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VC005

Phase 1

Renal Impairment | Small molecule | Nephrology |Co-Diagnostics, Inc.|Last Updated: Apr 27, 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
CONTROLLEDBiomarker
Total Trials1
Total Enrollment32
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07551570Pharmacokinetics of VC005 Tablets in Subjects With Renal Impairment and Normal Renal FunctionPHASE1 NOT YET_RECRUITING 32Apr 30, 2026Oct 30, 2026Apr 27, 20261 China
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Study Endpoints
Primary Endpoints
Area under the plasma concentration-time curve(AUC)
Day1-Day3
Maximum Observed Plasma Concentration (Cmax)
Day1-Day3
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Normal Renal FunctionEXPERIMENTAL -
Mild Renal ImpairmentEXPERIMENTAL -
Moderate Renal ImpairmentEXPERIMENTAL -
Severe Renal ImpairmentEXPERIMENTAL -
Interventions
NameTypeDescription
VC005 TabletsDRUGOral single dose
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Eligibility Criteria
Age Range18 Years — 70 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Voluntarily sign the informed consent form prior to the trial, fully understand the trial content, procedures, and possible adverse reactions, and be able to complete the study in accordance with the protocol requirements; 2. Participants (including their partners) are willin...

Countries:China
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