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OPSUMIT® (macitentan) milestones from the past, present, and future

The ongoing commitment of Actelion, a Janssen Pharmaceutical Company, to advancing the treatment of PAH

2008

Recruitment for the SERAPHIN clinical trial begins1

2013

FDA approves OPSUMIT® as the first oral once-daily ERA with long-term (average treatment duration 2 years) outcomes data2,3

2017

Presented open-label extension data to add to the understanding of the long-term use of OPSUMIT®2,4

2022

More than 45,000 patients prescribed OPSUMIT® in the United States, since approval in 20135*

ONGOING

Continued commitment to PAH through:

  • Patient support
  • Clinical research including numerous, ongoing phase 2 and 3 clinical trials

Learn about the proven efficacy of OPSUMIT®

See Seraphin Results

SERAPHIN PAH-related hospitalization results

View the Data

View SERAPHIN PAH-CTD subgroup data

See the Data

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*As of December 2022.

ERA=endothelin receptor antagonist; PAH=pulmonary arterial hypertension; SERAPHIN=Study with an Endothelin Receptor Antagonist in Pulmonary Arterial Hypertension to Improve CliNical Outcome.
References: 1. US Dept of Health and Human Services, National Institutes of Health, US National Library of Medicine. Study of Macitentan (ACT-064992) on Morbidity and Mortality in Patients With Symptomatic Pulmonary Arterial Hypertension (SERAPHIN). Accessed October 14, 2022. https://clinicaltrials.gov/ct2/show/NCT00660179 2. OPSUMIT® [prescribing information]. Actelion Pharmaceuticals US, Inc. 3. Data on file. Actelion Pharmaceuticals US, Inc. 4. Souza R, Delcroix M, Galié N, et al. Long-term safety, tolerability and survival in patients with pulmonary arterial hypertension treated with macitentan: results from the SERAPHIN open-label extension. Adv Ther. 2022;39(9):4374-4390. 5. Data on file. Actelion Pharmaceuticals US, Inc., as of December 2022.

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