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Drug ReportsDroxidopa
Droxidopa
Droxidopa, Northera (droxidopa) is a small molecule pharmaceutical. Droxidopa was first approved as Northera on 2014-02-18. It is used to treat orthostatic hypotension in the USA. It is known to target muscarinic acetylcholine receptor M1.
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FDA approval date
EMA approval date
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Last update post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
nervous system diseasesD009422
cardiovascular diseasesD002318
Trade Name
FDA
EMA
Droxidopa, Northera (discontinued: Droxidopa)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Droxidopa
Tradename
Company
Number
Date
Products
NORTHERALundbeckN-203202 RX2014-02-18
3 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
droxidopaANDA2024-01-25
northeraNew Drug Application2021-12-08
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
orthostatic hypotension—D007024I95.1
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
C: Cardiovascular system drugs
— C01: Cardiac therapy drugs
— C01C: Cardiac stimulants excl. cardiac glycosides
— C01CA: Adrenergic and dopaminergic cardiac stimulants
— C01CA27: Droxidopa
HCPCS
No data
Clinical
Clinical Trials
48 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
HypotensionD007022EFO_0005251I953695122
Orthostatic hypotensionD007024—I95.12595120
Parkinson diseaseD010300EFO_0002508G203624114
FatigueD005221HP_0012378R53.83—2—1—3
Parkinsonian disordersD020734HP_0001300G20.C—1—1—2
Spinal cord injuriesD013119EFO_1001919—1——1—2
Wounds and injuriesD014947—T14.8———1—1
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Autonomic nervous system diseasesD001342EFO_0009532G90235—18
Shy-drager syndromeD012791EFO_1001050—233—17
Multiple system atrophyD019578——233—17
Pure autonomic failureD054970——1—4——5
Peripheral nervous system diseasesD010523HP_0009830G641—4——5
Primary dysautonomiasD054969——231—14
Nervous system diseasesD009422—G00-G99231——3
Orthostatic intoleranceD054971——121—13
AtrophyD001284———12——2
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
SyndromeD013577——13———3
Postural orthostatic tachycardia syndromeD054972—G90.A12———2
TachycardiaD013610HP_0001649R00.012———2
Neurologic gait disordersD020233HP_0003376R26.111———1
Congenital pain insensitivityD000699Orphanet_88642G60.8—1———1
Hereditary sensory and autonomic neuropathiesD009477———1———1
HypohidrosisD007007HP_0000966L74.4—1———1
Myofascial pain syndromesD009209EFO_1001054——1———1
FibromyalgiaD005356EFO_0005687M79.1—1———1
HyperkinesisD006948HP_0000752——1———1
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Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
NeoplasmsD009369—C803————3
GliomaD005910EFO_0000520—1————1
Diffuse intrinsic pontine gliomaD000080443——1————1
Chronic kidney failureD007676EFO_0003884N18.91————1
Kidney diseasesD007674EFO_0003086N081————1
Retinal diseasesD012164HP_0000479H35.91————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
KyphosisD007738HP_0002808M40.20————11
OsteoarthritisD010003EFO_0002506M15-M19————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameDroxidopa
INNdroxidopa
Description
Droxidopa is a serine derivative that is L-serine substituted at the beta-position by a 3,4-dihydroxyphenyl group. A prodrug for noradrenalone, it is used for treatment of neurogenic orthostatic hypotension It has a role as a prodrug, a vasoconstrictor agent and an antihypertensive agent. It is a L-tyrosine derivative and a member of catechols.
Classification
Small molecule
Drug classdopamine receptor agonists
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
N[C@H](C(=O)O)[C@H](O)c1ccc(O)c(O)c1
Identifiers
PDB—
CAS-ID23651-95-8
RxCUI—
ChEMBL IDCHEMBL2103827
ChEBI ID31524
PubChem CID92974
DrugBankDB06262
UNII IDJ7A92W69L7 (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
CHRM1
CHRM1
Organism
Homo sapiens
Gene name
CHRM1
Gene synonyms
NCBI Gene ID
Protein name
muscarinic acetylcholine receptor M1
Protein synonyms
acetylcholine receptor, muscarinic 1
Uniprot ID
Mouse ortholog
Chrm1 (12669)
muscarinic acetylcholine receptor M1 (Q8BJN3)
Variants
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Safety
Black-box Warning
Black-box warning for: Droxidopa, Northera
Adverse Events
Top Adverse Reactions
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19,951 adverse events reported
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