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Yimitasvir

Phase 1

Hepatic Impairment | Small molecule | Gastrointestinal |Co-Diagnostics, Inc.|Last Updated: Oct 27, 2022

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 Enrollment16
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04552808To Evaluate the Pharmacokinetics and Safety of Yimitasvir Phosphate Capsules in Subjects With Moderate and Severe Liver Function Impairment and in Healthy SubjectsPHASE1 COMPLETED 16Oct 19, 2020Jun 9, 2022Oct 27, 20221 China
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Study Endpoints
Primary Endpoints
Adverse Events
From Days 1-7

Incidence of adverse events

Cmax
From Days 1-5

Maximum plasma concentration of study drugs

AUC
From Days 1-5

Maximum plasma concentration of study drugs

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Study Design & Arms
AllocationNA
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Yimitasvir Phosphate CapsulesEXPERIMENTALThe mechanism of action of Yimitasvir is the specific inhibition of HCV non-structural protein NS5A
Interventions
NameTypeDescription
Yimitasvir PhosphateDRUGCohort A: On the first day, 100 mg of Yimitasvir phosphate was given in a single dose on fasted by each subjects
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Eligibility Criteria
Age Range18 Years — 70 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Sign the informed consent form before the trial and fully understand the contents of the trial, the process and possible adverse reactions. 2. subjects and must be 18 to 70 years of age inclusive. 3. Subjects (including partners) have no pregnancy plan within 3 months after t...

Countries:China
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