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Drug ReportsDuloxetine
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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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
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Primary completion date
Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
musculoskeletal diseasesD009140
nervous system diseasesD009422
urogenital diseasesD000091642
nutritional and metabolic diseasesD009750
endocrine system diseasesD004700
signs and symptoms pathological conditionsD013568
psychological phenomenaD011579
mental disordersD001523
musculoskeletal and neural physiological phenomenaD055687
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
CYMBALTAEli LillyN-021427 RX2004-08-03
3 products, RLD, RS
DRIZALMA SPRINKLESun Pharmaceutical IndustriesN-212516 RX2019-07-19
4 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
cymbaltaNew Drug Application2023-08-18
drizalma sprinkleNew Drug Application2024-05-14
duloxetineANDA2024-10-18
duloxetine delayed-releaseANDA2017-04-21
duloxetine duloxetineANDA2024-04-08
duloxetine duloxetine hydrochlorideANDA2017-08-14
duloxetine hclANDA2023-03-24
duloxetine hydrochlorideANDA2024-10-02
duloxetine hydrochloride delayed releaseANDA2019-03-14
duloxicaineunapproved drug other2023-01-25
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Agency Specific
FDA
EMA
Expiration
Code
DULOXETINE HYDROCHLORIDE, CYMBALTA, LILLY
2023-04-20NPP
Patent Expiration
Patent
Expires
Flag
FDA Information
Duloxetine Hydrochloride, Drizalma Sprinkle, Sun Pharm
98396262037-04-13DP
104135252037-04-13DP
109599822037-04-13DP
112027722037-04-13DP
ATC Codes
N: Nervous system drugs
N06: Psychoanaleptics
N06A: Antidepressants
N06AX: Other antidepressants in atc
N06AX21: Duloxetine
HCPCS
No data
Clinical
Clinical Trials
415 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 disorderD003866EFO_1002014F32.A521455226147
DepressionD003863F33.9421384226129
Major depressive disorderD003865EFO_0003761F22314343219101
FibromyalgiaD005356EFO_0005687M79.111951227
OsteoarthritisD010003EFO_0002506M15-M191389626
Myofascial pain syndromesD009209EFO_100105411851125
NeuralgiaD009437EFO_00094301537824
PainD010146EFO_0003843R52454922
Diabetic neuropathiesD003929EFO_10007831469121
Knee osteoarthritisD020370EFO_0004616M171475319
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Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Substance-related disordersD019966EFO_0003890F13112
Therapeutic equivalencyD01381022
Cocaine-related disordersD019970F1422
Drug interactionsD00434711
Alcohol drinkingD000428EFO_000432911
Amphetamine-related disordersD019969EFO_0004701F1511
HyperalgesiaD00693011
Indications Without Phase
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameDuloxetine
INNduloxetine
Description
(S)-duloxetine is a duloxetine. It is an enantiomer of a (R)-duloxetine.
Classification
Small molecule
Drug classantidepressants (fluoxetine type)
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
CNCC[C@H](Oc1cccc2ccccc12)c1cccs1
Identifiers
PDB
CAS-ID116539-59-4
RxCUI
ChEMBL IDCHEMBL1175
ChEBI ID36795
PubChem CID60835
DrugBankDB00476
UNII IDO5TNM5N07U (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
£
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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Refill frequency
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 13,602 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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