Cymbalta
(Duloxetine)ApprovedSmall molecule
Jazz PharmaceuticalsDuloxetine is used to treat depression, anxiety, and chronic pain conditions like fibromyalgia and nerve pain. It works by helping balance certain chemicals in the brain that affect mood and pain perception.[2] Cymbalta is currently approved and in use across 61 indications[4].[1]
Cymbalta is one of 869 small molecule programs targeting Fibromyalgia. It is currently in Approved.
61
Indications
287
Total Trials
20
Active Trials
868
Competitors
41
FDA Applications
NDA/BLA/ANDA regulatory filings
5
Patents
Pipeline
Status by Indication[4][1]
Indication
Showing 10 of 58 indications
Competition
Competitive Landscape
744 competitors in Breast Cancer
#DrugCompanyPhaseTrials
1Cymbalta
Jazz PharmaceuticalsApproved
Lexiscan
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NovartisPreclinical
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Methylthioninium Chloride
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Preclinical
MS Contin
HHikma Pharmaceuticals LLC
Preclinical
Duragesic-100
CCephalon
Preclinical
MS Contin
HHikma Pharmaceuticals LLC
Preclinical
Sporanox
SSebela Pharmaceuticals Development LLC
Preclinical
Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.
Timeline
Expected Milestones
Clinical
Trials by Indication[1]
Major Depressive Disorder20 trials
Show 17 more trials
Intestinal Flora and Major Depressive Disorders
Unknown status·—··NCT04347577·40 enrolled
Fibromyalgia9 trials
Show 6 more trials
Study to Assess Mechanisms in Peripheral Tissue Innervation for Fibromyalgia
Completed·—·N/A·NCT01127490·25 enrolled
Osteoarthritis9 trials
Show 6 more trials
Depression9 trials
Show 6 more trials
Treatment8 trials
86 more indications
Neuropathic Pain8 trials
Show 5 more trials
Stress urinary incontinence7 trials
Peripheral Neuropathy7 trials
Botulinum Toxin Type A in Diabetic Peripheral Neuropathy
Completed·—·Phase 4·NCT05296759·30 enrolled
Show 4 more trials
Qutenza Versus Duloxetine in Chemotherapy-induced Peripheral Neuropathy (CIPN)
Unknown status·—·N/A·NCT05560516·102 enrolled
Treatment Resistant Depression7 trials
Generalized Anxiety Disorder6 trials
Low back pain5 trials
Cognitive Function3 trials
Inflammatory Markers and Cognitive Function in Major Depression
Unknown status·—·Phase 4·NCT01391221·20 enrolled
Pain3 trials
Pregabalin3 trials
Pilot Study2 trials
Pilot Study of Duloxetine in Psychological Resilience
Completed·—·Phase 2·NCT00331799·18 enrolled
Chronic pain2 trials
Hysterectomy2 trials
Perioperative Duloxetine for Pain Management After Laparoscopic Hysterectomy
Completed·—·N/A·NCT03350334·100 enrolled
Breast Cancer2 trials
Improvement of Quality of Life Through Supportive Treatments for Hormone Therapy - Related Symptoms in Patients With Early Breast Cancer
Not yet recruiting·EEuropean Organisation for Research and Treatment of Cancer - EORTC·Phase 3·NCT06407401·399 enrolled
Anxiety2 trials
Analgesic Efficacy2 trials
Analgesic Efficacy of Duloxetine in Patients Undergoing Lumbar Discectomy
Unknown status·—·N/A·NCT03549026·70 enrolled
Duloxetine Potentiates the Analgesic Efficacy of Intrathecal Morphine
Completed·—·N/A·NCT03560427·60 enrolled
Tics2 trials
Headache2 trials
Total Knee Arthroplasty2 trials
Antidepressants2 trials
Getting Biased Treatment Study: How Psychotherapy and Antidepressants Change Brain Activity in Chronic Depression
Unknown status·—·N/A·NCT00596986·30 enrolled
Severe Depression2 trials
Mastectomy2 trials
Metabolism2 trials
Duloxetine on Bone Metabolism
Unknown status·—··NCT05550506·102 enrolled
Major Depression2 trials
Postoperative Pain Control2 trials
Oral Duloxetine as a Premedication for Postoperative Pain Control
Completed·—·Phase 4·NCT05050656·70 enrolled
Diabetic Neuropathy1 trial
Myalgia1 trial
Duloxetine for Succinylcholine-induced Postoperative Myalgia
Completed·—·Phase 2/3·NCT03037073·70 enrolled
Interaction1 trial
Effectiveness1 trial
Efficacy and Safety1 trial
Post-Traumatic Stress Disorder, PTSD1 trial
Acute Kidney Injury1 trial
Serotonin-norepinephrine Reuptake Inhibitors and Acute Kidney Injury
