AMPHOTERICIN B
AMPHOTERICIN B is indicated for the treatment of Fungal Infection; Cryptococcal Meningitis; Aspergillus Infections; Candida Infections; Visceral Leishmaniasis.
Details
- Status
- Prescription
- First Approved
- 1987-04-13
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE, LIPOSOMAL, INJECTABLE
AMPHOTERICIN B Approval History
What AMPHOTERICIN B Treats
5 indicationsAMPHOTERICIN B is approved for 5 conditions since its original approval in 1987. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Fungal Infection
- Cryptococcal Meningitis
- Aspergillus Infections
- Candida Infections
- Visceral Leishmaniasis
AMPHOTERICIN B Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to AMPHOTERICIN B
3 of 12FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
7 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT02629419 CAMB results posted | MB-70004 16-I-0002 | Ph 2 | completed | CAMB/MAT2203 in Patients With Mucocutaneous Candidiasis |
| NCT06413056 | micafungin in neonates | Ph 4 | completed | Micafungin Versus Amphotercine B in Treatment of Invasive Fungal Infection |
| NCT04031833 EnACT | MB-70007 | Ph 1, Ph 2 | completed | Encochleated Oral Amphotericin for Cryptococcal Meningitis Trial (EnACT) |
| NCT00885703 results posted | A5225 (HiFLAC) 10149, ACTG A5225 | Ph 1, Ph 2 | completed | High-Dose Fluconazole for the Treatment of Cryptococcal Meningitis in HIV-Infected Individuals |
| NCT03112031 | 28CN | Ph 2 | completed | Treatment With Tamoxifen in Cryptococcal Meningitis |
| NCT04018417 | 2019-005 | Ph 2, Ph 3 | withdrawn | Evaluation of Amphotericin B in Optisol-GS for Prevention of Post-Keratoplasty Fungal Infections. |
| NCT01615809 results posted | FSJD-ABELNEB-2010 | Ph 2 | completed | Nebulized Amphotericin B Lipid Complex in Invasive Pulmonary Aspergillosis in Paediatric Patients With Acute Leukaemia |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
AMPHOTERICIN B FDA Label Details
Indications & Usage
AMPHOTERICIN B is indicated for the treatment of Fungal Infection; Cryptococcal Meningitis; Aspergillus Infections; Candida Infections; Visceral Leishmaniasis.
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AMBISOME
Full clinical data, patents, trials, and competitive landscape for amphotericin b.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.