Orladeyo(berotralstat)
Orladeyo (berotralstat) is a small molecule pharmaceutical. Berotralstat was first approved as Orladeyo on 2020-12-03. It has been approved in Europe to treat hereditary angioedemas. It is known to target plasma kallikrein.
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Commercial
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Orladeyo
Drug Products
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New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Berotralstat hydrochloride
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| ORLADEYO | BioCryst Pharmaceuticals | N-214094 RX | 2020-12-03 | 2 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| orladeyo | New Drug Application | 2023-11-29 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| hereditary angioedemas | EFO_0004131 | D054179 | — |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
BEROTRALSTAT HYDROCHLORIDE, ORLADEYO, BIOCRYST | |||
| 2027-12-03 | ODE-333 | ||
| 2025-12-03 | NCE | ||
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Clinical
Clinical Trials
12 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 |
|---|---|---|---|---|---|---|---|---|---|
| Hereditary angioedemas | D054179 | EFO_0004131 | — | 4 | 3 | 5 | — | 1 | 12 |
| Angioedema | D000799 | EFO_0005532 | T78.3 | 4 | 3 | 5 | — | 1 | 12 |
| Antibiotic prophylaxis | D019072 | — | — | — | 1 | 1 | — | 1 | 2 |
Indications Phases 2
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Indications Phases 1
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Berotralstat |
| INN | berotralstat |
| Description | Berotralstat, sold under the brand name Orladeyo, is a medication used to prevent attacks of hereditary angioedema (HAE) in people aged twelve years and older.
|
| Classification | Small molecule |
| Drug class | enzyme inhibitors: 1) kallikrein inhibitors or 2) serine protease inhibitors |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | N#Cc1cccc(C(NCC2CC2)c2ccc(F)c(NC(=O)c3cc(C(F)(F)F)nn3-c3cccc(CN)c3)c2)c1 |
Identifiers
| PDB | — |
| CAS-ID | 1809010-50-1 |
| RxCUI | — |
| ChEMBL ID | CHEMBL4594271 |
| ChEBI ID | — |
| PubChem CID | 137528262 |
| DrugBank | DB15982 |
| UNII ID | XZA0KB1BDQ (ChemIDplus, GSRS) |
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Orladeyo – BioCryst Pharmaceuticals
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Safety
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247 adverse events reported
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