AMBISOME

LOE Approaching

amphotericin b

NDAINJECTIONINJECTABLE, LIPOSOMALPriority Review
Approved
Aug 1997
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20

Mechanism of Action

CLINICAL PHARMACOLOGY Pharmacokinetics The assay used to measure amphotericin B in the serum after administration of Am B isome does not distinguish amphotericin B that is complexed with the phospholipids of Am B isome from amphotericin B that is uncomplexed. The pharmacokinetic profile of…

Pharmacologic Class:

Lipid-based Polyene Antifungal

Clinical Trials (5)

NCT06525389Phase 3Not Yet Recruiting

Liposomal Amphotericin B and Flucytosine Antifungal Strategy for Talaromycosis (LAmB-FAST)

Started Apr 2026
428 enrolled
Talaromycosis
NCT07357038N/ARecruiting

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
NCT06977490N/ACompleted

Human Bioequivalence Study of Amphotericin B Liposome for Injection

Started May 2025
NCT05814432Phase 3Recruiting

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
NCT01945281Phase 2Terminated

Safety, Tolerability, and Efficacy of Caspofungin Versus Amphotericin B Deoxycholate in the Treatment of Invasive Candidiasis in Neonates and Infants (MK-0991-064)

Started Jan 2014
51 enrolled
Candidiasis, Invasive