NDAINJECTIONINJECTABLE, LIPOSOMALPriority Review
Approved
Aug 1997
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
5/8 — Partial
Priority Review
AMBISOME (amphotericin b) by Astellas. Approved for lipid-based polyene antifungal [epc]. First approved in 1997.
Drug data last refreshed Yesterday · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
AmBisome is a lipid-based liposomal formulation of amphotericin B, a polyene antifungal that binds to fungal cell membrane ergosterol to disrupt membrane integrity and cause cell death. It treats serious invasive fungal infections including cryptococcal meningitis, aspergillosis, candidiasis, and leishmaniasis, primarily in immunocompromised patients such as those with HIV, hematologic malignancies, or undergoing transplantation.
$1MPart D
LOE ApproachingProduct is in late-stage maturity with minimal Part D spending, signaling a small and specialized commercial footprint with limited team expansion opportunities.
Mechanism of Action
Pharmacologic Class:
Lipid-based Polyene Antifungal
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Liposomal Amphotericin B and Flucytosine Antifungal Strategy for Talaromycosis (LAmB-FAST)
Started Jul 2026
428 enrolled
Talaromycosis
Deposition of Inhaled Liposomal Amphotericin B in Chronic Pulmonary Aspergillosis (CPA)
Started May 2026
18 enrolled
Chronic Pulmonary Aspergillosis
A Real-world Prospective Observational Study on the Efficacy and Safety of L-AmB(Liposomal Amphotericin B) for br- IFD(Breakthrough Invasive Fungal Disease) in Children and Adolescent Patients With Hematological Malignancies Receiving Triazoles or Echinocandins Prophylaxis
Started Sep 2025
38 enrolled
Fungal Disease
Human Bioequivalence Study of Amphotericin B Liposome for Injection
Started May 2025
42 enrolled
Invasive Fungal InfectionsNeutropenic FeverVisceral Leishmaniasis
Efficacy and Safety of High-dose Liposomal Amphotericin B for Disseminated Histoplasmosis in AIDS
Started Jan 2025
279 enrolled
Disseminated Histoplasma Capsulatum InfectionAIDS and InfectionsImmunosuppression+1 more
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.