Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 being developed for the treatment of chronic hepatitis B infections. It is currently in Phase 1 clinical development and has not been approved by the FDA. The drug is being studied in patients with moderate hepatic impairment and in healthy subjects.
Pevifoscorvir is being developed by Aligos Therapeutics, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol ALGS. The company is conducting clinical trials to evaluate the drug's pharmacokinetics, safety, and tolerability in various patient populations.
Pevifoscorvir is in Phase 1 clinical development. It is an investigational drug and has not received FDA approval. The drug has been granted Fast Track and Breakthrough Therapy designations by the FDA for the treatment of chronic hepatitis B infections.
Pevifoscorvir has two completed Phase 1 clinical trials. NCT07342868 evaluated the drug in subjects with moderate hepatic impairment and healthy subjects with normal hepatic function. NCT07342881 evaluated the drug in participants with renal impairment and healthy participants with normal renal function. Both trials were conducted in the United States.
Yes, Pevifoscorvir is also known as ALG-000184. In clinical trials, the drug is referred to as Pevifoscorvir Sodium (ALG-000184). Both names refer to the same investigational small molecule being developed by Aligos Therapeutics for chronic hepatitis B.