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.
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
Therapeutic Areas
Trade Name
FDA
EMA
Drizalma, Duloxetine (discontinued: Cymbalta, 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 |
|---|---|---|---|---|
| DRIZALMA SPRINKLE | Sun Pharmaceutical Industries | N-212516 RX | 2019-07-19 | 4 products, RLD, RS |
Show 1 discontinued
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 | 2025-09-26 |
| 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 |
Show 1 more
Indications
FDA
EMA
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
DULOXETINE HYDROCHLORIDE, CYMBALTA, LILLY | |||
| 2023-04-20 | NPP | ||
HCPCS
No data
Clinical
Clinical Trials
433 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 |
|---|---|---|---|---|---|---|---|---|---|
| Major depressive disorder | D003865 | EFO_0003761 | F22 | 3 | 15 | 34 | 34 | 20 | 105 |
| Depression | D003863 | — | F33.9 | 5 | 20 | 22 | 29 | 18 | 90 |
| Depressive disorder | D003866 | EFO_1002014 | F32.A | 3 | 11 | 16 | 11 | 10 | 49 |
| Pain | D010146 | EFO_0003843 | R52 | 1 | 8 | 8 | 12 | 13 | 40 |
| Fibromyalgia | D005356 | EFO_0005687 | M79.1 | 1 | 3 | 11 | 5 | 14 | 31 |
| Anxiety disorders | D001008 | EFO_0006788 | F41.1 | 1 | 2 | 11 | 4 | 6 | 23 |
| Diabetic neuropathies | D003929 | EFO_1000783 | — | 1 | 4 | 7 | 9 | 1 | 22 |
| Osteoarthritis | D010003 | EFO_0002506 | M15-M19 | 1 | 2 | 6 | 5 | 6 | 19 |
| Stress urinary incontinence | D014550 | — | — | — | 2 | 13 | 2 | 1 | 18 |
| Knee osteoarthritis | D020370 | EFO_0004616 | M17 | 1 | 4 | 4 | 6 | 3 | 17 |
Show 76 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Diabetes mellitus | D003920 | EFO_0000400 | E08-E13 | — | 2 | 3 | — | 1 | 5 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | — | 1 | 2 | — | 2 | 5 |
| Urinary incontinence | D014549 | — | R32 | — | 1 | 1 | — | 1 | 3 |
| Social phobia | D000072861 | EFO_1001917 | F40.1 | — | — | 1 | — | 2 | 3 |
| Fatigue | D005221 | — | R53.83 | — | 1 | 3 | — | — | 3 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | — | 1 | 1 | — | — | 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 |
Show 20 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 |
| Suicidal ideation | D059020 | EFO_0004320 | R45.851 | — | 1 | — | — | 1 | 2 |
| Cardiovascular diseases | D002318 | EFO_0000319 | I98 | — | 1 | — | — | 1 | 2 |
| Attention deficit disorder with hyperactivity | D001289 | EFO_0003888 | F90 | — | 1 | — | — | 1 | 2 |
| Cough | D003371 | — | R05 | — | 2 | — | — | — | 2 |
| Chronic cough | D000096822 | — | R05.3 | — | 2 | — | — | — | 2 |
| Male infertility | D007248 | EFO_0004248 | N46 | — | 1 | — | — | — | 1 |
| Prediabetic state | D011236 | EFO_1001121 | R73.03 | — | 1 | — | — | — | 1 |
| Insulin resistance | D007333 | EFO_0002614 | E88.819 | — | 1 | — | — | — | 1 |
| Glucose intolerance | D018149 | HP_0000833 | R73.03 | — | 1 | — | — | — | 1 |
Show 11 more
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 |
| Psychological stress | D013315 | — | — | 1 | — | — | — | — | 1 |
| Psychological well-being | D000092862 | — | — | 1 | — | — | — | — | 1 |
| Amphetamine-related disorders | D019969 | EFO_0004701 | F15 | 1 | — | — | — | — | 1 |
| Hyperalgesia | D006930 | — | — | 1 | — | — | — | — | 1 |
| Communicable diseases | D003141 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Cancer pain | D000072716 | — | G89.3 | — | — | — | — | 3 | 3 |
| Motor activity | D009043 | EFO_0003940 | — | — | — | — | — | 2 | 2 |
| Wounds and injuries | D014947 | — | T14.8 | — | — | — | — | 2 | 2 |
| Bipolar disorder | D001714 | EFO_0000289 | F30.9 | — | — | — | — | 2 | 2 |
| Suicide | D013405 | — | — | — | — | — | — | 2 | 2 |
| Systemic scleroderma | D012595 | EFO_0000717 | M34 | — | — | — | — | 1 | 1 |
| Localized scleroderma | D012594 | EFO_1001361 | L94.0 | — | — | — | — | 1 | 1 |
| Diffuse scleroderma | D045743 | EFO_0000404 | — | — | — | — | — | 1 | 1 |
| Spinal stenosis | D013130 | EFO_0007490 | M48.0 | — | — | — | — | 1 | 1 |
| Chemical and drug induced liver injury | D056486 | EFO_0004228 | — | — | — | — | — | 1 | 1 |
Show 35 more
Epidemiology
Epidemiological information for investigational and approved indications
View more details
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
No data
Variants
No data
Financial
Revenue by drug
$
€
£
₣
Cymbalta – Eli Lilly
Mock data
Subscribe for the real data
Subscribe for the real data
Mock data
Subscribe for the real data
Subscribe for the real data
Tabular view
Estimated US medical usage
Duloxetine
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 15,695 documents
View more details
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
Mock data
Subscribe for the real data
Subscribe for the real data
81,838 adverse events reported
View more details
© 2020-2025 Collaborative Drug Discovery Inc. (CDD) | Terms of Use