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FDC macitentan/tadalafil — Competitive Intelligence Brief

FDC macitentan/tadalafil (FDC macitentan/tadalafil) 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

FDC macitentan/tadalafil (FDC macitentan/tadalafil) — Actelion. This fixed-dose combination blocks endothelin-1 receptors (via macitentan) and phosphodiesterase-5 (via tadalafil) to reduce pulmonary vascular resistance and improve exercise capacity in pulmonary arterial hypertension.

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
FDC macitentan/tadalafil TARGET FDC macitentan/tadalafil Actelion phase 3 Endothelin receptor antagonist / Phosphodiesterase-5 inhibitor combination Endothelin receptor A and B / Phosphodiesterase-5
Macitentan/Tadalafil FDC Macitentan/Tadalafil FDC 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). FDC macitentan/tadalafil — Competitive Intelligence Brief. https://druglandscape.com/ci/fdc-macitentan-tadalafil. Accessed 2026-06-10.

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