Duloxetine

Generic Name: Duloxetine

Brand Names: Cymbalta, Drizalma, Irenka, Yentreve, Duloxetine Zentiva, Duloxetine Mylan, Duloxetine Lilly

Drug Type: Small Molecule

Chemical Formula: C_₁₈H_₁₉NOS

CAS Number: 116539-59-4

Unique Ingredient Identifier: O5TNM5N07U

Background: Duloxetine is a dual serotonin and norepinephrine reuptake inhibitor. It was originally discovered in 1993 and developed by Eli Lilly and Company as LY248686. Duloxetine first received approval from the FDA in August, 2004 as Cymbalta for the treatment of Major Depressive Disorder. It has since received approval for a variety of indications including the treatment of neuropathic pain, Generalized Anxiety disorder, osteoarthritis, and stress incontinence. Duloxetine continues to be investigated for the treatment of pain in cancer, surgery, and more.

Indication: Indicated for:

1) Management of Major Depressive Disorder.

2) Management of Generalized Anxiety Disorder.

3) Management of diabetic peripheral neuropathy.

4) Management of fibromyalgia.

5) Management of chronic musculoskeletal pain.

6) Management of osteoarthritis of the knee in adults.

7) Management of chronic lower back pain in adults.

8) Management of stress urinary incontinence in adult women.

Off-label uses include:

1) Management of chemotherapy-induced peripheral neuropathy.

2) Management of stress urinary incontinence in adult men after prostatectomy until recovery is complete.

Associated Conditions: Chronic Lower Back Pain (CLBP), Chronic Musculoskeletal Pain, Diabetic Peripheral Neuropathic Pain (DPN), Fibromyalgia, Generalized Anxiety Disorder, Major Depressive Disorder (MDD), Osteoarthritis of the Knee, Stress Urinary Incontinence (SUI)

Clinical Trials

Evaluating the Safety and Efficacy of Duloxetine in the Prevention of Post Endoscopic Retrograde Cholangiopancreatography Pancreatitis

Phase 3

Recruiting

Conditions: Biliary Disease

Interventions: Other: Placebo capsule
Drug: Duloxetine

First Posted Date: 2025-03-06

Last Posted Date: 2025-04-04

Lead Sponsor: Tanta University

Target Recruit Count: 44

Registration Number: NCT06860984

Locations: 🇪🇬
Tanta Unuversity, Tanta, Egypt

A Phase II Study to Evaluate NH102 for Depression

Phase 2

Recruiting

Conditions: Major Depressive Disorder (MDD)

Interventions: Drug: NH102
Drug: Duloxetine Hydrochloride Enteric-coated Capsule
Drug: Placebo

First Posted Date: 2025-02-24

Last Posted Date: 2025-02-24

Lead Sponsor: Jiangsu Nhwa Pharmaceutical Co., Ltd.

Target Recruit Count: 240

Registration Number: NCT06842992

Locations: 🇨🇳
Shanghai Mental Health Center, Shanghai, China

Duloxetine As an Analgesic in Patients Without Central Sensitivity After Same Sitting Bilateral Total Knee Arthroplasty

Phase 4

Completed

Conditions: Osteoarthritis of Knee
Central Sensitization
Central Sensitisation

Interventions: Drug: Duloxetine - low dose
Drug: Placebo

First Posted Date: 2025-02-20

Last Posted Date: 2025-02-20

Lead Sponsor: Orthopaedic Arthroscopy Knee and Shoulder Clinic

Target Recruit Count: 106

Registration Number: NCT06837012

Locations: 🇮🇳
Orthopaedic Arthroscopy Knee and shoulder clinic, Mumbai, Maharasthra, India

Duloxetine for Perioperative Pain in Hip Arthroplasty: A RCT

Phase 4

Recruiting

Conditions: THA

Interventions: Drug: Duloxetine
Other: Placebo

First Posted Date: 2025-02-04

Last Posted Date: 2025-03-19

Lead Sponsor: University of Miami

Target Recruit Count: 64

Registration Number: NCT06807866

Locations: 🇺🇸
University of Miami, Miami, Florida, United States

Efficacy and Safety of the N0750 Compared to Monotherapies in the Treatment of Painful Diabetic Peripheral Neuropathy

Phase 3

Not yet recruiting

Conditions: Painful Diabetic Peripheral Neuropathy (PDPN)

Interventions: Drug: N0750
Drug: Cymbalta®
Drug: Lyrica®

First Posted Date: 2024-12-04

Last Posted Date: 2025-02-13

Lead Sponsor: Eurofarma Laboratorios S.A.

Target Recruit Count: 666

Registration Number: NCT06715462

Locations: 🇧🇷
Eurofarma Laboratórios S.A, Itapevi, São Paulo, Brazil

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 Applicable

Not yet recruiting

Conditions: CIPN
CIPN - Chemotherapy-Induced Peripheral Neuropathy
CIPN in Adjuvant Breast Cancer Patients
Duloxetine
Mirogabalin

Interventions: Drug: Duloxetine
Drug: Mirogabalin

First Posted Date: 2024-12-02

Last Posted Date: 2024-12-02

Lead Sponsor: Pusan National University Yangsan Hospital

Target Recruit Count: 66

Registration Number: NCT06711978

Locations: 🇰🇷
Yangsan Pusan National University Hospital, Mulgeum, Korea, Republic of

SPENDD: Quantitative Sensory Testing and Analgesic Response for Painful Peripheral Neuropathy.

Phase 2

Not yet recruiting

Conditions: Painful Peripheral Neuropathy
Diabetic Peripheral Neuropathic Pain (DPN)
Chemotherapy Induced Peripheral Neuropathy (CIPN)
Idiopathic Peripheral Neuropathy

Interventions: Drug: Pregabalin
Drug: Duloxetine
Other: Placebo

First Posted Date: 2024-09-26

Last Posted Date: 2024-09-26

Lead Sponsor: University of Rochester

Target Recruit Count: 190

Registration Number: NCT06614322

Locations: 🇺🇸
Beth Israel Deaconess Medical Center for Autonomic and Peripheral Nerve Disorders, Boston, Massachusetts, United States
🇺🇸
Washington University School of Medicine, St. Louis, Missouri, United States
🇺🇸
University of Rochester, Rochester, New York, United States

and more 2 locations