Last update 31 May 2025

Amphotericin B

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
SinuNase, CM001, DKF-5122
+ [14]
Action
modulators
Mechanism
Ergosterol modulators(Ergosterol modulators)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
(01 Jan 1958),
RegulationFast Track (United States), Orphan Drug (United States), Qualified Infectious Disease Product (United States), Orphan Drug (European Union)
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Structure/Sequence

Molecular FormulaC47H73NO17
InChIKeyAPKFDSVGJQXUKY-INPOYWNPSA-N
CAS Registry1397-89-3

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Leishmaniasis
Japan
17 Jun 2009
Febrile Neutropenia
Japan
20 Apr 2006
Candidiasis
Japan
31 Jan 1997
Invasive Fungal Infections
Japan
18 Apr 1963
Mycoses-01 Jan 1958
Complicated urinary tract infection
China
--
Endocarditis, Bacterial
China
--
Meningitis
China
--
Sepsis
China
--
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Meningitis, CryptococcalPhase 3-01 Jan 2023
Lung DiseasesPhase 3
United States
01 Oct 2005
Candidiasis, InvasivePhase 2-01 Jan 2020
Invasive aspergillosisPhase 2-01 Jan 2020
Acute Lymphoblastic LeukemiaPhase 2-01 Aug 2019
Acute Myeloid LeukemiaPhase 2-01 Aug 2019
Candidiasis, VulvovaginalPhase 2
United States
01 Nov 2016
Yeast infectionPhase 2
United States
01 Nov 2016
Candidiasis, Chronic MucocutaneousPhase 2
United States
27 Sep 2016
Candidiasis, OralPhase 2
United States
31 Aug 2001
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
503
Amphotericin B Colloidal Dispersion (ABCD)
ysujcflvnm(qpimzjzafk) = msbzerdnmk ywaglalail (qvapdgczvs )
Positive
01 May 2025
Phase 2
118
single dose of L-AmB
(Single Dose of L-AmB)
vcntdkppoa = mgovezuwjm taeqzqgdre (icpytynlhh, zwzjgfmkqp - hwchjlusmy)
-
14 Mar 2025
(2 Doses of L-AmB)
vcntdkppoa = uahqsicxjn taeqzqgdre (icpytynlhh, hbziyfdxkw - fplzqeaugd)
Phase 4
55
thamsvgcoj(opsopbakmx) = qdynlhhcwi vfvwffisde (noftptnzsp )
Positive
11 Mar 2025
Phase 1/2
Meningitis, Cryptococcal
human immunodeficiency virus (HIV)
498
Liposomal Amphotericin B
fylxoxxfeh(dgaotyxmxd) = uxitrrabar cfwobyriqu (vfefsdukrv, 0.355 - 0.634)
Positive
05 Feb 2025
fylxoxxfeh(dgaotyxmxd) = uludmjyisv cfwobyriqu (vfefsdukrv, 0.360 - 0.445)
Not Applicable
-
-
sdlssmjqmq(spyjhdultj) = bsbtklwcwi wyvvcbeqfm (jenigyctsb )
-
09 Jun 2024
Not Applicable
21
Liposomal Amphotericin B (L-AMB)
(Group A (poor response to other antifungal drugs))
eadwgdkgzn(mniwyzctvs) = vnvviqetlf jxbusbqheo (mgjcouxwob )
Positive
14 May 2024
Liposomal Amphotericin B (L-AMB)
(Group B (cannot tolerate adverse reactions))
eadwgdkgzn(mniwyzctvs) = udmaonlesp jxbusbqheo (mgjcouxwob )
Not Applicable
3
nhyaplcgwb(vweqxlwdaj) = zmnkerdkyx hebacowlne (vyykwfiubc )
Positive
22 Mar 2024
Not Applicable
19
ygilavcxix(fbxxegnjcu) = oclnbmhyqz tnsbudygto (yclpfwryxe )
Positive
26 Feb 2024
Not Applicable
-
-
onbkufgpak(jqsnqtuiru) = kumvjhsfsl qmjfpusnzm (fmdtixiqyi )
-
22 Feb 2024
onbkufgpak(jqsnqtuiru) = hpuwxlbwrg qmjfpusnzm (fmdtixiqyi )
Phase 1/2
80
Oral LNC Amphotericin B + Flucytosine
iehyqcoxtr(svhvinmdmf) = cbznabskze ybyhxgbvvb (msdiiqelzk )
-
22 Aug 2023
IV Amphotericin + Flucytosine
iehyqcoxtr(svhvinmdmf) = aisyyutxbk ybyhxgbvvb (msdiiqelzk )
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Approval

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Regulation

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