Completed·CCanadian Network for Observational Drug Effect Studies, CNODES··NCT02320240·3,255,526 enrolled
Temporomandibular Joint Disorder1 trial
Colorectal Cancer1 trial
Efficacy of Perioperative Duloxetine as a Part of Multimodal Analgesia in Laparoscopic Colorectal Cancer Surgery
Unknown status·—·Phase 2·NCT04294953·60 enrolled
Eating Disorder1 trial
Urinary Stress Incontinence1 trial
Tic Disorder1 trial
Patient Education and Duloxetine, Alone and in Combination, for Patients With Multisystem Functional Somatic Disorder
Recruiting·—·Phase 4·NCT06232473·424 enrolled
Depressive Disorder1 trial
Function1 trial
Methamphetamine1 trial
Migraine1 trial
Hyperalgesia1 trial
Randomized1 trial
Neuropathy1 trial
Combination Pain Therapy in HIV Neuropathy
Terminated·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00863057·15 enrolled
Brain Injury1 trial
Feasibility Study of Duloxetine in the Treatment of Depression in Patients With Traumatic Brain Injury
Terminated·—·Phase 2·NCT01223001·8 enrolled
Attention Deficit Hyperactivity Disorder1 trial
Parkinson's Disease1 trial
Cohort Study1 trial
Cognitive impairment1 trial
Physical Stress1 trial
Adolescent1 trial
Sequenced Treatment Alternatives to Relieve Adolescent Depression (STAR-AD)
Recruiting·FFirst Affiliated Hospital of Chongqing Medical University·Phase 1/2·NCT05814640·520 enrolled
Burning Mouth Syndrome1 trial
Shoulder pain1 trial
Duloxetine for Post Laparoscopic Shoulder Pain
Completed·—·Phase 3·NCT03249168·60 enrolled
Interstitial Lung Disease1 trial
Opioid Consumption1 trial
Duloxetine Role in Reducing Opioid Consumption After Thoracotomy
Completed·—·Phase 4·NCT03618225·60 enrolled
Chronic Cough1 trial
Cancer Pain1 trial
Efficacy of Duloxetine in Conjunction With Tramadol for Chronic Cancer Pain
Completed·—·N/A·NCT05311774·400 enrolled
Alcohol1 trial
Prophylaxis1 trial
Delirium1 trial
Transcranial Direct Current Stimulation1 trial
Unspecified5 trials
Bioavailability Study of Duloxetine Delayed-Release Capsules 60 mg Under Fasting Condition
Completed·—·Phase 1·NCT02291367·76 enrolled
Show 2 more trials
Duloxetine Tibial Plateau
Withdrawn·—·Phase 4·NCT04639011
Regulatory
FDA Approval Timeline[5]
Aug 3, 2004
CYMBALTA
NDA NDA021427
Aug 3, 2004
CYMBALTA
NDA NDA021427
Feb 18, 2005
CYMBALTA
NDA NDA021427
Jun 6, 2006
CYMBALTA
NDA NDA021427
Sep 20, 2006
CYMBALTA
NDA NDA021427
Feb 23, 2007
CYMBALTA
NDA NDA021427
Feb 23, 2007
CYMBALTA
NDA NDA021427
Feb 23, 2007
CYMBALTA
NDA NDA021427
Aug 2, 2007
CYMBALTA
NDA NDA021427
Nov 28, 2007
CYMBALTA
NDA NDA021427
Nov 28, 2007
CYMBALTA
NDA NDA021427
Jan 30, 2009
CYMBALTA
NDA NDA021427
Mar 18, 2009
CYMBALTA
NDA NDA021427
Mar 18, 2009
CYMBALTA
NDA NDA021427
Mar 18, 2009
CYMBALTA
NDA NDA021427
Nov 19, 2009
CYMBALTA
NDA NDA021427
Mar 4, 2011
CYMBALTA
NDA NDA021427
Apr 12, 2011
CYMBALTA
NDA NDA021427
Sep 2, 2011
CYMBALTA
NDA NDA021427
Aug 24, 2012
CYMBALTA
NDA NDA021427
Aug 24, 2012
CYMBALTA
NDA NDA021427
Oct 18, 2012
CYMBALTA
NDA NDA021427
Oct 18, 2012
CYMBALTA
NDA NDA021427
Jul 17, 2014
CYMBALTA
NDA NDA021427
Oct 16, 2014
CYMBALTA
NDA NDA021427
Oct 16, 2014
CYMBALTA
NDA NDA021427
Nov 25, 2014
CYMBALTA
NDA NDA021427
Nov 25, 2014
CYMBALTA
NDA NDA021427
Jun 18, 2015
CYMBALTA
NDA NDA021427
Jul 12, 2016
CYMBALTA
NDA NDA021427
Sep 2, 2016
CYMBALTA
NDA NDA021427
Jan 4, 2017
CYMBALTA
NDA NDA021427
Dec 19, 2017
CYMBALTA
NDA NDA021427
Jul 19, 2019
DRIZALMA SPRINKLE
NDA NDA212516
Oct 4, 2019
CYMBALTA
NDA NDA021427
Apr 20, 2020
CYMBALTA
NDA NDA021427
Oct 1, 2020
CYMBALTA
NDA NDA021427
Sep 20, 2021
CYMBALTA
NDA NDA021427
Aug 18, 2023
CYMBALTA
NDA NDA021427
Aug 18, 2023
CYMBALTA
NDA NDA021427
Feb 27, 2026
DULOXETINE HYDROCHLORIDE
NDA NDA219131
Sources
References
- [1]
- [2]MedlinePlus Drug Information — Cymbalta drug information. U.S. National Library of Medicine, National Institutes of Health.
- [3]
- [4]Open Targets Platform — Drug–disease associations for Duloxetine. EMBL-EBI & Wellcome Sanger Institute.
- [5]
- [6]
- [7]
Details
Drug Info
Quick Facts
- Mechanism of Action
- Norepinephrine Transporter Inhibitor; Serotonin Transporter Inhibitor[3]
- Modality
- Small molecule[3]
- Highest Phase
- Approved[1]
- Company