Cymbalta

(Duloxetine)

ApprovedSmall molecule

Duloxetine 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 871 small molecule programs targeting Compulsive behaviors. It is currently in Approved.

Indications

288

Total Trials

Active Trials

870

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Compulsive BehaviorsActive, not recruiting

Neuropathic PainCompleted

Low Back PainCompleted

Depressive DisorderActive, not recruiting

Eating DisorderCompleted

Biliary DyskinesiaApproved

Cognitive ImpairmentCompleted

StrokeApproved

NeurotoxicityRecruiting

Tic DisorderRecruiting

Compulsive BehaviorsPreclinical

Active, not recruiting

Neuropathic PainApproved

Completed

Low Back PainApproved

Completed

Depressive DisorderApproved

Active, not recruiting

Eating DisorderApproved

Completed

Biliary DyskinesiaApproved

Approved

Cognitive ImpairmentApproved

Completed

StrokeApproved

Approved

NeurotoxicityPhase 2

Recruiting

Tic DisorderApproved

Recruiting

Showing 10 of 58 indications

Competition

Competitive Landscape

706 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Cymbalta

Jazz Pharmaceuticals

Approved

3 2

Adenocard

Astellas

Preclinical

2 3

Lexiscan

Astellas

Preclinical

1 4

Zolymbus

AbbVie

Preclinical

1 5

Blenoxane

Bristol-Myers Squibb

Preclinical

1 6

MS Contin

HHikma Pharmaceuticals LLC

Preclinical

3 7

Sporanox

SSebela Pharmaceuticals Development LLC

Preclinical

1 8

Acupan

YYonsei University

Preclinical

1 9

Chantix

PPrism Pharmaceuticals

Preclinical

1 10

Feraheme

AAzurity Pharmaceuticals

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 2/3Active, not recruiting

Peripheral Neuropathy

NCT04137107

Q1 2027

Phase 3Recruiting

Peripheral Neuropathy

NCT05840562

Q2 2027

Post-ApprovalRecruiting

Study completion

NCT05851976

Q3 2027

Phase 1/2Recruiting

Adolescent

NCT05814640

Clinical

Trials by Indication[1]

Major Depressive Disorder23 trials

A Comparative Study of Sage-217 Plus an Antidepressant (ADT) Versus Placebo Plus an ADT in Adults With Major Depressive Disorder

Completed· Biogen logo

Biogen·Phase 3·NCT04476030·440 enrolled

A Study in the Treatment of Children and Adolescents With Major Depressive Disorder

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT00849901·337 enrolled

Dose-finding Study With Lu AA24530 in Major Depressive Disorder

Completed· Lundbeck logo

Lundbeck·Phase 2·NCT00599911·652 enrolled

Show 20 more trials

Algorithm Guided Treatment Strategies for Major Depressive Disorder

Unknown status·SShanghai Mental Health Center·Phase 4·NCT01764867·1,080 enrolled

Study of Duloxetine in Elderly Patients With Major Depressive Disorder

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT00062673·311 enrolled

A Study to Assess the Safety and Effect of TC-5214 in Patients With Major Depressive Disorder.

Terminated· AstraZeneca logo

AstraZeneca·Phase 2·NCT01288079·145 enrolled

Safety and Efficacy of Vortioxetine (Lu AA21004) in Adults With Major Depressive Disorder

Completed· Takeda logo

Takeda·Phase 3·NCT01153009·614 enrolled

Study of Placebo Without Deception Versus Standard Antidepressant for Major Depressive Disorder

Terminated·SSunnybrook Health Sciences Centre·N/A·NCT01650740·1 enrolled

Efficacy and Safety of Vortioxetine (Lu AA21004) in the Treatment of Patients With Major Depressive Disorder

Completed· Takeda logo

Takeda·Phase 3·NCT00672620·611 enrolled

A Study of Duloxetine in Major Depressive Disorder (MDD) and Associated Painful Symptoms

Completed· Eli Lilly logo

Eli Lilly·Phase 4·NCT01000805·528 enrolled

6-week Study Treatment to Evaluate the Safety and Effectiveness of AZD2066 in Patients With Major Depressive Disorder

Terminated· AstraZeneca logo

AstraZeneca·Phase 2·NCT01145755·131 enrolled

Efficacy of Seroquel SR in Combination With an Antidepressant in Treatment of Major Depressive Disorder

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT00351910·494 enrolled

A Study in the Treatment of Children and Adolescents With Major Depressive Disorder

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT00849693·463 enrolled

Efficacy and Tolerability of Escitalopram and Duloxetine in Outpatients With Major Depressive Disorder

Completed· Lundbeck logo

Lundbeck·Phase 4·NCT01148472·294 enrolled

Study to Evaluate the Efficacy of Duloxetine in Outpatients With Major Depressive Disorder and Pain

