Amphotericin B

Generic Name: Amphotericin B

Brand Names: Abelcet, Ambisome, Amphotec, Fungizone

Drug Type: Small Molecule

Chemical Formula: C_₄₇H_₇₃NO_₁₇

CAS Number: 1397-89-3

Unique Ingredient Identifier: 7XU7A7DROE

Background: 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

A Pilot Bioequivalence Study Between Amphotericin B Liposome for Injection and AmBisome® in Healthy Subjects

Phase 1

Completed

Conditions: Bioequivalence

Interventions: Drug: Amphotericin B liposome for injection
Drug: AmBisome®

First Posted Date: 2021-08-06

Last Posted Date: 2021-08-06

Lead Sponsor: CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.

Target Recruit Count: 12

Registration Number: NCT04993222

Locations: 🇨🇳
Wuhan Medical Treatment Center, Wuhan, Hubei, China

AmB Dose for Cryptococcal Meningitis

Phase 3

Conditions: Cryptococcal Meningitis
HIV Infections

Interventions: Drug: Amphotericin B
Drug: Flucytosine

First Posted Date: 2019-10-25

Last Posted Date: 2019-10-29

Lead Sponsor: Shanghai Public Health Clinical Center

Target Recruit Count: 40

Registration Number: NCT04140461

Locations: 🇨🇳
Shanghai Public Health Clinical Center, Shanghai, Shanghai, China

Encochleated Oral Amphotericin for Cryptococcal Meningitis Trial (EnACT)

Phase 1

Completed

Conditions: Cryptococcal Meningitis

Interventions: Drug: MAT2203
Drug: Amphotericin B

First Posted Date: 2019-07-24

Last Posted Date: 2023-03-31

Lead Sponsor: Matinas BioPharma Nanotechnologies, Inc.

Target Recruit Count: 178

Registration Number: NCT04031833

Locations: 🇺🇬
Infectious Disease Institute, Kampala, Uganda

Evaluation of Amphotericin B in Optisol-GS for Prevention of Post-Keratoplasty Fungal Infections.

Phase 2

Withdrawn

Conditions: Fuchs' Endothelial Dystrophy

Interventions: Drug: Amphotericin B

First Posted Date: 2019-07-12

Last Posted Date: 2019-07-12

Lead Sponsor: Cornea Research Foundation of America

Registration Number: NCT04018417

Locations: 🇺🇸
Price Vision Group, Indianapolis, Indiana, United States

Steady State Global Bioequivalence Study of Amphotericin B Liposome for Injection 50 mg/ Vial in Fed Condition

Phase 1

Completed

Conditions: Visceral Leishmaniasis

Interventions: Drug: Amphotericin B Liposome
Drug: AmBisome (Amphotericin B) Liposome

First Posted Date: 2018-08-17

Last Posted Date: 2019-08-26

Lead Sponsor: Aurobindo Pharma Ltd

Target Recruit Count: 140

Registration Number: NCT03636659

Locations: 🇮🇳
Kala-Azar medical Research Centre, Muzaffarpur, Bihar, India
🇮🇳
Rajendra Memorial Research Institute of Medical Sciences, Patna, Bihar, India
🇧🇩
International Centre for Diarrhoeal Disease Research b, Dhaka, Bangladesh

Short Course Regimens for Treatment of PKDL (Sudan)

Phase 2

Conditions: PKDL - Post-Kala-Azar Dermal Leishmanioid

Interventions: Drug: Paromomycin
Drug: Ambisome
Drug: Miltefosine

First Posted Date: 2018-01-17

Last Posted Date: 2020-01-18

Lead Sponsor: Drugs for Neglected Diseases

Target Recruit Count: 110

Registration Number: NCT03399955

Locations: 🇸🇩
Prof. Elhassan Centre for tropical Medicine, Doka, Gedaref, Sudan

Safety and Effectiveness of Short-course AmBisome in the Treatment of PKDL in Bangladesh

Phase 4

Completed

Conditions: Post-kala-azar Dermal Leishmaniasis

Interventions: Drug: AmBisome

First Posted Date: 2017-10-17

Last Posted Date: 2017-10-17

Lead Sponsor: Medecins Sans Frontieres, Netherlands

Target Recruit Count: 280

Registration Number: NCT03311607

Treatment With Tamoxifen in Cryptococcal Meningitis

Phase 2

Completed

Conditions: Meningitis
Meningitis Streptococcal
Meningoencephalitis
Hiv

Interventions: Drug: Tamoxifen
Drug: Amphotericin B
Drug: Fluconazole

First Posted Date: 2017-04-13

Last Posted Date: 2019-12-02

Lead Sponsor: Oxford University Clinical Research Unit, Vietnam

Target Recruit Count: 50

Registration Number: NCT03112031

Locations: 🇻🇳
Oxford University Clinical Research Unit, Ho Chi Minh City, Vietnam
🇻🇳
Cho Ray Hospital, Ho Chi Minh City, Vietnam
🇻🇳
Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam