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IDH305

Phase 1

Advanced Malignancies That Harbor IDHR132 Mutations | Small molecule | Other |Novartis AG|Last Updated: Apr 13, 2026

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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment166
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02381886A Study of IDH305 in Patients With Advanced Malignancies That Harbor IDH1R132 MutationsPHASE1 ACTIVE NOT_RECRUITING 166Mar 6, 2015Oct 31, 2030Apr 13, 202616 United States, Australia +6
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Study Endpoints
Primary Endpoints
Incident rate of dose limiting toxicities (DLTs)
21 days

To estimate the maximum tolerated dose/recommended dose for expansion (MTD/RDE)

Secondary Endpoints
Incidence of adverse events (AEs)
30 months
Plasma PK parameters (AUC, Cmax, Tmax)
30 months
Changes of 2-hydroxyglutarate concentration in patient specimens
30 months
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
IDH305EXPERIMENTAL -
Interventions
NameTypeDescription
IDH305DRUG -
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Eligibility Criteria
Age Range18 Years — 100 Years
SexALL
Healthy VolunteersNo
Study Sites16

Inclusion Criteria: * Documented IDH1R132-mutant tumors * ECOG performance status ≤ 2 Exclusion Criteria: * Patients who have received prior treatment with a mutant-specific IDH1 inhibitor (with the exception of glioma patients) * Medical conditions that would prevent the patient's participation ...

Countries:United StatesAustraliaBelgiumCanadaGermanyNetherlandsSingaporeSpain
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Recent Changes (Last 90 Days)
MEDIUMMay 26, 2026NCT02381886primaryCompletionDate: changed
LOWMay 24, 2026NCT02381886studyFirstPostDate: changed