AMPHOTEC

LOE Approaching

amphotericin b

NDAINJECTIONINJECTABLE, LIPID COMPLEX

Approved

Nov 1996

Lifecycle

LOE Approaching

Competitive Pressure

30/100

Clinical Trials

Mechanism of Action

CLINICAL PHARMACOLOGY Pharmacokinetics The pharmacokinetics of amphotericin B, administered as AMPHOTEC, were studied in 51 bone marrow transplant patients with systemic fungal infections. The median (range) age and weight of those patients were 32 (3 to 52) years and 69.5 (14 to 116) kg,…

Indications (2)

invasive aspergillosis in patients where renal impairment unacceptable toxicity precludes the use of amphotericin B deoxycholate in effective doses

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

External Resources

DailyMed

Full prescribing information

FDA Drugs@FDA

FDA approval history

RxNorm

Drug nomenclature & identifiers