Dutasteride

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Dutasteride
Systematic (IUPAC) name
(5α, 17β)-N-{2,5 bis(trifluoromethyl) phenyl}-3-oxo-4-azaandrost-1-ene-17-carboxamide
Identifiers
CAS number 164656-23-9
ATC code G04CB02
PubChem 152945
DrugBank APRD00385
Chemical data
Formula C27H30F6N2O2 
Mol. mass 528.53 g/mol
Pharmacokinetic data
Bioavailability 60%
Protein binding 99%
Metabolism Hepatic (CYP3A4-mediated)
Half life 5 weeks
Excretion Fecal
Therapeutic considerations
Pregnancy cat.

X(US) Not to be handled by pregnant women

Legal status

POM(UK) -only(US)

Routes Oral

Dutasteride (marketed as Avodart, Avidart, Avolve, Duagen, Dutas, Dutagen, Duprost) is a 5-alpha-reductase inhibitor, a drug which inhibits the conversion of testosterone into dihydrotestosterone (DHT). It is used to treat conditions caused by DHT, such as benign prostatic hyperplasia (BPH).

Contents

Dutasteride belongs to a class of drugs called 5-alpha-reductase inhibitors, which block the action of the 5-alpha-reductase enzymes that convert testosterone into dihydrotestosterone (DHT). Finasteride also belongs to this group. Dutasteride inhibits both isoforms of 5-alpha reductase, while finasteride inhibits only one. But a clinical study done by GlaxoSmithKline, the EPICS trial, did not find dutasteride to be more effective than finasteride in treating BPH.

While dutasteride is officially approved to treat enlargement of the prostate gland. Clinical trials for dutasteride as a hair loss drug were undertaken, but called off in late 2002. The reason the trials were called off is not publicly known. Industry sources speculate that Avodart would have been seen as too similar to Propecia to have proved profitable as a hair loss treatment.

In December 2006, Avodart manufacturer GlaxoSmithKline embarked on a new Phase III, six month study in Korea to test the safety, tolerability and effectiveness of a once-daily dose of dutasteride (0.5mg) for the treatment of male pattern baldness in the vertex region of the scalp (types IIIv, IV and V on the Hamilton-Norwood scale).[1] The future impact that this study will have on the FDA's approval or disapproval of Avodart for the treatment of male pattern baldness in the United States is yet to be determined.

  1. ^ ClinicalTrials.gov NCT00441116


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