Cymbalta, Ariclaim(duloxetine)
Cymbalta, Drizalma, 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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Commercial
Therapeutic Areas
Trade Name
FDA
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Cymbalta, Drizalma, Duloxetine (discontinued: Duloxetine)
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 |
| DRIZALMA SPRINKLE | Sun Pharmaceutical Industries | N-212516 RX | 2019-07-19 | 4 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| cymbalta | New Drug Application | 2023-08-18 |
| drizalma sprinkle | New Drug Application | 2024-05-14 |
| duloxetine | ANDA | 2024-10-28 |
| duloxetine delayed-release | ANDA | 2017-04-21 |
| duloxetine duloxetine | ANDA | 2024-04-08 |
| duloxetine duloxetine hydrochloride | ANDA | 2017-08-14 |
| duloxetine hcl | ANDA | 2023-03-24 |
| duloxetine hydrochloride | ANDA | 2024-10-02 |
| 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
416 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Depressive disorder | D003866 | EFO_1002014 | F32.A | 5 | 21 | 45 | 52 | 26 | 147 |
| Depression | D003863 | — | F33.9 | 4 | 21 | 38 | 42 | 26 | 129 |
| Major depressive disorder | D003865 | EFO_0003761 | F22 | 3 | 14 | 34 | 32 | 19 | 101 |
| Fibromyalgia | D005356 | EFO_0005687 | M79.1 | 1 | 1 | 9 | 5 | 13 | 28 |
| Osteoarthritis | D010003 | EFO_0002506 | M15-M19 | 1 | 3 | 8 | 9 | 6 | 26 |
| Myofascial pain syndromes | D009209 | EFO_1001054 | — | 1 | 1 | 8 | 5 | 12 | 26 |
| Neuralgia | D009437 | EFO_0009430 | — | 1 | 5 | 3 | 7 | 8 | 24 |
| Pain | D010146 | EFO_0003843 | R52 | — | 4 | 5 | 4 | 9 | 22 |
| Diabetic neuropathies | D003929 | EFO_1000783 | — | 1 | 4 | 6 | 9 | 1 | 21 |
| Knee osteoarthritis | D020370 | EFO_0004616 | M17 | 1 | 4 | 7 | 5 | 3 | 19 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Breast neoplasms | D001943 | EFO_0003869 | C50 | — | — | 2 | — | 2 | 4 |
| Mood disorders | D019964 | EFO_0004247 | F30-F39 | 1 | — | 1 | — | 1 | 3 |
| Diabetes mellitus | D003920 | HP_0000819 | E08-E13 | — | 2 | 1 | — | 1 | 3 |
| Neoplasms | D009369 | — | C80 | — | 2 | 1 | — | — | 3 |
| Social phobia | D000072861 | EFO_1001917 | F40.1 | — | — | 1 | — | 2 | 3 |
| Recurrence | D012008 | — | — | — | — | 2 | — | — | 2 |
| Neurotoxicity syndromes | D020258 | — | G92 | — | 1 | 1 | — | — | 2 |
| Hiv infections | D015658 | EFO_0000764 | B20 | — | 1 | 1 | — | — | 2 |
| Drug-related side effects and adverse reactions | D064420 | — | T88.7 | — | — | 1 | — | 1 | 2 |
| Colorectal neoplasms | D015179 | — | — | — | 2 | 1 | — | — | 2 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Wounds and injuries | D014947 | — | T14.8 | — | 1 | — | — | 4 | 5 |
| Alcoholism | D000437 | EFO_0003829 | F10.1 | 1 | 1 | — | — | — | 2 |
| Brain injuries | D001930 | — | S06.9 | — | 1 | — | — | 1 | 2 |
| Suicidal ideation | D059020 | EFO_0004320 | R45.851 | — | 1 | — | — | 1 | 2 |
| Attention deficit disorder with hyperactivity | D001289 | EFO_0003888 | F90 | — | 1 | — | — | 1 | 2 |
| Male infertility | D007248 | EFO_0004248 | N46 | — | 1 | — | — | — | 1 |
| Infertility | D007246 | HP_0000789 | — | — | 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 | — | — | 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 |
| Alcohol drinking | D000428 | EFO_0004329 | — | 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 | M34.0 | — | — | — | — | 1 | 1 |
| Localized scleroderma | D012594 | EFO_1001361 | L94.0 | — | — | — | — | 1 | 1 |
| Diffuse scleroderma | D045743 | EFO_0000404 | — | — | — | — | — | 1 | 1 |
| Pathologic constriction | D003251 | — | — | — | — | — | — | 1 | 1 |
| Spinal stenosis | D013130 | EFO_0007490 | M48.0 | — | — | — | — | 1 | 1 |
| Chemical and drug induced liver injury | D056486 | EFO_0004228 | — | — | — | — | — | 1 | 1 |
| Bipolar disorder | D001714 | EFO_0000289 | F30.9 | — | — | — | — | 1 | 1 |
| Psychological trauma | D000067073 | — | — | — | — | — | — | 1 | 1 |
| Hyperbaric oxygenation | D006931 | — | — | — | — | — | — | 1 | 1 |
| Pain management | D059408 | — | — | — | — | — | — | 1 | 1 |
Show 35 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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Duloxetine
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Trends
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Additional graphs summarizing 13,646 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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77,925 adverse events reported
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