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
EMA
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 | 2025-07-21 |
| drizalma sprinkle | New Drug Application | 2024-05-14 |
| duloxetine | ANDA | 2025-08-08 |
| duloxetine d/r | ANDA | 2025-07-25 |
| duloxetine delayed-release | ANDA | 2017-04-21 |
| duloxetine duloxetine | ANDA | 2025-04-03 |
| duloxetine duloxetine hydrochloride | ANDA | 2017-08-14 |
| duloxetine hcl | ANDA | 2024-12-31 |
| duloxetine hydrochloride | ANDA | 2025-06-08 |
| 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
No data
Clinical
Clinical Trials
431 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 | 1 | 2 | 15 | 31 | 6 | 55 |
| Depression | D003863 | — | F33.9 | — | 2 | 10 | 25 | 4 | 41 |
| Major depressive disorder | D003865 | EFO_0003761 | F22 | 1 | 1 | 11 | 21 | 4 | 38 |
| Stress urinary incontinence | D014550 | — | — | — | 2 | 11 | 2 | — | 15 |
| Urinary incontinence | D014549 | — | R32 | — | 2 | 9 | 2 | — | 13 |
| Enuresis | D004775 | — | R32 | — | 1 | 9 | 2 | — | 12 |
| Diabetic neuropathies | D003929 | EFO_1000783 | — | — | — | 6 | 4 | 1 | 11 |
| Fibromyalgia | D005356 | EFO_0005687 | M79.1 | — | — | 7 | 3 | 1 | 11 |
| Osteoarthritis | D010003 | EFO_0002506 | M15-M19 | — | — | 7 | 2 | 1 | 10 |
| Myofascial pain syndromes | D009209 | EFO_1001054 | — | — | — | 7 | 3 | — | 10 |
Show 23 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Knee osteoarthritis | D020370 | EFO_0004616 | M17 | — | — | 6 | — | — | 6 |
| Multiple sclerosis | D009103 | EFO_0003885 | G35 | — | 1 | 2 | — | — | 2 |
| Sclerosis | D012598 | — | — | — | 1 | 2 | — | — | 2 |
| Chronic pain | D059350 | — | — | — | — | 1 | — | — | 1 |
| Neurotic disorders | D009497 | — | F48.9 | — | — | 1 | — | — | 1 |
| Bariatric surgery | D050110 | — | — | — | — | 1 | — | — | 1 |
| Post-traumatic stress disorders | D013313 | EFO_0001358 | F43.1 | — | — | 1 | — | — | 1 |
| Traumatic stress disorders | D040921 | — | — | — | — | 1 | — | — | 1 |
| Anxiety | D001007 | EFO_0005230 | F41.1 | — | — | 1 | — | — | 1 |
| Fatigue | D005221 | — | R53.83 | — | 1 | 1 | — | — | 1 |
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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 | — | — | — | 1 |
| Traumatic brain injuries | D000070642 | — | S06 | — | 1 | — | — | — | 1 |
| Brain injuries | D001930 | — | S06.9 | — | 1 | — | — | — | 1 |
Indications Phases 1
No data
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Breast neoplasms | D001943 | EFO_0003869 | C50 | — | — | — | — | 1 | 1 |
| Diabetes mellitus | D003920 | EFO_0000400 | E08-E13 | — | — | — | — | 1 | 1 |
| Pregnancy | D011247 | EFO_0002950 | Z33.1 | — | — | — | — | 1 | 1 |
| Attempted suicide | D013406 | EFO_0004321 | T14.91 | — | — | — | — | 1 | 1 |
| Suicide | D013405 | — | — | — | — | — | — | 1 | 1 |
| Sleep deprivation | D012892 | — | F51.12 | — | — | — | — | 1 | 1 |
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) |
Target
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Financial
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Cymbalta – Eli Lilly
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Estimated US medical usage
Duloxetine
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 15,186 documents
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Safety
Black-box Warning
Black-box warning for: Cymbalta, Drizalma sprinkle, Duloxetine, Duloxetine d/r, Duloxetine delayed-release, Duloxetine duloxetine, Duloxetine duloxetine hydrochloride, Duloxetine hcl, Duloxetine hydrochloride, Duloxicaine, Na
Adverse Events
Top Adverse Reactions
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81,040 adverse events reported
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