Overview
One of the triazole antifungal agents that inhibits cytochrome P-450-dependent enzymes resulting in impairment of ergosterol synthesis. It has been used against histoplasmosis, blastomycosis, cryptococcal meningitis & aspergillosis.
Indication
For the treatment of the following fungal infections in immunocompromised and non-immunocompromised patients: pulmonary and extrapulmonary blastomycosis, histoplasmosis, aspergillosis, and onychomycosis.
Associated Conditions
- Aspergillosis
- Blastomycosis
- Chromoblastomycosis
- Coccidioidal meningitis
- Esophageal Candidiasis
- Fungal Infections
- Fungal skin infection
- Histoplasmosis
- Onychomycosis
- Oropharyngeal Candidiasis
- Paracoccidioidomycosis
- Penicillium marneffei infection
- Pulmonary coccidioides
- Sporotrichosis
- Vulvovaginal Candidiasis
- Disseminated Other specified protozoal diseases
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2025/07/17 | Not Applicable | Recruiting | |||
2025/07/17 | Not Applicable | Not yet recruiting | |||
2025/07/16 | Not Applicable | Recruiting | Muhammad Aamir Latif | ||
2025/07/15 | Not Applicable | Not yet recruiting | |||
2025/06/12 | Phase 1 | Recruiting | |||
2025/04/25 | Phase 1 | Recruiting | |||
2025/04/24 | Phase 1 | Recruiting | |||
2025/04/10 | Phase 4 | Recruiting | |||
2025/04/09 | Phase 1 | Recruiting | |||
2025/04/02 | Phase 1 | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
Par Pharmaceutical, Inc. | 49884-239 | ORAL | 100 mg in 1 1 | 9/12/2023 | |
Alembic Pharmaceuticals Inc. | 62332-204 | ORAL | 100 mg in 1 1 | 2/12/2024 | |
Zydus Pharmaceuticals USA Inc. | 68382-697 | ORAL | 100 mg in 1 1 | 11/10/2022 | |
AvPAK | 50268-450 | ORAL | 100 mg in 1 1 | 1/9/2024 | |
Natco Pharma USA LLC | 69339-159 | ORAL | 10 mg in 1 mL | 4/11/2022 | |
Janssen Pharmaceuticals, Inc. | 50458-295 | ORAL | 10 mg in 1 mL | 3/29/2024 | |
Amneal Pharmaceuticals LLC | 65162-087 | ORAL | 10 mg in 1 mL | 3/22/2024 | |
Patriot Pharmaceuticals | 10147-1700 | ORAL | 100 mg in 1 1 | 3/25/2024 | |
Patriot Pharmaceuticals, LLC | 10147-0150 | ORAL | 10 mg in 1 mL | 11/16/2023 | |
Accord Healthcare Inc. | 16729-271 | ORAL | 100 mg in 1 1 | 12/2/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
No EMA approvals found for this drug. |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
JAMP ITRACONAZOLE ORAL SOLUTION 10MG/ML | SIN16379P | SOLUTION | 10 mg/mL | 11/17/2021 | |
SPORANOX CAPSULE 100 mg | SIN08206P | CAPSULE | 100 mg | 6/10/1995 | |
SPORANOX ORAL SOLUTION 10 mg/ml | SIN09823P | SOLUTION | 10 mg/ml | 6/12/1998 | |
CANDITRAL CAPSULE 100 mg | SIN11355P | CAPSULE | 100 mg | 7/27/2000 | |
UNITRAC CAPSULE 100 mg | SIN12459P | CAPSULE | 100 mg | 10/30/2003 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
No NMPA approvals found for this drug. |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
---|---|---|---|---|---|
ITRACAN CAP 100MG | N/A | N/A | N/A | 5/16/2006 | |
ICOMEIN CAPSULES 100MG | N/A | N/A | N/A | 8/14/2024 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
Tolsura Itraconazole 65mg Capsules | 311171 | Medicine | A | 11/5/2018 | |
ITRACAP itraconazole 100 mg capsule blister pack | 244472 | Medicine | A | 8/9/2016 | |
Lozanoc 50 mg capsules | 216603 | Medicine | A | 10/25/2013 | |
