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Treats pulmonary arterial hypertension (PAH) (WHO Group 1). Sold as Tracleer. Every FDA application for this active ingredient: 2 branded and 13 generic.
As of Nov 14, 2026, FDA lists 15 applications for Bosentan (sold as Tracleer), first approved Nov 20, 2001, with 5 new uses approved and 0 published complete response letters.
First approved: Nov 20, 2001
Applications: 15
New uses approved: 5
Complete response letters: 0
Medicare spending, 2025: $27.4M
First approved in the EU: May 14, 2002
Safety program: REMS
Medicare Spending
CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name
Tracleer pediatric dispersible tablets, new approvalA drug with a new indication and a new dosage in a new additional dosage form indicated for the treatment of pulmonary arterial hypertension. · Actelion Pharmaceuticals Japan Ltd. · Sep 28, 2015 · Review report
TracleerA drug with a new additional indication for inhibiting development of digital ulcer in patients with systemic scleroderma (only for patients who currently… · Actelion Pharmaceuticals Japan Ltd. · Aug 24, 2015
TracleerA drug with a new additional indication for the treatment of pulmonary arterial hypertension (WHO functional class II). · Actelion Pharmaceuticals Japan Ltd. · Nov 21, 2012
Safety Programs (REMS)
FDA requires these when a drug's risks need more than a label: training, enrollment or extra checks before it is prescribed or dispensed
Program
Updated
Bosentan REMSRestricted: prescribers, pharmacies or patients must be certified or enrolled
Oct 27, 2026
Clinical Trials
13 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all
Endothelin Role In COronary MicrocirculationCoronary Microvascular Dysfunction (CMD), Angina Pectoris With Normal Coronary Arteriogram · Liverpool University Hospitals NHS Foundation Trust
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient.Drugs@FDA
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