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Ibrexafungerp
Brexafemme (ibrexafungerp) is a small molecule pharmaceutical. Ibrexafungerp was first approved as Brexafemme on 2021-06-01. It is used to treat vulvovaginal candidiasis in the USA.
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FDA Novel Drug Approvals 2021
Commercial
Therapeutic Areas
Therapeutic Area
MeSH
infectionsD007239
urogenital diseasesD000091642
Trade Name
FDA
EMA
Brexafemme
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Ibrexafungerp citrate
Tradename
Company
Number
Date
Products
BREXAFEMMEScynexisN-214900 RX2021-06-01
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
brexafemmeNew Drug Application2021-06-04
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
vulvovaginal candidiasisEFO_0007543D002181B37.3
Agency Specific
FDA
EMA
Expiration
Code
IBREXAFUNGERP CITRATE, BREXAFEMME, SCYNEXIS
2031-06-01GAIN
2026-06-01NCE
2025-11-30I-903
Patent Expiration
Patent
Expires
Flag
FDA Information
Ibrexafungerp Citrate, Brexafemme, Scynexis
115344332039-06-10U-3159, U-3508
101740742035-01-19DS, DP
103704062035-01-19U-3159
109271422035-01-19DP
81880852030-08-28DS, DPU-3159
ATC Codes
No data
HCPCS
No data
Clinical
Clinical Trials
1 clinical trials
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Indications Phases 4
No data
Indications Phases 3
No data
Indications Phases 2
No data
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients—1————1
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameIBREXAFUNGERP
INNibrexafungerp
Description
Ibrexafungerp, sold under the brand name Brexafemme, is an antifungal medication used to treat vulvovaginal candidiasis (VVC) (vaginal yeast infection). It is taken orally (by mouth). It is also currently undergoing clinical trials for other indications via an intravenous (IV) formulation. An estimated 75% of women will have at least one episode of VVC and 40 to 45% will have two or more episodes in their lifetime.
Classification
Small molecule
Drug classantifungals, triterpinoids
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
CC(C)[C@@H](C)[C@@]1(C)CC[C@]2(C)[C@H]3CC[C@H]4[C@@]5(C)COC[C@@]4(C[C@@H](n4ncnc4-c4ccncc4)[C@@H]5OC[C@](C)(N)C(C)(C)C)C3=CC[C@@]2(C)[C@@H]1C(=O)O
Identifiers
PDB—
CAS-ID1207753-03-4
RxCUI—
ChEMBL IDCHEMBL4297513
ChEBI ID—
PubChem CID46871657
DrugBankDB12471
UNII IDA92JFM5XNU (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 306 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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13 adverse events reported
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