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

A Study of the Effects of Posaconazole on Alectinib (RO5424802) Pharmacokinetics in Healthy Volunteers

Phase 1

Completed

Conditions: Healthy Volunteer

Interventions: Drug: Alectinib
Drug: Posaconazole

First Posted Date: 2013-11-14

Last Posted Date: 2016-10-11

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 23

Registration Number: NCT01984229

A Study of the Drug-Drug Interaction of RO5503781 and Posaconazole, the Relative Bioavailability of New Formulations of RO5503781 and the Food-Effect on the Pharmacokinetics of RO5503781 in Patients With Solid Tumors

Phase 1

Completed

Conditions: Neoplasms

Interventions: Drug: RO5503781
Drug: posaconazole

First Posted Date: 2013-07-17

Last Posted Date: 2015-08-18

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 61

Registration Number: NCT01901172

A Study of the Safety and Efficacy of Posaconazole Versus Voriconazole for the Treatment of Invasive Aspergillosis (MK-5592-069)

Phase 3

Completed

Conditions: Fungal Infections
Invasive Pulmonary Aspergillosis

Interventions: Drug: Posaconazole
Drug: Voriconazole
Drug: Placebo

First Posted Date: 2013-02-01

Last Posted Date: 2024-01-18

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 585

Registration Number: NCT01782131

Pharmacokinetics and Safety of Posaconazole Tablet in Participants at High Risk for Invasive Fungal Infections (MK-5592-065/P05615)

Phase 1

Completed

Conditions: Fungal Infections

Interventions: Drug: Posaconazole 200 mg
Drug: Posaconazole 300 mg

First Posted Date: 2013-01-29

Last Posted Date: 2017-04-07

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 230

Registration Number: NCT01777763

A Study of the Safety, Tolerance, and Pharmacokinetics of Oral Posaconazole in Immunocompromised Children (P03579)

Phase 1

Terminated

Conditions: Fungal Infections

Interventions: Drug: Posaconazole 18 mg/kg/day BID
Drug: Posaconazole 12 mg/kg/day TID
Drug: Posaconazole 18 mg/kg/day TID
Drug: Posaconazole 12 mg/kg/day BID

First Posted Date: 2012-10-29

Last Posted Date: 2018-08-27

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 142

Registration Number: NCT01716234

A Pharmacokinetic Analysis of Posaconazole in Lung Transplant Recipients (MK-5592-105)

Phase 4

Terminated

Conditions: Fungal Infection

Interventions: Drug: Posaconazole
Drug: Calogen®

First Posted Date: 2012-08-17

Last Posted Date: 2018-10-09

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 26

Registration Number: NCT01667107

Safety and Efficacy of Posaconazole Oral Suspension in Usual Practice in Korea (P08547)

Completed

Conditions: Fungal Infections

Interventions: Drug: Posaconazole oral suspension 40 mg/mL

First Posted Date: 2011-09-19

Last Posted Date: 2015-07-07

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 273

Registration Number: NCT01436578

A Study of the Use of Oral Posaconazole (POS) in the Treatment of Asymptomatic Chronic Chagas Disease (P05267)

Phase 2

Completed

Conditions: Chagas Disease

Interventions: Drug: Placebo for posaconazole
Drug: Posaconazole
Drug: Benznidazole

First Posted Date: 2011-06-21

Last Posted Date: 2018-08-27

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 120

Registration Number: NCT01377480

Posaconazole Versus Micafungin for Prophylaxis Against Invasive Fungal Infections During Neutropenia in Patients Undergoing Chemotherapy for Acute Myelogenous Leukemia, Acute Lymphocytic Leukemia or Myelodysplastic Syndrome

Phase 4

Completed

Conditions: Acute Myelogenous Leukemia
Myelodysplastic Syndrome

Interventions: Drug: posaconazole
Drug: micafungin

First Posted Date: 2010-09-13

Last Posted Date: 2018-05-07

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Target Recruit Count: 113

Registration Number: NCT01200355

Locations: 🇺🇸
Memorial Sloan Kettering Cancer Center, New York, New York, United States

Clinical Trial For The Treatment Of Chronic Chagas Disease With Posaconazole And Benznidazole

Phase 2

Completed

Conditions: Chagas Disease

Interventions: Drug: Posaconazole
Drug: Benznidazole

First Posted Date: 2010-07-15

Last Posted Date: 2013-09-10

Lead Sponsor: Hospital Universitari Vall d'Hebron Research Institute

Target Recruit Count: 78

Registration Number: NCT01162967

Locations: 🇪🇸
International Health Unit Drassanes, Barcelona, Spain
🇪🇸
Infectious Disease Department Vall d'Hebron Hospital, Barcelona, Spain
🇪🇸
International Health Unit Metropolitana Nord, Santa Coloma, Barcelona, Spain

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