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Drug ReportsBirch triterpenes
Birch triterpenes
Filsuvez (birch triterpenes) is a small molecule pharmaceutical. Birch triterpenes was first approved as Filsuvez on 2023-12-18. It is used to treat epidermolysis bullosa in the USA.
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Trade Name
FDA
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Filsuvez
Drug Products
FDA
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New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Birch triterpenes
Tradename
Company
Number
Date
Products
FILSUVEZChiesi FarmaceuticiN-215064 RX2023-12-18
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
filsuvezNew Drug Application2024-05-16
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
epidermolysis bullosaD004820Q81
Agency Specific
FDA
EMA
Expiration
Code
BIRCH TRITERPENES, FILSUVEZ, CHIESI
2030-12-18ODE-460
Patent Expiration
Patent
Expires
Flag
FDA Information
Birch Triterpenes, Filsuvez, Chiesi
110837332039-01-04DP
112666602039-01-04U-3811
93520412030-11-24U-3811
98272142030-11-24U-3811
88284442025-06-21DP
ATC Codes
No data
HCPCS
No data
Clinical
Clinical Trials
2 clinical trials
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Indications Phases 4
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Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Epidermolysis bullosaD004820Q81112
Indications Phases 2
No data
Indications Phases 1
No data
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Epidermolysis bullosa dystrophicaD016108Q81.211
Junctional epidermolysis bullosaD016109Q81.111
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameBirch triterpenes
INN
Description
Birch triterpenes, sold under the brand name Filsuvez, is an extract of birch bark used as a topical medication for the treatment of epidermolysis bullosa. The active ingredients are triterpenes extracted from the outer bark of silver birch (Betula pendula) and downy birch (Betula pubescens).
Classification
Small molecule
Drug class
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Structure (InChI/SMILES or Protein Sequence)
Identifiers
PDB
CAS-ID
RxCUI
ChEMBL IDCHEMBL4650246
ChEBI ID
PubChem CID
DrugBankDB16536
UNII ID
Target
No data
Variants
No data
Financial
No data
Trends
No data
Safety
Black-box Warning
No Black-box warning
Adverse Events
0 adverse events reported
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