1993: Icos begins research on IC351, a
compound that inhibits the PDE5 enzyme.
1994: Icos receives its first patent on
IC351.
1995: Phase I clinical trials begin.
1997: Icos conducts its first study in
patients with erectile dysfunction.
1998: Icos and Eli Lilly and Co. form
a joint venture to commercialize drugs for the treatment
of sexual dysfunction.
1999: Phase III clinical studies begin
on IC351.
2001: New drug application is filed with
the U.S. Food and Drug Administration for IC351. The company
renames the drug Cialis.
April 2002: FDA reviews drug application,
saying the company must complete more clinical studies,
resolve manufacturing issues and complete labeling. Launch
date for Cialis is pushed back for further testing.
May 2002: Lilly and Icos reports positive Phase
III test results for Cialis. Data shows that Cialis remains
in the system and keeps working for up to 36 hours. Findings
are presented at the 97th Annual Meeting of the American
Urological Association in Orlando, Florida.
July 2002: European Committee for Proprietary
Medicinal Products issues a favorable report about Cialis
and recommends to the European Commission that approval
be granted.
November 2002: Cialis is approved in Europe.
February 2003: Marketing of Cialis begins
in Europe. Cialis becomes available in pharmacies for the
first time throughout parts of Europe as well as Australia
and New Zealand.
November 2003: Lilly and Icos win U.S.
approval for Cialis by the FDA.