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 3·NCT02232555·327 enrolled

Safety & Efficacy Study of Quetiapine Fumarate (SEROQUEL®) vs. Placebo and Active Control in Major Depressive Disorder

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT00321490·600 enrolled

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

Completed· Lundbeck logo

Lundbeck·Phase 3·NCT01140906·607 enrolled

Efficacy of Lu AA21004 on Cognitive Dysfunction in Major Depressive Disorder

Completed· Takeda logo

Takeda·Phase 2·NCT01564862·602 enrolled

Intestinal Flora and Major Depressive Disorders

Unknown status·—··NCT04347577·40 enrolled

A Study of Patients With Major Depressive Disorder and Residual Apathy

Completed· Eli Lilly logo

Eli Lilly·Phase 4·NCT00985504·483 enrolled

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

Completed· Lundbeck logo

Lundbeck·Phase 3·NCT00811252·453 enrolled

Randomised Placebo-controlled Duloxetine-referenced Efficacy and Safety Study of 2.5, 5 and 10 mg of Vortioxetine (Lu AA21004) in Acute Treatment of Major Depressive Disorder

Completed· Lundbeck logo

Lundbeck·Phase 3·NCT00635219·766 enrolled

Duloxetine Versus Placebo in the Prevention of Recurrence of Major Depressive Disorder

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT00105989·514 enrolled

Fibromyalgia9 trials

Comparative Efficacy of Duloxetine vs Escitalopram in Patients With Fibromyalgia

Completed·SShaheed Zulfiqar Ali Bhutto Medical University·Phase 2/3·NCT03487211·200 enrolled

Study of Duloxetine Versus Placebo in the Treatment of Fibromyalgia Syndrome

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT00190866·210 enrolled

Duloxetine Versus Placebo for Fibromyalgia

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT00489073·345 enrolled

Show 6 more trials

Mechanism-based Choice of Therapy: Can Treatments Success in Fibromyalgia Patients be Coupled to Psychophysical Pain Modulation Profile?

Unknown status·TTel-Aviv Sourasky Medical Center·N/A·NCT01268631·150 enrolled

A Study of Duloxetine in the Treatment of Fibromyalgia

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT00125892·320 enrolled

A Study of Duloxetine in Adolescents With Juvenile Primary Fibromyalgia Syndrome

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT01237587·184 enrolled

The Effect of Central Sensitization on Treatment Response in Patients With Fibromyalgia

Unknown status·MMarmara University··NCT05020600·40 enrolled

A Study for Adolescents With Fibromyalgia Syndrome

Withdrawn· Eli Lilly logo

Eli Lilly·Phase 4·NCT01089621

Study to Assess Mechanisms in Peripheral Tissue Innervation for Fibromyalgia

Completed·—·N/A·NCT01127490·25 enrolled

Peripheral Neuropathy8 trials

Duloxetine to Prevent Oxaliplatin-Induced Peripheral Neuropathy in Patients With Stage II-III Colorectal Cancer

Active, not recruiting·AAlliance for Clinical Trials in Oncology·Phase 2/3·NCT04137107·220 enrolled

Methadone to Treat Painful Chemotherapy Induced Peripheral Neuropathy

Recruiting·UUniversity of British Columbia·Phase 2/3·NCT05786599·50 enrolled

Safety and Efficacy Study of ADL5859 in Participants With Neuropathic Pain Associated With Diabetic Peripheral Neuropathy

Completed· Merck & Co. logo

Merck & Co.·Phase 2·NCT00603265·226 enrolled

Show 5 more trials

Botulinum Toxin Type A in Diabetic Peripheral Neuropathy

Completed·—·Phase 4·NCT05296759·30 enrolled

Capsaicin 179 mg Patch Versus Oral Duloxetine in Patients With Chemotherapy-induced Peripheral Neuropathy

Recruiting·IInstitut Cancerologie de l'Ouest·Phase 3·NCT05840562·274 enrolled

Comparison of the Efficacy and Safety of Mirogabalin and Duloxetine in Chemotherapy-induced Peripheral Neuropathy in a Randomized Controlled Trial: a Quality of Life Study in Cancer Survivors

Not yet recruiting·PPusan National University Yangsan Hospital·N/A·NCT06711978·66 enrolled

Qutenza Versus Duloxetine in Chemotherapy-induced Peripheral Neuropathy (CIPN)

Unknown status·—·N/A·NCT05560516·102 enrolled

Lidocaine Versus Duloxetine for the Prevention of Taxane-Induced Peripheral Neuropathy In Breast Cancer Patients

Completed·GGamal Mohamed Taha Abouelmagd·N/A·NCT04732455·60 enrolled

Stress urinary incontinence8 trials

Therapeutic Efficacy in Women With Stress Urinary Incontinence

Unknown status·FFar Eastern Memorial Hospital·Phase 3·NCT05677295·90 enrolled

Efficacy and Safety of Duloxetine, Placebo and Pelvic Floor Muscle Training in Subjects With Stress Urinary Incontinence

