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Macitentan/Tadalafil FDC — Competitive Intelligence Brief

Macitentan/Tadalafil FDC (Macitentan/Tadalafil FDC) competitive landscape: 1 comparator, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Endothelin receptor antagonist / Phosphodiesterase-5 inhibitor combination. Area: Cardiovascular.

phase 3 Endothelin receptor antagonist / Phosphodiesterase-5 inhibitor combination Endothelin receptor A and B / Phosphodiesterase-5 Cardiovascular Small molecule Live · refreshed every 30 min

Target snapshot

Macitentan/Tadalafil FDC (Macitentan/Tadalafil FDC) — Actelion. This fixed-dose combination blocks endothelin-1 receptors (via macitentan) to reduce pulmonary vascular resistance while simultaneously inhibiting phosphodiesterase-5 (via tadalafil) to promote vasodilation in the pulmonary circulation.

Comparator set (1 drugs)

Auto-detected by same drug class / molecular target / therapeutic area, ranked by phase + recency. Override with ?vs=slug1,slug2,….

DrugGenericSponsorPhaseClassTargetApproval / PDUFA
Macitentan/Tadalafil FDC TARGET Macitentan/Tadalafil FDC Actelion phase 3 Endothelin receptor antagonist / Phosphodiesterase-5 inhibitor combination Endothelin receptor A and B / Phosphodiesterase-5
FDC macitentan/tadalafil FDC macitentan/tadalafil Actelion phase 3 Endothelin receptor antagonist / Phosphodiesterase-5 inhibitor combination Endothelin receptor A and B / Phosphodiesterase-5

Recent regulatory actions (last 90 days)

No regulatory actions in the last 90 days for this set.

Upcoming PDUFA dates (next 180 days)

No PDUFA dates in the next 180 days for this set.

Patent timeline (forward window)

No upcoming patent expiries for this set.

Sponsor landscape (Endothelin receptor antagonist / Phosphodiesterase-5 inhibitor combination class)

  1. Actelion · 2 drugs in this class

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Cite this brief

Drug Landscape (2026). Macitentan/Tadalafil FDC — Competitive Intelligence Brief. https://druglandscape.com/ci/macitentan-tadalafil-fdc. Accessed 2026-06-10.

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing