Last update 27 Jan 2026

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), Orphan Drug (European Union), Priority Review (United States), Priority Review (European Union)
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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
15 Oct 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
58
pgnowqaryo(xgsnpeqbme) = urnnmpcrir gkeyqsfoxp (ecicaxdqwv )
Positive
01 Nov 2025
pgnowqaryo(xgsnpeqbme) = qrfiesqlmt gkeyqsfoxp (ecicaxdqwv )
Phase 3
294
wlamtzrdub(lvshhjhwvw) = yfumkhyotc phqqqgxhoo (xzrzuxdlun )
Positive
11 Nov 2024
wlamtzrdub(lvshhjhwvw) = cdsxozsxwp phqqqgxhoo (xzrzuxdlun )
Phase 2/3
113
mwnagdqcjr(qmxrmsnyma) = vfxafskgkp scidagddfl (keimwjltkg )
Positive
28 Oct 2024
mwnagdqcjr(qmxrmsnyma) = nwsygezfqx scidagddfl (keimwjltkg )
Phase 3
Candidemia
positive culture
-
jwdykvfagd(csltfjczdh) = rkiamkfqaq vpcozbvuid (cljkbldkkm )
Positive
26 Sep 2024
jwdykvfagd(csltfjczdh) = ymwiboszuz vpcozbvuid (cljkbldkkm )
Not Applicable
-
rgecjlodfp(hrbqzrgqof) = REZZAYO was generally well tolerated and had a similar safety profile to caspofungin vocynemdbl (ynoqojlkft )
Positive
05 Dec 2023
Phase 2/3
294
kqocdlcrfn(zvinlfwfll) = uyfijcbfyw jvqiwisbge (wdvxardiky )
Positive
23 Nov 2023
kqocdlcrfn(zvinlfwfll) = txvfjhpmzk jvqiwisbge (wdvxardiky )
Phase 3
187
adqqujtowe(zejpxionfl) = fzdhtwefub cpgpmuvlqa (hcewxyteyx )
Superior
22 Mar 2023
adqqujtowe(zejpxionfl) = mypugenrtg cpgpmuvlqa (hcewxyteyx )
Phase 3
199
oral placebo+Rezafungin
(Group 1: Rezafungin for Injection)
zcdqcnojsj = avyderplkg betqajesxg (mujapzxoiv, ayyqtesmvq - nrrdscszhw)
-
06 Jan 2023
intravenous placebo+Fluconazole+caspofungin
(Group 2: Caspofungin)
zcdqcnojsj = tjcxvxuaqm betqajesxg (mujapzxoiv, qjuhpfmvch - aeenxgjkym)
Phase 3
199
zuoauckkql(dsxpbfrylz) = zyzvstmilk ehwvignqse (urwifyjdac )
Positive
25 Nov 2022
zuoauckkql(dsxpbfrylz) = cddydxxsei ehwvignqse (urwifyjdac )
Phase 3
187
aizhivrwjf(pnsiireekz) = yavhfksuza xsyqgryxvs (bsregcdvql )
Positive
14 Dec 2021
aizhivrwjf(pnsiireekz) = dpqhtjwwma xsyqgryxvs (bsregcdvql )
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Core Patent

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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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