Completed· Eli Lilly logo

Eli Lilly·Phase 2·NCT00190606·200 enrolled

Efficacy and Safety Stress Urinary Incontinence Study

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT00475358·120 enrolled

Show 5 more trials

Effectiveness of Duloxetine in the Treatment of Stress Urinary Incontinence(Uncontrolled Leakage of Urine)

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT00190827·500 enrolled

Duloxetine Stress Urinary Incontinence Efficacy and Safety Study

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT00475397·120 enrolled

To Evaluate the Safety in Patients Taking Duloxetine for Stress Urinary Incontinence

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT00190632·600 enrolled

Comparisons of the Impact of Duloxetine Versus Imipramine on Therapeutic Efficacy, Psychological Distress, Sexual Function, Urethral and Bladder Wall Structure and Blood Flow in Women With Stress Urinary Incontinence: a Randomized Controlled Study

Withdrawn·FFar Eastern Memorial Hospital·Phase 3·NCT04412876

To Evaluate the Safety of Duloxetine in Patients With Stress Urinary Incontinence

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT00190645·600 enrolled

Treatment8 trials

Identifying Factors That Predict Antidepressant Treatment Response

Completed·EEmory University·N/A·NCT00360399·344 enrolled

Towards Neurobiology-based Diagnosis and Treatment of Affective Disorders

Unknown status·PPeking University··NCT03294525·400 enrolled

Duloxetine Versus Placebo in the Treatment of FMS

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT00233025·320 enrolled

Show 5 more trials

Duloxetine for the Treatment of Dysthymia

Completed·SStanford University·N/A·NCT00185575·24 enrolled

A Mechanism Based Proof of Concept Study of the Effects of Duloxetine in the Treatment of Patients With Osteoarthritic Knee Pain

Completed·KKristian Kjær Petersen·Phase 2·NCT04224584·40 enrolled

Duloxetine Treatment in Elderly With Dysthymia

Completed·NNew York State Psychiatric Institute·Phase 4·NCT01852383·30 enrolled

Open Label Study of Duloxetine for the Treatment of Phantom Limb Pain

Terminated·—·N/A·NCT00425230·15 enrolled

Psychiatric Orders in Psychoanalytic Treatment of ASD

Unknown status·YYang I. Pachankis, PhD··NCT05930912·1 enrolled

88 more indications

Osteoarthritis7 trials

A Study of Duloxetine in Participants With Chronic Pain Due to Osteoarthritis in China

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT01931475·407 enrolled

A Sequenced Strategy for Improving Outcomes in People With Knee Osteoarthritis Pain

Completed·JJohns Hopkins University·Phase 3·NCT04504812·1,937 enrolled

A Study of Duloxetine (LY248686) in Participants With Chronic Osteoarthritis and Knee Pain in Japan

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT02248480·354 enrolled

Show 4 more trials

Brain-Based and Clinical Phenotyping of Pain Pharmacotherapy in Knee Osteoarthritis

Recruiting·NNorthwestern University·Phase 4·NCT06245109·180 enrolled

A Study Comparing Duloxetine Versus Placebo in Patients Taking a Nonsteroidal Anti-inflammatory Drug (NSAID) for Knee Pain Due to Osteoarthritis

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT01018680·524 enrolled

Duloxetine in Osteoarthritis (OA) Pain

Completed·NNorthwestern University·Phase 4·NCT01558700·40 enrolled

Comparison of the Efficacy of Duloxetine and Pregabalin in Patients With Knee Osteoarthritis With Mix Type Pain

Completed·FFatih Sultan Mehmet Training and Research Hospital·Phase 4·NCT04532684·66 enrolled

Low back pain7 trials

An Open Label Extension Study of Duloxetine (LY248686) in Participants With Chronic Low Back Pain

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT01914666·151 enrolled

Duloxetine Versus Placebo in Chronic Low Back Pain

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT00424593·236 enrolled

Imaging Study of Chronic Low Back Pain in Patients Taking Pain Medication

Completed·SStanford University·N/A·NCT00388414·14 enrolled

Show 4 more trials

A Study for Patient With Chronic Low Back Pain

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT00767806·401 enrolled

Duloxetine Versus Placebo in Chronic Low Back Pain

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT00408876·404 enrolled

Duloxetine Treatment of Major Depression and Chronic Low Back Pain For Older Adults

Completed·UUniversity of Pittsburgh·Phase 4·NCT00696293·30 enrolled

Genetic Variants Associated With Low Back Pain and Their Response to Treatment With Duloxetine or Propranolol

Terminated·MMark Ware·Phase 2·NCT03364075·10 enrolled

Depression6 trials

Chronos: the Use of Chronobiological Treatment in Depression

Completed·HHillerod Hospital, Denmark·N/A·NCT00149110·75 enrolled

Switching to Duloxetine in Patients With Depression

Completed· Eli Lilly logo

Eli Lilly·Phase 4·NCT00696774·242 enrolled

Duloxetine Compared to Escitalopram and Placebo in the Treatment of Patients With Depression

