Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Pevifoscorvir Sodium (ALG-000184)
Pevifoscorvir · 2 trials · 2 indications
Plasma PK parameters in each cohort of total ALG-001075 and the metabolite ALG-000302
Plasma PK parameters in each cohort of total ALG-001075 and the metabolite ALG-000302
Plasma PK parameters in each cohort of total ALG-001075 and the metabolite ALG-000302
Plasma PK parameters in each cohort of total ALG-001075 and the metabolite ALG-000302
Plasma PK parameters in each cohort of total ALG-001075 and the metabolite ALG-000302
Plasma PK parameters in each cohort of total ALG-001075 and the metabolite ALG-000302
Plasma PK parameters in each cohort of total ALG-001075 and the metabolite ALG-000302
Plasma PK parameters in each cohort of total ALG-001075 and the metabolite ALG-000302
Urine PK parameters in each cohort of total ALG-001075 and the metabolite ALG-000302
Urine PK parameters in each cohort of total ALG-001075 and the metabolite ALG-000302
PK parameters of total ALG-001075 and the major metabolite ALG-000302 in plasma
| Arm | Type | Description |
|---|---|---|
| Subjects with renal Impairment | EXPERIMENTAL | Subjects 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 impairment | EXPERIMENTAL | Subjects 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. |
| Subjects with Hepatic Impairment | EXPERIMENTAL | Subjects with hepatic 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 Hepatic impairment | EXPERIMENTAL | Subjects without hepatic 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. |
| Name | Type | Description |
|---|---|---|
| Pevifoscorvir Sodium (ALG-000184) | DRUG | Pevifoscorvir Sodium (ALG-000184) Single oral doses of 100 mg pevifoscorvir sodium |
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 ...
Pevifoscorvir is an investigational small molecule antiviral being developed for the treatment of chronic hepatitis B infection. It is also known as pevifoscorvir sodium, or by the code ALG-000184. It is a Phase 1 clinical-stage candidate and has received Fast Track and Breakthrough Therapy designations from the FDA.
Pevifoscorvir is being developed for chronic hepatitis B infection. Both completed Phase 1 trials enrolled participants with chronic hepatitis B infection or evaluated the drug in volunteers with renal or hepatic impairment relevant to that patient population. It has not been approved for any use and remains investigational.
Pevifoscorvir is developed by Aligos Therapeutics, Inc., which trades on the Nasdaq under the ticker ALGS. The company is the sponsor of the clinical program for pevifoscorvir sodium, also known as ALG-000184, in chronic hepatitis B infection.
Pevifoscorvir is in Phase 1 clinical development. Two Phase 1 trials have been completed, and neither is currently active. The drug is investigational and has not been approved by the FDA for chronic hepatitis B infection or any other indication.
Two completed Phase 1 trials have studied pevifoscorvir sodium. NCT07342881 evaluated single-dose pharmacokinetics, safety and tolerability in participants with renal impairment and healthy participants with normal renal function, enrolling 12. NCT07342868 evaluated single-dose pharmacokinetics, safety and tolerability in subjects with moderate hepatic impairment and healthy subjects with normal hepatic function, enrolling 20.
Yes. Pevifoscorvir is also known as pevifoscorvir sodium and by the development code ALG-000184. These names refer to the same investigational small molecule antiviral from Aligos Therapeutics that is being studied in chronic hepatitis B infection.