TheraRadar
Data updated: Jun 28, 2026

ABELCET (amphotericin b) · LEADIANT BIOSCI INC

Infectious Disease Approved 1995-11-20

ABELCET is FDA-approved to treat 6 conditions (same as AMBISOME).

Source: FDA Label
Jump to: Indications Approvals Trials Competitors Safety Patents
2
Indications
--
Phase 3 Trials
2
Priority Reviews
30
Years on Market

Details

Status
Discontinued
First Approved
1995-11-20
Routes
INJECTION
Dosage Forms
INJECTABLE, LIPID COMPLEX

Companies

LEADIANT BIOSCI INC
Active Ingredient: AMPHOTERICIN B

ABELCET Approval History

1996
1997
1998
1999
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
10 FDA actions from 1995 to 2013 · 1 indication expansions
Dec 2013 SUPPL Priority
Mfg · Manufacturing (CMC)
Aug 2013 SUPPL Priority
Mfg · Manufacturing (CMC)
Sep 1999 SUPPL Priority
Mfg · Manufacturing (CMC)

What ABELCET Treats

6 indications

ABELCET is approved for 6 conditions since its original approval in 1995. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Fungal Infection
  • Cryptococcal Meningitis
  • Aspergillus Infections
  • Candida Infections
  • Cryptococcus Infections
  • Visceral Leishmaniasis

Same approved indications as AMBISOME (same active ingredient).

Source: FDA Label
📋

Clinical Trial Registry

7 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
NCT04031833 EnACT MB-70007 Ph 1, Ph 2 completed Encochleated Oral Amphotericin for Cryptococcal Meningitis Trial (EnACT)
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NCT04018417 2019-005 Ph 2, Ph 3 withdrawn Evaluation of Amphotericin B in Optisol-GS for Prevention of Post-Keratoplasty Fungal Infections.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
🔬

Active Pipeline

Pro

Ongoing clinical trials by development phase

Loading...
⭐

Key Completed Trials

Pro

Completed studies with published results, ranked by significance

Loading...
📊

Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

|
Loading...
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.

ABELCET FDA Label Details

Indications & Usage

ABELCET is FDA-approved to treat 6 conditions — same approved indications as AMBISOME.

Track ABELCET with TheraRadar Pro

Watchlist alerts, full database access, CSV exports across 14,000+ drugs.

Upgrade to Pro

Data Sources

FDA Approval: NDA050724 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.