Cymbalta, Yentreve(duloxetine)
Cymbalta, Yentreve (duloxetine) is a small molecule pharmaceutical. Duloxetine was first approved as Cymbalta on 2004-08-03. It is used to treat anxiety disorders, diabetic neuropathies, major depressive disorder, and musculoskeletal pain in the USA. It has been approved in Europe to treat anxiety disorders, diabetes mellitus, diabetic neuropathies, major depressive disorder, and neuralgia amongst others. The pharmaceutical is active against sodium-dependent noradrenaline transporter and sodium-dependent serotonin transporter. In addition, it is known to target 5-hydroxytryptamine receptor 2C, 5-hydroxytryptamine receptor 6, and 5-hydroxytryptamine receptor 2A.
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Therapeutic Areas
Therapeutic Area | MeSH |
---|---|
musculoskeletal diseases | D009140 |
nervous system diseases | D009422 |
urogenital diseases | D000091642 |
nutritional and metabolic diseases | D009750 |
endocrine system diseases | D004700 |
signs and symptoms pathological conditions | D013568 |
psychological phenomena | D011579 |
mental disorders | D001523 |
musculoskeletal and neural physiological phenomena | D055687 |
Trade Name
FDA
EMA
Cymbalta (generic drugs available since 2013-12-11, discontinued: Drizalma)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Duloxetine hydrochloride
Tradename | Company | Number | Date | Products |
---|---|---|---|---|
CYMBALTA | Eli Lilly | N-021427 RX | 2004-08-03 | 3 products, RLD, RS |
Show 1 discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
---|---|---|
cymbalta | New Drug Application | 2021-09-20 |
drizalma sprinkle | New Drug Application | 2020-07-03 |
duloxetine | ANDA | 2023-06-07 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
---|---|---|---|
anxiety disorders | EFO_0006788 | D001008 | F41.1 |
diabetic neuropathies | EFO_1000783 | D003929 | — |
major depressive disorder | EFO_0003761 | D003865 | F22 |
musculoskeletal pain | — | D059352 | — |
Agency Specific
FDA
EMA
Expiration | Code | ||
---|---|---|---|
DULOXETINE HYDROCHLORIDE, CYMBALTA, LILLY | |||
2023-04-20 | NPP |
HCPCS
No data
Clinical
Clinical Trials
333 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Major depressive disorder | D003865 | EFO_0003761 | F22 | 3 | 8 | 26 | 24 | 9 | 69 |
Depression | D003863 | F33.9 | — | 6 | 8 | 15 | 4 | 32 | |
Fibromyalgia | D005356 | EFO_0005687 | M79.1 | 1 | 1 | 9 | 4 | 7 | 21 |
Diabetic neuropathies | D003929 | EFO_1000783 | 1 | 3 | 6 | 9 | 1 | 20 | |
Stress urinary incontinence | D014550 | HP_0010992 | — | 2 | 13 | 2 | — | 17 | |
Pain | D010146 | EFO_0003843 | R52 | — | 2 | 3 | 2 | 7 | 14 |
Anxiety disorders | D001008 | EFO_0006788 | F41.1 | — | — | 9 | 2 | 2 | 13 |
Osteoarthritis | D010003 | EFO_0002506 | M15-M19 | — | — | 5 | 4 | 3 | 12 |
Knee osteoarthritis | D020370 | EFO_0004616 | M17 | 1 | 3 | 2 | 3 | 3 | 11 |
Healthy volunteers/patients | — | 4 | — | — | 4 | 2 | 10 |
Show 36 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Treatment-resistant depressive disorder | D061218 | — | — | 7 | — | 1 | 8 | ||
Peripheral nervous system diseases | D010523 | G64 | — | 3 | 2 | — | 1 | 5 | |
Mood disorders | D019964 | EFO_0004247 | F30-F39 | 1 | — | 1 | — | 1 | 3 |
Breast neoplasms | D001943 | EFO_0003869 | C50 | — | — | 1 | — | 2 | 3 |
Bipolar disorder | D001714 | EFO_0000289 | F30.9 | — | — | 1 | — | 1 | 2 |
Neoplasms | D009369 | C80 | — | 1 | 1 | — | — | 2 | |
Hiv infections | D015658 | EFO_0000764 | B20 | — | 1 | 1 | — | — | 2 |
Colorectal neoplasms | D015179 | — | 2 | 1 | — | — | 2 | ||
Musculoskeletal pain | D059352 | — | 1 | 1 | — | — | 2 | ||
