Stem definition | Drug id | CAS RN |
---|---|---|
5048 | 362665-56-3 |
Dose | Unit | Route |
---|---|---|
18 | mg | O |
None
Date | Agency | Company | Orphan |
---|---|---|---|
March 31, 2016 | EMA | Bioprojet Pharma | |
Aug. 14, 2019 | FDA | HARMONY |
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 |
---|---|---|---|---|---|---|
Splenic infarction | 113.80 | 50.21 | 18 | 377 | 1542 | 50603187 |
None
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 |
---|---|---|---|---|---|---|
Splenic infarction | 113.63 | 50.82 | 18 | 229 | 3239 | 64495246 |
None
Source | Code | Description |
---|---|---|
ATC | N07XX11 | NERVOUS SYSTEM OTHER NERVOUS SYSTEM DRUGS OTHER NERVOUS SYSTEM DRUGS Other nervous system drugs |
Disease | Relation | SNOMED_ID | DOID |
---|---|---|---|
Narcolepsy | indication | 60380001 | DOID:8986 |
None
None
Dissociation level | Dissociation constant | Type (acidic/basic) |
---|---|---|
pKa1 | 9.59 | Basic |
Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
---|---|---|---|---|---|---|---|---|---|---|
EQ 17.8MG BASE | WAKIX | HARMONY | N211150 | Aug. 14, 2019 | RX | TABLET | ORAL | 8354430 | Feb. 6, 2026 | METHOD OF TREATING CATAPLEXY IN PATIENTS WITH NARCOLEPSY |
EQ 17.8MG BASE | WAKIX | HARMONY | N211150 | Aug. 14, 2019 | RX | TABLET | ORAL | 8354430 | Feb. 6, 2026 | METHOD OF TREATING EXCESSIVE DAYTIME SLEEPINESS IN PATIENTS WITH NARCOLEPSY |
EQ 4.45MG BASE | WAKIX | HARMONY | N211150 | Aug. 14, 2019 | RX | TABLET | ORAL | 8354430 | Feb. 6, 2026 | METHOD OF TREATING CATAPLEXY IN PATIENTS WITH NARCOLEPSY |
EQ 4.45MG BASE | WAKIX | HARMONY | N211150 | Aug. 14, 2019 | RX | TABLET | ORAL | 8354430 | Feb. 6, 2026 | METHOD OF TREATING EXCESSIVE DAYTIME SLEEPINESS IN PATIENTS WITH NARCOLEPSY |
EQ 17.8MG BASE | WAKIX | HARMONY | N211150 | Aug. 14, 2019 | RX | TABLET | ORAL | 8486947 | Sept. 26, 2029 | METHOD OF TREATING CATAPLEXY IN PATIENTS WITH NARCOLEPSY |
EQ 17.8MG BASE | WAKIX | HARMONY | N211150 | Aug. 14, 2019 | RX | TABLET | ORAL | 8486947 | Sept. 26, 2029 | METHOD OF TREATING EXCESSIVE DAYTIME SLEEPINESS IN PATIENTS WITH NARCOLEPSY |
EQ 4.45MG BASE | WAKIX | HARMONY | N211150 | Aug. 14, 2019 | RX | TABLET | ORAL | 8486947 | Sept. 26, 2029 | METHOD OF TREATING CATAPLEXY IN PATIENTS WITH NARCOLEPSY |
EQ 4.45MG BASE | WAKIX | HARMONY | N211150 | Aug. 14, 2019 | RX | TABLET | ORAL | 8486947 | Sept. 26, 2029 | METHOD OF TREATING EXCESSIVE DAYTIME SLEEPINESS IN PATIENTS WITH NARCOLEPSY |
Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
---|---|---|---|---|---|---|---|---|---|
EQ 17.8MG BASE | WAKIX | HARMONY | N211150 | Aug. 14, 2019 | RX | TABLET | ORAL | Oct. 13, 2023 | TREATMENT OF CATAPLEXY IN ADULT PATIENTS WITH NACROLEPSY |
