Amitriptyline
Amitriptyline, Amitriptyline / (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 muscarinic acetylcholine receptor M2, muscarinic acetylcholine receptor M4, muscarinic acetylcholine receptor M5, muscarinic acetylcholine receptor M3, muscarinic acetylcholine receptor M1, histamine H1 receptor, sodium-dependent serotonin transporter, and sodium-dependent noradrenaline transporter. In addition, it is known to target 5-hydroxytryptamine receptor 2A, 5-hydroxytryptamine receptor 7, 5-hydroxytryptamine receptor 2C, lysophosphatidic acid receptor 1, 5-hydroxytryptamine receptor 6, G protein-activated inward rectifier potassium channel 4, and G protein-activated inward rectifier potassium channel 2.
Download report
Favorite
Events Timeline
Commercial
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
Mock data
Subscribe for the real data
Subscribe for the real data
Commercial
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 |
|---|---|---|---|---|
| ELAVIL | AstraZeneca | N-012703 DISCN | 1982-01-01 | 6 products, RLD |
| ELAVIL | AstraZeneca | N-012704 DISCN | 1982-01-01 | 1 products |
Hide discontinued
Amitriptyline hydrochloride
+
Chlordiazepoxide
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| LIMBITROL | Chartwell Pharmaceuticals | N-016949 DISCN | 1982-01-01 | 1 products, RLD |
| LIMBITROL DS | Chartwell Pharmaceuticals | N-016949 DISCN | 1982-01-01 | 1 products, RLD |
Hide discontinued
Amitriptyline hydrochloride
+
Perphenazine
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| TRIAVIL 2-25 | New River Pharmaceuticals | N-014715 DISCN | 1982-01-01 | 1 products |
| TRIAVIL 4-10 | New River Pharmaceuticals | N-014715 DISCN | 1982-01-01 | 1 products |
| TRIAVIL 2-10 | New River Pharmaceuticals | N-014715 DISCN | 1982-01-01 | 1 products |
| TRIAVIL 4-25 | New River Pharmaceuticals | N-014715 DISCN | 1982-01-01 | 1 products |
| TRIAVIL 4-50 | New River Pharmaceuticals | N-014715 DISCN | 1982-01-01 | 1 products |
| ETRAFON-A | Merck Sharp & Dohme | N-014713 DISCN | 1982-01-01 | 1 products |
| ETRAFON 2-25 | Merck Sharp & Dohme | N-014713 DISCN | 1982-01-01 | 1 products |
| ETRAFON-FORTE | Merck Sharp & Dohme | N-014713 DISCN | 1982-01-01 | 1 products |
| ETRAFON 2-10 | Merck Sharp & Dohme | N-014713 DISCN | 1982-01-01 | 1 products |
Hide discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| amitriptyline | ANDA | 2021-04-20 |
| amitriptyline hcl | ANDA | 2023-08-03 |
| amitriptyline hydrochloride | ANDA | 2024-02-12 |
| chlordiazepoxide & amitriptyline hydrochloride | 2007-02-12 | |
| chlordiazepoxide and amitriptyline hydrochloride | ANDA | 2024-02-15 |
| chlordiazepoxide and amitriptyline hydrochloride chlordiazepoxide and amitriptyline hydrochloride | ANDA | 2023-01-19 |
| elavil | ANDA | 2021-08-31 |
| elavil 25 mg | ANDA | 2016-04-13 |
| perphenazine and amitriptyline hydrochloride | ANDA | 2019-09-26 |
| sentravil pm-25 | unapproved drug other | 2011-08-01 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| depressive disorder | EFO_1002014 | D003866 | F32.A |
| pain | EFO_0003843 | D010146 | R52 |
| psychotic affective disorders | — | D000341 | F39 |
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
144 clinical trials
View more details
Mock data
Subscribe for the real data
Subscribe for the real data
Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Migraine disorders | D008881 | EFO_0003821 | G43 | — | 1 | 4 | 2 | 6 | 13 |
| Fibromyalgia | D005356 | EFO_0005687 | M79.1 | 1 | 4 | 3 | 2 | 2 | 10 |
| Headache | D006261 | HP_0002315 | R51 | — | 1 | 3 | 1 | 3 | 8 |
| Pain | D010146 | EFO_0003843 | R52 | — | 1 | 3 | 3 | 1 | 8 |
| Neuralgia | D009437 | EFO_0009430 | — | — | 2 | 3 | 1 | — | 6 |
| Diabetic neuropathies | D003929 | EFO_1000783 | — | — | 4 | 3 | 1 | — | 5 |
| Low back pain | D017116 | HP_0003419 | M54.5 | — | — | 2 | 1 | 1 | 4 |
| Depressive disorder | D003866 | EFO_1002014 | F32.A | 1 | — | 1 | 1 | — | 3 |
| Myofascial pain syndromes | D009209 | EFO_1001054 | — | — | 1 | 1 | 1 | — | 2 |
| Postherpetic neuralgia | D051474 | — | — | — | 1 | — | 1 | — | 2 |
Show 20 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Depression | D003863 | — | F33.9 | 3 | — | 1 | — | 2 | 6 |
| Peripheral nervous system diseases | D010523 | HP_0009830 | G64 | — | 2 | 2 | — | 1 | 4 |
| Neoplasms | D009369 | — | C80 | — | — | 3 | — | — | 3 |
| Major depressive disorder | D003865 | EFO_0003761 | F22 | — | 1 | 1 | — | 1 | 3 |
| Interstitial cystitis | D018856 | EFO_1000869 | N30.1 | — | — | 2 | — | 1 | 3 |
| Musculoskeletal pain | D059352 | — | — | — | — | 2 | — | — | 2 |
| Tension-type headache | D018781 | HP_0012228 | G44.2 | — | — | 1 | — | 1 | 2 |
| Laryngeal diseases | D007818 | — | J38.7 | — | 2 | 2 | — | — | 2 |
