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The Type II 5a-reductase isozyme is primarily found in prostate, seminal vesicles, epididymides, and hair follicles as well as liver, and is responsible for two-thirds of circulating DHT.
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Soon, in 1994, ICOS received a patent for compound IC351 (structurally unlike sildenafil and vardenafil), and Phase 1 clinical trials began in 1995.
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Using native tissues (scalp and prostate), in vitro binding studies examining the potential of finasteride to inhibit either isozyme revealed a 100-fold selectivity for the human Type II 5a-reductase over Type I isozyme (IC50=500 and 4.
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Two distinct isozymes are found in mice, rats, monkeys, and humans: Type I and II.
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Although Glaxo had an agreement with ICOS to share profits 50/50 for drugs resulting from the partnership, Glaxo let the agreement lapse in 1996 as the drugs developed were not in the company’s core markets. In 1998, ICOS Corporation and Eli Lilly and Company formed the Lilly ICOS, LLC, joint venture company to further develop and commercialize sildenafil citrate as a treatment for ED.
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Although ICOS scientists were not testing compound IC351 for treating ED, they recognized its potential usefulness for treating said disorder.
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In humans, the mechanism of action of finasteride is based on its preferential inhibition of the Type II isozyme.
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Each of these isozymes is differentially expressed in tissues and developmental stages.
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The turnover for the enzyme complex is slow (t1/2 approximately 30 days for the Type II enzyme complex and 14 days for the Type I complex).
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