Duloxetine Hydrochloride

ApprovedSmall molecule

Duloxetine Hydrochloride is a small molecule that works as a Norepinephrine Transporter Inhibitor; Serotonin Transporter Inhibitor.[2] It is being used across 22 indications, with its most advanced program in Approved.[1]

Duloxetine Hydrochloride is one of 532 small molecule programs targeting Systemic Lupus Erythematosus. It is currently in Approved.

Indications

Total Trials

Active Trials

531

Competitors

Pipeline

Status by Indication[3][1]

Indication

Systemic Lupus ErythematosusActive, not recruiting

Neuropathic PainUnknown

Muscular DiseaseUnknown

Depressive DisorderUnknown

Peripheral NeuropathyActive, not recruiting

Stress Urinary IncontinenceUnknown

Chronic PainUnknown

Post-Traumatic Stress DisorderActive, not recruiting

Diabetes MellitusUnknown

AnxietyActive, not recruiting

Systemic Lupus ErythematosusPreclinical

Active, not recruiting

Neuropathic PainPreclinical

Unknown

Muscular DiseasePreclinical

Unknown

Depressive DisorderPreclinical

Unknown

Peripheral NeuropathyPhase 2/Phase 3

Active, not recruiting

Stress Urinary IncontinencePreclinical

Unknown

Chronic PainPreclinical

Unknown

Post-Traumatic Stress DisorderPhase 3

Active, not recruiting

Diabetes MellitusPreclinical

Unknown

AnxietyPhase 3

Active, not recruiting

Showing 10 of 21 indications

Competition

Competitive Landscape

2828 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Duloxetine Hydrochloride

Eli Lilly

Approved

1 2

Adriamycin

GGynecologic Oncology Group

Preclinical

87 3

Gemzar

GGynecologic Oncology Group

Preclinical

22 4

Cymbalta

Alnylam Pharmaceuticals

Preclinical

3 5

Zolymbus

AbbVie

Preclinical

1 6

Motexafin Gadolinium

PPharmacyclics LLC.

Preclinical

1 7

Lipegfilgrastim

Merck & Co.

Preclinical

1 8

Escitalopram Oxalate

TTorrent Pharmaceuticals Limited

Preclinical

1 9

Lapatinib Plus Capecitabine

GSK

Preclinical

2 10

QBX258

Novartis

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

Clinical

Trials by Indication[1]

Major Depressive Disorder6 trials

A Study Comparing Duloxetine and Placebo in Assessing Energy and Vitality in Major Depressive Disorder (MDD) Patients

Completed· Eli Lilly logo

Eli Lilly·Phase 4·NCT00536471·776 enrolled

A Duloxetine Dosing Strategy Study in Korean Patients With Major Depressive Disorder

Completed· Eli Lilly logo

Eli Lilly·Phase 4·NCT00960986·249 enrolled

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

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT00036309

Show 3 more trials

Early Versus Delayed Switch in Medication in Patients With Major Depressive Disorder

Completed· Eli Lilly logo

Eli Lilly·Phase 4·NCT00810069·840 enrolled

Study of Desvenlafaxine in Treating Major Depressive Disorder.

Completed· CSPC ZhongQi Pharmaceutical Technology Co., Ltd. logo

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.·Phase 3·NCT04364997·420 enrolled

A Comparison of Tolerability and Efficacy of Different Doses of Duloxetine for the Treatment of Major Depressive Disorder

Completed· Eli Lilly logo

Eli Lilly·Phase 4·NCT00191061·640 enrolled

Depression5 trials

Duloxetine vs. Active Comparator in the Treatment of Patients With Depression

Completed· Eli Lilly logo

Eli Lilly·Phase 4·NCT00071695·320 enrolled

Lilly's Emotional and Physical Symptoms of Depression Study (LEAPS)

