Duloxetine

Generic Name
Duloxetine
Brand Names
Cymbalta, Drizalma, Irenka, Yentreve, Duloxetine Zentiva, Duloxetine Mylan, Duloxetine Lilly
Drug Type
Small Molecule
Chemical Formula
C18H19NOS
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
-

Duloxetine for Treatment of Painful Temporomandibular Joint Disorder

Not Applicable
Completed
Conditions
Interventions
First Posted Date
2009-09-22
Last Posted Date
2021-05-25
Lead Sponsor
University of Maryland, Baltimore
Target Recruit Count
24
Registration Number
NCT00981149
Locations
🇺🇸

University of Maryland Dental School, Baltimore, Maryland, United States

A Study for Adult Patients With Fibromyalgia

First Posted Date
2009-08-25
Last Posted Date
2011-11-03
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
308
Registration Number
NCT00965081
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., Morelia, Mexico

An Open Label Trial of Duloxetine in the Treatment of Irritable Bowel Syndrome and Comorbid Generalized Anxiety Disorder

First Posted Date
2009-08-18
Last Posted Date
2014-07-09
Lead Sponsor
West Penn Allegheny Health System
Target Recruit Count
17
Registration Number
NCT00961298

Pilot Study of Duloxetine in Adult Attention Deficit Hyperactivity Disorder(ADHD)

First Posted Date
2009-07-16
Last Posted Date
2010-12-14
Lead Sponsor
Université de Montréal
Target Recruit Count
40
Registration Number
NCT00940693
Locations
🇨🇦

Centre Hospitalier Universitaire de Montréal: Hôpital Notre-Dame, Montreal, Quebec, Canada

Assessment of Cognitive Functioning Before and After Treatment With Duloxetine

Not Applicable
Completed
Conditions
Interventions
First Posted Date
2009-07-07
Last Posted Date
2013-08-13
Lead Sponsor
University of Texas Southwestern Medical Center
Target Recruit Count
30
Registration Number
NCT00933439
Locations
🇺🇸

Mood Disorders Research Program and Clinic - UT Southwestern Medical Center, Dallas, Texas, United States

A Study to Evaluate the Pharmacokinetics of Duloxetine in Chinese Han Healthy Subjects

Phase 1
Completed
Conditions
Interventions
First Posted Date
2009-07-07
Last Posted Date
2010-06-15
Lead Sponsor
Shanghai Mental Health Center
Target Recruit Count
36
Registration Number
NCT00933452
Locations
🇨🇳

Shanghai Mental Health Center, Shanghai, Shanghai, China

Duloxetine Versus Pregabalin for Alcohol Dependence

First Posted Date
2009-06-29
Last Posted Date
2017-05-04
Lead Sponsor
The Scripps Research Institute
Target Recruit Count
150
Registration Number
NCT00929344
Locations
🇺🇸

The Scripps Research Institute Pearson Center for Alcoholism and Addiction Research, La Jolla, California, United States

Duloxetine for Major Depression in Peri-/Postmenopausal Women

Phase 4
Conditions
Interventions
First Posted Date
2009-04-28
Last Posted Date
2012-02-08
Lead Sponsor
Hamilton Health Sciences Corporation
Target Recruit Count
70
Registration Number
NCT00889369
Locations
🇨🇦

Women's Health Concerns Clinic, Hamilton, Ontario, Canada

Combination Pain Therapy in HIV Neuropathy

First Posted Date
2009-03-17
Last Posted Date
2021-11-04
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Target Recruit Count
15
Registration Number
NCT00863057
Locations
🇺🇸

Houston AIDS Research Team CRS, Houston, Texas, United States

🇺🇸

Ucsd, Avrc Crs, San Diego, California, United States

🇺🇸

Harbor-UCLA Med. Ctr. CRS, Torrance, California, United States

and more 5 locations

A Study in the Treatment of Children and Adolescents With Major Depressive Disorder

First Posted Date
2009-02-24
Last Posted Date
2012-04-19
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
463
Registration Number
NCT00849693
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., Tlalnepantla, Mexico

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