Treats pulmonary arterial hypertension (PAH, WHO Group I). Sold as Opsynvi. Every FDA application for this active ingredient.
As of Nov 15, 2026, FDA lists 1 application for Macitentan; Tadalafil (sold as Opsynvi), first approved Mar 22, 2024, with 0 new uses approved and 0 published complete response letters.
| Product | Part | Spending, 2025 | Change | Beneficiaries |
|---|---|---|---|---|
| Opsynvi | Part D | $172M | +603% | 2,049 |
| A Study of Opsynvi in Adults Participants With Pulmonary Arterial Hypertension in KoreaPulmonary Arterial Hypertension · Janssen Korea, Ltd., Korea | — | Not yet recruiting | Oct 22, 2026 |
| Efficacy and Safety of Triple-targeted Drug Therapy in Treatment-naive Patients With Non-low-risk PAH: A Real-world, Multicenter StudyArterial Pulmonary Hypertension (PAH) · Qianfoshan Hospital | — | Recruiting | Dec 31, 2024 |
| Initial Triple Therapy Including Parenteral Treprostinil vs Initial Double Oral Therapy in PAH Group I PatientsPulmonary Arterial Hypertension · AOP Orphan Pharmaceuticals AG | Phase 4 | Recruiting | Mar 19, 2024 |
| A Study Providing Treatment Access in Participants With Pulmonary Hypertension Completing a Parent Study and Having no Other OptionHypertension, Pulmonary · Actelion | Phase 3 | Recruiting | Jan 5, 2022 |
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
