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granisetron system

Phase 1

Chemotherapy Induced Nausea and Vomiting | Small molecule | Other |Co-Diagnostics, Inc.|Last Updated: Jun 17, 2024

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
ACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment19
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01596400Safety and Pharmacokinetics of Sancuso and IV Granisetron in Patients Aged 13 to 17 YearsPHASE1 COMPLETED 19May 1, 2012Dec 1, 2016Jun 17, 202412 United States
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Study Endpoints
Primary Endpoints
Plasma concentration
Up to 7 days

Analysis of the plasma concentration of Intravenous granisetron vs transdermal granisetron in pediatric patients receiving chemotherapy over two sequential cycles.

Secondary Endpoints
Chang is Safety from baseline
Up to 7 days
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Sancuso ArmEXPERIMENTAL -
IV Granisetron ArmACTIVE_COMPARATORIV
Interventions
NameTypeDescription
granisetron transdermal systemDRUGpatch
Granisetron IVDRUGIV
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Eligibility Criteria
Age Range13 Years — 17 Years
SexALL
Healthy VolunteersNo
Study Sites12

Inclusion Criteria: 1. 13 to 17 years of age inclusive at screening. 2. Written patient or parental (or appropriate legal representative) IRB approved informed consent as appropriate. 3. Written patient assent (as appropriate). 4. Confirmed malignancy. 5. Scheduled to receive 2 or more cycles\* of ...

Countries:United States
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