Will Dutasteride Ever Get Approved for Hair Loss?

Dutasteride, better known under its trade name, Avodart, is considered by many dermatologists and hair loss sufferers to be the most effective treatment for male pattern baldness available today. In its activity it is similar to finasteride (Propecia) but more powerful since it is a dual 5-alpha reductase inhibitor. Unlike finasteride, it inhibits both types of 5-alpha reductase and thus is a more potent drug for inhibiting the conversion of testosterone to the follicle-harming dihydrotestosterone (DHT). Patients' experience and the clinical studies conducted to date confirm the assumption that it is more potent in promoting hair growth, too. One thing that is still missing, though, is the official stamp of approval from a major health supervisory authority such as the US Food and Drug Administration (FDA), so as to be officially admitted as a hair loss treatment. Dutasteride (Avodart) has been approved and used for years to treat benign prostatic hyperplasia (enlarged prostate) in many countries and thus it is readily available in pharmacies around the world. Furthermore, many doctors already prescribe Avodart for genetically determined hair thinning and numerous on-line pharmacies sell it as a hair loss drug.

But what has happened to Glaxo's Phase III clinical study conducted in Korea that has been going on since December 2006? The study is said to have finished in January 2009, but its results have not been published yet. Referring to the previous studies, it seems that Glaxo will be able to prove that dutasteride is a superior 5-alpha reductase inhibitor to finasteride and thus, in all likelihood, also a more potent hair loss treatment. But the conclusions that most of us are waiting for are those related to its safety. The question of whether the additional benefit over finasteride is worth the increased risk has not yet been answered.

As regards to the effectiveness of dutasteride, it seems fair to say that being a dual 5-alpha reductase inhibitor makes it a lot more effective, as half of its dose (2.5 mg versus finasteride's 5mg) has been proven to reduce serum DHT by about 90% compared with 70% for finasteride. Although human studies have not shown that dutasteride-induced side effects are any more severe than those from finasteride, dutasteride remains in the human body for much longer. The serum half-life of finasteride is only eight hours versus four weeks for dutasteride. Hence, it is estimated that finasteride disappears from our body within 24 hours whereas dutasteride stays for several months.

No matter whether dutasteride will ever get approved by the FDA for treating hair loss, for many men it has already become the weapon of last resort in their fight against receding hair.

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