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Enasidenib

Phase 2

Recurrent Acute Myeloid Leukemia | Small molecule | Oncology |Jazz Pharmaceuticals plc|Last Updated: Sep 28, 2023

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 Enrollment2
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03825796CPX-351 Plus Enasidenib for Relapsed AMLPHASE2 ACTIVE NOT_RECRUITING 2Apr 12, 2019Sep 1, 2024Sep 28, 20233 United States
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Study Endpoints
Primary Endpoints
Complete remission (CR)/CR with incomplete hematologic recovery (CRi) after induction therapy
Up to day 60
Secondary Endpoints
Proportion of patients with persistent grade 4 hematologic toxicity per Common Terminology Criteria for Adverse Events (CTCAE) version 4.03
At day 60
Proportion of patients who achieve CR/CRi during maintenance therapy
Up to 2 years
Proportion of patients who achieve CR/complete remission with partial hematologic recovery (CRp) after induction therapy
Up to 2 years
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Treatment (CPX-351, enasidenib mesylate)EXPERIMENTALSee detailed description
Interventions
NameTypeDescription
Enasidenib MesylateDRUGGiven PO
Liposome-encapsulated Daunorubicin-CytarabineDRUGGiven IV
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: * Bone marrow blasts \>= 5% that develops after CR/CRi in patient with prior history of AML, no restriction on prior number of relapses or regimens * AML characterized by the IDH2 gene mutation, without requirement for a particular allelic frequency * Patients previously treated...

Countries:United States
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Recent Changes (Last 90 Days)
LOWMay 24, 2026NCT03825796studyFirstPostDate: changed