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Drug

Duloxetine

Approved · EMA
Emerging researchLate-stage developmentCooling momentum
Also known as Cymbalta, Drizalma, Irenka, Duloxetina+1 more

Cymbalta, Drizalma, Irenka, Duloxetina, DULoxetine Hydrochloride.

RxNorm72625ChEMBLCHEMBL1175UNIIO5TNM5N07U
9
Research papers
17
Active clinical trials
5
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

The Effect of Preoperative Duloxetine on the Occurance of Postoperative Delirium in Patients Undergoing Cancer Surgery .

Clinical trial2026-08-01Primary completion · ClinicalTrials.gov

Efficacy of Perioperative Duloxetine in Patients at High Risk for Developing Chronic Postsurgical Pain After Inguinal Hernia Repair: a Multicenter Randomized Controlled Trial.

Clinical trial2026-07-31Primary completion · ClinicalTrials.gov

Optimizing Neurofeedback to Treat Chemotherapy Induced Peripheral Neuropathy

Clinical trial2026-06-24Results expected Q4 2026 · ClinicalTrials.gov

Duloxetine Plus Exercise to Improve Physical Function in Veterans With Knee Osteoarthritis, Pain, and Psychological Comorbidity

Clinical trial2026-06-16Results expected Q3 2031 · ClinicalTrials.gov

Duloxetine as an Analgesic Reduces Opioid Consumption After Spine Surgery: A Randomized, Double-Blind, Controlled Study.

Research2017-10-01The Clinical journal of pain

Approval: Duloxetine Zentiva (EMA)

Regulatory2015-08-20EMA

Approval: Duloxetine Viatris (previously Duloxetine Mylan) (EMA)

Regulatory2015-06-19EMA

Drug Safety Update: Duloxetine: marketed as Cymbalta▼ and Yentreve▼ for different disorders

Regulatory2014-12-11MHRA

Approval: Duloxetine Lilly (EMA)

Regulatory2014-12-08EMA

Duloxetine for major depressive disorder and daytime and nighttime hot flashes associated with the menopausal transition.

Research2013-04-17Maturitas

A randomized, double-blind, placebo-controlled, duloxetine-referenced, fixed-dose study comparing the efficacy and safety of Lu AA21004 in elderly patients with major depressive disorder.

Research2012-07-01International clinical psychopharmacology

A randomised, double-blind, placebo controlled, duloxetine-referenced, fixed-dose study of three dosages of Lu AA21004 in acute treatment of major depressive disorder (MDD).

Research2011-12-30European neuropsychopharmacology : the journal of the European College of Neuropsychopharmacology

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Duloxetine
Aliases & brands
CymbaltaDrizalmaIrenkaDuloxetinaDULoxetine Hydrochloride
RxNorm CUI
72625
ChEMBL ID
CHEMBL1175
UNII
O5TNM5N07U
Regulatory jurisdictions
emamhra

Regulatory timeline

5 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2004-12-17
Latest approval
2015-08-20
Authorities
EMA · MHRA
Total events
5
emaEuropean Medicines Agency· 4 events
2015-08-20Approval
Approval: Duloxetine Zentiva (EMA)

Indication: Treatment depressive disorder, diabetic neuropathic pain, anxiety disorder. Duloxetine Zentiva is indicated in adults.

Evidence ↗
2015-06-19Approval
Approval: Duloxetine Viatris (previously Duloxetine Mylan) (EMA)

Indication: Treatment of major depressive disorder Treatment of diabetic peripheral neuropathic pain Treatment of generalised anxiety disorder Duloxetine Viatris is indicated in adults

Evidence ↗
2014-12-08Approval
Approval: Duloxetine Lilly (EMA)
Indication: Duloxetine Lilly is indicated in adults for: Treatment of major depressive disorder Treatment of diabetic peripheral neuropathic pain Treatment of generalised anxiety disorder… Show full indication

Duloxetine Lilly is indicated in adults for: Treatment of major depressive disorder Treatment of diabetic peripheral neuropathic pain Treatment of generalised anxiety disorder Duloxetine Lilly is indicated in adults.

Evidence ↗
mhraMedicines and Healthcare products Regulatory Agency· 1 event
2014-12-11Safety communicationSafety
Drug Safety Update: Duloxetine: marketed as Cymbalta▼ and Yentreve▼ for different disorders
Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Contains public sector information from the Medicines and Healthcare products Regulatory Agency (MHRA) licensed under the Open Government Licence (OGL v3).

