TheraRadar
Data updated: May 26, 2026

ABELCET (amphotericin b)

Infectious Disease Approved 1995-11-20
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
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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

2 FDA approvals

Originally approved for its first indication in 1995 . Covers 2 distinct patient populations.

  • Other (2)
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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NCT04018417 2019-005 Ph 2, Ph 3 withdrawn Evaluation of Amphotericin B in Optisol-GS for Prevention of Post-Keratoplasty Fungal Infections.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
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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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

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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.