Posaconazole

Generic Name: Posaconazole

Brand Names: Noxafil, Posanol, Posaconazole Accord, Posaconazole AHCL

Drug Type: Small Molecule

Chemical Formula: C_₃₇H_₄₂F_₂N_₈O_₄

CAS Number: 171228-49-2

Unique Ingredient Identifier: 6TK1G07BHZ

Background: Posaconazole is a triazole antifungal drug that is used to treat invasive infections by Candida species and Aspergillus species in severely immunocompromised patients.

Indication: For prophylaxis of invasive Aspergillus and Candida infections in patients, 13 years of age and older, who are at high risk of developing these infections due to being severely immunocompromised as a result of procedures such as hematopoietic stem cell transplant (HSCT) recipients with graft-versus-host disease (GVHD), or due to hematologic malignancies with prolonged neutropenia from chemotherapy. Also for the treatment of oropharyngeal candidiasis, including oropharyngeal candidiasis refractory to itraconazole and/or fluconazole. Posaconazole is used as an alternative treatment for invasive aspergillosis, Fusarium infections, and zygomycosis in patients who are intolerant of, or whose disease is refractory to, other antifungals.

Associated Conditions: Candidiasis, Coccidioidomycosis, Esophageal Candidiasis, Fungal Infections, Invasive Aspergillosis, Invasive bronchopulmonary aspergillosis, Mucormycosis, Oropharyngeal Candidiasis, Prophylaxis of Aspergillus infection, Pulmonary cryptococcosis infection

Clinical Trials

King's Invasive Aspergillosis Study II

Phase 4

Completed

Conditions: Aplastic Anemia
Myelodysplastic Syndromes
Leukemia, Myeloid, Acute
Bone Marrow Transplantation

Interventions: Drug: Posaconazole

First Posted Date: 2016-08-23

Last Posted Date: 2020-04-02

Lead Sponsor: King's College Hospital NHS Trust

Target Recruit Count: 120

Registration Number: NCT02875743

Locations: 🇬🇧
King's College Hospital NHS Foundation Trust, London, United Kingdom

Pharmacokinetics of Posaconazole (Noxafil®) as Prophylaxis for Invasive Fungal Infections

Phase 4

Completed

Conditions: Acute Myeloid Leucaemia
Myelo Dysplastic Syndrome
Allogeneic Stem Cell Transplant
Acute Graft Versus Host Disease

Interventions: Drug: posaconazole

First Posted Date: 2016-06-20

Last Posted Date: 2019-12-16

Lead Sponsor: Radboud University Medical Center

Target Recruit Count: 21

Registration Number: NCT02805946

Locations: 🇳🇱
Radboudumc, Nijmegen, Netherlands
🇧🇪
Universitaire Ziekenhuizen Leuven, Leuven, Belgium

Effect of Inflammation on Pharmacokinetics of Posaconazole

Completed

Conditions: Mycoses

Interventions: Drug: posaconazole

First Posted Date: 2015-07-09

Last Posted Date: 2019-08-06

Lead Sponsor: University Medical Center Groningen

Target Recruit Count: 64

Registration Number: NCT02492802

Locations: 🇳🇱
University Medical Center Groningen, Groningen, Netherlands

Safety and Pharmacokinetics of Intravenous and Oral Posaconazole in Immunocompromised Children (MK-5592-097)

Phase 1

Completed

Conditions: Neutropenia

Interventions: Drug: Posaconazole IV solution
Drug: Posaconazole powder for oral suspension

First Posted Date: 2015-05-22

Last Posted Date: 2019-07-26

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 118

Registration Number: NCT02452034

Pharmacokinetics and Safety of Oral Posaconazole (MK-5592)Tablets in Chinese Participants at High Risk for Invasive Fungal Infections (MK-5592-117)

Phase 1

Completed

Conditions: Fungal Infection

Interventions: Drug: Posaconazole

First Posted Date: 2015-03-13

Last Posted Date: 2018-10-09

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 65

Registration Number: NCT02387983

A New Dosing Regimen for Posaconazole Prophylaxis in Children Based on Body Surface Area

Phase 4

Completed

Conditions: Hematological Malignancy

Interventions: Drug: Posaconazole prophylaxis 120 mg/m² tid
Procedure: Blood sampling

First Posted Date: 2015-02-26

Last Posted Date: 2015-03-03

Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

Target Recruit Count: 14

Registration Number: NCT02372357

Locations: 🇧🇪
Catholic University Leuven - Department of Pharmaceutical and Pharmacological Sciences, Leuven, Vlaams-Brabant, Belgium
🇷🇴
Institutul Clinic Fundeni, Bucharest, Sector 2, Romania

Genetic Variation and Variability in Posaconazole Pharmacokinetics in Children

Phase 1

Completed

Conditions: Fungal Infections

Interventions: Drug: Posaconazole

First Posted Date: 2015-02-09

Last Posted Date: 2020-12-22

Lead Sponsor: Children's Mercy Hospital Kansas City

Target Recruit Count: 31

Registration Number: NCT02358499

Locations: 🇺🇸
Children's Mercy Hospital Kansas City, Kansas City, Missouri, United States

Study of ABT-199 (GDC-0199) in Combination With Azacitidine or Decitabine (Chemo Combo) in Subjects With Acute Myelogenous Leukemia (AML)

Phase 1

Terminated

Conditions: Acute Myelogenous Leukemia
Myelogenous Leukemia
Treatment Naive AML

Interventions: Drug: ABT-199
Drug: Posaconazole
Drug: Azacitidine
Drug: Decitabine

First Posted Date: 2014-07-30

Last Posted Date: 2023-05-16

Lead Sponsor: AbbVie

Target Recruit Count: 212

Registration Number: NCT02203773

Locations: 🇺🇸
Johns Hopkins University /ID# 129699, Baltimore, Maryland, United States
🇺🇸
Northwestern University Feinberg School of Medicine /ID# 128741, Chicago, Illinois, United States
🇺🇸
Dana-Farber Cancer Institute /ID# 127857, Boston, Massachusetts, United States

and more 20 locations