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT00073411·675 enrolled

Show 3 more trials

Duloxetine for Perimenopausal Depression

Completed·UUniversity of Arizona·Phase 4·NCT00517985·7 enrolled

Duloxetine for Menopausal Depression

Completed·MMassachusetts General Hospital·Phase 4·NCT01117857·29 enrolled

Determining Optimal Treatment Sequences in Anxious Depression (DOTS-AD)

Recruiting·UUniversity of Cincinnati·Phase 4·NCT04245748·84 enrolled

Neuropathic Pain6 trials

Maintenance of Effect of Duloxetine in Patients With Diabetic Peripheral Neuropathic Pain (DPNP)

Completed· Eli Lilly logo

Eli Lilly·Phase 4·NCT00322621·216 enrolled

Determination of the Antidepressant Duloxetine in Plasma to Improve the Knowledge of the Analgesic Action of Antidepressants on Chronic Neuropathic Pain

Completed·UUniversity Hospital, Strasbourg, France·Phase 4·NCT02846701·8 enrolled

'Fix the Dysfunction' Concept for Mechanism-based Pharmacological Treatment of Neuropathic Pain by Drug

Completed·RRambam Health Care Campus·N/A·NCT03276689·300 enrolled

Show 3 more trials

Mechanism-based Choice of Therapy for Neuropathic Pain

Completed·RRambam Health Care Campus·N/A·NCT01359514·32 enrolled

A Study Comparing the Efficacy and Safety of ABT-652 to Placebo in Subjects With Diabetic Neuropathic Pain

Terminated· AbbVie logo

AbbVie·Phase 2·NCT01579279·1 enrolled

Safety and Efficacy Study in Subjects With Diabetic Neuropathic Pain

Completed· AbbVie logo

AbbVie·Phase 2·NCT00507936·280 enrolled

Generalized Anxiety Disorder5 trials

A Comparison of Duloxetine Hydrochloride, Marketed Comparator, and Placebo in the Treatment of Generalized Anxiety Disorder

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT00122837·560 enrolled

A Comparison of Duloxetine Hydrochloride, Marketed Comparator, and Placebo in the Treatment of Generalized Anxiety Disorder

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT00122850·480 enrolled

Efficacy of Vortioxetine (Lu AA21004) in Treating Generalized Anxiety Disorder

Completed· Takeda logo

Takeda·Phase 3·NCT00730691·781 enrolled

Show 2 more trials

A Study of Duloxetine in Elderly Generalized Anxiety Disorder

Completed· Eli Lilly logo

Eli Lilly·Phase 4·NCT01118780·291 enrolled

Duloxetine for the Treatment of Generalized Anxiety Disorder

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT00803361·210 enrolled

Treatment Resistant Depression5 trials

A Study of Esketamine Nasal Spray Plus a New Standard-of-care Oral Antidepressant or Placebo Nasal Spray Plus a New Standard-of-care Oral Antidepressant in Adult and Elderly Participants With Treatment-resistant Depression

Withdrawn· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT03852160

A Study to Evaluate the Efficacy, Pharmacokinetics, Safety and Tolerability of Flexible Doses of Intranasal Esketamine Plus an Oral Antidepressant in Adult Participants With Treatment-resistant Depression

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT03434041·252 enrolled

A Study to Evaluate the Efficacy, Safety, and Tolerability of Fixed Doses of Intranasal Esketamine Plus an Oral Antidepressant in Adult Participants With Treatment-resistant Depression

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT02417064·346 enrolled

Show 2 more trials

A Study to Evaluate the Efficacy, Safety, and Tolerability of Intranasal Esketamine Plus an Oral Antidepressant in Elderly Participants With Treatment-resistant Depression

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT02422186·139 enrolled

A Study to Evaluate the Efficacy, Safety, and Tolerability of Flexible Doses of Intranasal Esketamine Plus an Oral Antidepressant in Adult Participants With Treatment-resistant Depression

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT02418585·236 enrolled

Pregabalin3 trials

Comparison of Duloxetine Versus Pregabalin

Unknown status·NNational Cancer Institute, Egypt·Phase 2·NCT04727502·70 enrolled

Effects of Pregabalin, Duloxetine & Amitriptyline on Pain & Sleep

Completed·UUniversity of Surrey·Phase 2/3·NCT00370656·90 enrolled

Efficacy, Safety, Tolerability and Pharmacokinetics of Concomitant Administration of Tramadol With Duloxetine or Pregabalin

Withdrawn·TTurku University Hospital·Phase 4·NCT01116531

Efficacy and Safety3 trials

Efficacy and Safety of Duloxetine

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT00190619·100 enrolled

Efficacy and Safety of Flexibly Dosed BMS-820836 in the Treatment of Patients With Treatment Resistant Major Depression

