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Amitriptyline
Amitid, Amitril, Elavil, Endep, Etrafon, Etrafon-a, Etrafon-forte, Limbitrol, Triavil (amitriptyline) is a small molecule pharmaceutical. Amitriptyline was first approved as Elavil on 1982-01-01. It is used to treat depressive disorder, pain, and psychotic affective disorders in the USA. The pharmaceutical is active against sodium-dependent noradrenaline transporter, sodium-dependent serotonin transporter, muscarinic acetylcholine receptor M2, muscarinic acetylcholine receptor M4, histamine H1 receptor, muscarinic acetylcholine receptor M1, muscarinic acetylcholine receptor M5, and muscarinic acetylcholine receptor M3. In addition, it is known to target 5-hydroxytryptamine receptor 6, 5-hydroxytryptamine receptor 2A, 5-hydroxytryptamine receptor 7, 5-hydroxytryptamine receptor 2C, lysophosphatidic acid receptor 1, G protein-activated inward rectifier potassium channel 4, G protein-activated inward rectifier potassium channel 2, and alpha-1-acid glycoprotein 2.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
signs and symptoms pathological conditionsD013568
psychological phenomenaD011579
mental disordersD001523
musculoskeletal and neural physiological phenomenaD055687
Trade Name
FDA
EMA
No data
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Amitriptyline hydrochloride
Tradename
Company
Number
Date
Products
ELAVILAstraZenecaN-012703 DISCN1982-01-01
6 products, RLD
ELAVILAstraZenecaN-012704 DISCN1982-01-01
1 products
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Amitriptyline hydrochloride
+
Chlordiazepoxide
Tradename
Company
Number
Date
Products
LIMBITROLChartwell PharmaceuticalsN-016949 DISCN1982-01-01
1 products, RLD
LIMBITROL DSChartwell PharmaceuticalsN-016949 DISCN1982-01-01
1 products, RLD
Hide discontinued
Amitriptyline hydrochloride
+
Perphenazine
Tradename
Company
Number
Date
Products
TRIAVIL 2-25New River PharmaceuticalsN-014715 DISCN1982-01-01
1 products
TRIAVIL 4-10New River PharmaceuticalsN-014715 DISCN1982-01-01
1 products
TRIAVIL 2-10New River PharmaceuticalsN-014715 DISCN1982-01-01
1 products
TRIAVIL 4-25New River PharmaceuticalsN-014715 DISCN1982-01-01
1 products
TRIAVIL 4-50New River PharmaceuticalsN-014715 DISCN1982-01-01
1 products
ETRAFON-AMerck Sharp & DohmeN-014713 DISCN1982-01-01
1 products
ETRAFON 2-25Merck Sharp & DohmeN-014713 DISCN1982-01-01
1 products
ETRAFON-FORTEMerck Sharp & DohmeN-014713 DISCN1982-01-01
1 products
ETRAFON 2-10Merck Sharp & DohmeN-014713 DISCN1982-01-01
1 products
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Labels
FDA
EMA
Brand Name
Status
Last Update
amitriptyline hydrochlorideANDA2023-06-16
elavil 25 mgANDA2016-04-13
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
depressive disorderEFO_1002014D003866F32.A
painEFO_0003843D010146R52
psychotic affective disorders—D000341F39
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
— N06AA09: Amitriptyline
— N06C: Psycholeptics and psychoanaleptics in combination
— N06CA: Antidepressants in combination with psycholeptics
— N06CA01: Amitriptyline and psycholeptics
HCPCS
Code
Description
J1320
Injection, amitriptyline hcl, up to 20 mg
Clinical
Clinical Trials
87 clinical trials
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Mock data
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
FibromyalgiaD005356EFO_0005687M79.1132228
Migraine disordersD008881EFO_0003821G43—12137
PainD010146EFO_0003843R52—133—7
NeuralgiaD009437EFO_0009430—131—5
HeadacheD006261HP_0002315R51—12115
Irritable bowel syndromeD043183EFO_0000555K58———112
Postoperative painD010149G89.18——11—2
Chronic painD059350HP_0012532———2—2
Cerebral palsyD002547G80———1—1
Facial painD005157R51.9———1—1
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Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Peripheral nervous system diseasesD010523G64—22—14
NeoplasmsD009369C80——3——3
Interstitial cystitisD018856EFO_1000869N30.1——2—13
DepressionD003863F33.91—1——2
Major depressive disorderD003865EFO_0003761F22—11——2
Depressive disorderD003866EFO_1002014F32.A1—1——2
Laryngeal diseasesD007818J38.7—22——2
Sleep initiation and maintenance disordersD007319F51.01——1—12
DyspepsiaD004415EFO_0008533K30—11—12
DementiaD003704F03——1——1
Show 16 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Hiv infectionsD015658EFO_0000764B20—1——12
Cystic fibrosisD003550EFO_0000390E84—2———2
Head and neck neoplasmsD006258—1———1
Laron syndromeD046150Orphanet_633E34.321—1———1
Type 1 diabetes mellitusD003922EFO_0001359E10—1———1
HypoglycemiaD007003HP_0001943E16.2—1———1
PruritusD011537HP_0000989L29—1———1
Biliary dyskinesiaD001657EFO_0007169—1———1
Brain injuriesD001930S06.9—1———1
Post-traumatic headacheD051298G44.3—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———24
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Treatment-resistant depressive disorderD061218————11
Gastroesophageal refluxD005764EFO_0003948K21————11
Tension-type headacheD018781HP_0012228G44.2————11
Central nervous system sensitizationD059333————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameAMITRIPTYLINE
INNamitriptyline
Description
Amitriptyline is an organic tricyclic compound that is 10,11-dihydro-5H-dibenzo[a,d][7]annulene substituted by a 3-(dimethylamino)propylidene group at position 5. It has a role as an adrenergic uptake inhibitor, an antidepressant, an environmental contaminant, a xenobiotic and a tropomyosin-related kinase B receptor agonist. It is a tertiary amine and a carbotricyclic compound. 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)
Structure (InChI/SMILES or Protein Sequence)
CN(C)CCC=C1c2ccccc2CCc2ccccc21
Identifiers
PDB3APV
CAS-ID50-48-6
RxCUI704
ChEMBL IDCHEMBL629
ChEBI ID2666
PubChem CID2160
DrugBankDB00321
UNII ID1806D8D52K (ChemIDplus, GSRS)
Target
Agency Approved
SLC6A2
SLC6A2
SLC6A4
SLC6A4
CHRM2
CHRM2
CHRM4
CHRM4
HRH1
HRH1
CHRM1
CHRM1
CHRM5
CHRM5
CHRM3
CHRM3
Organism
Homo sapiens
Gene name
SLC6A2
Gene synonyms
NAT1, NET1, SLC6A5
NCBI Gene ID
6530
Protein name
sodium-dependent noradrenaline transporter
Protein synonyms
NET, neurotransmitter transporter, Norepinephrine transporter, solute carrier family 6 (neurotransmitter transporter), member 2, solute carrier family 6 (neurotransmitter transporter, noradrenalin), member 2, Solute carrier family 6 member 2, solute carrier family 6 member 5
Uniprot ID
Q96KH8
Mouse ortholog
Slc6a2 (20538)
sodium-dependent noradrenaline transporter (Q6QU62)
Alternate
HTR6
HTR6
HTR2A
HTR2A
HTR7
HTR7
HTR2C
HTR2C
LPAR1
LPAR1
KCNJ5
KCNJ5
KCNJ6
KCNJ6
ORM2
ORM2
Organism
Homo sapiens
Gene name
HTR6
Gene synonyms
NCBI Gene ID
3362
Protein name
5-hydroxytryptamine receptor 6
Protein synonyms
5-hydroxytryptamine (serotonin) receptor 6, G protein-coupled, Serotonin receptor 6
Uniprot ID
Q5TGZ1
Mouse ortholog
Htr6 (15565)
5-hydroxytryptamine receptor 6 (Q9R1C8)
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Mock data
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Additional graphs summarizing 18,169 documents
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Safety
Black-box Warning
Black-box warning for: Amitriptyline hydrochloride, Elavil 25 mg
Adverse Events
Top Adverse Reactions
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1,640 adverse events reported
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