Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
danoprevir · 16 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| with cirrhosis | EXPERIMENTAL | - |
| without cirrhosis | EXPERIMENTAL | - |
| A: setrobuvir | EXPERIMENTAL | - |
| B: setrobuvir + DNV/r | EXPERIMENTAL | - |
| Part 1: iv danoprevir | EXPERIMENTAL | - |
| Part 1: placebo | PLACEBO_COMPARATOR | - |
| Part 2 A: iv danoprevir | EXPERIMENTAL | - |
| Part 2 B: oral danoprevir | ACTIVE_COMPARATOR | - |
| Part 2 C: ritonavir | ACTIVE_COMPARATOR | - |
| Part 3 D: iv danoprevir | EXPERIMENTAL | - |
| Part 3 E: iv danoprevir + cyclosporine | EXPERIMENTAL | - |
| DNV + r reference | ACTIVE_COMPARATOR | - |
| DNV/r fixed dose combination | EXPERIMENTAL | - |
| A danoprevir+ritonavir | ACTIVE_COMPARATOR | - |
| B efavirenz | ACTIVE_COMPARATOR | - |
| C combination | EXPERIMENTAL | - |
| A danoprevir | ACTIVE_COMPARATOR | - |
| B darunavir | PLACEBO_COMPARATOR | - |
| C danoprevir/darunavir | EXPERIMENTAL | - |
| Period 1 Control | ACTIVE_COMPARATOR | - |
| Period 2 danoprevir/ritonavir | EXPERIMENTAL | - |
| Part 1 A | ACTIVE_COMPARATOR | - |
| Part 1 B | EXPERIMENTAL | - |
| Part 1 C | EXPERIMENTAL | - |
| Part 2 D | ACTIVE_COMPARATOR | - |
| Part 2 E | EXPERIMENTAL | - |
| Part 2 F | EXPERIMENTAL | - |
| DNV/r+cyclosporine | EXPERIMENTAL | - |
| cyclosporine | ACTIVE_COMPARATOR | - |
| danoprevir+ritonavir | ACTIVE_COMPARATOR | - |
| A | EXPERIMENTAL | - |
| B | EXPERIMENTAL | - |
| C | ACTIVE_COMPARATOR | - |
| D | PLACEBO_COMPARATOR | - |
| Single arm | EXPERIMENTAL | - |
| 1 | EXPERIMENTAL | - |
| 2 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| danoprevir + ritonavir | DRUG | 125 mg danoprevir + 100 mg ritonvir fixed-dose combination tablet, orally b.i.d., 12 weeks |
| peginterferon alfa-2a [Pegasys] | DRUG | 180 mcg sc weekly, 12 weeks |
| ribavirin [Copegus] | DRUG | 1000-1200 mg orally daily in divided doses, 12 weeks |
| danoprevir | DRUG | 100 mg orally every 12 hours |
| ritonavir | DRUG | 100 mg orally every 12 hours |
| setrobuvir | DRUG | 200 mg orally every 12 hours |
| placebo | DRUG | single iv infusion |
| efavirenz | DRUG | multiple oral doses |
| darunavir | DRUG | 600 mg q12h |
| raltegravir | DRUG | 400 mg q12h Days 1-4 and 18-21 |
| cyclosporine | DRUG | Single oral dose |
| danoprevir placebo | DRUG | single oral dose |
| moxifloxacin | DRUG | 400 mg single dose orally |
| moxifloxacin placebo | DRUG | single oral dose |
| ritonavir placebo | DRUG | single oral dose |
| escitalopram | DRUG | oral doses of escitalopram |
| omeprazole | DRUG | oral doses of omeprazole |
| ranitidine | DRUG | oral dose of ranitidine |
| methadone | DRUG | stable maintenance therapy: 20-120 mg daily single oral morning dose |
| ketoconazole | DRUG | Repeated daily doses |
| ribavirin | DRUG | 1000-1200mg/day po |
Inclusion Criteria: * Adult patients of East Asian or Southeast Asian origin, \>/= 18 years of age * Presence of chronic genotype 1 hepatitis C infection * Treatment-naïve Exclusion Criteria: * History or presence of decompensated liver disease * Presence or history of non-hepatitis C chronic liv...
Danoprevir is an investigational small molecule being studied for the treatment of chronic Hepatitis C, specifically in patients with genotype 1 infection. It has also been evaluated in healthy volunteer studies to assess its pharmacokinetics and potential drug interactions. The drug is still in clinical development and has not been approved by regulatory authorities.
Danoprevir is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company has sponsored multiple clinical trials evaluating the drug for chronic Hepatitis C and in healthy volunteer studies. Roche is responsible for the drug's development program, including its combination studies with other antiviral agents.
Danoprevir is in Phase 1 clinical development. While some completed trials have explored its use in Hepatitis C patients, the overall development program is at an early stage. The drug remains investigational and is not approved for any use. All 14 trials associated with danoprevir have been completed, with no active trials currently ongoing.
Danoprevir has been studied in several completed clinical trials, including NCT01185860, which evaluated ritonavir-boosted danoprevir with Pegasys and ribavirin in chronic Hepatitis C genotype 1 patients. Other trials include NCT01483729, a bioavailability study in healthy volunteers, and NCT01519336, a drug interaction study with darunavir. All trials are completed.
Yes, danoprevir is also known as RO5190591. This alternative name appears in clinical trial records, such as NCT01185860, which refers to ritonavir-boosted danoprevir (RO5190591) in combination with Pegasys and ribavirin. Researchers and investors may encounter either name when reviewing the drug's development history.
Danoprevir is a small molecule that targets the hepatitis C virus protease enzyme, which is essential for viral replication. By inhibiting this protease, the drug aims to block the virus from multiplying in infected cells. It is often administered with ritonavir, a booster that increases danoprevir's exposure in the body.