Cymbalta
(Duloxetine)ApprovedSmall molecule
Alnylam 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 70 indications[4].[1]
Cymbalta is one of 1319 small molecule programs targeting Compulsive behaviors. It is currently in Approved.
70
Indications
283
Total Trials
18
Active Trials
1,318
Competitors
3
FDA Applications
NDA/BLA/ANDA regulatory filings
5
Patents
Pipeline
Status by Indication[4][1]
Indication
Showing 10 of 66 indications
Competition
Competitive Landscape
2828 competitors in Breast Cancer
#DrugCompanyPhaseTrials
1Cymbalta
Alnylam PharmaceuticalsApproved
Halaven
EisaiPreclinical
Tykerb
GSKPreclinical
Trodelvy
GileadPreclinical
Tecentriq
RochePreclinical
Adriamycin
GGynecologic Oncology Group
Preclinical
Avastin
BBio-Thera Solutions
Preclinical
Nolvadex
SSan Diego Pacific Oncology & Hematology Associates
Preclinical
Prolia
AmgenPreclinical
Gemzar
GGynecologic Oncology Group
Preclinical
Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.
Timeline
Expected Milestones
Clinical
Trials by Indication[1]
Major Depressive Disorder19 trials
Show 16 more trials
Intestinal Flora and Major Depressive Disorders
Unknown status·—··NCT04347577·40 enrolled
Osteoarthritis10 trials
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Duloxetine Combined With Intra-articular Injection of Corticosteroid and Hyaluronic Acid Reduces Pain in the Treatment of Knee Osteoarthritis Patients
Completed·—·Phase 4·NCT04117893·150 enrolled
Treatment10 trials
Show 7 more trials
Open Label Study of Duloxetine for the Treatment of Phantom Limb Pain
Terminated·—·N/A·NCT00425230·15 enrolled
Low back pain9 trials
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Stress urinary incontinence9 trials
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85 more indications
Fibromyalgia8 trials
Show 5 more trials
Study to Assess Mechanisms in Peripheral Tissue Innervation for Fibromyalgia
Completed·—·N/A·NCT01127490·25 enrolled
Neuropathic Pain8 trials
Show 5 more trials
Efficacy of Pregabalin Vs Duloxetine in Diabetic Peripheral Neuropathic Pain at Variable Dose
Unknown status·—·Phase 1·NCT05292066·126 enrolled
Depression7 trials
Show 4 more trials
Peripheral Neuropathy7 trials
Show 4 more trials
Qutenza Versus Duloxetine in Chemotherapy-induced Peripheral Neuropathy (CIPN)
Unknown status·—·N/A·NCT05560516·102 enrolled
Botulinum Toxin Type A in Diabetic Peripheral Neuropathy
Completed·—·Phase 4·NCT05296759·30 enrolled
Generalized Anxiety Disorder5 trials
Pregabalin3 trials
Pain3 trials
Total Knee Arthroplasty3 trials
Treatment Resistant Depression3 trials
Methamphetamine2 trials
Mastectomy2 trials
Efficacy and Safety2 trials
AIN2 trials
Tic Disorder2 trials
Patient Education and Duloxetine, Alone and in Combination, for Patients With Multisystem Functional Somatic Disorder
Recruiting·—·Phase 4·NCT06232473·424 enrolled
Treatment of MDEs During the Course of Psychotic Disorders With Duloxetine
Completed·—·Phase 4·NCT00224302·20 enrolled
Cognitive Function2 trials
Anxiety2 trials
Major Depression2 trials
Hysterectomy2 trials
Perioperative Duloxetine for Pain Management After Laparoscopic Hysterectomy
Completed·—·N/A·NCT03350334·100 enrolled
Irritable Bowel Syndrome2 trials
Diabetic Neuropathy2 trials
Antidepressants2 trials
Chronic pain2 trials
Depressive Disorder1 trial
Function1 trial
Migraine1 trial
Prevention1 trial
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
Eating Disorder1 trial
Tics1 trial
Randomized1 trial
Urinary Stress Incontinence1 trial
Pilot Study1 trial
Pilot Study of Duloxetine in Psychological Resilience
Completed·—·Phase 2·NCT00331799·18 enrolled
Pancreatitis1 trial
Neuropathy1 trial
Combination Pain Therapy in HIV Neuropathy
Terminated·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00863057·15 enrolled
Interaction1 trial
Infants1 trial
Pharmacokinetics and Safety of Commonly Used Drugs in Lactating Women and Breastfed Infants
Recruiting·—··NCT03511118·1,600 enrolled
Cohort Study1 trial
Panic Disorder1 trial
Analgesic Efficacy1 trial
Analgesic Efficacy of Duloxetine in Patients Undergoing Lumbar Discectomy
Unknown status·—·N/A·NCT03549026·70 enrolled
Thoracotomy1 trial
Duloxetine vs Pregabalin for Thoracotomy Pain
Unknown status·—·Phase 4·NCT04782310·75 enrolled
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
Glioblastoma1 trial
Laparoscopic Surgery1 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
Headache1 trial
Myalgia1 trial
Duloxetine for Succinylcholine-induced Postoperative Myalgia
Completed·—·Phase 2/3·NCT03037073·70 enrolled
Severe Depression1 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
Obsessive Compulsive Disorder (OCD)1 trial
Effectiveness1 trial
Delirium1 trial
Burning Mouth Syndrome1 trial
Unspecified7 trials
Duloxetine for PHN
Completed·—·N/A·NCT04313335·750 enrolled
Duloxetine Tibial Plateau
Withdrawn·—·Phase 4·NCT04639011
Show 4 more trials
Regulatory
FDA Approval Timeline[5]
Aug 3, 2004
CYMBALTA
NDA NDA021427
Jul 19, 2019
DRIZALMA SPRINKLE
NDA NDA212516
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