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remimazolam 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| diazepam derivatives | 5400 | 308242-62-8 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
Remimazolam is a benzodiazepine and it binds to brain benzodiazepine sites (gamma amino butyric acid type A [GABAA] receptors), while its carboxylic acid metabolite (CNS7054) has a 300 times lower affinity for the receptor. Remimazolam, like other benzodiazepines, did not show clear selectivity between subtypes of the GABAA receptor.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
None
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| S (Water solubility) | 8.30 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 |
|---|---|---|---|---|---|
| azlogd74 | LogD at pH 7.4 | 2.619 | High | 1 | |
| caco2-efflux | Caco-2 efflux ratio (BA/AB) | 1.064 | High | 1 | |
| caco2-intrinsic-papp | Caco-2 intrinsic apparent permeability | 49.091 | 10^-6 cm/s | High | 1 |
| dh-clint | Dog hepatocyte intrinsic clearance | 84.333 | uL/min/10^6 cells | High | 1 |
| dppb | Dog plasma protein binding (% unbound) | 17.820 | % | High | 1 |
| fcs-ppb | Fetal calf serum protein binding (% unbound) | 28.800 | % | High | 1 |
| herg | hERG pIC50 | 4.602 | pIC50 | High | 1 |
| hh-clint | Human hepatocyte intrinsic clearance | 118.850 | uL/min/10^6 cells | High | 1 |
| hlm-clint | Human liver microsomal intrinsic clearance | 154.525 | uL/min/mg protein | High | 1 |
| hppb | Human plasma protein binding (% unbound) | 14.010 | % | High | 1 |
| kinase-safety-class | ACVR2B,AXL,BRAF,CAMK2B,CAMK2D,CDK5,CDK9,DYRK1B,EIF2AK3,ERBB2,GRK2,GSK3B,ITK,MAP3K21,MAP3K7,MAPK10,MAPK7,MARK4,PDK1,PDK2,PDK4,PIK3CB,PIK3CD,PIK3CG,PRKDC,STK33,TEK,TTK | 28 | |||
| kinase-selectivity-class | ACVR2B,AXL | 2 | |||
| mdck-mdr1-efflux | MDCK-MDR1 efflux ratio | 1.023 | High | 1 | |
| mh-clint | Mouse hepatocyte intrinsic clearance | 429.536 | High | 1 | |
| mppb | Mouse plasma protein binding (% unbound) | 16.760 | High | 1 | |
| nih-mdck-mdr1-efflux | NIH MDCK-MDR1 efflux ratio | 2.265 | High | 1 | |
| pfas-class | PFAS structural alert (1 = True, 0 = False) | 0 | |||
| pppb | Pig plasma protein binding (% unbound) | 29.950 | % | High | 1 |
| rh-clint | Rat hepatocyte intrinsic clearance | 295.801 | uL/min/10^6 cells | High | 1 |
| rh-fuinc | Rat hepatocyte fraction unbound in incubation | 80.360 | % | High | 1 |
| rppb | Rat plasma protein binding (% unbound) | 14.690 | % | High | 1 |
| solubility-dd | Solubility at pH 7.4 in DMSO | 674.528 | uM | High | 1 |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| July 2, 2020 | FDA | ACACIA | |
| Jan. 23, 2020 | PMDA | Anerem | |
| March 26, 2021 | EMA | PAION Netherlands B.V. |
FDA Adverse Event Reporting System (Female)
None
FDA Adverse Event Reporting System (Male)
None
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 |
|---|---|---|---|---|---|---|
| Anaphylactic shock | 113.50 | 109.64 | 24 | 156 | 51522 | 110537597 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | N05CD14 | NERVOUS SYSTEM PSYCHOLEPTICS HYPNOTICS AND SEDATIVES Benzodiazepine derivatives |
| CHEBI has role | CHEBI:35610 | antineoplastic agent |
| CHEBI has role | CHEBI:38070 | anti-arrhythmia drug |
| CHEBI has role | CHEBI:38867 | anaesthetic |
| CHEBI has role | CHEBI:48407 | antiparkinson drug |
| CHEBI has role | CHEBI:35480 | analgesic |
| CHEBI has role | CHEBI:35717 | sedative |
Related Drugs by ATC class:
N05CD Benzodiazepine derivatives 14 drugs
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Sedation | indication | 72641008 | |
| Non-allergic hypersensitivity to dextran | contraindication | 609536007 |
