Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Anidulafungin, VER002 · 5 trials · 2 indications
Number of deaths measured 6 weeks after start of treatment. Time to death defined as date of death minus first treatment date + 1.
| Arm | Type | Description |
|---|---|---|
| Voriconazole | ACTIVE_COMPARATOR | Voriconazole monotherapy |
| Voriconazole and Anidulafungin | EXPERIMENTAL | Combination therapy with voriconazole and anidulafungin |
| Name | Type | Description |
|---|---|---|
| voriconazole | DRUG | First week: Voriconazole 6 mg/kg IV bid for the first 24 hours, followed by 4 mg/kg IV BID plus anidulafungin placebo IV qd. Second week: Voriconazole 4 mg/kg IV bid or 300 mg PO bid plus anidulafungin placebo IV qd. Third and fourth weeks: Voriconazole 4 mg/kg IV bid OR 300 mg PO bid plus anidulafungin placebo IV qd, OR Voriconazole 4 mg/kg IV bid or 300 mg PO bid monotherapy. Fifth and sixth weeks: Voriconazole 4 mg/kg IV bid or 300 mg PO bid monotherapy. |
| anidulafungin | DRUG | First week: Voriconazole 6 mg/kg IV bid for the first 24 hours, followed by 4 mg/kg IV bid plus anidulafungin 200 mg IV on day 1, followed by 100 mg IV qd thereafter. Second week: Voriconazole 4 mg/kg IV bid or 300 mg PO bid plus anidulafungin 100 mg IV qd. Third and fourth weeks: Voriconazole 4 mg/kg IV bid OR 300 mg PO bid plus anidulafungin 100 mg IV qd, OR Voriconazole 4 mg/kg IV bid or 300 mg PO bid monotherapy. Fifth and sixth weeks: Voriconazole 4 mg/kg IV bid or 300 mg PO bid monotherapy. |
| Fluconazole | DRUG | - |
| Anidulafungin, VER002 | DRUG | - |
Inclusion Criteria: * Immunocompromised state due to either 1. receipt of hematopoeitic stem cell transplantation or 2. hematologic malignancy; * Diagnosis of possible, probable, or proven invasive aspergillosis. Exclusion Criteria: * Patients with aspergilloma or chronic aspergillosis * Receipt ...
Anidulafungin is an investigational small molecule being developed for infectious disease indications including neutropenia, invasive candidiasis, aspergillosis, candidiasis, and candidemia. It is administered intravenously and has been studied in clinical trials for the treatment of candidiasis and candidemia.
Anidulafungin is being developed by Pfizer, Inc., which trades under the ticker symbol PFE. The drug is an investigational small molecule intended for the treatment of fungal infections such as candidiasis and candidemia.
Anidulafungin has completed Phase 3 clinical trials. It is an investigational drug and has not been reported as FDA approved. The completed trials include Phase 2 and Phase 3 studies for candidiasis and candidemia.
Anidulafungin has completed three clinical trials: NCT00037219, a Phase 2 study in 120 patients with candidiasis; NCT00041704, a Phase 2 study in 19 patients with azole-refractory mucosal candidiasis; and NCT00056368, a Phase 3 study in 256 patients with candidemia and invasive candidiasis. A fourth trial, NCT00537329, was a Phase 3 study in 43 Asian subjects with candidemia.
Anidulafungin is not reported to have any alternative names in the available data. The drug is referred to solely as Anidulafungin in the clinical trial information provided.