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
- -
Efficacy and Tolerability of Escitalopram and Duloxetine in Outpatients With Major Depressive Disorder
- First Posted Date
- 2010-06-22
- Last Posted Date
- 2016-11-08
- Lead Sponsor
- H. Lundbeck A/S
- Target Recruit Count
- 294
- Registration Number
- NCT01148472
6-week Study Treatment to Evaluate the Safety and Effectiveness of AZD2066 in Patients With Major Depressive Disorder
- Conditions
- Interventions
- First Posted Date
- 2010-06-17
- Last Posted Date
- 2012-10-03
- Lead Sponsor
- AstraZeneca
- Target Recruit Count
- 131
- Registration Number
- NCT01145755
- Locations
- 🇺🇸
Research Site, Seattle, Washington, United States
Randomised Placebo-controlled Duloxetine-referenced Study of Efficacy and Safety of 15 and 20 mg of Vortioxetine (Lu AA21004) in Acute Treatment of Major Depressive Disorder in Adults
- Conditions
- Interventions
- First Posted Date
- 2010-06-10
- Last Posted Date
- 2014-02-11
- Lead Sponsor
- H. Lundbeck A/S
- Target Recruit Count
- 607
- Registration Number
- NCT01140906
Study to Assess Mechanisms in Peripheral Tissue Innervation for Fibromyalgia
- Conditions
- First Posted Date
- 2010-05-21
- Last Posted Date
- 2020-01-09
- Lead Sponsor
- Albany Medical College
- Target Recruit Count
- 25
- Registration Number
- NCT01127490
- Locations
- 🇺🇸
Neurosciences Institute, Albany Medical College, Albany, New York, United States
A Study of Duloxetine in Elderly Generalized Anxiety Disorder
- First Posted Date
- 2010-05-07
- Last Posted Date
- 2013-09-02
- Lead Sponsor
- Eli Lilly and Company
- Target Recruit Count
- 291
- Registration Number
- NCT01118780
- 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., Chesterfield, United Kingdom
Duloxetine for Menopausal Depression
- First Posted Date
- 2010-05-06
- Last Posted Date
- 2014-08-21
- Lead Sponsor
- Massachusetts General Hospital
- Target Recruit Count
- 29
- Registration Number
- NCT01117857
- Locations
- 🇺🇸
Massachusetts General Hospital, Boston, Massachusetts, United States
Efficacy, Safety, Tolerability and Pharmacokinetics of Concomitant Administration of Tramadol With Duloxetine or Pregabalin
- Conditions
- Interventions
- First Posted Date
- 2010-05-05
- Last Posted Date
- 2013-05-31
- Lead Sponsor
- Turku University Hospital
- Registration Number
- NCT01116531
- Locations
- 🇫🇮
Department of Anaesthesiology, Intensive Care, Emergency Care and Pain Medicine, Turku University and Turku University Hospital, Turku, Finland
A Study for Adolescents With Fibromyalgia Syndrome
- First Posted Date
- 2010-03-18
- Last Posted Date
- 2019-11-04
- Lead Sponsor
- Eli Lilly and Company
- Registration Number
- NCT01089621
- 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., Salt Lake City, Utah, United States
A Study in Painful Diabetic Neuropathy
- Conditions
- Interventions
- First Posted Date
- 2010-03-18
- Last Posted Date
- 2013-01-24
- Lead Sponsor
- Eli Lilly and Company
- Target Recruit Count
- 811
- Registration Number
- NCT01089556
- 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., Chorley, United Kingdom
The Cymbalta Pregnancy Registry
- First Posted Date
- 2010-02-24
- Last Posted Date
- 2022-07-18
- Lead Sponsor
- Eli Lilly and Company
- Target Recruit Count
- 144
- Registration Number
- NCT01074151
- Locations
- 🇺🇸
The Cymbalta Pregnancy Registry Call Center, Wilmington, North Carolina, United States
Drug Development Updates
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