NDACAPSULE, DELAYED RELEASE
Approved
Feb 2026
Lifecycle
Launch
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
3/8 — Basic
DULOXETINE (duloxetine) by Almatica Pharma 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 2026.
Drug data last refreshed 8h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Duloxetine is a serotonin-norepinephrine reuptake inhibitor (SNRI) approved as a delayed-release capsule for depression, anxiety, and chronic pain conditions. It works by potentiating serotonergic and noradrenergic activity in the central nervous system to produce antidepressant, anxiolytic, and central pain-inhibitory effects. The exact mechanisms underlying its analgesic and anxiolytic properties remain incompletely understood but are attributed to dual monoamine reuptake inhibition.
Launch
Early-stage launch product with moderate competitive pressure (30%) indicating a crowded SNRI market requiring aggressive positioning and cross-functional team expansion.
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 (20)
Leveraging EEG for Antidepressant Prediction With Duloxetine and Bupropion
Started Oct 2020
0Major Depressive Disorder
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
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
A Study of Duloxetine (LY248686) in the Treatment of Japanese Children and Adolescents With Depressive Disorder
Started Jan 2018
151 enrolled
Depressive Disorder
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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.