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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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FDA Novel Drug Approvals 2020
Commercial
Therapeutic Areas
Therapeutic Area
MeSH
cardiovascular diseasesD002318
hereditary congenital and neonatal diseases and abnormalitiesD009358
skin and connective tissue diseasesD017437
immune system diseasesD007154
Trade Name
FDA
EMA
Orladeyo
Drug Products
FDA
EMA
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
ORLADEYOBioCryst PharmaceuticalsN-214094 RX2020-12-03
2 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
orladeyoNew Drug Application2020-12-03
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
Expiration
Code
BEROTRALSTAT HYDROCHLORIDE, ORLADEYO, BIOCRYST
2027-12-03ODE-333
2025-12-03NCE
Patent Expiration
Patent
Expires
Flag
FDA Information
Berotralstat Hydrochloride, Orladeyo, Biocryst
106621602039-11-01DPU-3010
111178672039-11-01DPU-3010
116187332039-11-01U-3300
101251022035-04-07DPU-3010
103292602035-03-09DP
106893462035-03-09U-3010
112305302035-03-09U-3300
ATC Codes
B: Blood and blood forming organ drugs
— B06: Other hematological agents in atc
— B06A: Other hematological agents in atc
— B06AC: Drugs used in hereditary angioedema
— B06AC06: Berotralstat
HCPCS
No data
Clinical
Clinical Trials
12 clinical trials
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Indications Phases 4
No data
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Hereditary angioedemasD054179EFO_0004131435—112
Indications Phases 2
No data
Indications Phases 1
No data
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameBEROTRALSTAT
INNberotralstat
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 classenzyme 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-ID1809010-50-1
RxCUI—
ChEMBL IDCHEMBL4594271
ChEBI ID—
PubChem CID137528262
DrugBankDB15982
UNII IDXZA0KB1BDQ (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
KLKB1
KLKB1
Organism
Homo sapiens
Gene name
KLKB1
Gene synonyms
KLK3
NCBI Gene ID
3818
Protein name
plasma kallikrein
Protein synonyms
Fletcher factor, kallikrein B, plasma (Fletcher factor) 1, Kininogenin, PKK, Plasma prekallikrein
Uniprot ID
P03952
Mouse ortholog
Klkb1 (16621)
plasma kallikrein (Q8R0P5)
Variants
Clinical Variant
No data
Financial
Orladeyo - BioCryst Pharmaceuticals
$
€
£
₣
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 83 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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5,469 adverse events reported
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