| Sleep initiation and maintenance disorders | D007319 | — | F51.01 | — | — | 1 | — | 1 | 2 |
| Dyspepsia | D004415 | EFO_0008533 | K30 | — | 1 | 1 | — | 1 | 2 |
Show 14 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Intervertebral disc displacement | D007405 | EFO_1001800 | — | — | 1 | — | — | 2 | 3 |
| Hiv infections | D015658 | EFO_0000764 | B20 | — | 1 | — | — | 1 | 2 |
| Post-traumatic headache | D051298 | — | G44.3 | — | 1 | — | — | 1 | 2 |
| Cystic fibrosis | D003550 | EFO_0000390 | E84 | — | 2 | — | — | — | 2 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | — | 1 | — | — | — | 1 |
| Gastrointestinal neoplasms | D005770 | — | C26.9 | — | 1 | — | — | — | 1 |
| Multiple myeloma | D009101 | — | C90.0 | — | 1 | — | — | — | 1 |
| Female genital neoplasms | D005833 | — | — | — | 1 | — | — | — | 1 |
| Head and neck neoplasms | D006258 | — | — | — | 1 | — | — | — | 1 |
| Laron syndrome | D046150 | Orphanet_633 | E34.321 | — | 1 | — | — | — | 1 |
Show 14 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 4 | — | — | — | 2 | 6 |
| Enuresis | D004775 | — | R32 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Taste disorders | D013651 | — | — | — | — | — | — | 3 | 3 |
| Drug-related side effects and adverse reactions | D064420 | — | T88.7 | — | — | — | — | 2 | 2 |
| Drug interactions | D004347 | — | — | — | — | — | — | 1 | 1 |
| Arthritis | D001168 | HP_0001369 | M05-M14 | — | — | — | — | 1 | 1 |
| Tendinopathy | D052256 | EFO_1001434 | M77.9 | — | — | — | — | 1 | 1 |
| Synovitis | D013585 | EFO_0008997 | M67.5 | — | — | — | — | 1 | 1 |
| Spasm | D013035 | — | M62.83 | — | — | — | — | 1 | 1 |
| Radiculopathy | D011843 | — | M54.1 | — | — | — | — | 1 | 1 |
| Gout | D006073 | EFO_0004274 | M10 | — | — | — | — | 1 | 1 |
| Intractable pain | D010148 | — | — | — | — | — | — | 1 | 1 |
Show 7 more
Epidemiology
Epidemiological information for investigational and approved indications
View more details
Drug
General
| Drug common name | Amitriptyline |
| INN | amitriptyline |
| 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 class | antidepressants (dibenzol[a,d]cycloheptane derivatives) |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CN(C)CCC=C1c2ccccc2CCc2ccccc21 |
Identifiers
| PDB | — |
| CAS-ID | 50-48-6 |
| RxCUI | — |
| ChEMBL ID | CHEMBL629 |
| ChEBI ID | 2666 |
| PubChem CID | 2160 |
| DrugBank | DB00321 |
| UNII ID | 1806D8D52K (ChemIDplus, GSRS) |
Target
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
No data
Estimated US medical usage
Amitriptyline
Total medical expenditures per year (USD, in millions)
Mock data
Subscribe for the real data
Subscribe for the real data
Number of persons purchased
Mock data
Subscribe for the real data
Subscribe for the real data
Number of purchases
Mock data
Subscribe for the real data
Subscribe for the real data
Refill frequency
Mock data
Subscribe for the real data
Subscribe for the real data
Price per prescription (USD)
Mock data
Subscribe for the real data
Subscribe for the real data
Amitriptyline
+
Chlordiazepoxide
Total medical expenditures per year (USD, in millions)
Mock data
Subscribe for the real data
Subscribe for the real data
Number of persons purchased
Mock data
Subscribe for the real data
Subscribe for the real data
Number of purchases
Mock data
Subscribe for the real data
Subscribe for the real data
Refill frequency
Mock data
Subscribe for the real data
Subscribe for the real data
Price per prescription (USD)
Mock data
Subscribe for the real data
Subscribe for the real data
Amitriptyline
+
Perphenazine
Total medical expenditures per year (USD, in millions)
Mock data
Subscribe for the real data
Subscribe for the real data
Number of persons purchased
Mock data
Subscribe for the real data
Subscribe for the real data
Number of purchases
Mock data
Subscribe for the real data
Subscribe for the real data
Refill frequency
Mock data
Subscribe for the real data
Subscribe for the real data
Price per prescription (USD)
Mock data
Subscribe for the real data
Subscribe for the real data
Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Mock data
Subscribe for the real data
Subscribe for the real data
Additional graphs summarizing 19,909 documents
View more details
Safety
Black-box Warning
Black-box warning for: Amitriptyline hcl, Amitriptyline hydrochloride, Chlordiazepoxide & amitriptyline hydrochloride, Chlordiazepoxide and amitriptyline hydrochloride, Chlordiazepoxide and amitriptyline hydrochloride chlordiazepoxide and amitriptyline hydrochloride, Elavil 25 mg, Perphenazine and amitriptyline hydrochloride, Sentravil pm-25
Adverse Events
Top Adverse Reactions
Mock data
Subscribe for the real data
Subscribe for the real data
20,697 adverse events reported
View more details
© 2020-2023 Collaborative Drug Discovery Inc. (CDD) | Terms of Use