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
- -
A Study in the Treatment of Children and Adolescents With Major Depressive Disorder
- Conditions
- Interventions
- First Posted Date
- 2009-02-24
- Last Posted Date
- 2017-09-11
- Lead Sponsor
- Eli Lilly and Company
- Target Recruit Count
- 337
- Registration Number
- NCT00849901
- 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., Vinnytsya, Ukraine
Randomised Placebo-controlled Duloxetine-referenced Study of Efficacy and Safety of 5 mg of Vortioxetine (Lu AA21004) in Acute Treatment of Major Depressive Disorder in Elderly Patients
- Conditions
- Interventions
- First Posted Date
- 2008-12-18
- Last Posted Date
- 2014-01-29
- Lead Sponsor
- H. Lundbeck A/S
- Target Recruit Count
- 453
- Registration Number
- NCT00811252
Duloxetine for the Treatment of Generalized Anxiety Disorder
- First Posted Date
- 2008-12-05
- Last Posted Date
- 2010-12-17
- Lead Sponsor
- Eli Lilly and Company
- Target Recruit Count
- 210
- Registration Number
- NCT00803361
- 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., Xi'An, China
A Study for Patient With Chronic Low Back Pain
- First Posted Date
- 2008-10-07
- Last Posted Date
- 2010-10-18
- Lead Sponsor
- Eli Lilly and Company
- Target Recruit Count
- 401
- Registration Number
- NCT00767806
- 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., Madrid, Spain
Effects of Duloxetine on Fear Conditioning in Posttraumatic Stress Disorder (PTSD)
- First Posted Date
- 2008-09-30
- Last Posted Date
- 2015-04-23
- Lead Sponsor
- Yale University
- Target Recruit Count
- 26
- Registration Number
- NCT00763178
- Locations
- 🇺🇸
VA Connecticut Healthcare System, West Haven, Connecticut, United States
Efficacy of Vortioxetine (Lu AA21004) in Treating Generalized Anxiety Disorder
- Conditions
- Interventions
- First Posted Date
- 2008-08-08
- Last Posted Date
- 2013-12-18
- Lead Sponsor
- Takeda
- Target Recruit Count
- 781
- Registration Number
- NCT00730691
Switching to Duloxetine in Patients With Depression
- First Posted Date
- 2008-06-13
- Last Posted Date
- 2010-09-08
- Lead Sponsor
- Eli Lilly and Company
- Target Recruit Count
- 242
- Registration Number
- NCT00696774
- 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., Seoul, Korea, Republic of
Duloxetine Treatment of Major Depression and Chronic Low Back Pain For Older Adults
- First Posted Date
- 2008-06-12
- Last Posted Date
- 2017-02-01
- Lead Sponsor
- University of Pittsburgh
- Target Recruit Count
- 30
- Registration Number
- NCT00696293
- Locations
- 🇺🇸
University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, United States
Efficacy and Safety of Vortioxetine (Lu AA21004) in the Treatment of Patients With Major Depressive Disorder
- Conditions
- Interventions
- First Posted Date
- 2008-05-06
- Last Posted Date
- 2013-12-18
- Lead Sponsor
- Takeda
- Target Recruit Count
- 611
- Registration Number
- NCT00672620
A Study Comparing Duloxetine to Other Antidepressants in the Treatment of Severe Depression
- Conditions
- Interventions
- First Posted Date
- 2008-04-25
- Last Posted Date
- 2010-06-15
- Lead Sponsor
- Eli Lilly and Company
- Target Recruit Count
- 750
- Registration Number
- NCT00666757
- 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., Brown Deer, Wisconsin, United States
Drug Development Updates
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