Recent Updates
Recently added Catalysts

deferasirox

Phase 2

Mucormycosis | Small molecule | Other |Gilead Sciences, Inc.|Last Updated: Oct 16, 2023

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment20
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00419770The Deferasirox-AmBisome Therapy for Mucormycosis (DEFEAT Mucor) StudyPHASE2 COMPLETED 20Oct 1, 2007Dec 1, 2010Oct 16, 20237 United States
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Safety and Tolerability of Adjunctive Deferasirox Therapy in Patients Being Treated With LAmB for Mucormycosis
14 days
Global Response Rate (Composite of Clinical and Radiographic Response) at End of Study Drug Administration, as Determined by a Blinded Adjudication Committee
14 days
Total Adverse Events
30 Days After End of Therapy
Secondary Endpoints
Deferasirox Pharmacokinetic and Pharmacodynamic Parameters
7 days
Survival, Radiographic Improvement, Clinical Response, Time to Survival, Deferasirox vs. Free Iron Level Correlation
Up to 90 days
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
BEXPERIMENTALDeferasirox
APLACEBO_COMPARATOR -
Interventions
NameTypeDescription
deferasiroxDRUG20 mg/kg enterally per day
PlaceboDRUG -
Liposomal amphotericin BDRUG -
Unlock Study Design Details
Eligibility Criteria
Age Range2 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites7

Inclusion Criteria: * Age greater than 2 years. * Proven or probable invasive mucormycosis, as defined by modification of consensus European Organization for Research and Treatment of Cancer (EORTC)/Mycosis Study Group (MSG) criteria. In brief, proven mucormycosis is defined as: 1) histopathologic ...

Countries:United States
Unlock Eligibility Criteria