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ODSH

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment10

FDA Designations

No designations recorded

Clinical trial landscape

ODSH · 1 trial · 1 indication

Early Phase 1 1
NCT01843634Ph I Safety and Efficacy of ODSH in Patients Receiving Induction or Consolidation Therapy for Acute Myeloid LeukemiaAcute Myeloid Leukemia
COMPLETED10 Analytics
EARLY_PHASE1COMPLETED
Ph I Safety and Efficacy of ODSH in Patients Receiving Induction or Consolidation Therapy for Acute Myeloid Leukemia
Acute Myeloid LeukemiaUnlock trial analytics

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 to 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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Frequently asked questions about ODSH

What is ODSH used for in Acute Myeloid Leukemia?

ODSH is an investigational small molecule being studied for use in Acute Myeloid Leukemia (AML). It was evaluated in a Phase 1 clinical trial in patients receiving induction or consolidation therapy for AML. The drug is still in clinical development and is not approved by the FDA.

Who makes ODSH?

ODSH is being developed by Jazz Pharmaceuticals plc, a biopharmaceutical company traded on the NASDAQ under the ticker JAZZ. The company is conducting clinical research on this investigational small molecule for the treatment of Acute Myeloid Leukemia.

What phase is ODSH in?

ODSH is in Phase 1 clinical development. A Phase 1 trial, identified as NCT01843634, has been completed. This early-phase study evaluated the safety and efficacy of ODSH in patients with Acute Myeloid Leukemia. The drug remains investigational and has not received FDA approval.

What clinical trials is ODSH in?

ODSH has one completed clinical trial, NCT01843634, titled 'Ph I Safety and Efficacy of ODSH in Patients Receiving Induction or Consolidation Therapy for Acute Myeloid Leukemia'. This early Phase 1 study enrolled 10 participants in the United States and was not randomized or blinded.

Is ODSH the same as any other drug?

ODSH is not known by any alternative names in the available information. It is a distinct investigational small molecule being developed by Jazz Pharmaceuticals for Acute Myeloid Leukemia. No other names for this drug have been reported.