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.
Download report
Favorite
Events Timeline
Commercial
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
Mock data
Subscribe for the real data
Subscribe for the real data
Commercial
Therapeutic Areas
No data
Trade Name
FDA
EMA
Filsuvez
Drug Products
FDA
EMA
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 |
|---|---|---|---|---|
| FILSUVEZ | Chiesi Farmaceutici | N-215064 RX | 2023-12-18 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| filsuvez | New Drug Application | 2024-05-16 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| epidermolysis bullosa | — | D004820 | Q81 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
BIRCH TRITERPENES, FILSUVEZ, CHIESI | |||
| 2030-12-18 | ODE-460 | ||
ATC Codes
No data
HCPCS
No data
Clinical
Clinical Trials
3 clinical trials
View more details
Mock data
Subscribe for the real data
Subscribe for the real data
Indications Phases 4
No data
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Epidermolysis bullosa dystrophica | D016108 | — | Q81.2 | — | — | 1 | — | 1 | 2 |
| Junctional epidermolysis bullosa | D016109 | — | Q81.1 | — | — | 1 | — | 1 | 2 |
| Connective tissue diseases | D003240 | EFO_1001986 | M35 | — | — | 1 | — | — | 1 |
| Congenital abnormalities | D000013 | EFO_0003915 | Q89.9 | — | — | 1 | — | — | 1 |
| Inborn genetic diseases | D030342 | EFO_0000508 | — | — | — | 1 | — | — | 1 |
| Skin diseases | D012871 | — | L00-L99 | — | — | 1 | — | — | 1 |
| Epidermolysis bullosa | D004820 | — | Q81 | — | — | 1 | — | — | 1 |
| Skin abnormalities | D012868 | — | Q82.9 | — | — | 1 | — | — | 1 |
| Collagen diseases | D003095 | — | — | — | — | 1 | — | — | 1 |
Indications Phases 2
No data
Indications Phases 1
No data
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
View more details
Drug
General
| Drug common name | Birch 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 | — |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | — |
| RxCUI | — |
| ChEMBL ID | CHEMBL4650246 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB16536 |
| UNII ID | — |
Target
No data
Variants
No data
Financial
No data
Trends
No data
Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
Mock data
Subscribe for the real data
Subscribe for the real data
96 adverse events reported
View more details
© 2020-2025 Collaborative Drug Discovery Inc. (CDD) | Terms of Use