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Combodart®
Combodart combines dutasteride (a 5-alpha reductase inhibitor) and tamsulosin (an alpha-1A adrenergic receptor antagonist) to reduce prostate size and improve urinary symptoms in benign prostatic hyperplasia.
Combodart combines dutasteride (a 5-alpha reductase inhibitor) and tamsulosin (an alpha-1A adrenergic receptor antagonist) to reduce prostate size and improve urinary symptoms in benign prostatic hyperplasia. Used for Benign prostatic hyperplasia with lower urinary tract symptoms.
At a glance
| Generic name | Combodart® |
|---|---|
| Sponsor | Ache Laboratorios Farmaceuticos S.A. |
| Drug class | Combination therapy: 5-alpha reductase inhibitor + alpha-1A adrenergic antagonist |
| Target | 5-alpha reductase (types I and II); alpha-1A adrenergic receptor |
| Modality | Small molecule |
| Therapeutic area | Urology |
| Phase | Phase 3 |
Mechanism of action
Dutasteride inhibits both type I and type II 5-alpha reductase enzymes, reducing conversion of testosterone to dihydrotestosterone and shrinking the prostate gland. Tamsulosin relaxes smooth muscle in the prostate and bladder neck via alpha-1A receptor antagonism, improving urine flow. Together, these agents address both the obstructive and dynamic components of benign prostatic hyperplasia symptoms.
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
- Efficacy/ Safety of Product DNN.65.21.005 in Patients With Benign Prostatic Hyperplasia (PHASE3)
- 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.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |