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Dutasteride

Generic Name
Dutasteride
Brand Names
Avodart, Jalyn
Drug Type
Small Molecule
Chemical Formula
C27H30F6N2O2
CAS Number
164656-23-9
Unique Ingredient Identifier
O0J6XJN02I
Background

Dutasteride is an oral synthetic 4-azasteroid commonly marketed under the trade name Avodart. It is a novel dual 5α-reductase inhibitor that works by blocking both isoforms of 5α-reductase enzymes in a potent, selective, and irreversible manner. Type I and II 5α-reductase enzymes convert testosterone into dihydrotestosterone (DHT), a primary hormonal mediator that plays a role in the development and enlargement of the prostate gland. Dutasteride was approved by the FDA in 2001 for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men as monotherapy or in combination with the α-adrenergic antagonist tamsulosin to enhance the therapeutic response. Its clinical efficacy against benign prostate hyperplasia in male patients is comparable to that of finasteride, a specific type II 5α-reductase inhibitor. However, unlike finasteride, dutasteride is not yet indicated for the treatment of androgenic alopecia although it was demonstrated to be effective in several randomized, double-blind, placebo-controlled trials in androgenetic alopecia.

Indication

Indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate gland to improve symptoms, and reduce the risk of acute urinary retention and the need for BPH-related surgery alone or in combination with tamsulosin.

Associated Conditions
Benign Prostatic Hyperplasia (BPH), Symptomatic benign prostatic hyperplasia (BPH)
Clinical Trials
Related News

EU Regulator Confirms Suicidal Thoughts as Rare Side Effect of Hair Loss Drug Finasteride

• The European Medicines Agency has confirmed suicidal thoughts as a rare side effect of finasteride, a medication commonly used to treat male pattern hair loss in men aged 18-41. • Following a review of 313 reports of suicidal ideation, the EMA will now require patient warning cards in packages of 1mg finasteride tablets, though the regulator maintains that benefits outweigh risks. • Similar warnings will be added to dutasteride, another medication used for prostate enlargement, as a precautionary measure despite limited evidence linking it to suicidal thoughts.

FDA Approves Gemtesa (Vibegron) for Overactive Bladder in Men with BPH

• The FDA has approved Gemtesa (vibegron) for men with overactive bladder (OAB) symptoms receiving pharmacological therapy for benign prostatic hyperplasia (BPH). • Gemtesa is the first and only beta-3 adrenergic receptor agonist approved for OAB in men being treated for BPH, addressing a significant unmet need. • Approval was based on a Phase 3 trial demonstrating significant reductions in micturition and urgency episodes compared to placebo. • Common adverse reactions in the trial included hypertension and urinary tract infections, with a similar rate of serious adverse events to placebo.

EMA Reviews Finasteride and Dutasteride Hair Loss Drugs Over Suicidal Ideation Concerns

• The European Medicines Agency (EMA) is reviewing finasteride and dutasteride, drugs used for hair loss and benign prostatic hyperplasia, due to concerns about potential suicidal thoughts. • The review was initiated following a request from the French medicines agency, which suggested a possible link between the drugs and suicidal ideation based on new safety assessments. • Finasteride is the active ingredient in Organon's Propecia and Proscar, while dutasteride is found in GSK's Avodart, with psychiatric side effects already a known risk. • The EMA will assess whether marketing authorizations for these drugs should be maintained, changed, or withdrawn, while Organon has stated it stands by the safety of its finasteride products.
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