🐶 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 20MG BASE/VIAL | BYFAVO | ACACIA | N212295 | Oct. 6, 2020 | RX | POWDER | INTRAVENOUS | 10472365 | July 10, 2027 | USE OF REMIMAZOLAM FOR INDUCTION AND MAINTENANCE OF PROCEDURAL SEDATION IN ADULTS UNDERGOING PROCEDURES LASTING 30 MINUTES OR LESS |
| EQ 20MG BASE/VIAL | BYFAVO | ACACIA | N212295 | Oct. 6, 2020 | RX | POWDER | INTRAVENOUS | 10961250 | July 10, 2027 | USE OF REMIMAZOLAM FOR INDUCTION AND MAINTENANCE OF PROCEDURAL SEDATION IN ADULTS UNDERGOING PROCEDURES LASTING 30 MINUTES OR LESS |
| EQ 20MG BASE/VIAL | BYFAVO | ACACIA | N212295 | Oct. 6, 2020 | RX | POWDER | INTRAVENOUS | 10052334 | Nov. 7, 2031 | USE OF REMIMAZOLAM FOR INDUCTION AND MAINTENANCE OF PROCEDURAL SEDATION IN ADULTS UNDERGOING PROCEDURES LASTING 30 MINUTES OR LESS |
| EQ 20MG BASE/VIAL | BYFAVO | ACACIA | N212295 | Oct. 6, 2020 | RX | POWDER | INTRAVENOUS | 10195210 | Nov. 7, 2031 | USE OF REMIMAZOLAM FOR INDUCTION AND MAINTENANCE OF PROCEDURAL SEDATION IN ADULTS UNDERGOING PROCEDURES LASTING 30 MINUTES OR LESS |
| EQ 20MG BASE/VIAL | BYFAVO | ACACIA | N212295 | Oct. 6, 2020 | RX | POWDER | INTRAVENOUS | 10342800 | Nov. 7, 2031 | USE OF REMIMAZOLAM FOR INDUCTION AND MAINTENANCE OF PROCEDURAL SEDATION IN ADULTS UNDERGOING PROCEDURES LASTING 30 MINUTES OR LESS |
| EQ 20MG BASE/VIAL | BYFAVO | ACACIA | N212295 | Oct. 6, 2020 | RX | POWDER | INTRAVENOUS | 10722522 | Nov. 7, 2031 | USE OF REMIMAZOLAM FOR INDUCTION AND MAINTENANCE OF PROCEDURAL SEDATION IN ADULTS UNDERGOING PROCEDURES LASTING 30 MINUTES OR LESS |
| EQ 20MG BASE/VIAL | BYFAVO | ACACIA | N212295 | Oct. 6, 2020 | RX | POWDER | INTRAVENOUS | 9737547 | Nov. 7, 2031 | USE OF REMIMAZOLAM FOR INDUCTION AND MAINTENANCE OF PROCEDURAL SEDATION IN ADULTS UNDERGOING PROCEDURES LASTING 30 MINUTES OR LESS |
| EQ 20MG BASE/VIAL | BYFAVO | ACACIA | N212295 | Oct. 6, 2020 | RX | POWDER | INTRAVENOUS | 9561236 | April 30, 2033 | USE OF REMIMAZOLAM FOR INDUCTION AND MAINTENANCE OF PROCEDURAL SEDATION IN ADULTS UNDERGOING PROCEDURES LASTING 30 MINUTES OR LESS |
| EQ 20MG BASE/VIAL | BYFAVO | ACACIA | N212295 | Oct. 6, 2020 | RX | POWDER | INTRAVENOUS | 9827251 | Jan. 13, 2034 | USE OF REMIMAZOLAM FOR INDUCTION AND MAINTENANCE OF PROCEDURAL SEDATION IN ADULTS UNDERGOING PROCEDURES LASTING 30 MINUTES OR LESS |
Orange Book exclusivity data (new drug applications)
None
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| GABA-A receptor; benzodiazepine binding site | Ion channel | MODULATOR | Ki | 7.53 | SCIENTIFIC LITERATURE | DRUG LABEL | |||
| GABA A receptor alpha-3/beta-2/gamma-2 | Ion channel | MODULATOR | EC50 | 6.04 | SCIENTIFIC LITERATURE | ||||
| GABA-A receptor; alpha-1/beta-2/gamma-2 | Ion channel | MODULATOR | EC50 | 6.44 | SCIENTIFIC LITERATURE | ||||
| GABA A receptor alpha-2/beta-2/gamma-2 | Ion channel | MODULATOR | EC50 | 6.18 | SCIENTIFIC LITERATURE | ||||
| GABA A receptor alpha-5/beta-2/gamma-2 | Ion channel | MODULATOR | EC50 | 5.86 | SCIENTIFIC LITERATURE |
External reference:
| ID | Source |
|---|---|
| D11788 | KEGG_DRUG |
| 7V4A8U16MB | UNII |
| 1001415-66-2 | SECONDARY_CAS_RN |
| 4039938 | VANDF |
| C3179470 | UMLSCUI |
| CHEBI:757006 | CHEBI |
| CHEMBL4297526 | ChEMBL_ID |
| 9867812 | PUBCHEM_CID |
| DB12404 | DRUGBANK_ID |
| CHEMBL4594301 | ChEMBL_ID |
| 9232 | INN_ID |
| C522201 | MESH_SUPPLEMENTAL_RECORD_UI |
| 8442 | IUPHAR_LIGAND_ID |
| 926369003 | SNOMEDCT_US |
| 926383001 | SNOMEDCT_US |
| 926385008 | SNOMEDCT_US |
| 336210 | MMSL |
| 38618 | MMSL |
| d09651 | MMSL |
| 018433 | NDDF |
| 018438 | NDDF |
| 2383941 | RXNORM |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| BYFAVO | HUMAN PRESCRIPTION DRUG LABEL | 1 | 71390-011 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 2.50 mg | INTRAVENOUS | NDA | 35 sections |