Cymbalta, Yentreve(duloxetine)
Cymbalta, Duloxetine, 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 serotonin transporter and sodium-dependent noradrenaline transporter. In addition, it is known to target 5-hydroxytryptamine receptor 6, 5-hydroxytryptamine receptor 2A, and 5-hydroxytryptamine receptor 2C.
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Cymbalta (generic drugs available since 2013-12-11, discontinued: Drizalma)
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| cymbalta | New Drug Application | 2023-08-18 |
| drizalma sprinkle | New Drug Application | 2021-07-28 |
| duloxetine | ANDA | 2024-01-22 |
| duloxetine delayed-release | ANDA | 2017-04-21 |
| duloxetine duloxetine | ANDA | 2023-11-06 |
| duloxetine duloxetine hydrochloride | ANDA | 2017-08-14 |
| duloxetine hcl | ANDA | 2023-03-24 |
| duloxetine hydrochloride | ANDA | 2023-11-03 |
| duloxetine hydrochloride delayed release | ANDA | 2019-03-14 |
| duloxicaine | unapproved drug other | 2023-01-25 |
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Indications
FDA
EMA
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
DULOXETINE HYDROCHLORIDE, CYMBALTA, LILLY | |||
| 2023-04-20 | NPP | ||
HCPCS
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Clinical
Clinical Trials
408 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 | 14 | 32 | 27 | 17 | 92 |
| Depression | D003863 | — | F33.9 | 2 | 11 | 8 | 18 | 10 | 47 |
| Fibromyalgia | D005356 | EFO_0005687 | M79.1 | 1 | 1 | 9 | 5 | 12 | 27 |
| Diabetic neuropathies | D003929 | EFO_1000783 | — | 1 | 3 | 6 | 9 | 1 | 20 |
| Pain | D010146 | EFO_0003843 | R52 | — | 2 | 3 | 3 | 9 | 17 |
| Stress urinary incontinence | D014550 | HP_0010992 | — | — | 2 | 13 | 2 | — | 17 |
| Anxiety disorders | D001008 | EFO_0006788 | F41.1 | — | 1 | 9 | 2 | 4 | 16 |
| Osteoarthritis | D010003 | EFO_0002506 | M15-M19 | — | — | 5 | 4 | 4 | 13 |
| Depressive disorder | D003866 | EFO_1002014 | F32.A | 1 | — | 5 | 4 | 2 | 12 |
| Knee osteoarthritis | D020370 | EFO_0004616 | M17 | 1 | 3 | 2 | 4 | 3 | 12 |
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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 diseases | D010523 | HP_0009830 | 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 |
| Urinary incontinence | D014549 | HP_0000020 | R32 | — | 1 | 1 | — | 1 | 3 |
| 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 |
| Mental disorders | D001523 | EFO_0000677 | F91.9 | — | — | 1 | — | — | 1 |
| Psychophysiologic disorders | D011602 | — | F45.9 | — | — | 1 | — | — | 1 |
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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 |
| Suicidal ideation | D059020 | EFO_0004320 | R45.851 | — | 1 | — | — | 1 | 2 |
| Male infertility | D007248 | EFO_0004248 | N46 | — | 1 | — | — | — | 1 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | — | 1 | — | — | — | 1 |
| Prediabetic state | D011236 | EFO_1001121 | R73.03 | — | 1 | — | — | — | 1 |
| Insulin resistance | D007333 | HP_0000855 | E88.819 | — | 1 | — | — | — | 1 |
| Cardiovascular diseases | D002318 | HP_0001626 | — | — | 1 | — | — | — | 1 |
| Coronary artery disease | D003324 | — | I25.1 | — | 1 | — | — | — | 1 |
| Heart diseases | D006331 | EFO_0003777 | I51.9 | — | 1 | — | — | — | 1 |
| Traumatic brain injuries | D000070642 | — | S06 | — | 1 | — | — | — | 1 |
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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 |
| Cocaine-related disorders | D019970 | — | F14 | 2 | — | — | — | — | 2 |
| Drug interactions | D004347 | — | — | 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 |
|---|---|---|---|---|---|---|---|---|---|
| Systemic scleroderma | D012595 | EFO_0000717 | M34 | — | — | — | — | 1 | 1 |
| Chemical and drug induced liver injury | D056486 | EFO_0004228 | — | — | — | — | — | 1 | 1 |
| Bipolar disorder | D001714 | EFO_0000289 | F30.9 | — | — | — | — | 1 | 1 |
| Pain management | D059408 | — | — | — | — | — | — | 1 | 1 |
| Intractable pain | D010148 | — | — | — | — | — | — | 1 | 1 |
| 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 |
| Acute kidney injury | D058186 | HP_0001919 | N17 | — | — | — | — | 1 | 1 |
Show 14 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 | — |
| CAS-ID | 116539-59-4 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1175 |
| ChEBI ID | 36795 |
| PubChem CID | 60835 |
| DrugBank | DB00476 |
| UNII ID | O5TNM5N07U (ChemIDplus, GSRS) |
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Cymbalta – Eli Lilly
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Estimated US medical usage
Duloxetine
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Trends
PubMed Central
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Additional graphs summarizing 13,013 documents
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Safety
Black-box Warning
Black-box warning for: Cymbalta, Drizalma sprinkle, Duloxetine, Duloxetine delayed-release, Duloxetine duloxetine, Duloxetine duloxetine hydrochloride, Duloxetine hcl, Duloxetine hydrochloride, Duloxetine hydrochloride delayed release, Duloxicaine, Na
Adverse Events
Top Adverse Reactions
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68,609 adverse events reported
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