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

Posaconazole Plus Pembrolizumab and Chemotherapy Vs Pembrolizumab and Chemotherapy in Neoadjuvant Therapy for Triple Negative Breast Cancer

Phase 2

Recruiting

Conditions: Breast Cancer

Interventions: Drug: Nab-paclitaxel
Drug: Posaconazole
Drug: Carboplatin
Drug: Anthracycline
Drug: Cyclophosphamide
Drug: Pembrolizumab

First Posted Date: 2025-03-25

Last Posted Date: 2025-03-25

Lead Sponsor: Shandong Cancer Hospital and Institute

Target Recruit Count: 20

Registration Number: NCT06802757

Locations: 🇨🇳
Breast Cancer Center Shandong Cancer Hospital and Institute Shandong First Medical University and Shandong Academy of Medical Sciences, Jinan, Shandong, China

Posaconazole Tablet As Primary Prophylaxis of HSCT Patients with Gastrointestinal GVHD

Conditions: Invasive Fungal Disease
Graft Versus Host Disease
Hematopoietic Stem Cell Transplantation

Interventions: Drug: Posaconazole tablet

First Posted Date: 2024-11-20

Last Posted Date: 2024-11-20

Lead Sponsor: Institute of Hematology & Blood Diseases Hospital, China

Target Recruit Count: 40

Registration Number: NCT06698211

Locations: 🇨🇳
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Tianjin, China

Study of Posaconazole Prophylaxis in Patients Receiving Hematopoietic Stem Cell Allograft (allo-HSC) At High Risk of Invasive Fungal Infection (IFI)

Phase 2

Recruiting

Conditions: Hematologic Malignancy

Interventions: Drug: Posaconazole

First Posted Date: 2024-08-07

Last Posted Date: 2025-01-30

Lead Sponsor: Nantes University Hospital

Target Recruit Count: 30

Registration Number: NCT06541067

Locations: 🇫🇷
CHU Nantes, Nantes, France

Amphotericin Versus Posaconazole for Pulmonary Mucormycosis

Phase 2

Recruiting

Conditions: Mucormycosis; Pulmonary (Etiology)

Interventions: Drug: Liposomal Amphotericin B
Drug: Posaconazole 600 mg followed by posaconazole 300 mg once daily

First Posted Date: 2022-07-21

Last Posted Date: 2023-11-27

Lead Sponsor: Post Graduate Institute of Medical Education and Research, Chandigarh

Target Recruit Count: 30

Registration Number: NCT05468372

Locations: 🇮🇳
Postgraduate Institute of Medical Education and Research, Chandigarh, India

Posaconazole Prophylaxis for CAPA Prevention in Critically-Ill Patients

Completed

Conditions: COVID-19 Respiratory Infection
Aspergillosis

Interventions: Drug: Posaconazole

First Posted Date: 2021-10-04

Last Posted Date: 2025-02-17

Lead Sponsor: Medical University of Graz

Target Recruit Count: 249

Registration Number: NCT05065658

Locations: 🇮🇹
San Martino Polyclinic Hospital IRCCS, Genova, Italy
🇫🇷
University of Rennes, Rennes, France
🇦🇹
Medical University of Graz, Graz, Styria, Austria

Pilot Study of Posaconazole in Crohn's Disease

Phase 4

Terminated

Conditions: Crohn Disease
CARD9 S12N Risk Allele

Interventions: Drug: Posaconazole Delayed Release Oral Tablet
Drug: Matching Placebo Tablet

First Posted Date: 2021-07-19

Last Posted Date: 2025-02-21

Lead Sponsor: Cedars-Sinai Medical Center

Target Recruit Count: 10

Registration Number: NCT04966585

Locations: 🇺🇸
Cedars-Sinai Medical Center (CSMC), Los Angeles, California, United States
🇺🇸
Mayo Clinic, Rochester, Minnesota, United States

A New Posaconazole Dosing Regimen for Paediatric Patients With Cystic Fibrosis and Aspergillus Infection

Phase 2

Conditions: Cystic Fibrosis
Aspergillosis

Interventions: Drug: Posaconazole 100 MG [Noxafil]
Drug: Posaconazole 40 MG/ML

First Posted Date: 2021-07-19

Last Posted Date: 2021-07-19

Lead Sponsor: Bambino Gesù Hospital and Research Institute

Target Recruit Count: 135

Registration Number: NCT04966234

Locations: 🇳🇱
University Medical Center Groningen (UMCG), Groningen, Netherlands
🇨🇭
University Children's Hospital Zurich, Zürich, Switzerland
🇵🇹
Centro Hospitalar Universitário Lisboa Norte EPE, Lisbon, Portugal

and more 28 locations

Neuro-pharmacological Properties of Repurposed Posaconazole in Glioblastoma: a Phase 0 Clinical Trial

Early Phase 1

Terminated

Conditions: Glioblastoma Multiforme of Brain
Glioblastoma Multiforme, Adult
Glioblastoma Multiforme
Glioblastoma

Interventions: Drug: Posaconazole Pill

First Posted Date: 2021-04-01

Last Posted Date: 2025-03-13

Lead Sponsor: Milton S. Hershey Medical Center

Target Recruit Count: 6

Registration Number: NCT04825275

Locations: 🇺🇸
Penn State Milton S Hershey Medical Center, Hershey, Pennsylvania, United States

A Study of BGB-11417 in Participants With Myeloid Malignancies

Phase 1

Recruiting

Conditions: Acute Myeloid Leukemia
Myelodysplastic Syndromes
Myelodysplastic/Myeloproliferative Neoplasm

Interventions: Drug: BGB-11417
Drug: Azacitidine
Drug: Posaconazole

First Posted Date: 2021-02-25

Last Posted Date: 2025-05-09

Lead Sponsor: BeiGene

Target Recruit Count: 260

Registration Number: NCT04771130

Locations: 🇫🇷
Hopital Saint Louis, Paris, France
🇩🇪
Universitaetsklinikum Leipzig Aor, Leipzig, Germany
🇩🇪
Universitaetsklinikum Ulm, Ulm, Germany

and more 46 locations

DS-1594b With or Without Azacitidine, Venetoclax, or Mini-HCVD for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia

Phase 1

Completed

Conditions: Recurrent Chronic Myelomonocytic Leukemia
Hematopoietic and Lymphoid Cell Neoplasm
Recurrent Acute Myeloid Leukemia
Recurrent Acute Lymphoblastic Leukemia
Recurrent Myelodysplastic Syndrome
Refractory Acute Lymphoblastic Leukemia
Refractory Acute Myeloid Leukemia
Refractory Chronic Myelomonocytic Leukemia
Refractory Myelodysplastic Syndrome

Interventions: Drug: DS-1594b
Drug: Azacitidine
Drug: Cyclophosphamide
Drug: Posaconazole
Drug: Venetoclax
Drug: Cytarabine
Drug: Voriconazole
Drug: Dexamethasone
Biological: Filgrastim
Drug: Leucovorin
Drug: Mesna
Drug: Methotrexate
Drug: Prednisone
Biological: Rituximab
Drug: Vincristine

First Posted Date: 2021-02-12

Last Posted Date: 2023-11-15

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 17

Registration Number: NCT04752163

Locations: 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States

Drug Development Updates

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