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Posaconazole

Generic Name
Posaconazole
Brand Names
Noxafil, Posanol, Posaconazole Accord, Posaconazole AHCL
Drug Type
Small Molecule
Chemical Formula
C37H42F2N8O4
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

Pharmacokinetics, Safety, and Tolerability of Intravenous Posaconazole Solution Followed by Oral Posaconazole Suspension in Subjects at High Risk for Invasive Fungal Infections (P05520)

Phase 1
Completed
Conditions
Fungal Infection
Interventions
Drug: Dextrose 5% in water
First Posted Date
2010-02-25
Last Posted Date
2017-11-13
Lead Sponsor
Merck Sharp & Dohme LLC
Target Recruit Count
279
Registration Number
NCT01075984

Pharmacokinetics of Posaconazole Prophylaxis in Acute Leukemia

Phase 2
Completed
Conditions
Leukemia
Fungal Infection
Interventions
First Posted Date
2009-07-09
Last Posted Date
2019-02-27
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
25
Registration Number
NCT00936117
Locations
🇺🇸

UT MD Anderson Cancer Center, Houston, Texas, United States

Pharmacokinetic Study of Posaconazole Boosted Fosamprenavir

Phase 1
Completed
Conditions
Fungal Infection
HIV Infection
Interventions
First Posted Date
2009-01-06
Last Posted Date
2020-11-12
Lead Sponsor
Radboud University Medical Center
Target Recruit Count
24
Registration Number
NCT00817765
Locations
🇳🇱

Radboud University Nijmegen Medical Centre, Nijmegen, Gelderland, Netherlands

Posaconazole Treatment of Invasive Fungal Infection (IFI) (P05551)

Phase 3
Completed
Conditions
Fungal Infection
Interventions
First Posted Date
2008-12-19
Last Posted Date
2017-04-07
Lead Sponsor
Merck Sharp & Dohme LLC
Target Recruit Count
63
Registration Number
NCT00811642

Safety and Efficacy Study of Posaconazole vs. Fluconazole for Prevention of Invasive Fungal Infection (P05387 AM1)(COMPLETED)

Phase 3
Completed
Conditions
Leukopenia
Interventions
First Posted Date
2008-12-19
Last Posted Date
2017-04-07
Lead Sponsor
Merck Sharp & Dohme LLC
Target Recruit Count
252
Registration Number
NCT00811928

Pharmacokinetics of Posaconazole in Children With Chronic Granulomatous Disease (CGD)

Phase 2
Completed
Conditions
Chronic Granulomatous Disease
Interventions
First Posted Date
2008-11-27
Last Posted Date
2020-11-30
Lead Sponsor
Radboud University Medical Center
Target Recruit Count
12
Registration Number
NCT00799071
Locations
🇳🇱

Radboud University Medical Centre Nijmegen, Nijmegen, Gelderland, Netherlands

🇳🇱

AMC, Amsterdam, Netherlands

Oral Posaconazole Three Times Per Day vs Weekly High Dose Amphotericin B Lipid Complex (ABLC)

Phase 3
Completed
Conditions
Hematologic Malignancies
Invasive Fungal Infections
Interventions
First Posted Date
2008-09-11
Last Posted Date
2016-09-29
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
46
Registration Number
NCT00750737
Locations
🇺🇸

UT MD Anderson Cancer Center, Houston, Texas, United States

Post-marketing Surveillance Study of Invasive Mycosis With Posaconazole (Study P04641)

Completed
Conditions
Mycoses
Interventions
First Posted Date
2008-08-01
Last Posted Date
2015-03-05
Lead Sponsor
Merck Sharp & Dohme LLC
Target Recruit Count
214
Registration Number
NCT00726609

Oral Posaconazole in High Risk Patients With Gastrointestinal Dysfunction (Study P05115)

Phase 4
Completed
Conditions
Fungal Infection
Acute Myelogenous Leukemia
Neutropenia
Interventions
First Posted Date
2008-05-30
Last Posted Date
2017-04-07
Lead Sponsor
Merck Sharp & Dohme LLC
Target Recruit Count
75
Registration Number
NCT00686543
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