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FG2216

Phase 2

Renal Anemia | Small molecule | Hematology |Kyntra Bio, Inc.|Last Updated: Nov 6, 2007

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
RandomizedUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment145
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00456053A Randomized Study of the Safety and Efficacy of FG-2216 in Subjects With Renal Anemia Not Requiring Dialysis and Not Receiving Recombinant Human ErythropoietinPHASE2 COMPLETED 145Dec 1, 2005Jul 1, 2007Nov 6, 200727 United States
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Study Endpoints
Primary Endpoints
Hemoglobin (Hb) response
Secondary Endpoints
Attainment of Hb target range (11-13)
Duration of maintenance of Hb in target range (11-13)
Safety
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Study Design & Arms
AllocationRANDOMIZED
MaskingSINGLE
ModelFACTORIAL
PurposeTREATMENT
Interventions
NameTypeDescription
FG2216DRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites27

Inclusion Criteria: * Stage 3 or 4 chronic kidney disease * appropriate hemoglobin levels Exclusion Criteria: * Neovascular age related macular degeneration requiring treatment * Macular edema or proliferative retinopathy in diabetic subjects, requiring treatment * Any history of malignancy * The...

Countries:United States
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