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Pevifoscorvir

Phase 1

Chronic Hepatitis B Infection | Small molecule | Infectious Disease |Aligos Therapeutics, Inc.|Last Updated: Feb 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 Enrollment30
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07342881Single Dose Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Pevifoscorvir Sodium (ALG-000184) in Participants With Renal Impairment and in Healthy Participants With Normal Renal FunctionPHASE1 RECRUITING 30Feb 20, 2026Jul 1, 2026Feb 27, 20262 United States
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Study Endpoints
Primary Endpoints
Area under the concentration time curve [AUC]
Up to 4 days

Plasma PK parameters in each cohort of total ALG-001075 and the metabolite ALG-000302

Maximum plasma concentration [Cmax]
Up to 4 Days

Plasma PK parameters in each cohort of total ALG-001075 and the metabolite ALG-000302

Minimum plasma concentration [Cmin]
Up to 4 Days

Plasma PK parameters in each cohort of total ALG-001075 and the metabolite ALG-000302

C0 [predose]
Up to 4 days

Plasma PK parameters in each cohort of total ALG-001075 and the metabolite ALG-000302

Half-life [t1/2]
Up to 4 Days

Plasma PK parameters in each cohort of total ALG-001075 and the metabolite ALG-000302

Time to maximum plasma concentration [Tmax]
Up to 4 Days

Plasma PK parameters in each cohort of total ALG-001075 and the metabolite ALG-000302

Apparent Clearance (CL/F)
Up to 4 Days

Plasma PK parameters in each cohort of total ALG-001075 and the metabolite ALG-000302

Apparent Volume of Distribution (V/F)
Up to 4 Days

Plasma PK parameters in each cohort of total ALG-001075 and the metabolite ALG-000302

Total Amount of Drug Excreted in Urine (Ae)
Up to 4 Days

Urine PK parameters in each cohort of total ALG-001075 and the metabolite ALG-000302

Renal Clearance (CLr)
Up to 4 Days

Urine PK parameters in each cohort of total ALG-001075 and the metabolite ALG-000302

Secondary Endpoints
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Up to 15 days
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Subjects with renal ImpairmentEXPERIMENTALSubjects with renal impairment will receive single oral doses of 100 mg pevifoscorvir sodium. Subjects will be followed up for 14 days after the administration of study drug.
Subjects without renal impairmentEXPERIMENTALSubjects without renal impairment will receive single oral doses of 100 mg pevifoscorvir sodium. Subjects will be followed up for 14 days after the administration of study drug.
Interventions
NameTypeDescription
Pevifoscorvir Sodium (ALG-000184)DRUGPevifoscorvir Sodium (ALG-000184) Single oral doses of 100 mg pevifoscorvir sodium
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria for All Subjects: 1. Male and Female between 18 and 75 years old 2. Body Mass Index (BMI) 17.5 to 40.0 kg/m\^2 and a total body weight \>50 kg (110 lb) 3. Female subjects must either be not of childbearing potential or if they are a woman of childbearing potential, they are only ...

Countries:United States
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT07342881primaryCompletionDate: changed
LOWMay 24, 2026NCT07342881studyFirstPostDate: changed