Urinary incontinence | D014549 | HP_0000020 | R32 | — | 1 | 1 | — | — | 2 |
Show 10 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Alcoholism | D000437 | EFO_0003829 | F10.1 | 1 | 1 | — | — | — | 2 |
Male infertility | D007248 | EFO_0004248 | N46 | — | 1 | — | — | — | 1 |
Traumatic brain injuries | D000070642 | S06 | — | 1 | — | — | — | 1 | |
Attention deficit disorder with hyperactivity | D001289 | EFO_0003888 | F90 | — | 1 | — | — | — | 1 |
Interstitial lung diseases | D017563 | EFO_0004244 | J84.89 | — | 1 | — | — | — | 1 |
Opioid-related disorders | D009293 | EFO_0005611 | F11 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Substance-related disorders | D019966 | EFO_0003890 | F13 | 1 | — | — | — | 1 | 2 |
Therapeutic equivalency | D013810 | 2 | — | — | — | — | 2 | ||
Drug interactions | D004347 | 1 | — | — | — | — | 1 | ||
Cocaine-related disorders | D019970 | F14 | 1 | — | — | — | — | 1 | |
Stroke | D020521 | EFO_0000712 | I63.9 | 1 | — | — | — | — | 1 |
Amphetamine-related disorders | D019969 | EFO_0004701 | F15 | 1 | — | — | — | — | 1 |
Hyperalgesia | D006930 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Wounds and injuries | D014947 | T14.8 | — | — | — | — | 1 | 1 | |
Chronic disease | D002908 | — | — | — | — | 1 | 1 | ||
Brain injuries | D001930 | S06.9 | — | — | — | — | 1 | 1 | |
Alcohol-related disorders | D019973 | F10 | — | — | — | — | 1 | 1 | |
Suicidal ideation | D059020 | EFO_0004320 | R45.851 | — | — | — | — | 1 | 1 |
Acute kidney injury | D058186 | HP_0001919 | N17 | — | — | — | — | 1 | 1 |
Anorexia nervosa | D000856 | EFO_0004215 | F50.0 | — | — | — | — | 1 | 1 |
Social phobia | D000072861 | EFO_1001917 | F40.1 | — | — | — | — | 1 | 1 |
Systemic lupus erythematosus | D008180 | EFO_0002690 | M32 | — | — | — | — | 1 | 1 |
Pregnancy | D011247 | EFO_0002950 | Z33.1 | — | — | — | — | 1 | 1 |
Show 5 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common name | DULOXETINE |
INN | duloxetine |
Description | (S)-duloxetine is a duloxetine. It is an enantiomer of a (R)-duloxetine. |
Classification | Small molecule |
Drug class | antidepressants (fluoxetine type) |
Image (chem structure or protein) | |
Structure (InChI/SMILES or Protein Sequence) | CNCC[C@H](Oc1cccc2ccccc12)c1cccs1 |
Identifiers
PDB | 4MM6 |
CAS-ID | 116539-59-4 |
RxCUI | 72625 |
ChEMBL ID | CHEMBL1175 |
ChEBI ID | 36795 |
PubChem CID | 60835 |
DrugBank | DB00476 |
UNII ID | O5TNM5N07U (ChemIDplus, GSRS) |
Target
Agency Approved
SLC6A2
SLC6A2
SLC6A4
SLC6A4
Organism
Homo sapiens
Gene name
SLC6A2
Gene synonyms
NAT1, NET1, SLC6A5
NCBI Gene ID
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
Mouse ortholog
Slc6a2 (20538)
sodium-dependent noradrenaline transporter (Q6QU62)
Alternate
HTR2C
HTR2C
HTR6
HTR6
HTR2A
HTR2A
Organism
Homo sapiens
Gene name
HTR2C
Gene synonyms
HTR1C
NCBI Gene ID
Protein name
5-hydroxytryptamine receptor 2C
Protein synonyms
5-HT-1C, 5-HT1C, 5-hydroxytryptamine (serotonin) receptor 2C, G protein-coupled, 5-hydroxytryptamine receptor 1C, serotonin 5-HT-1C receptor, serotonin 5-HT-2C receptor, Serotonin receptor 2C
Uniprot ID
Mouse ortholog
Htr2c (15560)
5-hydroxytryptamine receptor 2C (Q5WRU6)
Variants
Clinical Variant
No data
Financial
Cymbalta - Eli Lilly
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 11,321 documents
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Safety
Black-box Warning
Black-box warning for: Cymbalta, Drizalma sprinkle, Duloxetine
Adverse Events
Top Adverse Reactions
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77,980 adverse events reported
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