Overview
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
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/01/31 | Phase 2 | Recruiting | Shandong Cancer Hospital and Institute | ||
2024/11/20 | N/A | ENROLLING_BY_INVITATION | |||
2024/08/07 | Phase 2 | Recruiting | |||
2022/07/21 | Phase 2 | Recruiting | Post Graduate Institute of Medical Education and Research, Chandigarh | ||
2021/10/04 | N/A | Completed | Medical University of Graz | ||
2021/07/19 | Phase 4 | Terminated | |||
2021/07/19 | Phase 2 | UNKNOWN | Bambino Gesù Hospital and Research Institute | ||
2021/04/01 | Early Phase 1 | Terminated | |||
2021/02/25 | Phase 1 | Recruiting | |||
2021/01/27 | N/A | UNKNOWN |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| ATLANTIC BIOLOGICALS CORP. | 17856-2133 | ORAL | 100 mg in 1 1 | 3/1/2022 | |
| Merck Sharp & Dohme LLC | 0085-4331 | INTRAVENOUS | 18 mg in 1 mL | 10/20/2023 | |
| Eugia US LLC | 55150-388 | INTRAVENOUS | 18 mg in 1 mL | 4/20/2022 | |
| Hikma Pharmaceuticals USA Inc. | 0054-0449 | ORAL | 40 mg in 1 mL | 3/7/2022 | |
| AvKARE | 42291-919 | ORAL | 100 mg in 1 1 | 4/25/2023 | |
| Par Pharmaceutical, Inc. | 42023-195 | INTRAVENOUS | 18 mg in 1 mL | 6/2/2022 | |
| Merck Sharp & Dohme LLC | 0085-2224 | ORAL | 300 mg in 1 1 | 10/20/2023 | |
| Cardinal Health 107, LLC | 55154-4322 | ORAL | 100 mg in 1 1 | 9/27/2023 | |
| A2A Integrated Pharmaceuticals | 73141-023 | ORAL | 100 mg in 1 1 | 2/28/2025 | |
| Merck Sharp & Dohme LLC | 0085-4324 | ORAL | 100 mg in 1 1 | 10/20/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 7/25/2019 | ||
Authorised | 10/25/2005 | ||
Authorised | 7/25/2019 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| POSACONAZOLE SANDOZ GASTRO-RESISTANT TABLETS 100MG | SIN15897P | TABLET, DELAYED RELEASE | 100.00 mg | 3/9/2020 | |
| NOXAFIL TABLET 100MG | SIN15045P | TABLET, DELAYED RELEASE | 100mg | 7/5/2016 | |
| NOXAFIL ORAL SUSPENSION 40 mg/ml | SIN13654P | SUSPENSION | 40mg/ml | 5/25/2009 | |
| SINOTRX POSACONAZOLE DELAYED RELEASE TABLET 100MG | SIN16477P | TABLET, DELAYED RELEASE | 100 mg | 4/13/2022 | |
| POSATIF POSACONAZOLE GASTRO-RESISTANT TABLETS 100MG | SIN17200P | TABLET, DELAYED RELEASE | 100 mg | 3/10/2025 |
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 |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| POSANOL | Merck Canada Inc | 02432676 | Solution - Intravenous | 300 MG / 16.7 ML | 11/24/2014 |
| MINT-POSACONAZOLE | mint pharmaceuticals inc | 02544644 | Tablet (Delayed-Release) - Oral | 100 MG | 7/25/2024 |
| APO-POSACONAZOLE | 02511878 | Tablet (Delayed-Release) - Oral | 100 MG | N/A | |
| POSANOL | Merck Canada Inc | 02424622 | Tablet (Delayed-Release) - Oral | 100 MG | 5/21/2014 |
| JAMP POSACONAZOLE | 02530333 | Suspension - Oral | 40 MG / ML | 5/24/2023 | |
| GLN-POSACONAZOLE | glenmark pharmaceuticals canada inc. | 02542021 | Tablet (Delayed-Release) - Oral | 100 MG | 10/4/2023 |
| SANDOZ POSACONAZOLE | 02496259 | Tablet (Delayed-Release) - Oral | 100 MG | 12/8/2020 | |
| POSANOL | Merck Canada Inc | 02293404 | Suspension - Oral | 200 MG / 5 ML | 6/6/2007 |
| TARO-POSACONAZOLE | 02543311 | Tablet (Delayed-Release) - Oral | 100 MG | 3/25/2024 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
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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