DULOXETINE

Launch

duloxetine

Almatica Pharma

NDACAPSULE, DELAYED RELEASE

Approved

Feb 2026

Lifecycle

Launch

Competitive Pressure

30/100

Clinical Trials

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 (4)

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 ( )anxiety

Clinical Trials (5)

NCT04388189Phase 4Withdrawn

Leveraging EEG for Antidepressant Prediction With Duloxetine and Bupropion

Started Oct 2020

NCT04137107Phase 2/3Active Not Recruiting

Duloxetine to Prevent Oxaliplatin-Induced Peripheral Neuropathy in Patients With Stage II-III Colorectal Cancer

Started Jun 2020

220 enrolled

Stage II Colorectal Cancer AJCC v8Stage III Colorectal Cancer AJCC v8

NCT03729284Phase 4Withdrawn

A Study of Duloxetine Hydrochloride Hard Gelatinous Capsule Compared To Cymbalta

Started Mar 2020

Healthy

NCT03794154Phase 4Withdrawn

A Study Of Duloxetine Hydrochloride Hard Gelatinous Capsule Compared To Cymbalta Under Fed Conditions

Started Mar 2020

Healthy

NCT03395353Phase 3Terminated

A Study of Duloxetine (LY248686) in the Treatment of Japanese Children and Adolescents With Depressive Disorder

Started Jan 2018

151 enrolled

Depressive Disorder

Company

External Resources

Full prescribing information

FDA Drugs@FDA

FDA approval history

RxNorm

Drug nomenclature & identifiers