Cialis – History of Creation

Cialis was developed by Glaxo Wellcome (today GlaxoSmithKline) in a partnership to create new drugs between Glaxo and ICOS, which began in August 1991. In 1993, Bothell, Washington, biotechnology company ICOS Corporation began studying compound IC351, an inhibitor of phosphodiesterase type 5 enzyme (PDE-5). In 1994, researchers of Pfizer discovered that sildenafil (future Viagra) also inhibits enzyme PDE-5, causing erection participating in clinical trial of medicament for cardiac disorder treatment.

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Clinical Trials

Although ICOS scientists were not testing compound IC351 for treating ED, they recognized its potential usefulness in this disorder treatment. Soon, in 1994, ICOS received a patent for compound IC351 and in 1995 the first phase of clinical trials began. In 1997 it began Phase 2 of clinical trials involving men suffering from erectile dysfunction, then tests have progressed to phase 3, after completion of which Cialis (tadalafil) was granted FDA approval. Although Glaxo had an agreement with ICOS to distribute profits 50/50 from the generic sale, resulting from collaboration, in 1996 Glaxo let agreement expire, as developed by drug was not a key to company’s main markets.

In 1998, ICOS Corporation and Eli Lilly and Company established Lilly ICOS, LLC, joint venture to further development and commercializing of tadalafil as erectile dysfunction treatment. Two years later, Lilly ICOS, LLC filed a new application to FDA on compound IC351 (under tadalafil generic name and brand name).

In May 2002, Lilly ICOS in American Urological Association reported that clinical trials have shown that tadalafil was effective up to 36 hours, and a year later, FDA approved tadalafil as means for ED treatment. One advantage in comparison with Viagra and Levitra is its 17.5-hour half-life (and thus advertised as this drug works up to 36 hours, after which on about 25 percent of the dose is present in the body) compared to the 4-hour period of sildenafil half-life (Viagra).

In 2007, Eli Lilly and Company bought ICOS Corporation for the US $ 2.3 billion. As a result, Eli Lilly acquired rights to Cialis and arrested ICOS operations, thus terminating joint venture and retiring most of ICOS employees, roughly about 500 people, with exception of 127 employees from biopharmaceuticals department, which was subsequently purchased by CMC Biopharmaceuticals A / S.

People objected to Eli Lilly and Company to call new drug in such a way, but the company claimed that Cialis trademark has nothing to do with the name.

October 6, 2011, FDA approved tadalafil as a treatment for benign prostatic hyperplasia symptoms. FDA also approved tadalafil for the treatment of BPH and erectile dysfunction (ED) at the same time.