duloxetine
Trade name: Cymbalta
Approved
Aug 3, 2004
Duloxetine (brand names Cymbalta, Yentreve, and in parts of Europe, Xeristar or Ariclaim) is indicated for the acute and maintenance treatment of major depressive disorder (MDD), as well as acute management of generalized anxiety disorder. Also used for the management of neuropathic pain associated with diabetic peripheral neuropathy, and fibromyalgia. Has been used in the management of moderate to severe stress urinary incontinence (SUI) in women. It is manufactured and marketed by Eli Lilly and Company. Duloxetine has not yet been FDA approved for stress urinary incontinence or for fibromyalgia. Duloxetine is a selective SNRI (selective serotonin-norepinephrine reuptake inhibitor). Duloxetine is a systemic drug therapy which affects the body as a whole. Known also under the code name LY248686, it is a potent dual reuptake inhibitor of serotonin (5-hydroxytryptamine, 5-HT) and norepinephrine (NE), possessing comparable affinities in binding to NE- and 5-HT transporter sites. It is a less potent inhibitor of dopamine reuptake. — NCATS
Clinical trial activity
359 trials · 215 clinical orgs · 34 marketing orgs
Earliest trial started Sep 1, 1996 (NCT01223001)
Timeline
1990s
- Jan 1, 1996
Earliest Phase 2 Sponsor(trial)
2000s
2010s
- Nov 18, 2010
Impax Laboratories — Marketing Organization
- Feb 2, 2011
Sandoz — Marketing Organization
- Feb 2, 2011
Novartis — Marketing Organization
- Jul 6, 2011
Wockhardt — Marketing Organization
- Dec 11, 2013
Aurobindo Pharma — Marketing Organization
- Dec 11, 2013
Lupin — Marketing Organization
- Dec 11, 2013
Marksans Pharma — Marketing Organization
- Dec 11, 2013
Sun Pharmaceuticals — Marketing Organization
- Dec 11, 2013
Teva — Marketing Organization
- Dec 11, 2013
Torrent Pharmaceuticals Limited — Marketing Organization
- Dec 11, 2013
Graviti Pharmaceuticals — Marketing Organization
- Dec 11, 2013
Adaptis Pharma — Marketing Organization
- Dec 17, 2013
Actavis — Marketing Organization
- Jan 8, 2014
Zydus Discovery DMCC — Marketing Organization
- Jun 9, 2014
Alembic — Marketing Organization
- Jun 11, 2014
Apotex — Marketing Organization
- Jun 11, 2014
Esteve Labs — Marketing Organization
- Aug 26, 2015
Alkem Labs Ltd — Marketing Organization
- Oct 28, 2015
Anchen Pharmaceuticals, Inc — Marketing Organization
- Oct 28, 2015
Inventia Hlthcare — Marketing Organization
- Oct 28, 2015
Endo Pharmaceuticals — Marketing Organization
- Oct 28, 2015
Bristol-Myers Squibb — Marketing Organization
- Oct 28, 2015
PH HEALTH — Marketing Organization
- Aug 3, 2016
Hetero Labs Ltd — Marketing Organization
- Jan 6, 2017
Ajanta Pharma Ltd — Marketing Organization
- Mar 23, 2017
Macleods Pharmaceuticals, Ltd — Marketing Organization
- Mar 23, 2017
Neogen — Marketing Organization
- May 18, 2017
Prinston Inc — Marketing Organization
- Oct 16, 2018
Shijiazhuang Pharma Group (CSPC) — Marketing Organization
- Apr 17, 2019
Baheal Pharmaceutical — Marketing Organization
- Jul 19, 2019
Sun Pharmaceuticals — NDA Secondary Org
- Aug 16, 2019
Fosun — Marketing Organization
2020s
- Feb 11, 2021
Sunshine Lake Pharma Co., Ltd. — Marketing Organization
- Feb 27, 2026
Alvogen — Marketing Organization
Indications
Approved for
