Overview
Amphotericin B shows a high order of in vitro activity against many species of fungi. Histoplasma capsulatum, Coccidioides immitis, Candida species, Blastomyces dermatitidis, Rhodotorula, Cryptococcus neoformans, Sporothrix schenckii, Mucor mucedo, and Aspergillus fumigatus are all inhibited by concentrations of amphotericin B ranging from 0.03 to 1.0 mcg/mL in vitro. While Candida albicans is generally quite susceptible to amphotericin B, non-albicans species may be less susceptible. Pseudallescheria boydii and Fusarium sp. are often resistant to amphotericin B. The antibiotic is without effect on bacteria, rickettsiae, and viruses.
Indication
Used to treat potentially life threatening fungal infections.
Associated Conditions
- Coccidioidomycosis
- Fungal Infections
- Histoplasmosis
- Invasive Aspergillosis
- Invasive Fungal Infections
- Leishmaniasis
- Meningitis, Cryptococcal
- Meningitis, Fungal
- Mucocutaneous Leishmaniasis
- Mycotic endophthalmitis
- Penicillium marneffei infection
- Visceral Leishmaniasis
- Candidal cystitis
- Disseminated Cryptococcosis
- Fungal osteoarticular infections
- Ocular aspergillosis
- Refractory aspergillosis
- Severe Coccidioidomycosis
- Severe Cryptococcosis
- Severe Fungal infection caused by Basidiobolus spp.
- Severe Fungal infection caused by Conidiobolus spp.
- Severe Fungal infection caused by sporotrichosis spp.
- Severe Histoplasmosis
- Severe Mucocutaneous leishmaniasis
- Severe North American blastomycosis
- Severe Systemic candidiasis
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2025/04/13 | Not Applicable | Not yet recruiting | |||
2025/01/01 | Phase 4 | Not yet recruiting | Bin Cao | ||
2024/05/14 | Phase 4 | Completed | |||
2023/09/15 | Phase 2 | Recruiting | University of Brasilia | ||
2023/06/22 | Phase 1 | Completed | |||
2023/03/01 | Phase 1 | Completed | |||
2022/10/25 | Phase 2 | Active, not recruiting | Drugs for Neglected Diseases | ||
2022/09/15 | Phase 3 | Not yet recruiting | |||
2022/07/21 | Phase 2 | Recruiting | Post Graduate Institute of Medical Education and Research, Chandigarh | ||
2021/11/01 | Phase 3 | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
Sun Pharmaceutical Industries, Inc. | 62756-233 | INTRAVENOUS | 50 mg in 1 1 | 2/9/2022 | |
XGen Pharmaceuticals DJB, Inc. | 39822-1055 | INTRAVENOUS | 50 mg in 10 mL | 8/14/2021 | |
Leadiant Biosciences, Inc. | 57665-101 | INTRAVENOUS | 5 mg in 1 mL | 11/21/2023 | |
Astellas Pharma US, Inc. | 0469-3051 | INTRAVENOUS | 50 mg in 12.5 mL | 2/6/2018 | |
Eugia US LLC | 55150-365 | INTRAVENOUS | 50 mg in 12.5 mL | 11/18/2022 |
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 |
---|---|---|---|---|---|
AMBISOME FOR INJECTION 50 mg/vial | SIN12021P | INJECTION, POWDER, FOR SOLUTION | 50 mg/vial | 7/15/2002 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
Amphotericin B Vaginal Effervescent Tablets | 国药准字H13023857 | 化学药品 | 片剂 | 8/2/2024 | |
Amphotericin B Liposome for Injection | 国药准字H20244839 | 化学药品 | 注射剂 | 9/10/2024 | |
Amphotericin B Liposome for Injection | 国药准字H20253083 | 化学药品 | 注射剂 | 1/8/2025 | |
Amphotericin B Liposome for Injection | 国药准字HJ20233123 | 化学药品 | 注射剂 | 2/28/2023 | |
Amphotericin B Liposome for Injection | 台湾微脂体股份有限公司 | 国药准字HC20250001 | 化学药品 | 注射剂 | 2/20/2025 |
Amphotericin B Liposome for Injection | 国药准字H20030892 | 化学药品 | 注射剂 | 6/23/2020 | |
Amphotericin B for Injection | 国药准字H13020285 | 化学药品 | 注射剂 | 10/27/2020 | |
Amphotericin B for Injection | 国药准字H31020821 | 化学药品 | 注射剂 | 6/23/2020 | |
Amphotericin B for Injection | 国药准字H13020284 | 化学药品 | 注射剂 | 7/8/2020 | |
Amphotericin B for Injection | 国药准字H13020283 | 化学药品 | 注射剂 | 10/27/2020 |
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 |
---|---|---|---|---|---|
AMPHOTERICIN LIPOSOMAL RBX amphotericin B (amphotericin) 50mg powder for injection vial | 380965 | Medicine | A | 3/15/2023 | |
AMPHOTERICIN LIPOSOMAL RAN amphotericin B (amphotericin) 50mg powder for injection vial | 380962 | Medicine | A | 3/15/2023 | |
AMBISOME amphotericin B (amphotericin) B 50mg powder for injection | 53783 | Medicine | A | 1/30/1996 | |
AMPHOTERICIN LIPOSOMAL SUN amphotericin B (amphotericin) 50mg powder for injection vial | 380963 | Medicine | A | 3/15/2023 | |
FUNGILIN amphotericin B (amphotericin) 10 mg lozenge bottle | 19295 | Medicine | A | 9/30/1991 |
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