AMBISOME (amphotericin b)
AMBISOME is indicated for the treatment of Fungal Infection; Cryptococcal Meningitis; Aspergillus Infections; Candida Infections; Cryptococcus Infections; Visceral Leishmaniasis.
Development Insights
Details
- Status
- Prescription
- First Approved
- 1997-08-11
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE, LIPOSOMAL
AMBISOME Approval History
What AMBISOME Treats
6 indicationsAMBISOME is approved for 6 conditions since its original approval in 1997. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Fungal Infection
- Cryptococcal Meningitis
- Aspergillus Infections
- Candida Infections
- Cryptococcus Infections
- Visceral Leishmaniasis
AMBISOME 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 AMBISOME
3 of 12FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
11 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 |
| NCT05913921 | HC1507-004 | Ph 1 | completed | Bioequivalence of Amphotericin B Liposome for Injection |
| NCT04031833 EnACT | MB-70007 | Ph 1, Ph 2 | completed | Encochleated Oral Amphotericin for Cryptococcal Meningitis Trial (EnACT) |
| NCT05749380 | DKF-5122-BE | Ph 1 | completed | Pharmacokinetics and Safety of AmBisome and DKF-5122 |
| 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| NCT04018417 | 2019-005 | Ph 2, Ph 3 | withdrawn | Evaluation of Amphotericin B in Optisol-GS for Prevention of Post-Keratoplasty Fungal Infections.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 |
| NCT03311607 | MSF PKDL STUDY | Ph 4 | completed | Safety and Effectiveness of Short-course AmBisome in the Treatment of PKDL in Bangladesh |
| NCT01652859 | TLC166.2 | Ph 1 | completed | An Bioequivalence Study to Compare Two 2 mg/ml Liposomal Amphotericin B Injections in Healthy Subjects |
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.
AMBISOME FDA Label Details
Indications & Usage
FDA Label (PDF)AMBISOME is indicated for the treatment of Fungal Infection; Cryptococcal Meningitis; Aspergillus Infections; Candida Infections; Cryptococcus Infections; Visceral Leishmaniasis.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment