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berotralstat 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| enzyme inhibitors | 5430 | 1809010-50-1 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
Berotralstat is a plasma kallikrein inhibitor that binds to plasma kallikrein and inhibits its proteolytic activity. Plasma kallikrein is a protease that cleaves high-molecular-weight-kininogen (HMWK) to generate cleaved HMWK (cHMWK) and bradykinin, a potent vasodilator that increases vascular permeability resulting in swelling and pain associated with HAE. In patients with HAE due to C1-inhibitor (C1-INH) deficiency or dysfunction, normal regulation of plasma kallikrein activity is not present, which leads to uncontrolled increases in plasma kallikrein activity and results in angioedema attacks. Berotralstat decreases plasma kallikrein activity to control excess bradykinin generation in patients with HAE.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
| Dose | Unit | Route |
|---|---|---|
| 0.15 | g | O |
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| S (Water solubility) | 1.09 mg/mL | Bocci G, Oprea TI, Benet LZ |
| BDDCS (Biopharmaceutical Drug Disposition Classification System) | 1 | Bocci G, Oprea TI, Benet LZ |
Predicted pharmacokinetic/toxicological properties (PK-AZ):
| Property | Description | Value | Unit | Confidence | Similarity |
|---|---|---|---|---|---|
| kinase-safety-class | AKT3,AXL,BRAF,CAMK2B,CAMK2D,CDK5,EGFR,EIF2AK3,ERBB2,GRK2,INSR,ITK,MAPK10,MET,NTRK2,PDK1,PDK2,PDK4 | 18 | |||
| kinase-selectivity-class | EIF2AK3,PDK4 | 2 | |||
| pfas-class | PFAS structural alert (1 = True, 0 = False) | 1 |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Dec. 3, 2020 | FDA | BIOCRYST | |
| April 30, 2021 | EMA | BioCryst Ireland Limited | |
| Jan. 22, 2021 | PMDA | ORPHAN PACIFIC, Inc |
FDA Adverse Event Reporting System (Female)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Hereditary angioedema | 187.00 | 40.17 | 30 | 195 | 9335 | 90618887 |
FDA Adverse Event Reporting System (Male)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Hereditary angioedema | 65.83 | 52.96 | 9 | 59 | 1472 | 42619795 |
FDA Adverse Event Reporting System (Geriatric)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Hereditary angioedema | 176.08 | 42.06 | 27 | 214 | 7087 | 110581971 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | B06AC06 | BLOOD AND BLOOD FORMING ORGANS OTHER HEMATOLOGICAL AGENTS OTHER HEMATOLOGICAL AGENTS Drugs used in hereditary angioedema |
| MeSH PA | D004791 | Enzyme Inhibitors |
| MeSH PA | D011480 | Protease Inhibitors |
| MeSH PA | D015842 | Serine Proteinase Inhibitors |
| FDA MoA | N0000182137 | Cytochrome P450 2D6 Inhibitors |
| FDA MoA | N0000182141 | Cytochrome P450 3A4 Inhibitors |
| FDA MoA | N0000184151 | Kallikrein Inhibitors |
| FDA MoA | N0000185503 | P-Glycoprotein Inhibitors |
| FDA EPC | N0000192750 | Plasma Kallikrein Inhibitor |
Related Drugs by ATC class:
B06AC Drugs used in hereditary angioedema 7 drugs
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Hereditary angioneurotic edema | indication | 82966003 | DOID:14735 |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
None
Orange Book patent data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
|---|---|---|---|---|---|---|---|---|---|---|
| EQ 110MG BASE | ORLADEYO | BIOCRYST | N214094 | Dec. 3, 2020 | RX | CAPSULE | ORAL | 10689346 | March 9, 2035 | PROPHYLAXIS TO PREVENT ATTACKS OF HEREDITARY ANGIOEDEMA (HAE) IN ADULT AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER |
| EQ 110MG BASE | ORLADEYO | BIOCRYST | N214094 | Dec. 3, 2020 | RX | CAPSULE | ORAL | 11230530 | March 9, 2035 | PROPHYLAXIS TO PREVENT ATTACKS OF HEREDITARY ANGIOEDEMA (HAE) IN ADULTS AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER |
| EQ 110MG BASE | ORLADEYO | BIOCRYST | N214094 | Dec. 3, 2020 | RX | CAPSULE | ORAL | 11708333 | March 9, 2035 | PROPHYLAXIS TO PREVENT ATTACKS OF HEREDITARY ANGIOEDEMA (HAE) IN ADULTS AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER |
| EQ 110MG BASE | ORLADEYO | BIOCRYST | N214094 | Dec. 3, 2020 | RX | CAPSULE | ORAL | 10125102 | April 7, 2035 | PROPHYLAXIS TO PREVENT ATTACKS OF HEREDITARY ANGIOEDEMA (HAE) IN ADULT AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER |
| EQ 110MG BASE | ORLADEYO | BIOCRYST | N214094 | Dec. 3, 2020 | RX | CAPSULE | ORAL | 10662160 | Nov. 1, 2039 | PROPHYLAXIS TO PREVENT ATTACKS OF HEREDITARY ANGIOEDEMA (HAE) IN ADULT AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER |
| EQ 110MG BASE | ORLADEYO | BIOCRYST | N214094 | Dec. 3, 2020 | RX | CAPSULE | ORAL | 11117867 | Nov. 1, 2039 | PROPHYLAXIS TO PREVENT ATTACKS OF HEREDITARY ANGIOEDEMA (HAE) IN ADULT AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER |
| EQ 110MG BASE | ORLADEYO | BIOCRYST | N214094 | Dec. 3, 2020 | RX | CAPSULE | ORAL | 11618733 | Nov. 1, 2039 | PROPHYLAXIS TO PREVENT ATTACKS OF HEREDITARY ANGIOEDEMA (HAE) IN ADULTS AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER |
| EQ 110MG BASE | ORLADEYO | BIOCRYST | N214094 | Dec. 3, 2020 | RX | CAPSULE | ORAL | 12344585 | Nov. 1, 2039 | PROPHYLAXIS TO PREVENT ATTACKS OF HEREDITARY ANGIOEDEMA (HAE) IN ADULT AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER |
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| EQ 110MG BASE | ORLADEYO | BIOCRYST | N214094 | Dec. 3, 2020 | RX | CAPSULE | ORAL | Dec. 3, 2027 | PROPHYLAXIS TO PREVENT ATTACKS OF HEREDITARY ANGIOEDEMA (HAE) IN ADULTS AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER |
| EQ 110MG BASE | ORLADEYO | BIOCRYST | N214094 | Dec. 3, 2020 | RX | CAPSULE | ORAL | June 3, 2028 | PEDIATRIC EXCLUSIVITY |
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Plasma kallikrein | Enzyme | INHIBITOR | IC50 | 7.80 | DRUG LABEL | DRUG LABEL | |||
| Plasminogen | Enzyme | IC50 | 5.40 | CHEMBL |
External reference:
| ID | Source |
|---|---|
| D11673 | KEGG_DRUG |
| XZA0KB1BDQ | UNII |
| 1809010-52-3 | SECONDARY_CAS_RN |
| C5392453 | UMLSCUI |
| CHEBI:759066 | CHEBI |
| 0RI | PDB_CHEM_ID |
| CHEMBL5189739 | ChEMBL_ID |
| 137528262 | PUBCHEM_CID |
| DB15982 | DRUGBANK_ID |
| CHEMBL6067995 | ChEMBL_ID |
| 10907 | INN_ID |
| C000706836 | MESH_SUPPLEMENTAL_RECORD_UI |
| 11347 | IUPHAR_LIGAND_ID |
| 1144607003 | SNOMEDCT_US |
| 1144608008 | SNOMEDCT_US |
| 1144618003 | SNOMEDCT_US |
| 4039913 | VANDF |
| 4039915 | VANDF |
| 341763 | MMSL |
| 39091 | MMSL |
| d09694 | MMSL |
| 018585 | NDDF |
| 018586 | NDDF |
| 2467540 | RXNORM |
| XZA0KB1BDQ | INXIGHT DRUGS |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Orladeyo | HUMAN PRESCRIPTION DRUG LABEL | 1 | 72769-101 | CAPSULE | 150 mg | ORAL | NDA | 31 sections |
| Orladeyo | HUMAN PRESCRIPTION DRUG LABEL | 1 | 72769-102 | CAPSULE | 110 mg | ORAL | NDA | 31 sections |
| Orladeyo | HUMAN PRESCRIPTION DRUG LABEL | 1 | 72769-111 | PELLET | 72 mg | ORAL | NDA | 31 sections |
| Orladeyo | HUMAN PRESCRIPTION DRUG LABEL | 1 | 72769-112 | PELLET | 96 mg | ORAL | NDA | 31 sections |
| Orladeyo | HUMAN PRESCRIPTION DRUG LABEL | 1 | 72769-113 | PELLET | 108 mg | ORAL | NDA | 31 sections |
| Orladeyo | HUMAN PRESCRIPTION DRUG LABEL | 1 | 72769-114 | PELLET | 132 mg | ORAL | NDA | 31 sections |