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 2·NCT01309945·889 enrolled

Efficacy and Safety of Fixed Doses of BMS 820836 in the Treatment of Patients With Treatment Resistant Major Depression

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 2·NCT01369095·976 enrolled

Breast Cancer3 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

Mechanistic Study of Duloxetine in Breast Cancer Patients With Chronic Pain

Completed·UUniversity of Michigan Rogel Cancer Center·Phase 2·NCT01912612·82 enrolled

Study to Assess Effect of 8 Wks of Duloxetine Therapy on Breast Cancer Patients With Aromatase-Inhibitor Associated Pain

Completed·UUniversity of Michigan Rogel Cancer Center·N/A·NCT01028352·35 enrolled

Cognitive Function3 trials

Inflammatory Markers and Cognitive Function in Major Depression

Unknown status·—·Phase 4·NCT01391221·20 enrolled

Assessment of Cognitive Functioning Before and After Treatment With Duloxetine

Completed·UUniversity of Texas Southwestern Medical Center·N/A·NCT00933439·30 enrolled

Efficacy of Pregabalin and Duloxetine in Patients With PDPN: the Effect of Pain on Cognitive Function, Sleep and Quality of Life

Terminated·KKRKA·Phase 4·NCT04246619·254 enrolled

Methamphetamine2 trials

Behavioral Effects of Drugs (Inpatient): 40 [Methamphetamine, Methylphenidate, Duloxetine]

Completed·CCraig Rush·Phase 1·NCT04178993·8 enrolled

Interaction Between Duloxetine and 3,4-Methylenedioxymethamphetamine (MDMA, Ecstasy)

Completed·UUniversity Hospital, Basel, Switzerland·Phase 1·NCT00990067·16 enrolled

Mastectomy2 trials

Duloxetine for Acute Post-mastectomy Pain

Completed·—·N/A·NCT03468348·88 enrolled

Pain Relieving Potentials of Combination of Oral Duloxetine and Intravenous Magnesium Sulphate in Post Mastectomy Pain

Completed·NNational Cancer Institute, Egypt·N/A·NCT06087211·90 enrolled

Chronic pain2 trials

Comparing Effectiveness of Duloxetine and Desipramine in Patients With Chronic Pain: A Pragmatic Trial Using Point of Care Randomization

Completed·SStanford University·Phase 4·NCT03548454·86 enrolled

Effect of Combined Morphine and Duloxetine on Chronic Pain

Completed·MMassachusetts General Hospital·Phase 4·NCT03249558·81 enrolled

Severe Depression2 trials

A Study Comparing Duloxetine to Other Antidepressants in the Treatment of Severe Depression

Completed· Eli Lilly logo

Eli Lilly·Phase 4·NCT00666757·750 enrolled

Study to Assess Clinical Response of Duloxetine in Patients Hospitalized for Severe Depression

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 4·NCT02229825·339 enrolled

Pain2 trials

A Study to Test the Use of Duloxetine for Pain in MS

Completed·BBrown, Theodore R., M.D., MPH·Phase 2/3·NCT00457730·38 enrolled

Shifting Pain Modulation From Pro-to Anti-nociceptive

Terminated·RRambam Health Care Campus·N/A·NCT02672202·9 enrolled

Pilot Study2 trials

Pilot Study of Duloxetine in Psychological Resilience

Completed·—·Phase 2·NCT00331799·18 enrolled

A Pilot Study Assessing Duloxetine's Efficacy in Atypical Depression

Completed·NNew York State Psychiatric Institute·Phase 4·NCT00296699·20 enrolled

Antidepressants2 trials

A Prediction Study of Multiple Indexes of the Effect of Different Mechanisms of Antidepressants Treatment on Depression

Unknown status·YYuqi Cheng·Phase 1·NCT03623711·200 enrolled

Getting Biased Treatment Study: How Psychotherapy and Antidepressants Change Brain Activity in Chronic Depression

Unknown status·—·N/A·NCT00596986·30 enrolled

Hysterectomy2 trials

Perioperative Duloxetine for Pain Management After Laparoscopic Hysterectomy

Completed·—·N/A·NCT03350334·100 enrolled

Evaluating the Efficacy and Safety of Preoperative Administration of Duloxetine for Pain Management in Women Undergoing Hysterectomy Via Vaginal Route

Completed·EErzincan Military Hospital·N/A·NCT06429605·80 enrolled

Major Depression2 trials

Duloxetine Versus Paroxetine for Major Depression

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT00489775·480 enrolled

Dose Escalation, Double-Blind Treatment With Duloxetine Hydrochloride Once Daily Dosing for Evaluation of Safety in Major Depression

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT00042575·120 enrolled

Anxiety2 trials

Acute and Long-Term Antidepressant Treatment Success in Adolescents With Anxiety (AtLAS-A)