Clinical trials

190 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
190
registered trials across all phases
LATEST COMPLETION 2025
17
Active studies
14
Recruiting
146
Late-stage (III+)
135
Completed
38
Discontinued
PHASE DISTRIBUTIONn = 190
Early Phase 14Phase 113Phase 1 / 22Phase 225Phase 2 / 36Phase 356Phase 452Phase N / A32

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Efficacy of Patient Education and Duloxetine, Alone or in Combination, for Patients With Multisystem Functional Somatic Disorder

RecruitingPH IVAarhus University Hospitaln=4242029

Identifying and Treating Depression in the Orthopaedic Trauma Population

RecruitingPH IVWake Forest University Health Sciencesn=1002027

Duloxetine for Patients With Low Back Pain Who Fail to Improve With Oral NSAIDs. A Randomized Placebo-controlled Exploratory Study

RecruitingPH IVMontefiore Medical Centern=1202027

Use of Duloxetine for Perioperative Pain Control After Total Hip Arthroplasty: Randomized Controlled Clinical Trial (RCT)

RecruitingPH IVUniversity of Miamin=642026

"Efficacy and Safety of Single Low-Dose Intravenous Ketamine for Postherpetic Neuralgia With Depression: A Randomized Controlled Study

Not yet recruitingPH IVHuazhong University of Science and Technologyn=502026

Recent completions

Trials that read out recently, adding to the completed evidence base.

Efficacy of Duloxetine in Conjunction With Tramadol for Chronic Cancer Pain

CompletedN/AAssiut Universityn=4002025

Incorporating Drug Metabolism by the Human Gut Microbiome Into Personalized Medicine

CompletedPH IRutgers, The State University of New Jerseyn=172025

A Prospective, Triple-Blind, Randomized Controlled Trial Evaluating Duloxetine on Post-Operative Outcomes Following Primary Total Knee Arthroplasty in Patients With and Without Central Sensitization

CompletedPH IVRush University Medical Centern=2412025

University of Michigan Mechanistic Research Center -The Back Pain Consortium Research Program

CompletedPH IVUniversity of Michigann=4942025

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

CompletedPH IIIKey trialJohns Hopkins Universityn=1,9372025

Pain Relieving Potentials of Preoperative Combination of Single Dose Oral Duloxetine and Intravenous Magnesium Sulphate in Acute and Chronic Post Mastectomy Pain: A Randomized Controlled Trial

CompletedN/ANational Cancer Institute, Egyptn=902025

Research activity

9 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time
20092017
Most influential

A randomized, double-blind, placebo-controlled, duloxetine-referenced, fixed-dose study comparing the efficacy and safety of Lu AA21004 in elderly patients with major depressive disorder.

International clinical psychopharmacology · 2012 · 281 cites

A randomised, double-blind, placebo controlled, duloxetine-referenced, fixed-dose study of three dosages of Lu AA21004 in acute treatment of major depressive disorder (MDD).

European neuropsychopharmacology : the journal of the European College of Neuropsychopharmacology · 2012 · 109 cites

Duloxetine in the treatment of irritable bowel syndrome: an open-label pilot study.

Human psychopharmacology · 2009 · 56 cites

Pilot study of duloxetine for treatment of aromatase inhibitor-associated musculoskeletal symptoms.

Cancer · 2011 · 43 cites

Duloxetine as an Analgesic Reduces Opioid Consumption After Spine Surgery: A Randomized, Double-Blind, Controlled Study.

The Clinical journal of pain · 2017 · 34 cites

Evaluating the maintenance of effect of duloxetine in patients with diabetic peripheral neuropathic pain.

Diabetes/metabolism research and reviews · 2009 · 26 cites
Recent papers

Duloxetine as an Analgesic Reduces Opioid Consumption After Spine Surgery: A Randomized, Double-Blind, Controlled Study.

The Clinical journal of pain · 2017 · 34 cites

Duloxetine for major depressive disorder and daytime and nighttime hot flashes associated with the menopausal transition.

Maturitas · 2013 · 9 cites

A randomized, double-blind, placebo-controlled, duloxetine-referenced, fixed-dose study comparing the efficacy and safety of Lu AA21004 in elderly patients with major depressive disorder.

International clinical psychopharmacology · 2012 · 281 cites

A randomised, double-blind, placebo controlled, duloxetine-referenced, fixed-dose study of three dosages of Lu AA21004 in acute treatment of major depressive disorder (MDD).

European neuropsychopharmacology : the journal of the European College of Neuropsychopharmacology · 2012 · 109 cites

Pilot study of duloxetine for treatment of aromatase inhibitor-associated musculoskeletal symptoms.

Cancer · 2011 · 43 cites

Duloxetine and care management treatment of older adults with comorbid major depressive disorder and chronic low back pain: results of an open-label pilot study.

International journal of geriatric psychiatry · 2010 · 17 cites
Major research themes2
Low Back Pain1Menopause1
Journals, researchers & institutions
Top journals
  • Cancer1
  • CNS neuroscience & therapeutics1
  • Diabetes/metabolism research and reviews1
  • European neuropsychopharmacology : the journal of the European College of Neuropsychopharmacology1
  • Human psychopharmacology1
  • International clinical psychopharmacology1
Leading researchers
  • Ashmawi HA1
  • Baldwin DS1
  • Banerjee M1
  • Bedin A1
  • Begley A1
  • Brennan BP1
  • Caldart Bedin RA1
  • Chappell AS1
Leading institutions
free-text, unnormalised
  • Advanced Center for Intervention and Services Research for Late Life Mood Disorders1
  • Biological Psychiatry Laboratory1
  • Center for Anxiety and Traumatic Stress Disorders1
  • Clinical and Experimental Sciences Academic Unit1
  • Massachusetts General Hospital1
  • University College London1
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.