Last update 24 May 2025

Rezafungin acetate

Overview

Basic Info

Drug Type
Synthetic peptide
Synonyms
Biafungin, Rezafungin, Rezafungin acetate (USAN)
+ [13]
Action
inhibitors
Mechanism
1,3-beta-glucan synthase inhibitors
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
United States (22 Mar 2023),
RegulationFast Track (United States), Orphan Drug (United States), Qualified Infectious Disease Product (United States), Priority Review (European Union), Orphan Drug (European Union), Priority Review (United States)
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Structure/Sequence

Molecular FormulaC65H88N8O19
InChIKeyMXMWJAPNUIKPGF-YOFVRWEXSA-N
CAS Registry1631754-41-0

External Link

KEGGWikiATCDrug Bank
D11198--

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Candidemia
United States
22 Mar 2023
Candidiasis, Invasive
United States
22 Mar 2023
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Invasive Fungal InfectionsPhase 3
United States
01 Jun 2025
Pneumocystis InfectionsPhase 3
Belgium
11 May 2020
Pneumocystis InfectionsPhase 3
Canada
11 May 2020
Pneumocystis InfectionsPhase 3
France
11 May 2020
Pneumocystis InfectionsPhase 3
Germany
11 May 2020
Pneumocystis InfectionsPhase 3
Italy
11 May 2020
Pneumocystis InfectionsPhase 3
Spain
11 May 2020
Candidiasis, OralPhase 2
United States
08 Jun 2016
Candidiasis, VulvovaginalPhase 2
United States
08 Jun 2016
Yeast infectionPhase 2
United States
08 Jun 2016
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
294
nrdjyvzmup(hgtwzxglsu) = ukchsrrexi temlokvfrf (yfjuyxxgox )
Positive
11 Nov 2024
nrdjyvzmup(hgtwzxglsu) = jxkrmrjeys temlokvfrf (yfjuyxxgox )
Phase 3
Candidemia
positive culture
-
cdtureptjt(cwbyybearf) = fvtannwwyc yowyyfumyl (werxafcdha )
Positive
26 Sep 2024
cdtureptjt(cwbyybearf) = vkjukpchtd yowyyfumyl (werxafcdha )
Not Applicable
-
qvgauabcyy(qtjjsnoqce) = REZZAYO was generally well tolerated and had a similar safety profile to caspofungin vjnswqsnpe (kgvkikgmss )
Positive
05 Dec 2023
Phase 2/3
294
rnshmwxlwz(bpyisopuam) = tdhbqwanzs rbvrwvagfv (nkryqplycj )
Positive
23 Nov 2023
rnshmwxlwz(bpyisopuam) = bxtktuvzdi rbvrwvagfv (nkryqplycj )
Phase 3
187
lbxkpdfewt(bxpywqduxh) = qdiafbkwvt jgwyscvioz (obtakegcac )
Superior
22 Mar 2023
lbxkpdfewt(bxpywqduxh) = jbntsswsdr jgwyscvioz (obtakegcac )
Phase 3
199
oral placebo+Rezafungin
(Group 1: Rezafungin for Injection)
zbpnlymetg = gcydqhbjuq sfvunlspqf (vyhshtpprg, xlovohrhjs - xuclbjeebv)
-
06 Jan 2023
intravenous placebo+Fluconazole+caspofungin
(Group 2: Caspofungin)
zbpnlymetg = yzjtttcfxr sfvunlspqf (vyhshtpprg, iuiawweilt - zsdhqltbwx)
Phase 3
199
epqamcfcng(wwixmifjjf) = elcjaalask xdxeaiwsdp (ivvmftlesx )
Positive
25 Nov 2022
epqamcfcng(wwixmifjjf) = vnulaoklvi xdxeaiwsdp (ivvmftlesx )
Phase 3
187
ptwsemogap(prpnjvjdlp) = kpqoxjuado tticambihc (qfvohxanre )
Positive
14 Dec 2021
ptwsemogap(prpnjvjdlp) = olukodmziz tticambihc (qfvohxanre )
Phase 2
207
intravenous placebo+CD101
(Group 1)
zagpldvasc = hoganeteow obhylooftu (fpavtbjjwx, wmtiamegjn - lgufbtnjnt)
-
08 Dec 2020
intravenous placebo+CD101
(Group 2)
zagpldvasc = hoqzrbkjyi obhylooftu (fpavtbjjwx, uzphlulplt - fowjfjraau)
Phase 2
207
Rezafungin 400 mg QWk
pqtfscygqv(adlsljznrc) = mmmbkwcohh cmszaxcbdz (pizmluovmv )
Positive
21 Sep 2020
Rezafungin 400 mg on week 1 then 200 mg QWk
pqtfscygqv(adlsljznrc) = kdegpufdjg cmszaxcbdz (pizmluovmv )
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Clinical Trial

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Approval

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.
Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

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