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Also known as setrobuvir
ANA598 · 3 trials · 3 indications
| Arm | Type | Description |
|---|---|---|
| 1 | PLACEBO_COMPARATOR | Peginterferon and ribavirin + placebo BID for 12 weeks, followed by Peg-IFN and RBV for an additional 12 or 36 weeks |
| 2 | EXPERIMENTAL | ANA598 200 mg BID + Peginterferon and ribavirin for 12 weeks, followed by Peg-IFN and RBV for an additional 12 or 36 weeks |
| 3 | EXPERIMENTAL | ANA598 400mg BID + Peginterferon and ribavirin for 12 weeks, followed by Peg-IFN and RBV for an additional 12 or 36 weeks |
| A: STV capsule (after high fat meal) | ACTIVE_COMPARATOR | - |
| B: STV capsule (fasted state) | ACTIVE_COMPARATOR | - |
| C: STV tablet (after high fat meal) | EXPERIMENTAL | - |
| D: STV tablet (fasted state) | EXPERIMENTAL | - |
| Cohort 1 | EXPERIMENTAL | Subjects randomized 8:2 (active:placebo) to receive ANA598 200 mg bid |
| Cohort 2 | EXPERIMENTAL | Subjects randomized 8:2 (active:placebo) to receive ANA598 400 mg bid |
| Cohort 3 | EXPERIMENTAL | Subjects randomized 8:2 (active:placebo) to receive ANA598 800 mg bid |
| Name | Type | Description |
|---|---|---|
| placebo | DRUG | oral BID |
| ANA598 | DRUG | oral 200mg BID |
| Peginterferon | DRUG | 180 μg dose via subcutaneous injection weekly |
| Ribavirin | DRUG | oral 1000 mg/day for patients who weighed \< 75 kg and 1200 mg/day for patients who weighed ≥ 75 kg |
| setrobuvir | DRUG | 200 mg capsule formulation, single oral dose |
| ANA598 200 mg bid or placebo | DRUG | ANA598 200 mg bid or placebo |
| ANA598 400 mg bid or placebo | DRUG | ANA598 400 mg bid or placebo |
| ANA598 800 mg bid or placebo | DRUG | ANA598 800 mg bid or placebo |
Inclusion Criteria: * Male or female, ages 18 to 65 years * Documented chronic HCV infection, genotype 1a or 1b * Treatment-naïve Exclusion Criteria: * Female patients who are pregnant or breast-feeding * Infection with non-genotype 1 HCV * Previous treatment for HCV infection * HIV or HBV positi...
Top 19 of 30 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Pfizer Inc. | PFE | 7 | PHASE3 | VLA15, Prevenar 20, 13vPnC, ATM-AVI, PG4 |
| Sanofi SA Sponsored ADR | SNY | 1 | PHASE3 | PCV21 |
| GSK plc Sponsored ADR | GSK | 4 | PHASE2 | Penmenvy, iNTS-TCV, Strep A vaccine, Pan-Salmonella vaccine |
| Grifols, S.A. Sponsored ADR Class B | GRFS | 1 | PHASE3 | Xembify |
| CorMedix Inc. | CRMD | 1 | PHASE3 | DefenCath |
| Sinovac Biotech Ltd. | SVA | 4 | PHASE3 | Sinovac PCV24, Group ACYW135X Meningococcal Conjugate Vaccine, Group ACYW135 Meningococcal Conjugate Vaccine |
| Novartis AG Sponsored ADR | NVS | 2 | PHASE2 | EDI048 |
| Innoviva, Inc. | INVA | 3 | PHASE2 | Eravacycline, Sulbactam-durlobactam |
| BiomX Inc. | PHGE | 1 | PHASE2 | BX004 |
| Hoffmann-La Roche | RHHBY | 1 | PHASE3 | Baloxavir Marboxil |
| Merck & Co., Inc. | MRK | 2 | PHASE1 | V118C |
| AstraZeneca PLC | AZN | 1 | PHASE1 | AZD7760 |
| BioNTech SE Sponsored ADR | BNTX | 1 | PHASE1 | BNT163 |
| 60 Degrees Pharmaceuticals, Inc. | SXTP | 1 | PHASE2 | Tafenoquine |
| Tarsus Pharmaceuticals, Inc. | TARS | 1 | PHASE2 | TP-05 |
| Moderna, Inc. | MRNA | 1 | PHASE2 | mRNA-1982 |
| AN2 Therapeutics, Inc. | ANTX | 1 | PHASE2 | Epetraborole |
| Emergent BioSolutions Inc. | EBS | 4 | - | AIGIV/kg |
| Phathom Pharmaceuticals, Inc. | PHAT | 1 | - | Vonoprazan |
ANA598 was studied for the treatment of genotype-1 chronic hepatitis C virus (HCV) infection. It was evaluated as part of combination antiviral regimens in adults aged 18 years and older. ANA598 is an investigational small molecule and is not an approved therapy for HCV.
ANA598 was developed by Roche Holding AG, which trades over the counter under the ticker RHHBY. Roche sponsored the clinical program evaluating the compound in chronic hepatitis C. The drug remains an investigational asset and is not a marketed product.
ANA598 is in Phase 1 development. Its clinical program includes a completed Phase 1 study and a completed Phase 2 study in genotype-1 chronic HCV infection. No trials are currently active, and the compound has not been approved for any indication.
ANA598 has been evaluated in two completed trials. NCT00782353 was a Phase 1 study of safety, tolerability, and antiviral activity in 35 patients with genotype-1 chronic HCV infection. NCT00978497 was a Phase 2 study of ANA598 combined with pegylated interferon and ribavirin in 97 patients with genotype-1 chronic HCV infection.
No. ANA598 is an investigational small molecule and has not been approved by the FDA for chronic hepatitis C or any other indication. Its clinical development program, consisting of one Phase 1 and one Phase 2 trial, has been completed.