Posaconazole
Small molecule targets CYP3A4 via inhibition
Regulatory milestones approvals, filings & regulatory actions · 8 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (2) | US (FDA) | NOXAFIL | — | 2021-05-31 – 2026-01-27 | fda.gov ↗ |
| Filed | EU (EMA) | NOXAFIL | — | 2013-11-18 | “Merck also announced that it has filed a marketing authorization application for NOXAFIL IV solution with the European Medicines Agency (EMA)” ligand.com ↗ “The company also has filed a marketing authorization application for NOXAFIL IV solution with the European Medicines Agency (EMA)” merck.com ↗ |
| Filed | US (FDA) | NOXAFIL | — | 2013-11-18 | “intravenous (IV) solution formulation of the company’s antifungal agent, NOXAFIL ® (posaconazole), has been accepted for priority review by the U.S.” merck.com ↗ “New Drug Application for the intravenous (IV) formulation of NOXAFIL® (posaconazole) had been accepted for Priority Review by the FDA.” ligand.com ↗ |
| Filed | EU (EMA) | NOXAFIL | — | 2013-04-10 | “In April, Merck announced that it had filed new drug applications for an investigational, tablet formulation of NOXAFIL with both the FDA and EMA.” merck.com ↗ “The company has filed a marketing authorization application for NOXAFIL tablets with the European Medicines Agency (EMA)” merck.com ↗ |
| Filed | US (FDA) | NOXAFIL | — | 2013-04-10 | “In April, Merck announced that it had filed new drug applications for an investigational, tablet formulation of NOXAFIL with both the FDA and EMA.” merck.com ↗ |
| Approved | US (FDA) | NOXAFIL | — | 2006-09-15 | fda.gov ↗ |
| Approved | EU (EMA) | Noxafil | — | 2005-10-25 | europa.eu ↗ |
Trials 66 · started per year
News releases announcing trial results or a regulatory action · 8
| Date | Issuer | Release |
|---|---|---|
| 2014-09-26 | Ligand Pharmaceuticals | Regulatory Ligand Earns Milestone Payment Triggered by EU Approval of Merck’s Captisol-enabled NOXAFIL® (posaconazole) Concentrate for Solution for Infusion ligand.com ↗
Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) announces that Merck, known as MSD outside the United States and Canada, has received approval for NOXAFIL® (posaconazole) 300 mg Concentrate for Solution for Infusion from the European Medicines Agency (EMA). |
| 2014-07-30 | Merck Sharp & Dohme LLC | Regulatory CHMP Issues Positive Opinion for Intravenous (IV) Formulation of Merck’s NOXAFIL® (posaconazole) merck.com ↗
Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of a new, investigational intravenous (IV) formulation of NOXAFIL ® (posaconazole). |
| 2014-03-17 | Ligand Pharmaceuticals | Regulatory Ligand Earns $1 Million Milestone Payment Triggered by FDA Approval of Merck’s NOXAFIL® (posaconazole) Injection for Intravenous Use, a New Captisol-enabled Formulation ligand.com ↗
Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) announces that it has earned a $1 million milestone payment as a result of the recent U.S. Food and Drug Administration (FDA) approval of Merck’s NOXAFIL® (posaconazole) injection (18 mg/mL). |
| 2014-03-14 | Merck Sharp & Dohme LLC | Regulatory FDA Approves Merck’s NOXAFIL® (posaconazole) Injection (18 mg/mL) for Intravenous Use merck.com ↗
Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration has approved NOXAFIL ® (posaconazole) injection (18 mg/ mL), a new formulation of NOXAFIL for intravenous (IV) use. |
| 2014-02-28 | Merck Sharp & Dohme LLC | Regulatory CHMP Issues Positive Opinion for Tablet Formulation of Merck’s NOXAFIL® (posaconazole) merck.com ↗
Merck (NYSE:MRK), known as MSD outside the United States and Canada, announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of a new, investigational tablet formulation of NOXAFIL ® (posaconazole). |
| 2013-11-26 | Merck Sharp & Dohme LLC | Regulatory FDA Approves Merck’s NOXAFIL® (posaconazole) Delayed-Release Tablets merck.com ↗
Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved NOXAFIL ® (posaconazole) 100 mg delayed-release tablets. |
| 2013-11-18 | Merck Sharp & Dohme LLC | Regulatory Merck’s New Drug Application for an Investigational Intravenous (IV) Formulation of NOXAFIL® (posaconazole) Receives FDA Priority Review merck.com ↗
its New Drug Application for an investigational intravenous (IV) solution formulation of the company’s antifungal agent, NOXAFIL ® (posaconazole), has been accepted for priority review by the U.S. Food and Drug Administration (FDA). |
| 2013-04-10 | Merck Sharp & Dohme LLC | Regulatory Merck Announces FDA Acceptance of New Drug Application for an Investigational Tablet Formulation of the Antifungal NOXAFIL® (posaconazole) merck.com ↗
Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that its New Drug Application for an investigational, tablet formulation of the company’s antifungal agent, NOXAFIL ® (posaconazole), has been accepted for review by the U.S. Food and Drug Administration (FDA). |
All press releases naming this drug 11 releases
Evidence & citations 18 cited values
Every value below carries the sentence it was read from. 78 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 ↗71“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 ↗ “Phase II Study of Safety, Tolerance, Efficacy, and Pharmacokinetics of Posaconazole (SCH 56592) for the Treatment of Invasive Fungal Infections in Immunocompromised Hosts” NCT00034671 ↗ “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 ↗ “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 ↗ |