Duloxetine

Generic Name: Duloxetine

Brand Names: Cymbalta, Drizalma, Irenka, Yentreve, Duloxetine Zentiva, Duloxetine Mylan, Duloxetine Lilly

Drug Type: Small Molecule

Chemical Formula: C_₁₈H_₁₉NOS

CAS Number: 116539-59-4

Unique Ingredient Identifier: O5TNM5N07U

Background: Duloxetine is a dual serotonin and norepinephrine reuptake inhibitor. It was originally discovered in 1993 and developed by Eli Lilly and Company as LY248686. Duloxetine first received approval from the FDA in August, 2004 as Cymbalta for the treatment of Major Depressive Disorder. It has since received approval for a variety of indications including the treatment of neuropathic pain, Generalized Anxiety disorder, osteoarthritis, and stress incontinence. Duloxetine continues to be investigated for the treatment of pain in cancer, surgery, and more.

Indication: Indicated for:

1) Management of Major Depressive Disorder.

2) Management of Generalized Anxiety Disorder.

3) Management of diabetic peripheral neuropathy.

4) Management of fibromyalgia.

5) Management of chronic musculoskeletal pain.

6) Management of osteoarthritis of the knee in adults.

7) Management of chronic lower back pain in adults.

8) Management of stress urinary incontinence in adult women.

Off-label uses include:

1) Management of chemotherapy-induced peripheral neuropathy.

2) Management of stress urinary incontinence in adult men after prostatectomy until recovery is complete.

Associated Conditions: Chronic Lower Back Pain (CLBP), Chronic Musculoskeletal Pain, Diabetic Peripheral Neuropathic Pain (DPN), Fibromyalgia, Generalized Anxiety Disorder, Major Depressive Disorder (MDD), Osteoarthritis of the Knee, Stress Urinary Incontinence (SUI)

Associated Therapies: -

Clinical Trials

Study of Brain Response to Emotional Pictures Using a fMRI While on Duloxetine

Phase 4

Completed

Conditions: Major Depression

Interventions: Drug: Duloxetine

First Posted Date: 2007-09-20

Last Posted Date: 2016-10-03

Lead Sponsor: Indiana University School of Medicine

Target Recruit Count: 10

Registration Number: NCT00532480

Locations: 🇺🇸
Indiana University Adult Psychiatric Clinic, Indianapolis, Indiana, United States

An Open Trial of Duloxetine on Comorbid Major Depression and Chronic Headache

Phase 4

Completed

Conditions: Major Depression
Chronic Primary Headache

First Posted Date: 2007-09-19

Last Posted Date: 2007-09-19

Lead Sponsor: Kraepelin Psiquiatria Clinica

Target Recruit Count: 30

Registration Number: NCT00531895

Locations: 🇧🇷
Hospital SOCOR, Belo Horizonte, MG, Brazil

Open-Label Study of Duloxetine in the Treatment of Children and Adolescents With Major Depressive Disorder

Phase 2

Completed

Conditions: Major Depressive Disorder

Interventions: Drug: duloxetine

First Posted Date: 2007-09-14

Last Posted Date: 2011-10-24

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 72

Registration Number: NCT00529789

Locations: 🇺🇸
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Bellevue, Washington, United States

Duloxetine for Perimenopausal Depression

Phase 4

Completed

Conditions: Major Depressive Disorder

First Posted Date: 2007-08-17

Last Posted Date: 2012-07-09

Lead Sponsor: University of Arizona

Target Recruit Count: 7

Registration Number: NCT00517985

Locations: 🇺🇸
Women's Mental Health Program; University of Arizona; Department of Psychiatry, Tucson, Arizona, United States

Safety and Efficacy Study in Subjects With Diabetic Neuropathic Pain

Phase 2

Completed

Conditions: Diabetic Neuralgia
Diabetic Neuropathies
Diabetic Neuropathy, Painful
Diabetic Polyneuropathy
Neuralgia, Diabetic

Interventions: Drug: ABT-894
Drug: placebo
Drug: Duloxetine

First Posted Date: 2007-07-27

Last Posted Date: 2013-01-23

Lead Sponsor: AbbVie (prior sponsor, Abbott)

Target Recruit Count: 280

Registration Number: NCT00507936

Locations: 🇺🇸
Site Reference ID/Investigator# 6052, Anaheim, California, United States
🇺🇸
Site Reference ID/Investigator# 5276, Clearwater, Florida, United States
🇵🇷
Site Reference ID/Investigator# 8121, San Juan, Puerto Rico

and more 46 locations

Duloxetine Versus Duloxetine Plus Non-Drug Therapy for Depression

Phase 4

Completed

Conditions: Depression

First Posted Date: 2007-06-29

Last Posted Date: 2007-07-02

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 940

Registration Number: NCT00494377

Locations: 🇦🇹
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Wien, Austria

Duloxetine Versus Placebo for Fibromyalgia

Phase 3

Completed

Conditions: Fibromyalgia

First Posted Date: 2007-06-21

Last Posted Date: 2007-06-21

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 345

Registration Number: NCT00489073

Locations: 🇺🇸
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Indianapolis, Indiana, United States

Duloxetine Versus Paroxetine for Major Depression

Phase 3

Completed

Conditions: Major Depressive Disorder

First Posted Date: 2007-06-21

Last Posted Date: 2007-06-21

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 480

Registration Number: NCT00489775

Locations: 🇨🇳
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Beijing, China

Urge Incontinence Bladder Overactivity Study

Phase 2

Completed

Conditions: Urinary Incontinence

First Posted Date: 2007-05-21

Last Posted Date: 2007-05-21

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 300

Registration Number: NCT00475696

Locations: 🇨🇦
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., North York, Ontario, Canada

Efficacy and Safety Stress Urinary Incontinence Study

Phase 3

Completed

Conditions: Urinary Incontinence, Stress

First Posted Date: 2007-05-21

Last Posted Date: 2007-05-21

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 120

Registration Number: NCT00475358

Locations: 🇨🇳
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Tao-Yuan, Taiwan

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