Tracleer Bosentan Tablets
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For patients with pulmonary arterial hypertension (PAH, WHO Group I)
WHO Class II, III, IV


About Actelion

Passion for discovery • Dedication to innovation • Focus on Patients

Over 10 years ago, Drs. Martine and Jean-Paul Clozel, along with their friend and colleague Walter Fischli, made an exciting discovery: a drug that might help those with pulmonary arterial hypertension (PAH).

Their employer at the time, a major pharmaceutical company, decided to abandon the project. Still, the researchers were determined. They firmly believed in the potential of the medicine. And so they risked everything—laying career and personal finances on the line—to start a new company and bring this promising product to market. Actelion and the first oral medication for PAH, Tracleer® (bosentan), were born.

"There is something magical about discovering and developing a compound that can change someone's life," said Dr. Jean-Paul Clozel, Actelion's CEO. "It's not about faceless diseases—there are people who suffer terribly because of these diseases. At Actelion, we want to make a difference."

Eight years later, Tracleer has made a difference in the lives of over 75,000 patients around the world.1 And Actelion has firmly cemented its role as a leading innovator in the PAH community.

Driven by innovation


Actelion's commitment to patients with PAH began in the 1980s, when Dr. Martine Clozel and her colleagues were the first scientists to discover an important substance in blood vessels (later named “endothelin”). They believed that blocking this substance was likely to help patients with PAH. Their passion, commitment, and dedication laid the groundwork for the discovery of Tracleer.

Since then, Actelion has continued to pave the way in the treatment of PAH by targeting additional therapeutic pathways.

Actelion's achievements with Tracleer

Leaders now and in the future


As part of Actelion's leadership team, Drs. Martine and Jean-Paul Clozel are still committed to science and the well-being of PAH patients. Innovation remains the driving force behind Actelion's dedication and commitment to the PAH community:
  Extensive ongoing research in PAH1
  Expanding the PAH knowledge base with REVEAL and QuERI patient registries
  Services and support every step of the way with PAH Pathways®
—  Ongoing patient education and support with Sure Steps
—  Financial assistance for eligible patients
—  Support for physician offices

To learn more, visit www.ActelionUS.com.

Tracleer is indicated for the treatment of pulmonary arterial hypertension (PAH, WHO Group I) in patients with WHO Class II-IV symptoms, to improve exercise ability and decrease the rate of clinical worsening. Patients with WHO Class II symptoms showed reduction in the rate of clinical deterioration and a trend for improvement in walk distance. Physicians should consider whether these potential benefits are sufficient to offset liver injury in WHO Class II patients, which may preclude future use as their disease progresses.

Important safety information

Because of the associated risks, Tracleer may be prescribed only through the Tracleer Access Program.

Potential for serious liver injury (including, after prolonged treatment, rare cases of liver failure and unexplained hepatic cirrhosis in a setting of close monitoring)—Liver monitoring of all patients is essential prior to initiation of treatment and monthly thereafter.

High potential for major birth defects—Pregnancy must be excluded and prevented through the use of reliable forms of birth control; monthly pregnancy tests should be obtained.

Contraindicated for use with cyclosporine A and glyburide.

Please see full prescribing information including BOXED WARNING.



  1. Data on file, Actelion Pharmaceuticals.
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