Recruiting·UUniversity of Cincinnati·Phase 4·NCT04245436·60 enrolled

Duloxetine vs Placebo in the Treatment of General Anxiety

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT00475969·327 enrolled

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

Depressive Disorder1 trial

Efficacy and Safety of Duloxetine Among Individuals With Depressive Disorder in a 12 Weeks Trial

Completed·TTaichung Veterans General Hospital·N/A·NCT03121573·30 enrolled

Function1 trial

Biomechanical Effects of Duloxetine on Bladder and Sphincter Muscle Function in Women in Pure Genuine Stress Incontinence

Completed· Eli Lilly logo

Eli Lilly·Phase 2·NCT00190567·50 enrolled

Drug Monitoring1 trial

Therapeutic Drug Monitoring in Child and Adolescent Psychiatry

Completed·MMedical University of Vienna··NCT01057329·200 enrolled

Sexual Dysfunction1 trial

Switching to Duloxetine to Ameliorate SSRI-Induced Sexual Dysfunction

Terminated·SStanford University·Phase 4·NCT00398632·6 enrolled

Gastric1 trial

Effects of Gastric Bypass on Blood Levels of Duloxetine

Completed·NNeuropsychiatric Research Institute, Fargo, North Dakota·Phase 3·NCT00989157·20 enrolled

Headache1 trial

An Open Trial of Duloxetine on Comorbid Major Depression and Chronic Headache

Completed·KKraepelin Psiquiatria Clinica·Phase 4·NCT00531895·30 enrolled

Migraine1 trial

Improvement the Anti-migraine Treatment Efficacy by Tailoring the Drug to Individual's Pain Modulation Profile

Completed·RRambam Health Care Campus·N/A·NCT01470339·200 enrolled

Prevention1 trial

Pain Prevention and Treatment Through the Enhancement of the Anti-nociceptive Component of Pain Modulation Profiles

Completed·RRambam Health Care Campus·N/A·NCT02020122·5 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

Pilot Study of Duloxetine in Adult Attention Deficit Hyperactivity Disorder(ADHD)

Completed·UUniversité de Montréal·Phase 2·NCT00940693·40 enrolled

Back pain1 trial

The Back Pain Consortium Research Program Study

Completed·UUniversity of Michigan·Phase 4·NCT04870957·494 enrolled

Tics1 trial

Study Evaluating the Effects of DVS SR and Duloxetine on the Pharmacokinetics of Desipramine in Healthy Subjects

Completed· Pfizer logo

Pfizer·Phase 3·NCT00366652·20 enrolled

Metabolism1 trial

Duloxetine on Bone Metabolism

Unknown status·—··NCT05550506·102 enrolled

Hyperalgesia1 trial

A Study Of GSK189254 And Duloxetine In The Electrical Hyperalgesia Model Of Healthy Volunteers

Completed· GSK logo

GSK·Phase 1·NCT00387413·40 enrolled

Gulf War Illness1 trial

Research Examining Gulf War Illness in Our Nations Service Members

Terminated·VVA Office of Research and Development·Phase 2·NCT01846182·112 enrolled

Hearing Loss1 trial

Treating Hearing Loss to Improve Mood and Cognition in Older Adults

Completed·NNew York State Psychiatric Institute·Phase 4·NCT03321006·25 enrolled

Diabetic Neuropathy1 trial

Three Way Interaction Between Gabapentin, Duloxetine, and Donepezil in Patients With Diabetic Neuropathy

Terminated·WWake Forest University·Phase 4·NCT00619983·22 enrolled

Randomized1 trial

Effect of Duloxetine and Venlafaxine on the Pharmacokinetics and Pharmacodynamics of Oral Tramadol: A Three-phase Randomized Balanced Cross-over Study in Healthy Volunteers

