Overview
Posaconazole is a triazole antifungal drug that is used to treat invasive infections by Candida species and Aspergillus species in severely immunocompromised patients.
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
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 | 7/25/2019 | ||
Authorised | 7/25/2019 | ||
Authorised | 7/25/2019 | ||
Authorised | 7/25/2019 | ||
Authorised | 10/25/2005 | ||
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 |
|---|---|---|---|---|---|
| Posaconazole Oral Suspension | 国药准字H20233242 | 化学药品 | 口服混悬剂 | 2/28/2023 | |
| Posaconazole Oral Suspension | 国药准字HJ20181110 | 化学药品 | 口服混悬剂 | 11/18/2022 | |
| Posaconazole Enteric-coated Tablets | 国药准字H20253931 | 化学药品 | 片剂 | 4/15/2025 | |
| Posaconazole Enteric-coated Tablets | 国药准字H20233928 | 化学药品 | 片剂 | 7/11/2023 | |
| Posaconazole Enteric-coated Tablets | 国药准字HJ20240139 | 化学药品 | 片剂 | 12/1/2024 | |
| Posaconazole Enteric-coated Tablets | 国药准字H20243431 | 化学药品 | 片剂 | 4/7/2024 | |
| Posaconazole Enteric-coated Tablets | 国药准字HJ20180086 | 化学药品 | 片剂 | 7/3/2023 | |
| Posaconazole Enteric-coated Tablets | 国药准字H20223729 | 化学药品 | 片剂 | 11/9/2022 | |
| Posaconazole Enteric-coated Tablets | 国药准字H20244926 | 化学药品 | 片剂 | 9/19/2024 | |
| Posaconazole Enteric-coated Tablets | 国药准字H20233962 | 化学药品 | 片剂 | 7/25/2023 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||