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POSACONAZOLE
Posaconazole is a marketed antifungal agent primarily indicated for the prophylaxis of invasive Aspergillus and Candida infections. Its key strength lies in its broad-spectrum activity against these pathogens, positioning it as a critical option in high-risk patient populations. The primary risk to posaconazole's market position is the expiration of its key composition patent in 2028, which could lead to increased competition from generics.
At a glance
| Generic name | POSACONAZOLE |
|---|---|
| Drug class | Azole Antifungal [EPC] |
| Modality | Small molecule |
| Phase | FDA-approved |
| First approval | 2005 |
Approved indications
- Prophylaxis of Invasive Aspergillus and Candida Infections
Common side effects
- Anemia
- Thrombocytopenia
- Abdominal Pain
- Constipation
- Diarrhea
- Nausea
- Vomiting
- Asthenia
- Chills
- Mucosal Inflammation
- Edema Peripheral
- Pyrexia
Drug interactions
- Rifabutin
- Phenytoin
- Efavirenz
- Cimetidine
- Esomeprazole
- Other drugs metabolized by CYP3A4
- Digoxin
- Fosamprenavir
- Metoclopramide
- Sirolimus
- Tacrolimus
- Cyclosporine
Key clinical trials
- A Phase 1/2 Study of Enzomenib (DSP-5336) in Patients With Acute Leukemia (Horizen-1) (PHASE1, PHASE2)
- A Multicenter RCT of "3+7" vs Venetoclax + CACAG in Newly Diagnosed Mid/High-Risk AML Patients (PHASE2)
- Study of AZD3632 Monotherapy or in Combination With Anticancer Agents in Participants With Advanced Haematologic Malignancies With KMT2Ar, NPM1m, or Other Genotypes Associated With HOX Overexpression (PHASE1, PHASE2)
- Fludarabine Plus Melphalan Versus Addition of Venetoclax to Fludarabine/Melphalan Conditioning Regimen for Allogeneic Hematopoietic Stem Cell Transplantation in AML/MDS Patients Aged > 50 Years: a Multicenter, Randomized, Phase 3 Trial (PHASE3)
- A Platform Protocol to Investigate Post-Transplant Cyclophosphamide-Based Graft-Versus-Host Disease Prophylaxis in Patients With Hematologic Malignancies Undergoing Mismatched Unrelated Donor Peripheral Blood Stem Cell Transplantation (PHASE2)
- Trial of Novel Anti-leukemia Agents in Flu/Mel RIC Transplant for Myeloid Malignancies (PHASE1)
- A Study of BGB-11417 in Participants With Myeloid Malignancies (PHASE1, PHASE2)
- FHD-286 With Low-Dose Weekly Decitabine/Venetoclax in Patients With Acute Myeloid Leukemia (PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- POSACONAZOLE CI brief — competitive landscape report
- POSACONAZOLE updates RSS · CI watch RSS