(PDE5 inhibitor)

Status:
Pulmonary arterial hypertension : Phase 3

Pulmonary arterial hypertension (PAH) is a rare, progressive disorder that is characterized by an elevation of blood pressure in the pulmonary (lung) arteries. Patients can experience shortness of breath, fatigue and heart failure. In the United States, PAH affects an estimated 100,000 people.

In August 2005, Lilly ICOS initiated a Phase 3 study to evaluate the efficacy and safety of tadalafil, compared to placebo, for the treatment of PAH. The study is being conducted in North America and Europe and is designed to enroll 400 patients. Tadalafil is the active ingredient in Cialis®.

Status:
Benign prostatic hyperplasia : Phase 2

Benign enlargement of the prostate gland or BPH can cause a number of troublesome urinary tract symptoms as a man ages. The enlarged prostate gland can irritate the bladder and it can also exert pressure upon the urethra, which is the passageway for urine leaving the bladder. The symptoms of BPH include difficulty initiating urination, straining to pass urine, frequent urination, repeated awakening at night to urinate, incomplete emptying of the bladder, and even the inability to urinate. More than half of men over age 50 have symptoms caused by BPH.

Lilly ICOS has completed a Phase 2 proof-of-concept study and is preparing for a Phase 3 program.

Status:
Hypertension : Phase 2

Hypertension is a common disorder of high blood pressure. In September 2005, Lilly ICOS initiated a Phase 2 proof-of-concept study to evaluate tadalafil, compared to placebo.

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