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Drug ReportsNortriptyline
Nortriptyline
Nortriptyline (nortriptyline) is a small molecule pharmaceutical. Nortriptyline was first approved as Aventyl hydrochloride on 1982-01-01. It is used to treat anxiety disorders, attention deficit disorder with hyperactivity, depressive disorder, enuresis, and pain amongst others in the USA. The pharmaceutical is active against sodium-dependent serotonin transporter and sodium-dependent noradrenaline transporter. In addition, it is known to target G protein-activated inward rectifier potassium channel 2, ATP-sensitive inward rectifier potassium channel 10, and G protein-activated inward rectifier potassium channel 4.
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FDA approval date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
urogenital diseasesD000091642
signs and symptoms pathological conditionsD013568
behavior and behavior mechanismsD001520
psychological phenomenaD011579
mental disordersD001523
musculoskeletal and neural physiological phenomenaD055687
Trade Name
FDA
EMA
Nortriptyline (discontinued: Aventyl, Nortriptyline, Pamelor)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Nortriptyline hydrochloride
Tradename
Company
Number
Date
Products
AVENTYL HYDROCHLORIDEEli LillyN-014684 DISCN1982-01-01
2 products
AVENTYLRanbaxy SignatureN-014685 DISCN1982-01-01
1 products, RLD
PAMELORSPECGXN-018012 DISCN1982-01-01
1 products
PAMELORSPECGXN-018013 DISCN1982-01-01
4 products, RLD
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FDA
EMA
Brand Name
Status
Last Update
nortriptyline hciANDA2022-10-05
nortriptyline hci nortriptyline hclANDA2019-03-11
nortriptyline hclANDA2026-09-16
nortriptyline hydrochlorideANDA2026-09-28
pamelorNew Drug Application2024-12-04
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
N: Nervous system drugs
— N06: Psychoanaleptics
— N06A: Antidepressants
— N06AA: Non-selective monoamine reuptake inhibitors
— N06AA10: Nortriptyline
HCPCS
No data
Clinical
Clinical Trials
68 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
DepressionD003863—F33.9—1212924
Depressive disorderD003866EFO_1002014F32.A12—9314
Major depressive disorderD003865EFO_0003761F2212—8212
Migraine disordersD008881EFO_0003821G43—1—517
Treatment-resistant depressive disorderD061218—————415
PainD010146EFO_0003843R52——2125
TinnitusD014012—H93.1———3—3
HeadacheD006261—R51———213
Gastroesophageal refluxD005764EFO_0003948K21—121—3
DementiaD003704EFO_0003862F03——11—2
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Indications Phases 3
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
SciaticaD012585—M54.3—1——23
RadiculopathyD011843—M54.1—1——23
Chronic painD059350———1——12
Irritable bowel syndromeD043183EFO_0000555K58—2———2
Temporomandibular joint disordersD013705—M26.6—2———2
Back painD001416—M54—1——12
Tension-type headacheD018781—G44.2—1——12
PsoriasisD011565EFO_0000676L40—2———2
Mood disordersD019964EFO_0004247F30-F39—1———1
VulvodyniaD056650—N94.81—1———1
Show 9 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients———2————2
Small cell carcinomaD018288——1————1
Atopic dermatitisD003876EFO_0000274L201————1
DermatitisD003872—L30.91————1
Indications Without Phase
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameNortriptyline
INNnortriptyline
Description
Nortriptyline is an organic tricyclic compound that is 10,11-dihydro-5H-dibenzo[a,d][7]annulene substituted by a 3-(methylamino)propylidene group at position 5. It is an active metabolite of amitriptyline. It has a role as a drug metabolite, an antidepressant, an adrenergic uptake inhibitor, an analgesic, an antineoplastic agent and an apoptosis inducer. It is an organic tricyclic compound and a secondary amine. It is functionally related to an amitriptyline. It derives from a hydride of a dibenzo[a,d][7]annulene.
Classification
Small molecule
Drug classantidepressants (dibenzol[a,d]cycloheptane derivatives)
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
CNCCC=C1c2ccccc2CCc2ccccc21
Identifiers
PDB—
CAS-ID72-69-5
RxCUI—
ChEMBL IDCHEMBL445
ChEBI ID7640
PubChem CID4543
DrugBankDB00540
UNII IDBL03SY4LXB (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
€
£
₣
No data
Estimated US medical usage
Nortriptyline
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Refill frequency
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 9,999 documents
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Safety
Black-box Warning
Black-box warning for: Nortriptyline hci, Nortriptyline hcl, Nortriptyline hydrochloride, Pamelor
Adverse Events
Top Adverse Reactions
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8,677 adverse events reported
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