Completed· Eli Lilly logo

Eli Lilly·Phase 4·NCT00479726·8,000 enrolled

Duloxetine vs. Active Comparator for the Treatment of Depression

Completed· Eli Lilly logo

Eli Lilly·Phase 4·NCT00067912·480 enrolled

Show 2 more trials

Study of Ammoxetine Hydrochloride Enteric-coated Tablets in Subjects With Depression

Unknown status· CSPC ZhongQi Pharmaceutical Technology Co., Ltd. logo

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.·Phase 2·NCT05018013·240 enrolled

A Phase II Study to Evaluate NH102 for Depression

Completed·JJiangsu Nhwa Pharmaceutical Co., Ltd.·Phase 2·NCT06842992·243 enrolled

Neuropathic Pain3 trials

Duloxetine Versus Placebo in the Treatment of Patients With Diabetic Peripheral Neuropathic Pain in China

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT00408993·215 enrolled

An Open-Label Comparison of Duloxetine to Other Alternatives for the Management of Diabetic Peripheral Neuropathic Pain

Completed· Eli Lilly logo

Eli Lilly·Phase 4·NCT00385671·407 enrolled

A Study for the Treatment of Diabetic Peripheral Neuropathic Pain

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT00552175·339 enrolled

Generalized Anxiety Disorder3 trials

Effects of Duloxetine on Pathological Worry in Patients With Generalized Anxiety Disorder: A fMRI Study

Terminated·NNational Taiwan University Hospital·N/A·NCT00491348·23 enrolled

Duloxetine Compared With Placebo in Patients With Generalized Anxiety Disorder

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT00122824·480 enrolled

Duloxetine Compared With Placebo in the Prevention of Relapse in Generalized Anxiety Disorder

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT00122863·380 enrolled

Peripheral Neuropathy2 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

Duloxetine in Treating Peripheral Neuropathy Caused by Chemotherapy in Patients With Cancer

Completed·AAlliance for Clinical Trials in Oncology·Phase 3·NCT00489411·231 enrolled

19 more indications

Stress urinary incontinence2 trials

To Determine How Effective Duloxetine is in Treating Women 65 Years and Older With Symptoms of Stress Urinary Incontinence, or With a Combination of Stress Urinary Incontinence and Urge Urinary Incontinence Symptoms

Completed· Eli Lilly logo

Eli Lilly·Phase 4·NCT00244296·276 enrolled

Evaluate Safety and Efficacy of Duloxetine in Predominant Stress Urinary Incontinence

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT00190996·2,765 enrolled

Diabetic Neuropathy2 trials

A Long-term Study for the Treatment of Painful Diabetic Neuropathy

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT00641719·258 enrolled

A Study for the Treatment of Painful Diabetic Neuropathy

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT00058968·660 enrolled

Depressive Disorder2 trials

A Study of Duloxetine (LY248686) in the Treatment of Japanese Children and Adolescents With Depressive Disorder

Terminated· Shionogi logo

Shionogi·Phase 3·NCT03395353·151 enrolled

A Study of Duloxetine (LY248686) in Japanese Children and Adolescents With Depressive Disorder

Completed· Shionogi logo

Shionogi·Phase 3·NCT03315793·149 enrolled

Fibromyalgia2 trials

Shugan Dingtong Decoction in the Treatment of Fibromyalgia

Completed·—·Phase 1·NCT05508516·72 enrolled

A Study Comparing Duloxetine and Placebo in the Treatment of Fibromyalgia

Completed· Eli Lilly logo

Eli Lilly·Phase 4·NCT00673452·530 enrolled

Randomized1 trial

A Randomized Double Blind Study Evaluating Duloxetine in Outpatients With MDD and Pain

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT00191919·310 enrolled

Trial1 trial

Open-Label Duloxetine Extension Phase in Patients Who Have Completed Previous Duloxetine Trials