EQ 4.45MG BASE | WAKIX | HARMONY | N211150 | Aug. 14, 2019 | RX | TABLET | ORAL | Oct. 13, 2023 | TREATMENT OF CATAPLEXY IN ADULT PATIENTS WITH NACROLEPSY |
EQ 17.8MG BASE | WAKIX | HARMONY | N211150 | Aug. 14, 2019 | RX | TABLET | ORAL | Aug. 14, 2024 | NEW CHEMICAL ENTITY |
EQ 4.45MG BASE | WAKIX | HARMONY | N211150 | Aug. 14, 2019 | RX | TABLET | ORAL | Aug. 14, 2024 | NEW CHEMICAL ENTITY |
EQ 17.8MG BASE | WAKIX | HARMONY | N211150 | Aug. 14, 2019 | RX | TABLET | ORAL | Aug. 14, 2026 | INDICATED FOR THE TREATMENT OF EXCESSIVE DAYTIME SLEEPINESS (EDS) IN ADULT PATIENTS WITH NARCOLEPSY |
EQ 4.45MG BASE | WAKIX | HARMONY | N211150 | Aug. 14, 2019 | RX | TABLET | ORAL | Aug. 14, 2026 | INDICATED FOR THE TREATMENT OF EXCESSIVE DAYTIME SLEEPINESS (EDS) IN ADULT PATIENTS WITH NARCOLEPSY |
EQ 17.8MG BASE | WAKIX | HARMONY | N211150 | Aug. 14, 2019 | RX | TABLET | ORAL | Oct. 13, 2027 | TREATMENT OF CATAPLEXY IN ADULT PATIENTS WITH NACROLEPSY |
EQ 4.45MG BASE | WAKIX | HARMONY | N211150 | Aug. 14, 2019 | RX | TABLET | ORAL | Oct. 13, 2027 | TREATMENT OF CATAPLEXY IN ADULT PATIENTS WITH NACROLEPSY |
Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
---|---|---|---|---|---|---|---|---|---|
Histamine H3 receptor | GPCR | INVERSE AGONIST | Ki | 9.80 | SCIENTIFIC LITERATURE | SCIENTIFIC LITERATURE | |||
Histamine H1 receptor | GPCR | Ki | 5.94 | CHEMBL | |||||
Histamine H2 receptor | GPCR | ANTAGONIST | Ki | 4.96 | IUPHAR | ||||
Potassium voltage-gated channel subfamily H member 2 | Ion channel | IC50 | 5.77 | CHEMBL | |||||
Histamine H3 receptor | GPCR | Ki | 7.77 | CHEMBL | |||||
Histamine H3 receptor | GPCR | Ki | 7.85 | CHEMBL | |||||
Histamine H3 receptor | GPCR | Ki | 9.80 | CHEMBL | |||||
Cholinesterase | Enzyme | IC50 | 5.08 | CHEMBL |
ID | Source |
---|---|
4BC83L4PIY | UNII |
903576-44-3 | SECONDARY_CAS_RN |
4038743 | VANDF |
4038744 | VANDF |
C3529928 | UMLSCUI |
CHEBI:134709 | CHEBI |
CHEMBL462605 | ChEMBL_ID |
9948102 | PUBCHEM_CID |
DB11642 | DRUGBANK_ID |
CHEMBL4164059 | ChEMBL_ID |
8952 | INN_ID |
C516975 | MESH_SUPPLEMENTAL_RECORD_UI |
8924 | IUPHAR_LIGAND_ID |
2197878 | RXNORM |
247019 | MMSL |
32128 | MMSL |
d08498 | MMSL |
421000220103 | SNOMEDCT_US |
716308007 | SNOMEDCT_US |
789360005 | SNOMEDCT_US |
017799 | NDDF |
017884 | NDDF |
Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
---|---|---|---|---|---|---|---|---|
Wakix | HUMAN PRESCRIPTION DRUG LABEL | 1 | 72028-045 | TABLET, FILM COATED | 4.45 mg | ORAL | NDA | 29 sections |
Wakix | HUMAN PRESCRIPTION DRUG LABEL | 1 | 72028-178 | TABLET, FILM COATED | 17.80 mg | ORAL | NDA | 29 sections |