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Drug

Duloxetine Hydrochloride

Approved · EMA
ClassNorepinephrine transporter inhibitorEmerging researchLate-stage developmentRising momentum
Also known as Cymbalta, Drizalma, Irenka, duloxetine (as hydrochloride)+1 more

Cymbalta, Drizalma, Irenka, duloxetine (as hydrochloride), duloxetine HCl.

RxNorm476250ChEMBLCHEMBL1200328UNII9044SC542W
3
Research papers
1
Active clinical trials
2
Protein targets
5
Regulatory events
Latest activity
beta

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

Recall (Class II): DULOXETINE HYDROCHLORIDE

Regulatory2026-06-04FDA

Recall (Class II): DULOXETINE HYDROCHLORIDE

Regulatory2026-06-04FDA

Duloxetine to Prevent Oxaliplatin-Induced Chemotherapy-Induced Peripheral Neuropathy: A Randomized, Double-Blind, Placebo-Controlled Phase II to Phase III Study

Clinical trial2026-02-28Primary completion · ClinicalTrials.gov

Recall (Class II): DULOXETINE HYDROCHLORIDE

Regulatory2025-07-15FDA

Recall (Class II): DULOXETINE HYDROCHLORIDE

Regulatory2024-12-06FDA

The Efficacy and Safety of the Shugan Dingtong Decoction in the Treatment of Fibromyalgia

Clinical trial2024-10-18Completed · ClinicalTrials.gov

A Randomized Placebo-Controlled Phase III Study of Duloxetine for Treatment of Aromatase Inhibitor-Associated Musculoskeletal Symptoms in Women With Early Stage Breast Cancer

Clinical trial2022-12-16Results posted · ClinicalTrials.gov

A Double-blind, Efficacy and Safety Study of Duloxetine Hydrochloride Versus Placebo in the Treatment of Japanese Children and Adolescents With Depressive Disorder

Clinical trial2021-01-05Results posted · ClinicalTrials.gov

A Long-term Safety Study of Duloxetine Hydrochloride in the Treatment of Japanese Children and Adolescents With Depressive Disorder

Clinical trial2020-07-04Terminated · ClinicalTrials.gov

Prevention and management of chemotherapy-induced peripheral neuropathy in survivors of adult cancers: American Society of Clinical Oncology clinical practice guideline.

Research2014-04-14Journal of clinical oncology : official journal of the American Society of Clinical Oncology

Duloxetine versus placebo in the treatment of patients with diabetic neuropathic pain in China.

Research2010-11-01Chinese medical journal

Efficacy and safety of duloxetine 60 mg and 120 mg daily in patients hospitalized for severe depression: a double-blind randomized trial.

Research2010-09-21The Journal of clinical psychiatry

Profile

Identifiers & mechanism

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

Canonical name
Duloxetine Hydrochloride
Aliases & brands
CymbaltaDrizalmaIrenkaduloxetine (as hydrochloride)duloxetine HCl
RxNorm CUI
476250
ChEMBL ID
CHEMBL1200328
UNII
9044SC542W
Primary mechanism
Norepinephrine transporter inhibitor
Regulatory jurisdictions
fdaema

Pharmacology & targets

2 targets

Known molecular targets and mechanisms supported by curated pharmacology databases.

Sodium-dependent noradrenaline transporter
SLC6A2 · P23975
INHIBITORNorepinephrine transporter inhibitor
Sodium-dependent serotonin transporter
SLC6A4 · P31645
INHIBITORSerotonin transporter inhibitor

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
2004-08-11
Latest approval
2004-08-11
Authorities
FDA · EMA
Total events
5
fdaU.S. Food and Drug Administration· 4 events
2026-06-04RecallSafety
Recall (Class II): DULOXETINE HYDROCHLORIDE
Evidence ↗
2026-06-04RecallSafety
Recall (Class II): DULOXETINE HYDROCHLORIDE
Evidence ↗
2025-07-15RecallSafety
Recall (Class II): DULOXETINE HYDROCHLORIDE
Evidence ↗
emaEuropean Medicines Agency· 1 event
2004-08-11Approval
Approval: Yentreve (EMA)

Indication: Yentreve is indicated for women for the treatment of moderate to severe stress urinary incontinence (SUI).

