MedPath

Amphotericin B

Generic Name
Amphotericin B
Brand Names
Abelcet, Ambisome, Amphotec, Fungizone
Drug Type
Small Molecule
Chemical Formula
C47H73NO17
CAS Number
1397-89-3
Unique Ingredient Identifier
7XU7A7DROE

Overview

Amphotericin B shows a high order of in vitro activity against many species of fungi. Histoplasma capsulatum, Coccidioides immitis, Candida species, Blastomyces dermatitidis, Rhodotorula, Cryptococcus neoformans, Sporothrix schenckii, Mucor mucedo, and Aspergillus fumigatus are all inhibited by concentrations of amphotericin B ranging from 0.03 to 1.0 mcg/mL in vitro. While Candida albicans is generally quite susceptible to amphotericin B, non-albicans species may be less susceptible. Pseudallescheria boydii and Fusarium sp. are often resistant to amphotericin B. The antibiotic is without effect on bacteria, rickettsiae, and viruses.

Indication

Used to treat potentially life threatening fungal infections.

Associated Conditions

  • Coccidioidomycosis
  • Fungal Infections
  • Histoplasmosis
  • Invasive Aspergillosis
  • Invasive Fungal Infections
  • Leishmaniasis
  • Meningitis, Cryptococcal
  • Meningitis, Fungal
  • Mucocutaneous Leishmaniasis
  • Mycotic endophthalmitis
  • Penicillium marneffei infection
  • Visceral Leishmaniasis
  • Candidal cystitis
  • Disseminated Cryptococcosis
  • Fungal osteoarticular infections
  • Ocular aspergillosis
  • Refractory aspergillosis
  • Severe Coccidioidomycosis
  • Severe Cryptococcosis
  • Severe Fungal infection caused by Basidiobolus spp.
  • Severe Fungal infection caused by Conidiobolus spp.
  • Severe Fungal infection caused by sporotrichosis spp.
  • Severe Histoplasmosis
  • Severe Mucocutaneous leishmaniasis
  • Severe North American blastomycosis
  • Severe Systemic candidiasis

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2025/04/13
Not Applicable
Not yet recruiting
2025/01/01
Phase 4
Not yet recruiting
Bin Cao
2024/05/14
Phase 4
Completed
2023/09/15
Phase 2
Recruiting
University of Brasilia
2023/06/22
Phase 1
Completed
2023/03/01
Phase 1
Completed
2022/10/25
Phase 2
Active, not recruiting
Drugs for Neglected Diseases
2022/09/15
Phase 3
Not yet recruiting
2022/07/21
Phase 2
Recruiting
Post Graduate Institute of Medical Education and Research, Chandigarh
2021/11/01
Phase 3
Recruiting

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Sun Pharmaceutical Industries, Inc.
62756-233
INTRAVENOUS
50 mg in 1 1
2/9/2022
XGen Pharmaceuticals DJB, Inc.
39822-1055
INTRAVENOUS
50 mg in 10 mL
8/14/2021
Leadiant Biosciences, Inc.
57665-101
INTRAVENOUS
5 mg in 1 mL
11/21/2023
Astellas Pharma US, Inc.
0469-3051
INTRAVENOUS
50 mg in 12.5 mL
2/6/2018
Eugia US LLC
55150-365
INTRAVENOUS
50 mg in 12.5 mL
11/18/2022

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
Amphotericin B Vaginal Effervescent Tablets
国药准字H13023857
化学药品
片剂
8/2/2024
Amphotericin B Liposome for Injection
国药准字H20244839
化学药品
注射剂
9/10/2024
Amphotericin B Liposome for Injection
国药准字H20253083
化学药品
注射剂
1/8/2025
Amphotericin B Liposome for Injection
国药准字HJ20233123
化学药品
注射剂
2/28/2023
Amphotericin B Liposome for Injection
台湾微脂体股份有限公司
国药准字HC20250001
化学药品
注射剂
2/20/2025
Amphotericin B Liposome for Injection
国药准字H20030892
化学药品
注射剂
6/23/2020
Amphotericin B for Injection
国药准字H13020285
化学药品
注射剂
10/27/2020
Amphotericin B for Injection
国药准字H31020821
化学药品
注射剂
6/23/2020
Amphotericin B for Injection
国药准字H13020284
化学药品
注射剂
7/8/2020
Amphotericin B for Injection
国药准字H13020283
化学药品
注射剂
10/27/2020

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.

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