Posaconazole
Small molecule targets CYP3A4 via inhibition
Regulatory milestones approvals, filings & regulatory actions · 5 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (3) | US (FDA) | NOXAFIL | — | 2021-05-31 – 2026-01-27 | fda.gov ↗ |
| Approved | US (FDA) | NOXAFIL | — | 2006-09-15 | fda.gov ↗ |
| Approved | EU (EMA) | Noxafil | — | 2005-10-25 | europa.eu ↗ |
Trials 64 · started per year
Also used as a comparator or background therapy in 8 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 02 trials | ||||||
| Phase 0 | NCT05528354 Background | Jun 2022 → Dec 2025 | disease related to hematopoietic stem cell transplant | Zhejiang University | Unknown | No outcome recorded |
| Phase 0 | NCT03614455 Background | Jul → Oct 2018 | — | Daiichi Sankyo | Completed | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT07155226 Background | Jan 2026 → Feb 2029 expected | acute lymphoblastic leukemia, acute myeloid leukemia, myelodysplastic syndrome | AstraZeneca | Recruiting | No outcome recorded |
| Phase 1/2 | NCT04988555 Background | Feb 2022 → Jun 2027 expected | acute lymphoblastic leukemia, acute myeloid leukemia, myelodysplastic syndrome, plasma cell myeloma | Sumitomo Pharma America, Inc. | Recruiting | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT04294641 Background | May 2021 → Jun 2024 | chronic graft versus host disease | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 33 trials | ||||||
| Phase 3 | NCT04876716 Background | May 2021 → May 2024 | invasive aspergillosis | Erasmus Medical Center | Terminated | No outcome recorded |
| Phase 3 | NCT04368559 Comparator | May 2020 → Jan 2026 | aspergillosis, candidemia, pneumocystosis | Mundipharma Research Limited | Completed | No outcome recorded |
| Phase 3 | NCT00811928 Comparator | Nov 2008 → May 2010 | leukopenia | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
Evidence & citations 18 cited values
Every value below carries the sentence it was read from. 76 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Posaconazole | “Posaconazole delayed-release tablet [available in 100 mg tablets]: 300 mg twice daily on the first day followed by a maintenance dose of 300 mg once a day, starting on the day...” NCT03434704 ↗69“Voriconazole or isavuconazole or posaconazole will be dosed according to the SPC and according to the route of administration (IV or orally) that is preferred by the treating physician.” NCT04876716 ↗ “compare the efficacy and safety of posaconazole oral suspension vs itraconazole oral solution in preventing IFD post-HSCT.” NCT03631602 ↗ “if Voriconazole or Posaconazole is used to prevent or treat fungal infections” NCT05528354 ↗ “Posaconazole, Voriconazole, or Fluconazole” NCT04988555 ↗ |
| Known as | C-posaconazole | ChEMBL registry synonym — accepted as the source's own label CHEMBL1397 ↗ |
| Known as | Noxafil | “Posaconazole Injection [Noxafil] 300mg” NCT03246386 ↗1“Posaconazole 100 MG [Noxafil]” NCT04966234 ↗ |
| Known as | Noxafil powdermix kit | ChEMBL registry synonym — accepted as the source's own label CHEMBL1397 ↗ |
| Known as | PCZ | “Previous preclinical work has suggested a role for repurposed posaconazole (PCZ) in downregulating HK2 activity, reducing lactate and pyruvate production, interfering with...” PMID 35861778 ↗ Jul 20221“We would like to translate these preclinical findings into the clinical setting by implementing a proof-of biological concept study with two azole drugs: ketoconazole (KCZ) and...” NCT03763396 ↗ |
| Known as | POS | “This study aims to evaluate the pharmacokinetics of posaconazole (POS) administered intravenously (IV) or orally to immunocompromised pediatric participants.” NCT02452034 ↗2“Posaconazole (POS) is a potent triazole antifungal agent approved in adults for treatment and prophylaxis of invasive fungal infections (IFIs).” PMID 30913226 ↗ Mar 2019 “Posaconazole (POS) 6 mg/kg body weight by IV infusion” NCT04218851 ↗ |
| Known as | Posaconazol | ChEMBL registry synonym — accepted as the source's own label CHEMBL1397 ↗ |
| Known as | Posaconazole accord | ChEMBL registry synonym — accepted as the source's own label CHEMBL1397 ↗ |
| Known as | Posaconazole ahcl | ChEMBL registry synonym — accepted as the source's own label CHEMBL1397 ↗ |
| Known as | Posaconazole sp | ChEMBL registry synonym — accepted as the source's own label CHEMBL1397 ↗ |
| Known as | POZ | “This trial is in high risk patients to determine the safety, tolerance and efficacy of posaconazole (POZ) vs. fluconazole in the prophylaxis against development of invasive...” NCT00034645 ↗ |
| Known as | PSZ | “Posaconazole (PSZ) may be an attractive alternative for antifungal prophylaxis” PMID 21772229 ↗ Sep 2011 |
| Known as | SCH 56592 | “The experimental treatment use protocol physician will examine the subject at regular scheduled clinical visits during this experimental treatment use protocol, to determine...” NCT00177749 ↗6“This study is designed to evaluate the safety, tolerance and efficacy of Posaconazole (SCH 56592) under an open label, treatment protocol for subjects with invasive fungal infections:” NCT00034632 ↗ “A Randomized Controlled Trial of Posaconazole (SCH 56592) vs. Standard Azole Therapy for the Prevention of Invasive Fungal Infections Among High-Risk Neutropenic Patients” NCT00044486 ↗ “Phase II Study of Safety, Tolerance, Efficacy, and Pharmacokinetics of Posaconazole (SCH 56592) for the Treatment of Invasive Fungal Infections in Immunocompromised Hosts” NCT00034671 ↗ “This study is designed to evaluate the safety, tolerance and efficacy of Posaconazole (SCH 56592) under an open label, treatment protocol” NCT00034658 ↗ “Oral Posaconazole (SCH 56592)” NCT00686543 ↗ |
| Known as | Suspension Fasted State | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02048345 ↗ |
| Action | Inhibit | “PSZ is known to be a CYP3A4 inhibitor” NCT00799071 ↗ |
| Modality | Small molecule | “experimental triazole antifungal” NCT00033982 ↗ |
| Route | Oral | “This drug will be administered orally twice daily.” NCT00033982 ↗ |
| Target | CYP3A4 | “PSZ is known to be a CYP3A4 inhibitor” NCT00799071 ↗ |