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT00191594·105 enrolled

Efficacy1 trial

Short-term Efficacy of Antidepressant in Patients Underwent TKA

Unknown status·—·Phase 1/2·NCT03110172·32 enrolled

Clinical Trial1 trial

Duloxetine Compassionate Use in Patients Who Have Completed a Previous Neuroscience Duloxetine Clinical Trial

Approved for marketing· Eli Lilly logo

Eli Lilly··NCT00071708

Parkinson's Disease1 trial

Study on the Tolerability of Duloxetine in Depressed Patients With Parkinson's Disease

Completed· Eli Lilly logo

Eli Lilly·Phase 4·NCT00437125·151 enrolled

Nerve Pain1 trial

Tolerability of Switching to Duloxetine for the Management of Diabetic Nerve Pain

Completed· Eli Lilly logo

Eli Lilly·Phase 4·NCT00266643·205 enrolled

Efficacy and Safety1 trial

A Study Comparing the Efficacy and Safety of Duloxetine and Placebo for the Treatment of Depression in Elderly Patients

Completed· Eli Lilly logo

Eli Lilly·Phase 4·NCT00406848·370 enrolled

Severe Depression1 trial

A Study Evaluating Duloxetine in Patients Hospitalized for Severe Depression

Completed· Eli Lilly logo

Eli Lilly·Phase 4·NCT00422162·339 enrolled

Fed1 trial

A Study Of Duloxetine Hydrochloride Hard Gelatinous Capsule Compared To Cymbalta Under Fed Conditions

Withdrawn· Pfizer logo

Pfizer·Phase 4·NCT03794154

Multiple Sclerosis1 trial

Duloxetine for Multiple Sclerosis Pain

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT00755807·239 enrolled

MPA1 trial

A Study of Duloxetine Hydrochloride Hard Gelatinous Capsule Compared To Cymbalta

Withdrawn· Pfizer logo

Pfizer·Phase 4·NCT03729284

COVID-191 trial

Medicine-induced Cardiac Hemodialysis on COVID-19

Completed·YYang I. Pachankis·Phase 4·NCT05711810·1 enrolled

Post-Traumatic Stress Disorder1 trial

Open-Label Duloxetine Monotherapy in the Treatment of Posttraumatic Stress Disorder

Unknown status·—·Phase 3·NCT00583193·20 enrolled

Breast Cancer1 trial

S1202: Duloxetine Hydrochloride for Muscle/Joint Pain in Early-Stage Breast Cancer Receiving Hormone Therapy

Completed·SSWOG Cancer Research Network·Phase 3·NCT01598298·299 enrolled

Major Depression1 trial

Subject Information and Consent Form F1J-US-HMCB Duloxetine Once-Daily Dosing Versus Placebo in Patients With Major Depression and Pain

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT00036335·286 enrolled

Sources

References

[1]
ClinicalTrials.gov — 42 trial records for Duloxetine Hydrochloride. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Duloxetine Hydrochloride compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Duloxetine Hydrochloride. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Eli Lilly company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Norepinephrine Transporter Inhibitor; Serotonin Transporter Inhibitor[2]
Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: Eli Lilly

Duloxetine Hydrochloride

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Trials by Indication[1]

Major Depressive Disorder6 trials

Depression5 trials

Neuropathic Pain3 trials

Generalized Anxiety Disorder3 trials

Peripheral Neuropathy2 trials

Stress urinary incontinence2 trials

Diabetic Neuropathy2 trials

Depressive Disorder2 trials

Fibromyalgia2 trials

Randomized1 trial

Trial1 trial

Efficacy1 trial

Clinical Trial1 trial

Parkinson's Disease1 trial

Nerve Pain1 trial

Efficacy and Safety1 trial

Severe Depression1 trial

Fed1 trial

Multiple Sclerosis1 trial

MPA1 trial

COVID-191 trial

Post-Traumatic Stress Disorder1 trial

Breast Cancer1 trial

Major Depression1 trial

References

Drug Info

Quick Facts

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