ITRACONAZOLE GXP itraconazole 100 mg capsule blister pack | 244332 | Medicine | A | 8/9/2016 | |
LOZANOC itraconazole 50 mg capsule bottle | 206360 | Medicine | A | 4/16/2014 | |
ITRACONAZOLE-WGR itraconazole 100 mg capsule blister pack | 244334 | Medicine | A | 8/9/2016 | |
SPINOX itraconazole 100 mg capsule blister pack | 244452 | Medicine | A | 8/9/2016 | |
ITRACONAZOLE GPPL itraconazole 100 mg capsule blister pack | 244292 | Medicine | A | 8/9/2016 | |
ITRACONAZOLE GENPAR itraconazole 100 mg capsule blister pack | 244333 | Medicine | A | 8/9/2016 | |
ITRANOX itraconazole 100 mg capsule blister pack | 244432 | Medicine | A | 8/9/2016 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
---|---|---|---|---|---|
SPORANOX | 02047454 | Capsule - Oral | 100 MG | 12/31/1993 | |
MINT-ITRACONAZOLE | mint pharmaceuticals inc | 02462559 | Capsule - Oral | 100 MG | 5/18/2017 |
JAMP ITRACONAZOLE ORAL SOLUTION | 02484315 | Solution - Oral | 10 MG / ML | 7/31/2019 | |
SPORANOX | 02231347 | Solution - Oral | 10 MG / ML | 7/28/1997 | |
ODAN ITRACONAZOLE | odan laboratories ltd | 02495988 | Solution - Oral | 10 MG / ML | 7/8/2020 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
---|---|---|---|---|---|
ITRAGERM 50 MG CAPSULAS DURAS | 77459 | CÁPSULA DURA | Medicamento Sujeto A Prescripción Médica | Commercialized | |
ITRACONAZOL TECNIGEN 100 MG CAPSULAS DURAS EFG | Tecnimede España Industria Farmaceutica S.A. | 78838 | CÁPSULA DURA | Medicamento Sujeto A Prescripción Médica | Commercialized |
ITRACONAZOL ALTER 100 mg CAPSULAS DURAS EFG | Laboratorios Alter S.A. | 65762 | CÁPSULA DURA | Medicamento Sujeto A Prescripción Médica | Commercialized |
ITRACONAZOL SANDOZ 100 mg CAPSULAS DURAS EFG | Sandoz Farmaceutica S.A. | 65775 | CÁPSULA DURA | Medicamento Sujeto A Prescripción Médica | Commercialized |
CANADIOL 10 mg/ml SOLUCION ORAL | 61864 | SOLUCIÓN ORAL | Medicamento Sujeto A Prescripción Médica | Not Commercialized | |
ITRACONAZOL VIATRIS 100 MG CAPSULAS EFG | Viatris Pharmaceuticals S.L.U. | 65765 | CÁPSULA DURA | Medicamento Sujeto A Prescripción Médica | Commercialized |
ITRACONAZOL TARBIS 100 mg CAPSULAS DURAS EFG | Tarbis Farma S.L. | 71196 | CÁPSULA DURA | Medicamento Sujeto A Prescripción Médica | Commercialized |
ITRACONAZOL NORMON 100 mg CAPSULAS DURAS EFG | Laboratorios Normon S.A. | 71234 | CÁPSULA DURA | Medicamento Sujeto A Prescripción Médica | Commercialized |
SPORANOX 100 mg CAPSULAS | Janssen Cilag S.A. | 59343 | CÁPSULA DURA | Medicamento Sujeto A Prescripción Médica | Commercialized |
ITRACONAZOL ALTAN 10 MG/ML CONCENTRADO Y DISOLVENTE PARA SOLUCION PARA PERFUSION EFG | Altan Pharmaceuticals Sa | 78446 | CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN | Uso Hospitalario | Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Philippines FDA approvals found for this drug. |
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Saudi SFDA approvals found for this drug. |
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Malaysia NPRA approvals found for this drug. |
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
---|---|---|---|---|---|
No UK EMC drug information found for this drug. |
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