Completed·TTurku University Hospital·Phase 4·NCT01443520·12 enrolled

Fatigue1 trial

Mechanisms of Neuromuscular Fatigue Post Stroke

Completed·MMedical College of Wisconsin·Phase 1·NCT01688570·27 enrolled

Drug Therapy1 trial

Duloxetine Versus Duloxetine Plus Non-Drug Therapy for Depression

Completed· Eli Lilly logo

Eli Lilly·Phase 4·NCT00494377·940 enrolled

Electroencephalography1 trial

Electroencephalography (EEG) Signal Processing

Unknown status·SSt. Joseph's Healthcare Hamilton··NCT01369290·150 enrolled

Bipolar Disorder1 trial

Longitudinal Comparative Effectiveness of Bipolar Disorder Therapies

Terminated·UUniversity of New Mexico··NCT02893371·1,037,352 enrolled

Myalgia1 trial

Duloxetine for Succinylcholine-induced Postoperative Myalgia

Completed·—·Phase 2/3·NCT03037073·70 enrolled

Prostatectomy1 trial

Prospective RCT on Post Prostatectomy Urine Leak

Unknown status·IInstitut Mutualiste Montsouris·Phase 3·NCT02367404·240 enrolled

Pregnancy1 trial

The Cymbalta Pregnancy Registry

Completed· Eli Lilly logo

Eli Lilly··NCT01074151·144 enrolled

NAC1 trial

Levomilnacipran in Healthy Males

Unknown status·UUniversity of Ottawa·Phase 4·NCT03249311·36 enrolled

Chronic Fatigue Syndrome1 trial

Double Blind Trial of Duloxetine in Chronic Fatigue Syndrome

Completed·UUniversity of Cincinnati·Phase 2/3·NCT00375973·60 enrolled

Neuropathy1 trial

Combination Pain Therapy in HIV Neuropathy

Terminated·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00863057·15 enrolled

Parkinson's Disease1 trial

Evaluation of the Role of the Noradrenergic System in Pain Perception in Parkinson's Disease

Completed·UUniversity Hospital, Toulouse·Phase 3·NCT01504178·28 enrolled

Interaction1 trial

A Phase 1, Drug Interaction Study Between AVP-786 and Paroxetine and Between AVP-786 and Duloxetine in Healthy Subjects

Completed· Otsuka logo

Otsuka·Phase 1·NCT02174822·56 enrolled

Cohort Study1 trial

Non-interventional, Retrospective Cohort Study to Explore Antidepressant Treatment in Korea

Completed· Pfizer logo

Pfizer··NCT04446039·370,212 enrolled

Cognitive impairment1 trial

The Use of Duloxetine for Cognition Improvement in Individuals With Mild Cognitive Impairment

Completed·UUniversity of North Texas Health Science Center·Phase 4·NCT02590874·19 enrolled

Parkinson1 trial

A Multidisciplinary Approach to Manage Gait Difficulty in Parkinson Patients

Withdrawn·UUniversity of Chicago·Phase 2·NCT02857244

Postpartum Depression1 trial

Duloxetine for the Treatment of Postpartum Depression

Withdrawn·YYale University·N/A·NCT00617045

Physical Stress1 trial

Effectiveness and Safety of Duloxetine in Women Experiencing Urinary Leakage Due to Physical Stress and Urge.

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT00190814·600 enrolled

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

Cocaine Dependence1 trial

Methylphenidate-Duloxetine Combinations for Cocaine Dependence

Completed·UUniversity of Kentucky·Phase 1·NCT02700711·13 enrolled

Obsessive Compulsive Disorder (OCD)1 trial

Duloxetine for the Treatment of Obsessive Compulsive Disorder (OCD)

Completed·MMassachusetts General Hospital·Phase 4·NCT00464698·20 enrolled

Obsessive-Compulsive Disorder1 trial

Predicting Medication Response in Obsessive Compulsive Disorder

Completed·SSunnybrook Health Sciences Centre·N/A·NCT01404871·26 enrolled

Effectiveness1 trial

The Role of Central Serotonergic and Adrenergic Systems in the Effectiveness of DNIC (Diffuse Noxious Inhibitory Control

Completed·RRambam Health Care Campus·N/A·NCT00660751·64 enrolled

Tic Disorder1 trial

Treatment of MDEs During the Course of Psychotic Disorders With Duloxetine

Completed·—·Phase 4·NCT00224302·20 enrolled

Laparoscopic Cholecystectomy1 trial

Duloxetine for Postoperative Pain of Laparoscopic Cholecystectomy

Completed·MMansoura University·Phase 2·NCT05115123·60 enrolled

Genetic Polymorphism1 trial

Impact of Genetic Polymorphism on Drug-Drug Interactions Involving CYP2D6

Completed·JJules Desmeules·N/A·NCT03054220·34 enrolled

Double-blind1 trial

Duloxetine for Chronic Depression: a Double-blind Study

Completed·NNew York State Psychiatric Institute·Phase 4·NCT00360724·65 enrolled

Pancreatic1 trial

Duloxetine in Patients With Suspected Functional Pancreatic/Biliary Pain (Sphincter of Oddi Dysfunction)

Completed·MMedical University of South Carolina·Phase 3·NCT00471315·18 enrolled

Social Anxiety Disorder1 trial

Duloxetine for Social Anxiety Disorder: Prediction of Long Term Outcome

Completed·MMassachusetts General Hospital·Phase 3·NCT00114127·28 enrolled

Chronic Pelvic Pain1 trial

Duloxetine for the Treatment of Chronic Pelvic Pain

Terminated·UUniversity of Maryland, Baltimore·Phase 4·NCT01451606·34 enrolled

Panic Disorder1 trial

The Efficacy and Tolerability of Duloxetine for the Treatment of Panic Disorder

Completed·MMassachusetts General Hospital·Phase 4·NCT00438971·15 enrolled

Post-Traumatic Stress Disorder, PTSD1 trial

Effects of Duloxetine on Fear Conditioning in Posttraumatic Stress Disorder (PTSD)

