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.
Background
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 |
|---|---|---|---|---|---|
2025/06/12 | Phase 1 | Not yet 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 | |||
2025/03/25 | Phase 1 | Active, not recruiting | |||
2025/02/26 | Phase 1 | Completed | |||
2025/02/26 | Phase 1 | Completed | |||
2025/01/22 | 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 |
|---|---|---|---|---|---|
| Itraconazole Injection | H20160558 | 化学药品 | 注射剂 | 11/28/2019 | |
| Itraconazole Oral Solution | 国药准字H20243039 | 化学药品 | 口服溶液剂 | 1/9/2024 | |
| Itraconazole Oral Solution | 黄氏制药股份有限公司 | 国药准字HC20240001 | 化学药品 | 口服溶液剂 | 1/9/2024 |
| Itraconazole Hydrochloride | 国药准字H20070141 | 化学药品 | 胶囊剂 | 1/29/2022 | |
| Itraconazole Granules | 国药准字H20090168 | 化学药品 | 颗粒剂 | 1/24/2024 | |
| Itraconazole Capsules | 国药准字H20000124 | 化学药品 | 胶囊剂 | 9/23/2020 | |
| Itraconazole Capsules | 国药准字H20123428 | 化学药品 | 胶囊剂 | 6/28/2022 | |
| Itraconazole Capsules | 国药准字H20090329 | 化学药品 | 胶囊剂 | 1/10/2024 | |
| Itraconazole Capsules | 国药准字H20020367 | 化学药品 | 胶囊剂 | 5/28/2020 | |
| Itraconazole Capsules | 国药准字H20010767 | 化学药品 | 胶囊剂 | 12/2/2019 |
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 |