CYMBALTA
LOE ApproachingNDAORALCAPSULE, DELAYED REL PELLETSPriority Review
Approved
Sep 2004
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
5
Data completeness
4/8 — Partial
Priority Review
CYMBALTA by Eli Lilly and Company is antidepressant, central pain inhibitory and anxiolytic actions of duloxetine in humans are unknown, these actions are believed to be related to its potentiation of serotonergic and noradrenergic activity in the cns. First approved in 2004.
Drug data last refreshed 1m ago · AI intelligence enriched 1m ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
CYMBALTA (duloxetine) is an oral serotonin-norepinephrine reuptake inhibitor (SNRI) approved in 2004 for depression, anxiety, and chronic pain conditions. It works by potentiating serotonergic and noradrenergic activity in the central nervous system to achieve antidepressant, anxiolytic, and central pain inhibitory effects. The drug is formulated as a delayed-release capsule for once-daily oral dosing.
$18.0MPart D
LOE ApproachingDeclining
As LOE approaches, commercial teams are shifting focus to lifecycle management and defending market share against generic entrants and newer alternatives.
Mechanism of Action
antidepressant, central pain inhibitory and anxiolytic actions of duloxetine in humans are unknown, these actions are believed to be related to its potentiation of serotonergic and noradrenergic activity in the CNS.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (5)
A Study of Duloxetine Hydrochloride Hard Gelatinous Capsule Compared To Cymbalta
Started Mar 2020
0Healthy
A Study Of Duloxetine Hydrochloride Hard Gelatinous Capsule Compared To Cymbalta Under Fed Conditions
Started Mar 2020
0Healthy
The Cymbalta Pregnancy Registry
Started Jul 2009
144 enrolled
Pregnancy
Cymbalta for Depression as a Complication of Bereavement
Started Apr 2008
20 enrolled
DepressionBereavement
Post-Marketing Surveillance Study on the Safety and Efficacy of Cymbalta (Duloxetine) on Diabetic Peripheral Neuropathic Pain Among Filipino Patients
Started Jul 2006
269 enrolled
Pain
Worked on CYMBALTA at Eli Lilly and Company? Share your interview experience or compensation data (+7 days Pro)
Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.