemia; however, prior hydroxyurea to control white blood cell count is allowed. * No prior chemotherapy or lenalinomide for trea...

Countries:United States
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