PAH/PH Treatments: Macitentan (Opsumit™)

Author: Shelley Ensz. Scleroderma is highly variable. See Types of Scleroderma. Read Disclaimer
Overview Patient Stories


Macitentan (Opsumit) is a novel oral dual endothelin receptor antagonist for pulmonary hypertension. Actelion submitted its FDA new drug application for macitentan in October 2012.

Bosentan and macitentan (ERA's) prevent the endothelial–to–mesenchymal transition (EndoMT) in systemic sclerosis: in vitro study. The present study provides further in vitro evidence of the use of ERA in inhibiting the EndoMT process, supporting the clinical efficacy of these drugs in SSc therapy and their usefulness for interfering with progressive fibrosis. PMC, Arthritis Res Ther, October 2016; 18: 228. (Also see Tracleer (Bosentan) and Fibroblasts)

Actelion’s Opsumit™ Approved by FDA for Pulmonary Arterial Hypertension. The FDA has approved the use of Opsumit (Macitentan) for treatment of pulmonary arterial hypertension (PAH). The Guardian. 10/20/2013.

Actelion says FDA accepts Macitentan for review. Actelion has submitted an FDA application for macitentan for the treatment of pulmonary arterial hypertension (PAH), a condition characterized by abnormally high blood pressure in the arteries of the lungs. The review is expected to take 12 months. Reuters. 12/14/12. (Also see Pulmonary Hypertension)

Phase III PAH outcome study with macitentan (Opsumit™) presented at CHEST - Significant reduction in the risk of morbidity and mortality. Macitentan administered once daily provided a significant and clinically relevant reduction in the risk of morbidity and mortality. Reuters. 10/23/12.

Actelion submits a New Drug Application to the FDA for macitentan (Opsumit™) for the treatment of patients with pulmonary arterial hypertension. Macitentan, a novel oral dual endothelin receptor antagonist, was studied in the pivotal, long-term, event-driven Phase III outcome study, SERAPHIN. Reuters. 10/22/12. (Also see What is Pulmonary Hypertension?)

Opsumit Patient Stories

(Update) Sherri M: CREST Syndrome. I have been put on Opsumit for the Pulmonary Hypertension. I have been on it for ten weeks now. I started to notice a tiny difference at around week 7; I felt just a little less short of breath… Posted 08/24/2015.

Go to Sildenafil (Revatio)
Most Recent Donors

Winn Schillberg
Reading Voices of Scleroderma Books: Diana Kramer.
Sharing Scleroderma Awareness Bracelets: Deb Martin, Brenda Miller, Vickie Risner.
Thanks to UNITED WAY donors of Central New Mexico and Snohomish County!

In Loving Memory

Patricia Ann Black: Marilyn Currier, Shelley Ensz, Richard Howitt, Gerald and Pat Ivanejko, Juno Beach Condo Association, Keith and Rosalyn Miller, and Elaine Wible.
Gayle Hedlin: Daniel and Joann Pepper and Nancy Smithberg.
Janet Paulmenn: Anonymous, Mary Jo Austin, Shelley Blaser, Susan Book, Dennis and Pat Clayton, Grace Cunha, Cindy Dorio, Michael and Patricia Donahue, Shelley Ensz, Nancy Falkenhagen, Jo Frowde, Alice Gigl, Margaret Hollywood, Karen Khalaf and Family, Susan Kvarantan, Bradley Lawrence, Jillyan Little, Donna Madge, Michele Maxson, Barry and Judith McCabe, John Moffett, My Tribute Foundation, Joan-Marie Permison, John Roberts, Margaret Roof, Maryellen Ryan, Mayalin and Kiralee Murphy, Nancy Settle-Murphy, and Bruce and Elizabeth Winter.


SCLERO.ORG is the world leader for trustworthy research, support, education and awareness for scleroderma and related illnesses, such as pulmonary hypertension. We are a service of the nonprofit International Scleroderma Network (ISN), which is a 501(c)(3) U.S.-based public charitable foundation, established in 2002. Meet Our Team, or Volunteer. Donations may also be mailed to:

International Scleroderma Network (ISN)
7455 France Ave So #266
Edina, MN 55435-4702 USA

Email [email protected] to request our Welcome email, or to report bad links or to update this page content.

TOLL FREE HOTLINE 800-564-7099
Free to U.S. and Canadian Callers. Ask for our Free Info Packet by mail or email!
Scleroderma, Pulmonary Arterial Hypertension, and related illnesses.
Privacy Policy.

The most important thing in the world to know about scleroderma is!
Donate Now
Copyright 1998-2016, International Scleroderma Network. AKA Scleroderma from A to Z and SCLERO.ORG. All Rights Reserved.