Overview
Micafungin is an antifungal drug. It belongs to the antifungal class of compounds known as echinocandins and exerts its effect by inhibiting the synthesis of 1,3-beta-D-glucan, an integral component of the fungal cell wall.
Indication
Indicated for the treatment of candidemia, acute disseminated candidiasis, and certain other invasive Candida infections, as well as esophageal candidiasis, and prophylaxis of Candida infections in patients undergoing hematopoietic stem cell transplantation. Micafungin is also used as an alternative for the treatment of oropharyngeal candidiases and has been used with some success as primary or salvage therapy, alone or in combination with other antifungals, for the treatment of invasive aspergillosis. Indicated for the prophylaxis of Candida infections in patients undergoing hematopoietic stem cell transplantation.
Associated Conditions
- Abscesses
- Aspergillosis
- Candidemia
- Candidiasis
- Esophageal Candidiasis
- Fungal Infections
- Fungal peritonitis caused by Candida
- Acute disseminated Candidiasis
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/05/14 | Phase 4 | Completed | |||
2023/03/27 | Phase 4 | Recruiting | |||
2022/08/11 | Phase 4 | Completed | |||
2021/02/04 | Phase 4 | UNKNOWN | |||
2021/01/28 | Phase 4 | Not yet recruiting | Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine | ||
2019/04/08 | Phase 4 | Terminated | Fadoi Foundation, Italy | ||
2018/02/05 | Phase 2 | Completed | |||
2017/06/02 | N/A | Completed | |||
2017/04/06 | Phase 4 | Completed | |||
2016/02/10 | N/A | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Apotex Corp. | 60505-6119 | INTRAVENOUS | 10 mg in 1 mL | 7/12/2023 | |
| Zydus Pharmaceuticals USA Inc. | 70710-1725 | INTRAVENOUS | 20 mg in 1 mL | 6/24/2023 | |
| Fresenius Kabi USA, LLC | 63323-729 | INTRAVENOUS | 100 mg in 1 1 | 9/30/2020 | |
| Zydus Lifesciences Limited | 70771-1683 | INTRAVENOUS | 10 mg in 1 mL | 11/23/2022 | |
| Civica, Inc. | 72572-427 | INTRAVENOUS | 100 mg in 1 1 | 9/28/2022 | |
| Zydus Lifesciences Limited | 70771-1684 | INTRAVENOUS | 20 mg in 1 mL | 11/23/2022 | |
| Hikma Pharmaceuticals USA Inc. | 0143-9361 | INTRAVENOUS | 10 mg in 1 mL | 7/26/2021 | |
| Astellas Pharma US, Inc. | 0469-3211 | INTRAVENOUS | 20 mg in 1 mL | 7/23/2020 | |
| Apotex Corp. | 60505-6120 | INTRAVENOUS | 20 mg in 1 mL | 7/12/2023 | |
| Sagent Pharmaceuticals | 25021-191 | INTRAVENOUS | 100 mg in 5 mL | 3/4/2022 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 4/25/2008 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| MYCAMINE POWDER FOR SOLUTION FOR INFUSION 50MG/VIAL | SIN14464P | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 50 mg/vial | 12/18/2013 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Micafungin Sodium for Injection | 国药准字H20203155 | 化学药品 | 注射剂 | 4/9/2020 | |
| Micafungin Sodium for Injection | 国药准字HJ20160524 | 化学药品 | 注射剂 | 3/23/2021 | |
| Micafungin Sodium for Injection | 国药准字H20233637 | 化学药品 | 注射剂 | 5/29/2023 | |
| Micafungin Sodium for Injection | 国药准字H20183082 | 化学药品 | 注射剂 | 11/14/2022 | |
| Micafungin Sodium for Injection | 国药准字H20223683 | 化学药品 | 注射剂 | 9/20/2022 | |
| Micafungin Sodium for Injection | 国药准字H20183111 | 化学药品 | 注射剂 | 3/23/2023 | |
| Micafungin Sodium for Injection | 国药准字H20213463 | 化学药品 | 注射剂 | 6/8/2021 | |
| Micafungin Sodium for Injection | 国药准字H20223731 | 化学药品 | 注射剂 | 10/11/2022 | |
| Micafungin Sodium for Injection | 国药准字H20234655 | 化学药品 | 注射剂 | 12/19/2023 | |
| Micafungin Sodium for Injection | 国药准字H20203079 | 化学药品 | 注射剂 | 3/3/2020 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| MYCAMINE micafungin (as sodium) 50 mg powder for injection vial | 196108 | Medicine | A | 5/8/2013 | |
| MYCAMINE micafungin (as sodium) 100 mg powder for injection vial | 196109 | Medicine | A | 5/8/2013 |
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