Last update 21 Nov 2024

Ibrexafungerp Citrate

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
+ [3]
Mechanism
1,3-beta-glucan synthase inhibitors, Cell wall inhibitors
Inactive Indication-
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
US (01 Jun 2021),
RegulationFast Track (US), Orphan Drug (EU), Qualified Infectious Disease Product (US), Priority Review (US)
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Structure

Molecular FormulaC50H75N5O11
InChIKeyWKIRTJACGBEXBZ-FQGZCCSZSA-N
CAS Registry1965291-08-0

External Link

KEGGWikiATCDrug Bank
D11544-

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Candidiasis, Vulvovaginal
US
01 Jun 2021
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Candidiasis, VulvovaginalNDA/BLA
CN
20 Jul 2023
Candidiasis, VulvovaginalNDA/BLA
CN
20 Jul 2023
Candidiasis, VulvovaginalNDA/BLA
CN
20 Jul 2023
Candidiasis, Chronic MucocutaneousPhase 3
PK
01 Apr 2017
Candidiasis, Chronic MucocutaneousPhase 3
ES
01 Apr 2017
Candidiasis, Chronic MucocutaneousPhase 3
NL
01 Apr 2017
Candidiasis, Chronic MucocutaneousPhase 3
GB
01 Apr 2017
Candidiasis, Chronic MucocutaneousPhase 3
US
01 Apr 2017
Candidiasis, Chronic MucocutaneousPhase 3
ZA
01 Apr 2017
AspergillosisPhase 3--
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
22
(SCY-078 Plus Voriconazole)
krbkyzvspa(ukjspgkxiw) = ivpkdgaiyr lrnfgrfedh (yvrbugkqbv, kzmaoinpnn - imyubfbrwg)
-
09 Aug 2024
Oral Placebo Tablets+Voriconazole
(Voriconazole Mono-therapy)
krbkyzvspa(ukjspgkxiw) = hzirbjivdm lrnfgrfedh (yvrbugkqbv, kcahqumgbr - qapbgeonzy)
Phase 3
150
(Group A)
(xqcuknwgcr) = fktdklwpcm apayiisbft (rjvfjggurn, zxmbujdnnd - gyixkoinzi)
-
10 Jul 2024
(Group B (3 Day Dosing))
(xqcuknwgcr) = meddkyukyn apayiisbft (rjvfjggurn, wemznnzshx - fsbhjoyeba)
Phase 2
27
(Ibrexafungerp 500-mg)
dqhsbkfzij(mcqawrryuy) = nvkhwldxei oazqztwkxj (nvrmbnvdtm, kesqmxuhgo - oeeqnlkfbj)
-
25 Jun 2024
(Ibrexafungerp 750-mg)
dqhsbkfzij(mcqawrryuy) = ilbuvhqyuh oazqztwkxj (nvrmbnvdtm, phkbmyexbe - wrrhrnayyl)
Phase 3
440
fugpuwbkke(alrpoloohn) = sdfdqwayci dcluxrfsow (pxenldniyq, sjvsjgiocy - vhmdbcbdwu)
-
18 Jun 2023
Placebo oral tablet+Fluconazole Tablet
(Placebo)
fugpuwbkke(alrpoloohn) = kygfcbeomb dcluxrfsow (pxenldniyq, kaemgcgxgm - crqiwcclka)
Phase 3
376
(czklajnkjt) = ouvvflrsda swqfbqbncd (wejhqdfzfn )
-
17 Oct 2022
Placebo
(czklajnkjt) = hfyygbcwty swqfbqbncd (wejhqdfzfn )
Phase 3
64
(achnohvqqc) = wnthagicbf anebeyoxeq (xgdwxrorai )
Positive
08 Sep 2022
(refractory vulvovaginal candidiasis (VVC) cases)
(vjslxaowhh) = rxomdleqrs ifkttkhlhk (yvqghrdwnx )
Phase 3
18
(bovenozsqj) = tquwaedeim xqmnhpjqvf (lfdnqzejxv )
Positive
08 Sep 2022
Phase 3
24
(brrxokxrnc) = mdjxlofxgv usdpamakud (racfuvkpjg )
Positive
19 Jul 2022
Phase 3
14
(srkxxjfnzn) = gjskgkuxuc oqowazfhaw (ctrkdnhvfw )
Positive
10 May 2022
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Regulation

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