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

Mechanism-based Choice of Therapy for Neuropathic Pain

Not Applicable

Completed

Conditions: Pain

Interventions: Drug: Pregabalin
Drug: Duloxetine

First Posted Date: 2011-05-24

Last Posted Date: 2017-10-11

Lead Sponsor: Rambam Health Care Campus

Target Recruit Count: 32

Registration Number: NCT01359514

Locations: 🇮🇱
Rambam Medical center, Haifa, Israel

Efficacy and Safety of Flexibly Dosed BMS-820836 in the Treatment of Patients With Treatment Resistant Major Depression

Phase 2

Completed

Conditions: Depression

Interventions: Drug: Placebo matching with Duloxetine
Drug: Duloxetine
Drug: Placebo matching with BMS-820836
Drug: BMS-820836

First Posted Date: 2011-03-07

Last Posted Date: 2015-10-12

Lead Sponsor: Bristol-Myers Squibb

Target Recruit Count: 889

Registration Number: NCT01309945

Locations: 🇺🇸
Univ Of Penn, Philadelphia, Pennsylvania, United States
🇺🇸
Psychiatric Consultants, Pc, Franklin, Tennessee, United States
🇺🇸
Pacific Clinical Research Medical Group, Upland, California, United States

and more 45 locations

A Study to Assess the Safety and Effect of TC-5214 in Patients With Major Depressive Disorder.

Phase 2

Terminated

Conditions: Major Depressive Disorder

Interventions: Drug: TC-5214
Drug: Duloxetine
Drug: Placebo

First Posted Date: 2011-02-02

Last Posted Date: 2012-11-20

Lead Sponsor: AstraZeneca

Target Recruit Count: 145

Registration Number: NCT01288079

Locations: 🇯🇵
Research Site, Kumamoto, Japan

Mechanism-based Choice of Therapy: Can Treatments Success in Fibromyalgia Patients be Coupled to Psychophysical Pain Modulation Profile?

Not Applicable

Conditions: Fibromyalgia

Interventions: Drug: Duloxetine
Drug: Pregabalin

First Posted Date: 2010-12-31

Last Posted Date: 2010-12-31

Lead Sponsor: Tel-Aviv Sourasky Medical Center

Target Recruit Count: 150

Registration Number: NCT01268631

Locations: 🇮🇱
Rheumatology Institute, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel

A Study of Duloxetine in Adolescents With Juvenile Primary Fibromyalgia Syndrome

Phase 3

Completed

Conditions: Fibromyalgia

Interventions: Drug: Duloxetine
Drug: Placebo

First Posted Date: 2010-11-09

Last Posted Date: 2019-09-20

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 184

Registration Number: NCT01237587

Locations: 🇵🇷
Centro de Investigaciones Clinicas, San Juan, Puerto Rico
🇺🇸
Synergy Clinical Research, National City, California, United States
🇺🇸
Northwest Clinical Research Center, Bellevue, Washington, United States

and more 26 locations

A Study in Pediatric Participants With Generalized Anxiety Disorder

Phase 3

Completed

Conditions: Anxiety Neuroses
Neuroses, Anxiety
Anxiety States, Neurotic

Interventions: Drug: Duloxetine
Drug: Placebo

First Posted Date: 2010-10-22

Last Posted Date: 2014-03-05

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 281

Registration Number: NCT01226511

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., Pretoria, South Africa

Feasibility Study of Duloxetine in the Treatment of Depression in Patients With Traumatic Brain Injury

Phase 2

Terminated

Conditions: Traumatic Brain Injury
Depression

Interventions: Drug: Sugar pill
Drug: Duloxetine

First Posted Date: 2010-10-18

Last Posted Date: 2014-12-17

Lead Sponsor: Rehabilitation Hospital of Indiana

Target Recruit Count: 8

Registration Number: NCT01223001

Locations: 🇺🇸
Rehabilitation Hospital of Indiana, Indianapolis, Indiana, United States

A Study in Participants With Diabetic Peripheral Neuropathic Pain in China

Phase 3

Completed

Conditions: Diabetic Neuropathy, Painful

Interventions: Drug: Placebo
Drug: Duloxetine

First Posted Date: 2010-08-11

Last Posted Date: 2014-10-13

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 405

Registration Number: NCT01179672

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., Yueyang, China