Completed·YYale University·Phase 1·NCT00763178·26 enrolled

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

Irritable Bowel Syndrome1 trial

An Open-Label Trial of Duloxetine for the Treatment of Irritable Bowel Syndrome

Completed·MMclean Hospital·Phase 4·NCT00401258·15 enrolled

Temporomandibular Joint Disorder1 trial

Duloxetine for Treatment of Painful Temporomandibular Joint Disorder

Completed·UUniversity of Maryland, Baltimore·N/A·NCT00981149·24 enrolled

Spine Surgery1 trial

Duloxetine as an Analgesic Agent in Patients Undergoing Elective Spine Surgery

Completed·SServiço de Anestesiologia de Joinville·Phase 4·NCT02535000·60 enrolled

Glioblastoma1 trial

The Effect of Duloxetine on Mood, Quality of Life and Cognitive Functioning in Glioblastoma Patients

Terminated·Mmichal roll·Phase 3·NCT02443194·50 enrolled

AIN1 trial

Study of Brain Response to Emotional Pictures Using a fMRI While on Duloxetine

Completed·IIndiana University School of Medicine·Phase 4·NCT00532480·10 enrolled

MPA1 trial

Impact of Duloxetine on Male Fertility

Completed·WWeill Medical College of Cornell University·Phase 2·NCT03038867·69 enrolled

Postmenopausal Women1 trial

Duloxetine for Major Depression in Peri-/Postmenopausal Women

Unknown status·HHamilton Health Sciences Corporation·Phase 4·NCT00889369·70 enrolled

Biomarkers1 trial

The BEST Trial: Biomarkers for Evaluating Spine Treatments

Completed·UUniversity of North Carolina, Chapel Hill·Phase 4·NCT05396014·1,014 enrolled

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

Cirrhosis1 trial

Dose Optimization of Sitagliptin and Duloxetine in Diabetic Cirrhosis

Completed·KKafrelsheikh University·Phase 4·NCT07439536·64 enrolled

Burning Mouth Syndrome1 trial

Comparison of Vortioxetine Versus Other Antidepressants With Pregabalin Augmentation in Burning Mouth Syndrome

Unknown status·FFederico II University·Phase 3·NCT06025474·203 enrolled

Shoulder pain1 trial

Duloxetine for Post Laparoscopic Shoulder Pain

Completed·—·Phase 3·NCT03249168·60 enrolled

Interstitial Lung Disease1 trial

Efficacy of Two Doses of Duloxetine & Amitriptyline in Interstitial Lung Disease-related Cough

Recruiting·MMayo Clinic·Phase 2·NCT05120934·25 enrolled

Postherpetic Neuralgia1 trial

Ketamine for Postherpetic Neuralgia With Depression

Not yet recruiting·HHuazhong University of Science and Technology·Phase 4·NCT06968624·50 enrolled

Postoperative Pain Control1 trial

Oral Duloxetine as a Premedication for Postoperative Pain Control

Completed·—·Phase 4·NCT05050656·70 enrolled

Opioid Consumption1 trial

Duloxetine Role in Reducing Opioid Consumption After Thoracotomy

Completed·—·Phase 4·NCT03618225·60 enrolled

Unspecified8 trials

Duloxetine for PHN

Completed·—·N/A·NCT04313335·750 enrolled

Bioavailability Study of Duloxetine Delayed-Release Capsules 60 mg Under Fasting Condition

Completed·—·Phase 1·NCT02291367·76 enrolled

Duloxetine - Warfarin Pharmacodynamic Study

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT00533026·60 enrolled

Show 5 more trials

Evaluation of the Effects of Duloxetine on Norepinephrine

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT00414323·35 enrolled

Duloxetine Tibial Plateau

Withdrawn·—·Phase 4·NCT04639011

Duloxetine for LBP

Recruiting·MMontefiore Medical Center·Phase 4·NCT05851976·120 enrolled

Pharmacovigilance in Gerontopsychiatric Patients

Terminated·HHannover Medical School·Phase 3·NCT02374567·407 enrolled

Urge Incontinence Bladder Overactivity Study

Completed· Eli Lilly logo

Eli Lilly·Phase 2·NCT00475696·300 enrolled

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]
ClinicalTrials.gov — 288 trial records for Duloxetine. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Cymbalta drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Duloxetine compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Duloxetine. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA219131). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Cymbalta. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Jazz Pharmaceuticals company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Norepinephrine Transporter Inhibitor; Serotonin Transporter Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Jazz Pharmaceuticals

Patent Landscape[6]

Patent Cliff

Apr 13, 2037

Earliest patent expiration — generic entry possible after this date

Patent #Expires

10959982Apr 13, 2037

9839626Apr 13, 2037

11202772Apr 13, 2037

10413525Apr 13, 2037

12171742Apr 13, 2037