Overview
A fluorinated cytosine analog that is used as an antifungal agent.
Background
A fluorinated cytosine analog that is used as an antifungal agent.
Indication
For the treatment (in combination with amphotericin B) of serious infections caused by susceptible strains of Candida (septicemia, endocarditis and urinary system infections) and/or Cryptococcus (meningitis and pulmonary infections).
Associated Conditions
- Candidiasis
- Candidiasis, Systemic
- Cryptococcal infections
- Fungal Infections
- Fungal endocarditis
- Meningitis, Fungal
- Septicemia
- Urinary tract infection fungal
- Disseminated Cryptococcosis
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/07/29 | Phase 3 | Not yet recruiting | |||
2024/05/16 | Phase 2 | Completed | |||
2022/07/22 | Not Applicable | UNKNOWN | |||
2020/03/30 | Phase 1 | Terminated | |||
2019/12/11 | Phase 1 | Terminated | |||
2019/10/25 | Phase 3 | UNKNOWN | |||
2019/09/26 | Phase 2 | Withdrawn | |||
2018/10/30 | Phase 1 | Terminated | |||
2013/12/19 | Phase 1 | Completed | City of Hope Medical Center | ||
2012/10/29 | Phase 2 | UNKNOWN |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Bryant Ranch Prepack | 63629-9156 | ORAL | 250 mg in 1 1 | 5/5/2021 | |
| Bryant Ranch Prepack | 63629-9157 | ORAL | 500 mg in 1 1 | 5/5/2021 | |
| Hikma Pharmaceuticals USA Inc. | 0054-0427 | ORAL | 250 mg in 1 1 | 3/15/2022 | |
| Sigmapharm Laboratories, LLC | 42794-010 | ORAL | 500 mg in 1 1 | 1/10/2023 | |
| Sigmapharm Laboratories, LLC | 42794-009 | ORAL | 250 mg in 1 1 | 1/10/2023 | |
| Novel Laboratories, Inc. | 40032-771 | ORAL | 250 mg in 1 1 | 5/6/2022 | |
| Cameron Pharmaceuticals, LLC | 42494-340 | ORAL | 500 mg in 1 1 | 10/5/2022 | |
| Bryant Ranch Prepack | 72162-1326 | ORAL | 250 mg in 1 1 | 8/30/2023 | |
| Bausch Health US LLC | 0187-3555 | ORAL | 500 mg in 1 1 | 2/2/2022 | |
| American Health Packaging | 60687-610 | ORAL | 500 mg in 1 1 | 9/27/2022 |
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 |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Flucytosine Injection | 国药准字H20056426 | 化学药品 | 注射剂 | 3/9/2020 | |
| Flucytosine Injection | 国药准字H20033696 | 化学药品 | 注射剂 | 4/8/2020 | |
| Flucytosine Injection | 国药准字H20033188 | 化学药品 | 注射剂 | 9/1/2020 | |
| Flucytosine Tablets | 国药准字H37023171 | 化学药品 | 片剂 | 4/17/2020 | |
| Flucytosine Tablets | 国药准字H37023172 | 化学药品 | 片剂 | 4/17/2020 | |
| Flucytosine Tablets | 国药准字H32025643 | 化学药品 | 片剂 | 5/19/2020 | |
| Flucytosine Tablets | 国药准字H32026330 | 化学药品 | 片剂 | 8/21/2020 | |
| Flucytosine Tablets | 国药准字H32025798 | 化学药品 | 片剂 | 5/19/2020 |
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 |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||