Studied for
- Acute Pain · Phase 4
- Aged · Phase 4
- Alcoholism · Phase 2
- Amphetamine-Related Disorders · Phase 1
- Analgesics, Opioid · Phase 2
- Anesthesia · Phase 4
- Anticoagulants · Phase 1
- Anxiety · Phase 4
- Anxiety Disorders · Phase 4
- Arthroplasty, Replacement, Knee · Phase 4
- Attention Deficit Disorder with Hyperactivity · Phase 2
- Back Pain · Phase 4
- Bariatric Surgery · Phase 3
- Bereavement · Phase 4
- Biliary Tract Diseases · Phase 3
- Bipolar Disorder · Phase 4
- Brain Injuries, Traumatic · Phase 2
- Breast Neoplasms · Phase 3
- Bulimia · Phase 4
- Burning Mouth Syndrome · Phase 3
- Central Nervous System Sensitization · Phase 4
- Chronic Pain · Phase 4
- Cocaine-Related Disorders · Phase 1
- Cognition · Phase 3
- Cognitive Dysfunction · Phase 4
- Colorectal Neoplasms · Phase 2/Phase 3
- Cough · Phase 2
- Delirium · Phase 1/Phase 2
- Dementia · Phase 4
- Depression · Phase 4
- Depressive Disorder, Treatment-Resistant · Phase 3
- Diabetes Mellitus · Phase 2/Phase 3
- Diabetic Neuropathies · Phase 4
- Drug Interactions · Phase 1
- Drug-Related Side Effects and Adverse Reactions · Phase 3
- Duloxetine Hydrochloride · Phase 4
- Dysthymic Disorder · Phase 4
- Fatigue Syndrome, Chronic · Phase 2/Phase 3
- Fibromyalgia · Phase 4
- Fractures, Bone · Phase 4
- Gastrointestinal Microbiome · Phase 1
- Gulf War · Phase 2
- Gynecologic Surgical Procedures · Phase 4
- Headache · Phase 4
- Healthy Volunteers · Phase 4
- Hearing Loss · Phase 4
- HIV Infections · Phase 3
- Hyperalgesia · Phase 1
- Hypersensitivity · Phase 4
- Infertility, Male · Phase 4
- Intervertebral Disc Degeneration · Phase 4
- Irritable Bowel Syndrome · Phase 4
- Joint Diseases · Phase 4
- Knee Injuries · Phase 3
- Laparoscopy · Phase 4
- Low Back Pain · Phase 4
- Lung Diseases, Interstitial · Phase 2
- Lymphoma · Phase 2
- Magnesium Sulfate · Phase 4
- Major Depressive Disorder · Phase 4
- Menopause · Phase 4
- Methamphetamine · Phase 1
- Migraine Disorders · Phase 4
- Mood Disorders · Phase 1
- Multiple Sclerosis · Phase 3
- Musculoskeletal Diseases · Phase 3
- Musculoskeletal Pain · Phase 3
- Narcotics · Phase 2
- Neoplasms · Phase 4
- Nerve Degeneration · Phase 2
- Neuralgia · Phase 4
- Neuralgia, Postherpetic · Phase 4
- Obsessive-Compulsive Disorder · Phase 4
- Opioid-Related Disorders · Phase 2
- Osteoarthritis · Phase 4
- Osteoarthritis, Knee · Phase 4
- Pain · Phase 4
- Panic Disorder · Phase 4
- Parkinson Disease · Phase 4
- Peripheral Nervous System Diseases · Phase 3
- Pharmacokinetics · Phase 2
- Polyradiculoneuropathy · Phase 4
- Postoperative Complications · Phase 2/Phase 3
- Postoperative Pain · Phase 4
- Prostatic Neoplasms · Phase 3
- Psychophysiologic Disorders · Phase 3
- Psychotic Disorders · Phase 4
- Renal Dialysis · Phase 4
- Schizophrenia · Phase 4
- Severe acute respiratory syndrome-related coronavirus · Phase 4
- Soft Tissue Injuries · Phase 4
- Sphincter of Oddi Dysfunction · Phase 3
- Stress Disorders, Post-Traumatic · Phase 4
- Stroke · Early Phase 1
- Substance-Related Disorders · Phase 1
- Tacrine · Phase 4
- Therapeutic Equivalency · Phase 1
- Urinary Incontinence · Phase 3
- Urinary Incontinence, Stress · Phase 4
- Urinary Incontinence, Urge · Phase 3
- Vaccines · Phase 4
- Vasomotor System · Phase 4
- Virus Diseases · Phase 4
Mechanism of action
- Norepinephrine transporterINHIBITOR
SLC6A2 inhibitor
- Serotonin transporterINHIBITOR
SLC6A4 inhibitor
Approval history
- approvedAug 3, 2004
Chemistry & pharmacology
SMILES
CNCC[C@H](Oc1cccc2ccccc12)c1cccs1- Mol. weight
- 297.42 g/mol
- Lipinski Ro5
- Pass
- Rule of 3
- No
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Oral
- Availability
- Prescription Only
Oral
Yes
Parenteral
No
Topical
No
Sources
- ChEMBLCHEMBL1175 ↗
- WikipediaDuloxetine ↗
- NCATSO5TNM5N07U ↗
- ChEMBLCHEMBL1200328 ↗
Also known as
- (3s)-n-methyl-3-(1-naphthyloxy)-3-(2-thienyl)propan-1-amine
- (3s)-n-methyl-3-(1-naphthyloxy)-3-(2-thienyl)propan-1-amine
- ariclaim
- ariclaim
- cymbalta
- cymbalta
- cymbalta
- cymbalta
- cymbalta
- doluxetine
- duciltia
- duloxetine
- duloxetine
- duloxetine
- duloxetine
- duloxetine
- duloxetine
- duloxetine
- duloxetine
- duloxetine
- duloxetine
- duloxetine hcl
- duloxetine hcl
- duloxetine hcl
- duloxetine hydrochloride
- duloxetine hydrochloride
- duloxetine hydrochloride
- duloxetine hydrochloride
- duloxetine hydrochloride
- ly-248686
- ly-248686
- (s)-duloxetine
- (s)-duloxetine
- (s)-duloxetine
- yentreve
- yentreve
- yentreve
- yentreve
- yentreve
- yentreve
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT06715462 | Phase 3 | Nov 30, 2025 | Eurofarma Laboratorios S.A. |
| NCT06614322 | Phase 2 | Sep 30, 2025 | Harvard University, University of Rochester |
| NCT07203339 | N/A | Sep 30, 2025 | Federal University of Health Science of Porto Alegre |
| NCT06968624 | Phase 4 | Jun 15, 2025 | Huazhong University of Science and Technology |
| NCT07025590 | N/A | Apr 22, 2025 | Shantou University |
| NCT06965569 | Phase 1 | Apr 21, 2025 | Alar Pharmaceuticals Inc. |
| NCT06807866 | Phase 4 | Apr 1, 2025 | University of Miami |
| NCT06860984 | Phase 3 | Mar 10, 2025 | Tanta University |
| NCT06407401 | Phase 3 | Dec 31, 2024 | European Organisation for Research and Treatment of Cancer |
| NCT06842992 | Phase 2 | Dec 4, 2024 | Jiangsu Nhwa Pharmaceutical Co., Ltd. |
| NCT06711978 | N/A | Dec 1, 2024 | Pusan National University |
| NCT07253207 | Phase 3 | Oct 17, 2024 | Zhejiang Huahai Pharmaceutical Co., Ltd. |
| NCT06606067 | Phase 3 | Sep 3, 2024 | Institut Hospital del Mar d'Investigacions Mèdiques, Universidad Carlos III Madrid |
| NCT06551051 | Phase 2 | Aug 6, 2024 | Fudan University |
| NCT06429605 | N/A | May 20, 2024 | Erzincan University |
| NCT06423716 | Phase 4 | May 15, 2024 | University of Toronto |
| NCT06301061 | N/A | Apr 1, 2024 | University of Naples Frederico II |
| NCT05851898 | Phase 4 | Feb 29, 2024 | Wake Forest University |
| NCT05976347 | Phase 4 | Feb 29, 2024 | Wake Forest University |
| NCT06245109 | Phase 4 | Feb 26, 2024 | Harvard University, Northwestern University |
Organizations
Research & Development (215)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Eli Lilly | For profit | 126 | 94 | 5 | 1996 |
| Boehringer Ingelheim | For profit | 37 | 4 | 4 | 2001 |
| Shionogi | For profit | 11 | 0 | 2 | 2007 |
| Technion University | Academic/Hospital | 10 | 8 | 1 | 2007 |
| Assiut University | Academic/Hospital | 9 | 9 | 4 | 2017 |
