CYMBALTA
LOE ApproachingNDAORALCAPSULE, DELAYED REL PELLETSPriority Review
Approved
Sep 2004
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
5
Data completeness
5/8 — 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. Approved for the following conditions: major depressive disorder (mdd) in adults () generalized anxiety disorder (gad) in adults, older () diabetic peripheral neuropathic pain (dpnp) in adults () fibromyalgia (fm) in adults, older () chronic musculoskeletal pain in adults (). First approved in 2004.
Drug data last refreshed 21h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
CYMBALTA (duloxetine) is an oral serotonin-norepinephrine reuptake inhibitor (SNRI) approved since 2004 for major depressive disorder, generalized anxiety disorder, diabetic peripheral neuropathic pain, fibromyalgia, and chronic musculoskeletal pain in adults. The drug works by potentiating serotonergic and noradrenergic activity in the central nervous system to produce antidepressant, anxiolytic, and central pain inhibitory effects. As a small-molecule oral capsule with delayed-release pellet formulation, it represents a foundational therapy in the SNRI class and serves as a standard comparator in many pain and psychiatric indication studies.
$0.0BPart D
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.
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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.