Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Posaconazole/kg · 1 trial · 1 indication
The Cavg of IV POS is based on population PK analysis.
The Cmax of IV POS is based on population PK analysis.
The Tmax of IV POS is based on population PK analysis.
The AUC 0-24 of IV POS is based on population PK analysis.
The clearance (CL) of IV POS is based on population PK analysis.
The AUC0-∞ of IV POS is based on population PK analysis.
The Cavg of IV POS is based on population PK analysis.
The Cmax of IV POS is based on population PK analysis.
The Tmax of IV POS is based on population PK analysis.
The AUC0-24 of IV POS is based on population PK analysis.
The CL of IV POS is based on population PK analysis.
The Cavg of PFS POS is based on population PK analysis.
The Cmax of PFS POS is based on population PK analysis.
The AUC0-24 of PFS POS is based on population PK analysis.
| Arm | Type | Description |
|---|---|---|
| Panel A: POS IV | EXPERIMENTAL | Posaconazole 6 mg/kg body weight administered in a single dose by IV infusion on Day 1. |
| Panel B: POS IV | EXPERIMENTAL | Posaconazole 6 mg/kg body weight administered twice daily by IV infusion on Day 1, and then once daily from Day 2 to a maximum 84 days. |
| Panel B: POS PFS | EXPERIMENTAL | Following a minimum of 7 days IV dosing, participants as clinically able will be transitioned from POS IV to POS PFS nominal 6 mg/kg body weight based on weight bands administered on Day 8, once daily to a maximum 84 days. |
| Name | Type | Description |
|---|---|---|
| Posaconazole IV 6 mg/kg | DRUG | POS 6 mg/kg body weight by IV infusion |
| Posaconazole PFS 6 mg/kg | DRUG | POS nominal 6 mg/kg body weight based on weight bands taken orally |
Inclusion Criteria: * Panel A: is undergoing treatment for possible, probable, or proven IFI known or suspected to be cause by fungal pathogens against which POS has demonstrated activity (which can include candidiasis) * Panel B: has an investigator-assessed diagnosis of possible, probable, or pro...
Posaconazole is an antifungal drug in Phase 3 development for the prevention and treatment of invasive fungal infections, including invasive aspergillosis, in patients with neutropenia or leukopenia. It is also studied for other fungal infections. It is being developed by Merck & Company, Inc. (MRK).
Posaconazole is a small molecule antifungal that works by inhibiting the synthesis of ergosterol, a key component of the fungal cell membrane. This action disrupts the fungal cell membrane, leading to cell death. It is being studied for use in patients with compromised immune systems who are at risk for invasive fungal infections.
Posaconazole is being developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. The company is conducting clinical trials to evaluate the drug's efficacy and safety in treating and preventing invasive fungal infections.
Posaconazole is currently in Phase 3 clinical development for the treatment of invasive fungal infections. It is an investigational drug and has not yet been approved by regulatory authorities. The drug is also being studied in earlier phase trials for other indications, including Chagas disease.
Posaconazole has been studied in several clinical trials, including NCT00034671 and NCT00550732 for refractory fungal infections, NCT01377480 for Chagas disease, and NCT04665037 for invasive fungal infection in children under 2 years. These trials have enrolled a total of 1074 participants across various phases.
Posaconazole IV 6 mg/kg is a formulation and dosing regimen of Posaconazole. The drug is also known by this name, which specifies the intravenous administration at a dose of 6 mg per kilogram of body weight. This formulation is used in clinical studies to evaluate the drug's pharmacokinetics and efficacy.