NDAINJECTIONINJECTABLE, LIPID COMPLEXPriority Review
Approved
Nov 1995
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
3/8 — Basic
Priority Review
ABELCET (amphotericin b) by Leadiant Biosciences is mechanism of action amphotericin b, the active ingredient of amphotericin b liposome for injection, acts by binding to the sterol component, ergosterol, of the cell membrane of susceptible fungi. First approved in 1995.
Drug data last refreshed 7m ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ABELCET is a liposomal formulation of amphotericin B, a polyene antifungal agent used to treat serious systemic fungal infections. It works by binding to ergosterol in fungal cell membranes, disrupting membrane integrity and causing cell death. The liposomal delivery system enhances fungal penetration while reducing mammalian cell toxicity compared to conventional amphotericin B.
LOE Approaching
As LOE approaches, commercial teams will focus on retention and cost management; headcount expansion is unlikely, but specialty pharmacy and reimbursement roles may intensify.
Mechanism of Action
Mechanism of Action Amphotericin B, the active ingredient of amphotericin B liposome for injection, acts by binding to the sterol component, ergosterol, of the cell membrane of susceptible fungi. It forms transmembrane channels leading to alterations in cell permeability through which monovalent…
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
Phase 2 EL219 Versus Liposomal Amphotericin B or Voriconazole for Early Antifungal Therapy
Started Feb 2026
60 enrolled
Invasive Mould Infection
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
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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.