Macitentan is under clinical development by Johnson & Johnson and currently in the Phase II and Phase III in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.

According to GlobalData, the latest event to affect Macitentan’s likelihood of approval (LoA) and phase transition for Congenital Heart Disease took place on 29 Aug 2022, which decreased the likelihood that the drug progresses to the next phase in its clinical pathway and decreased the likelihood of final approval for this indication.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their Macitentan Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

Macitentan overview

Macitentan (ACT-064992, Opsumit, Zependo) is a novel dual endothelin receptor antagonist (ERA). It is formulated as film coated tablets for the oral route of administration. Macitentan s indicated for the treatment of pulmonary arterial hypertension (PAH, WHO Group I) to reduce the risks of disease progression and hospitalization for pulmonary arterial hypertension.

Macitentan (ACT-064992) is under development for the treatment of congenital heart disease with fontan-palliated, chronic thromboembolic pulmonary hypertension, pulmonary arterial hypertension (PAH) in pediatric patients, combined pre- and post-capillary pulmonary hypertension (CpcPH) and heart failure with preserved ejection fraction (diastolic heart failure), pulmonary vascular disease. It was also under development for the treatment of idiopathic pulmonary fibrosis, glioblastoma and digital ulcers associated with systemic sclerosis, chronic thromboembolic pulmonary hypertension (CTEPH) and Eisenmenger syndrome.

Johnson & Johnson overview

Johnson & Johnson (J&J) researches, develops, manufactures, and sells pharmaceutical products, medical devices, and consumer products. The company provides pharmaceuticals for immune diseases, cancer, neurological disorders, infectious, cardiovascular and metabolic diseases; consumer products in oral care, baby care, beauty, over-the-counter (OTC) medicines, women’s health and wound care categories; and medical devices for use in the cardiovascular, orthopaedic, general surgery and vision care fields. J&J distributes pharmaceutical and medical products to retailers, wholesalers, health care professionals and hospitals; and offers consumer products through retail outlets and distributors. The company offers its products in the US; Europe; Asia-Pacific and Africa; and Western Hemisphere (excluding the US). J&J is headquartered in New Brunswick, New Jersey, the US.

Quick View Macitentan LOA Data

Report Segments
  • Innovator (NME)
Drug Name
  • Macitentan
Administration Pathway
  • Oral
Therapeutic Areas
  • Cardiovascular
  • Oncology
  • Respiratory
Key Developers
Highest Development Stage
  • Marketed

GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.