Active Ingredient History
SPORANOX is the brand name for itraconazole, an azole antifungal agent. Itraconazole is a 1:1:1:1 racemic mixture of four diastereomers (two enantiomeric pairs), each possessing three chiral centers. In vitro studies have demonstrated that itraconazole inhibits the cytochrome P450-dependent synthesis of ergosterol, which is a vital component of fungal cell membranes. As ergosterol is an essential component of the fungal cell membrane, inhibition of its synthesis results in increased cellular permeability causing leakage of cellular contents. Itraconazole may also inhibit endogenous respiration, interact with membrane phospholipids, inhibit the transformation of yeasts to mycelial forms, inhibit purine uptake, and impair triglyceride and/or phospholipid biosynthesis. SPORANOX capsules are indicated for the treatment of the following fungal infections in immunocompromised and non-immunocompromised patients: Blastomycosis, pulmonary and extrapulmonary; Histoplasmosis, including chronic cavitary pulmonary disease and disseminated, nonmeningeal histoplasmosis, and Aspergillosis, pulmonary and extrapulmonary, in patients who are intolerant of or who are refractory to amphotericin B therapy. SPORANOX is also indicated for the treatment of the following fungal infections in non-immunocompromised patients: Onychomycosis of the toenail, with or without fingernail involvement, due to dermatophytes (tinea unguium), and Onychomycosis of the fingernail due to dermatophytes (tinea unguium). Itraconazole is mainly metabolized through CYP3A4. Other drugs that either share this metabolic pathway or modify CYP3A4 activity may influence the pharmacokinetics of itraconazole. Similarly, itraconazole may modify the pharmacokinetics of other drugs that share this metabolic pathway. Itraconazole is a potent CYP3A4 inhibitor and a P-glycoprotein inhibitor. When using concomitant medication, it is recommended that the corresponding label be consulted for information on the route of metabolism and the possible need to adjust dosages. NCATS
Drug Pricing (per unit)
Note: This drug pricing data is preliminary, incomplete, and may contain errors.
| Organization | Org Type | FDA approvals | Clinical Trials involvement | Org ID | Force Sort |
|---|
| Organization | Org Type | FDA approvals | Clinical Trials involvement | Org ID | Force Sort |
|---|
Achlorhydria (Phase 1)
Alzheimer Disease (Phase 1)
Arthritis, Rheumatoid (Phase 1)
Aspergillosis (Phase 4)
Aspergillosis, Allergic Bronchopulmonary (Phase 4)
Asthma (Phase 1)
Autoimmune Diseases (Phase 1)
Bacterial Infections (Phase 1)
Biological Availability (Phase 1)
Blastomycosis (Phase 3)
Brain Neoplasms (Phase 4)
Breast Neoplasms (Phase 1)
Bronchiectasis (Phase 3)
Cachexia (Phase 1)
Candidiasis (Phase 3)
Carcinoma, Basal Cell (Phase 2)
Carcinoma, Non-Small-Cell Lung (Phase 2)
Carcinoma, Renal Cell (Phase 1)
Cardiovascular Diseases (Phase 1)
Clinical Trial, Phase I (Phase 1)
Clinical Trials, Phase I as Topic (Phase 1)
Coccidioidomycosis (Phase 2)
Contraception (Phase 1)
COVID-19 (Phase 1)
Crohn Disease (Phase 2)
Cryptococcosis (Phase 3)
Cystic Fibrosis (Phase 4)
Cytochrome P-450 Enzyme System (Phase 1)
Dermatomycoses (Phase 3)
Diabetic Foot (Early Phase 1)
Diagnostic Self Evaluation (Phase 1)
Drug Interactions (Phase 1/Phase 2)
Erectile Dysfunction (Phase 1)
Esophageal Diseases (Phase 2)
Esophageal Neoplasms (Phase 2)
Esophageal Squamous Cell Carcinoma (Phase 2)
Febrile Neutropenia (Phase 2)
Fever (Phase 4)
Fibrosis (Phase 1)
Fungemia (Phase 3)
Glioblastoma (Phase 1)
Graft vs Host Disease (Phase 4)
Healthy Volunteers (Phase 4)
Heart Failure (Phase 1)
Heart Failure, Diastolic (Phase 1)
Hematologic Diseases (Phase 2)
Hematologic Neoplasms (Phase 4)
Hematopoietic Stem Cell Transplantation (Phase 2/Phase 3)
Hepatic Insufficiency (Phase 1)
Hepatitis B (Phase 1)
Hepatitis B, Chronic (Phase 1)
Hepatitis C, Chronic (Phase 1/Phase 2)
Histoplasmosis (Phase 3)
HIV Infections (Phase 3)
Inflammatory Bowel Diseases (Phase 2)
Invasive Fungal Infections (Phase 4)
Leukemia (Phase 1)
Leukemia, Myeloid, Acute (Phase 2)
Ligaments, Articular (Phase 1)
Lung Diseases, Fungal (Phase 4)
Lung Neoplasms (Phase 2)
Lymphoma (Phase 1)
Lymphoma, Follicular (Phase 1)
Lymphoma, Large B-Cell, Diffuse (Phase 1)
Lymphoma, Large-Cell, Anaplastic (Phase 1)
Lymphoma, Non-Hodgkin (Phase 1)
Malaria (Phase 1)
Medical Oncology (Phase 1)
Melanoma (Phase 1)
Meningitis, Cryptococcal (Phase 2)
Mesothelioma (Phase 1)
Multiple Myeloma (Phase 1)
Muscular Atrophy, Spinal (Phase 1)
Mycoses (Phase 4)
Mycosis Fungoides (Phase 3)
Neoplasm Metastasis (Phase 2)
Neoplasms (Phase 3)
Neoplasms, Second Primary (Phase 3)
Neuralgia (Phase 1)
Neuroblastoma (Phase 4)
Neutropenia (Phase 4)
Nocturia (Phase 1)
Non-alcoholic Fatty Liver Disease (Phase 1)
Non-Smokers (Phase 1)
Obesity (Phase 1)
Onychomycosis (Phase 4)
Ovarian Neoplasms (Phase 3)
Pain (Phase 1)
Pharmacokinetics (Phase 4)
Pharmacologic Actions (Phase 1)
Pharmacology, Clinical (Phase 1)
Primary Myelofibrosis (Phase 1)
Prostatic Neoplasms (Phase 2)
Pulmonary Disease, Chronic Obstructive (Phase 1)
Renal Insufficiency, Chronic (Phase 1)
Respiratory Syncytial Virus Infections (Phase 1)
Retinoblastoma (Phase 4)
Rhabdoid Tumor (Phase 1)
Rosacea (Phase 2)
Sarcoma (Phase 1)
Sarcoma, Synovial (Phase 1)
Sinusitis (Phase 2/Phase 3)
Skin Neoplasms (Phase 2)
Small Cell Lung Carcinoma (Phase 2)
Sporotrichosis (Phase 1/Phase 2)
Thrombosis (Phase 1)
Tinea (Phase 2/Phase 3)
Tinea cruris (Phase 2/Phase 3)
Tinea Versicolor (Phase 2)
Wilms Tumor (Phase 4)
Women (Phase 1)
| Trial | Phase | Start Date | Organizations | Indications |
|---|
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