| Columbia University | Academic/Hospital | 8 | 8 | 3 | 2005 |
| Harvard University | Academic/Hospital | 7 | 5 | 3 | 2004 |
| Johnson and Johnson | For profit | 7 | 7 | 1 | 2015 |
| Lundbeck | For profit | 7 | 5 | 3 | 2005 |
| National Cancer Institute (NCI) | Government | 5 | 2 | 3 | 2008 |
| The University of Texas, Dallas | Academic/Hospital | 5 | 1 | 3 | 2005 |
| AstraZeneca | For profit | 4 | 4 | 2 | 2006 |
| Bristol-Myers Squibb | For profit | 4 | 4 | 2 | 2004 |
| Catholic University of Korea | Academic/Hospital | 4 | 4 | 1 | 2015 |
| Department of Veteran Affairs | Government | 4 | 3 | 4 | 2005 |
| National Institute of Mental Health (NIMH) | Government | 4 | 0 | 3 | 2003 |
| Northwestern University | Academic/Hospital | 4 | 4 | 2 | 2011 |
| Peking University | Academic/Hospital | 4 | 3 | 3 | 2017 |
| Pfizer | For profit | 4 | 4 | 2 | 2006 |
| Shire | For profit | 4 | 4 | 2 | 2009 |
Marketing (42)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Actavis | For profit | MKTG | Dec 17, 2013 |
| Adaptis Pharma | For profit | MKTG | Dec 11, 2013 |
| Ajanta Pharma Ltd | For profit | MKTG | Jan 6, 2017 |
| Alembic | For profit | MKTG | Jun 9, 2014 |
| Alembic | For profit | SYN | Jun 9, 2014 |
| Alkem Labs Ltd | For profit | MKTG | Aug 26, 2015 |
| Alvogen | For profit | MKTG | Feb 27, 2026 |
| Anchen Pharmaceuticals, Inc | For profit | MKTG | Oct 28, 2015 |
| Apotex | For profit | MKTG | Jun 11, 2014 |
| Apotex | For profit | SYN | Jun 11, 2014 |
| Aurobindo Pharma | For profit | MKTG | Dec 11, 2013 |
| Baheal Pharmaceutical | For profit | MKTG | Apr 17, 2019 |
| Bristol-Myers Squibb | For profit | MKTG | Oct 28, 2015 |
| Eli Lilly | For profit | NDA | Aug 3, 2004 |
| Endo Pharmaceuticals | For profit | MKTG | Oct 28, 2015 |
| Esteve Labs | For profit | SYN | Jun 11, 2014 |
| Esteve Labs | For profit | MKTG | Jun 11, 2014 |
| Fosun | For profit | MKTG | Aug 16, 2019 |
| Graviti Pharmaceuticals | For profit | MKTG | Dec 11, 2013 |
| Hetero Labs Ltd | For profit | MKTG | Aug 3, 2016 |
| Impax Laboratories | For profit | MKTG | Nov 18, 2010 |
| Inventia Hlthcare | For profit | MKTG | Oct 28, 2015 |
| Inventia Hlthcare | For profit | SYN | Oct 28, 2015 |
| Lupin | For profit | MKTG | Dec 11, 2013 |
| Lupin | For profit | SYN | Dec 11, 2013 |
| Macleods Pharmaceuticals, Ltd | For profit | MKTG | Mar 23, 2017 |
| Marksans Pharma | For profit | MKTG | Dec 11, 2013 |
| Neogen | For profit | MKTG | Mar 23, 2017 |
| Novartis | For profit | MKTG | Feb 2, 2011 |
| PH HEALTH | For profit | MKTG | Oct 28, 2015 |
| Prinston Inc | For profit | MKTG | May 18, 2017 |
| Sandoz | For profit | MKTG | Feb 2, 2011 |
| Shijiazhuang Pharma Group (CSPC) | For profit | MKTG | Oct 16, 2018 |
| Sun Pharmaceuticals | For profit | MKTG | Dec 11, 2013 |
| Sun Pharmaceuticals | For profit | SYN | Dec 11, 2013 |
| Sun Pharmaceuticals | For profit | NDA2 | Jul 19, 2019 |
| Sunshine Lake Pharma Co., Ltd. | For profit | MKTG | Feb 11, 2021 |
| Teva | For profit | MKTG | Dec 11, 2013 |
| Torrent Pharmaceuticals Limited | For profit | MKTG | Dec 11, 2013 |
| Wockhardt | For profit | MKTG | Jul 6, 2011 |
| Zydus Discovery DMCC | For profit | MKTG | Jan 8, 2014 |
| Zydus Discovery DMCC | For profit | SYN | Jan 8, 2014 |