Product Description
Posaconazole is a novel second-generation Triazole oral antifungal agent. It is highly effective in the prophylaxis of invasive fungal infections in immunocompromised patients. It is used as a first-line agent as well as for salvage therapy in invasive fungal infections including aspergillosis, oropharyngeal and esophageal candidiasis. (Sourced from: https://pubmed.ncbi.nlm.nih.gov/20622401/)
Mechanisms of Action: CYP51A1 Inhibitor
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral,Intravenous
FDA Designation: None *
Approval Status: Approved
Approved Countries: Algeria | Argentina | Australia | Austria | Bangladesh | Belgium | Brazil | Canada | Chile | China | Colombia | Croatia | Cyprus | Czech | Denmark | Dominican Republic | Egypt | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | India | Ireland | Israel | Italy | Japan | Korea | Latvia | Lebanon | Lithuania | Luxembourg | Malaysia | Malta | Mexico | Netherlands | New Zealand | Norway | Peru | Poland | Portugal | Romania | Russia | Saudi Arabia | Serbia | Singapore | Slovakia | Slovenia | South Africa | Spain | Sweden | Switzerland | Taiwan | Thailand | Turkey | Ukraine | United Arab Emirates | United Kingdom | United States | Uruguay | Venezuela | Vietnam
Approved Indications: Neutropenia | Graft vs Host Disease | Candidiasis | Candidiasis, Invasive | Candidiasis, Oral | Invasive Fungal Infections | Oncology Hematological Unspecified | Neutropenia | Graft vs Host Disease | Candidiasis | Candidiasis, Invasive | Candidiasis, Oral | Invasive Fungal Infections | Oncology Hematological Unspecified | Neutropenia | Graft vs Host Disease | Aspergillosis | Candidiasis | Candidiasis, Invasive | Candidiasis, Oral | Invasive Fungal Infections | Oncology Hematological Unspecified | Hematopoietic Stem Cell Transplant | Stem Cell Transplant
Known Adverse Events: Headache | Diarrhea | Hypokalemia | Hypertension | Stomatitis | Febrile Neutropenia | Neutropenia | Pruritus | Inflammation
Company: Merck
Company Location: KENILWORTH NJ 07033
Company CEO: Robert M. Davis
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: Belgium, China, Greece, Hungary, Israel, Italy, Korea, Mexico, Peru, Poland, Russia, United States
Active Clinical Trial Count: 13
Highest Development Phases
Phase 2: Anemia, Aplastic|Aspergillosis|Communicable Diseases|Invasive Fungal Infections|Myelodysplastic Syndrome|Onychomycosis|Other|Preleukemia
Phase 1: Graft vs Host Disease|Healthy Volunteers|Hematopoietic Stem Cell Transplant|Neutropenia
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| MK-5592-127 | P2 |
Recruiting |
Communicable Diseases|Invasive Fungal Infections |
2025-12-16 |
|
| MK-5592-127 | P2 |
Unknown Status |
Other |
2025-09-22 |
|
| MK-5592-104 | P2 |
Completed |
Aspergillosis |
2023-12-18 |
24% |
| H-1706-207-866 | P2 |
Completed |
Preleukemia|Myelodysplastic Syndrome|Anemia, Aplastic |
2023-07-15 |