Evidence ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

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

Clinical trials

40 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
40
registered trials across all phases
LATEST COMPLETION 2024
1
Active studies
38
Late-stage (III+)
32
Completed
7
Discontinued
PHASE DISTRIBUTIONn = 40
Early Phase 11Phase 1 / 21Phase 2 / 31Phase 317Phase 418Phase N / A2

Late-stage studies

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

A PHASE IV, SINGLE-DOSE, OPEN-LABEL, RANDOMIZED, 2-WAY CROSSOVER STUDY TO DETERMINE THE BIOEQUIVALENCE OF DULOXETINE HYDROCHLORIDE HARD GELATINOUS CAPSULE WITH DELAYED RELEASE MICROGRANULES (60 MG; PFIZER S.R.L - ARGENTINA) COMPARED WITH CYMBALTA(REGISTERED) ( 60 MG; ELI LILLY DO BRASIL LTDA) IN HEALTHY MALE RESEARCH SUBJECTS UNDER FASTED CONDITIONS

WithdrawnPH IVPfizer2020

A PHASE IV, SINGLE-DOSE, OPEN-LABEL, RANDOMIZED, 2-WAY CROSSOVER STUDY TO DETERMINE THE BIOEQUIVALENCE OF DULOXETINE HYDROCHLORIDE HARD GELATINOUS CAPSULE WITH DELAYED RELEASE MICROGRANULES (60 MG; PFIZER S.R.L - ARGENTINA.) COMPARED TO CYMBALTA (REGISTERED) MICROGRANULES (60 MG; ELI LILLY DO BRASIL LTDA) IN HEALTHY MALE RESEARCH SUBJECTS UNDER FED CONDITIONS

WithdrawnPH IVPfizer2020

Pre-emptive Effect of Duloxetine in the Second Knee in Staged Total Knee Arthroplasty: A Randomized Controlled Study

Unknown statusPH IVSeoul National University Hospitaln=902019

A Phase 4 Comparison of Duloxetine Dosing Strategies in the Treatment of Korean Patients With Major Depressive Disorder

CompletedPH IVEli Lilly and Companyn=2492011

Comparison of Two Different Treatment Strategies in Patients With Major Depressive Disorder Not Exhibiting Improvement on Escitalopram Treatment: Early vs. Delayed Intervention Strategy

CompletedPH IVEli Lilly and Companyn=8402010

Recent completions

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

The Efficacy and Safety of the Shugan Dingtong Decoction in the Treatment of Fibromyalgia

CompletedPH IChina-Japan Friendship Hospitaln=722024

A Double-blind, Efficacy and Safety Study of Duloxetine Hydrochloride Versus Placebo in the Treatment of Japanese Children and Adolescents With Depressive Disorder

CompletedPH IIIShionogin=1492019

A Randomized Placebo-Controlled Phase III Study of Duloxetine for Treatment of Aromatase Inhibitor-Associated Musculoskeletal Symptoms in Women With Early Stage Breast Cancer

CompletedPH IIISWOG Cancer Research Networkn=2992018

A Phase III Double Blind Trial of Oral Duloxetine for Treatment of Pain Associated With Chemotherapy-Induced Peripheral Neuropathy

CompletedPH IIIAlliance for Clinical Trials in Oncologyn=2312013

Duloxetine for Pain in Older Adults With Knee Osteoarthritis (OA)

CompletedN/AUniversity of Alexandrian=2882011

A Phase 4 Comparison of Duloxetine Dosing Strategies in the Treatment of Korean Patients With Major Depressive Disorder

CompletedPH IVEli Lilly and Companyn=2492011

Research activity

3 papers

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

Publications over time
20102014
Major research themes2
Hospitalization1Survivors1
Journals, researchers & institutions
Top journals
  • Chinese medical journal1
  • Journal of clinical oncology : official journal of the American Society of Clinical Oncology1
  • The Journal of clinical psychiatry1
Leading researchers
  • Desaiah D2
  • Bak K1
  • Bleeker J1
  • Brecht S1
  • Cavaletti G1
  • Chauhan C1
  • Cheng LL1
  • Dworkin RH1
Leading institutions
free-text, unnormalised
  • Columbia University Medical Center1
  • Peking University First Hospital1

Related drugs

5 matches

Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).

Amitriptyline

Studied across 3 of the same disease areas as Duloxetine Hydrochloride in the shared literature.

3 shared diseases1 shared paper
Baclofen

Studied across 3 of the same disease areas as Duloxetine Hydrochloride in the shared literature.

3 shared diseases1 shared paper
Gabapentin

Studied across 3 of the same disease areas as Duloxetine Hydrochloride in the shared literature.

3 shared diseases1 shared paper
gamma-Aminobutyric Acid

Studied across 3 of the same disease areas as Duloxetine Hydrochloride in the shared literature.

3 shared diseases1 shared paper
Ketamine

Studied across 3 of the same disease areas as Duloxetine Hydrochloride in the shared literature.

3 shared diseases1 shared paper
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.