The History Of Cialis

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The History of Cialis


Overview

Cialis, known generically as tadalafil, is a prescription medication used to treat erectile dysfunction (ED). Classified as a "reversible phosphodiesterase type 5 (PDE5) inhibitor," it works by increasing blood flow to the genitals. Like other PDE5 inhibitors such as Viagra and Levitra, Cialis requires sexual stimulation to be effective.

Origins and Development

Cialis is a product of a collaboration between the pharmaceutical company Lilly, based in Indiana, and ICOS, a biotechnology firm in Washington State. The journey began in 1993 when ICOS started researching IC351, a compound targeting the PDE5 enzyme. By 1994, ICOS secured the first patent for IC351, and clinical trials commenced the following year.

Key Milestones

- 1997: ICOS conducted its initial study on patients with impotence.
- 1998: A partnership was established with Lilly to commercialize ED treatments.
- 1999: Phase III clinical studies on the patented compound were launched.
- 2001: The new drug application for Cialis was filed with the FDA.

Approval Process

In April 2002, the FDA reviewed Cialis but requested further clinical studies, resolution of manufacturing issues, and complete labeling. In May, Lilly ICOS reported positive Phase III results, highlighting Cialis's extended effectiveness of up to 36 hours, a significant advantage over Viagra. These findings were presented at the American Urological Association meeting in Orlando, Florida.

Global Approval and Market Entry

- July 2002: The European Committee for Proprietary Medicinal Products recommended approval for Cialis in Europe.
- November 2002: Cialis was approved for European sales, with marketing starting in February 2003.
- November 2003: The FDA approved Cialis for sale in the United States.

Conclusion

Cialis made a significant impact in the field of erectile dysfunction treatment, offering a longer duration of action compared to its competitors. Through persistent research and collaboration, it has become a key option for men seeking an effective solution for ED.

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