Last reviewed 2026-05-14 · How we verify

Dutasteride/Tamsulosin

Dutasteride/Tamsulosin is a 5-alpha reductase inhibitor / alpha-1 adrenergic antagonist combination Small molecule drug developed by GlaxoSmithKline. It is currently FDA-approved for Benign prostatic hyperplasia with lower urinary tract symptoms. Also known as: Duodart, combodart, Duodart® 0.5 mg / 0.4 mg.

Dutasteride/Tamsulosin combines a 5-alpha reductase inhibitor and an alpha-1 adrenergic antagonist to reduce prostate size and relax urinary tract smooth muscle.

Dutasteride/Tamsulosin combines a 5-alpha reductase inhibitor and an alpha-1 adrenergic antagonist to reduce prostate size and relax urinary tract smooth muscle. Used for Benign prostatic hyperplasia with lower urinary tract symptoms.

At a glance

Mechanism of action

Dutasteride inhibits the enzyme 5-alpha reductase, which converts testosterone to dihydrotestosterone (DHT), thereby reducing prostate volume and improving urinary flow obstruction. Tamsulosin is an alpha-1A adrenergic receptor antagonist that relaxes smooth muscle in the prostate and bladder neck, providing rapid symptomatic relief of lower urinary tract symptoms. Together, these agents address both the mechanical obstruction and dynamic component of benign prostatic hyperplasia.

Approved indications

• Benign prostatic hyperplasia with lower urinary tract symptoms

Common side effects

• Erectile dysfunction
• Decreased libido
• Retrograde ejaculation
• Dizziness
• Headache
• Asthenia/fatigue

Key clinical trials

• A Study to Evaluate the Safety and Pharmacokinetics of AD-116 and AD-1161 in Healthy Adult Male Subjects (PHASE1)
• Feasibility of Hormones and Radiation for Intermediate or High Risk Prostate Cancer (NA)
• The Efficacy of Nano-water in Combination With Tamsulosin- Dutasteride for Lower Urinary Tract Symptoms (NA)
• The Changes of Urine Growth Factors Level (EARLY_PHASE1)
• Efficacy and Safety of the DTT106 in the Treatment of Erectile Dysfunction Associated With Benign Prostatic Hyperplasia (PHASE3)
• Α Prospective Observational Study for the Evaluation of Disease Control and Quality of Life in Patients With Benign PROStatic hyPERplasia Under Fixed Dose combΙnaTion Treatment With Dutasteride and Tamsulosin . PROSPERITY Group of Studies (I&II)
• Prostate Medication, Metabolism and Gut Microbiota (PHASE4)
• Prostatic Artery Embolization Versus Medical Treatment in Symptomatic Benign Prostatic Hyperplasia (PHASE3)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• Dutasteride/Tamsulosin CI brief — competitive landscape report
• Dutasteride/Tamsulosin updates RSS · CI watch RSS
• GlaxoSmithKline portfolio CI

Frequently asked questions about Dutasteride/Tamsulosin

Related

• Drug class: All 5-alpha reductase inhibitor / alpha-1 adrenergic antagonist combination drugs
• Target: All drugs targeting 5-alpha reductase (type I and II) / alpha-1A adrenergic receptor
• Manufacturer: GlaxoSmithKline — full pipeline
• Therapeutic area: All drugs in Urology
• Indication: Drugs for Benign prostatic hyperplasia with lower urinary tract symptoms
• Also known as: Duodart, combodart, Duodart® 0.5 mg / 0.4 mg

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing