A new drug is scheduled for to be submitted for marketing approval to the FDA in the year 2000 which could be the next most potent treatment for hair loss.   The new drug, GI198745, is being studied currently for both hair loss and benign prostatic hyperplasia (BPH).  It is currently in Phase II FDA trials for hair loss (small scale human studies to determine safety and dosage) and in Phase III FDA trials for BPH (large scale human studies prior to approval to prove the effectiveness of the treatment in large numbers of people).  According to Glaxo Wellcome's own web site (http://www.glaxowellcome.co.uk/news/pipeline.html), GI198745 is scheduled to be submitted to the FDA for approval for BPH in the year 1999 and (assuming it is effective and safe) will file for marketing approval in 2000.

Propecia underwent a similar history.  Propecia, a pill containing a 1mg dose of the drug Finasteride, was originally approved in 1992 for BPH in a 5mg pill called Proscar.  It was during and after the original studies that it was realized that Finasteride could induce hair growth, so studies were initiated which resulted in the approval of Propecia being submitted for approval in December 1996 and approved in December 1997.  Prior to 1997 when it was approved, many men knew that it was under study and had heard that the drug could be obtained by getting a prescription for Proscar, which was approved already.  Unlike Propecia, Glaxo Wellcome realizes already that their new drug may work for hair loss, and has already initiated hair loss studies before the new drug is even approved for BPH.  The version for hair loss is rumored to be on track for FDA approval in 2003.  Since it is in Phase II trials now, most likely the large scale trials will begin in either late 1999 or the year 2000.

GI198745 is a dual 5-alpha reductase inhibitor.  5-alpha reductase is the enzyme in the body that converts Testosterone to DHT, the hormone believed to cause hair loss.  Propecia (Finasteride), inhibits only one of the two variations of 5-alpha reductase, so it only inhibits part of the DHT being created in the body.  GI198745 will inhibit both types and produce DHT levels close to that of men who have been castrated.  There are several questions that will need to be answered before this medication is approved.  The two most important for FDA approval will be whether the medication is more effective than Propecia and whether it is as safe or safer than Propecia.  It is unknown whether further DHT reduction will produce better results than Propecia.  Only further study will tell.  It is also unknown whether further inhibiting DHT will cause more side effects.  With Finasteride, the larger the dose and inhibition, the greater the chance of side effects.  Many doctors debated whether Propecia would be approved at all because of side effects -- if the side effects for GI198745, the FDA may not approve it even if it is a much better treatment.   They are much more likely to approve it for BPH, because BPH is a much more serious medical condition than hair loss, which is judged to be a cosmetic condition only.

So the good news is that in as little as a year and a half, we may have a new treatment we can use to fight hair loss, which may be more effective.   Even if it is ultimately not approved for hair loss due to side effects, it will most likely be available to us by prescription for BPH treatment, as many of us used Proscar before Propecia was available.  The further good news is that the BPH studies will help us determine what the side effects will be and whether the FDA may approve it.   The hair loss studies which will hopefully follow will, even if the treatment is not approved, tell us whether a dual 5-alpha reductase inhibitor would improve results and help clarify the role of DHT in hair loss, so we come out winners almost any way you look at it.  Representatives of Glaxo Wellcome were unavailable for comment (and would not have provided us with any useful information anyway due to their being under FDA regulation).

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