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Macitentan

Phase 3
Johnson & Johnson (JNJ)

Phase 3

Development Phase

0

Upcoming Catalysts

0

Historical Events

3

Regulatory Approvals

No Catalysts Found

No catalyst events have been recorded for this drug yet.

Competitive Landscape

2 competitors in Pulmonary Arterial Hypertension

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Drug Information

Target Indication

Pulmonary Arterial Hypertension

Clinical Trial

NCT05167825

Last updated: 1/24/2026

Patent & Exclusivity

No patent data available. Pre-approval drugs may not have Orange Book listings.

Regulatory Approvals
EMA9/24/2025

Macitentan AccordPharma

AdultsMacitentan AccordPharma, as monotherapy or in combination, is indicated for the long-term treatmentof pulmonary arterial hypertension (PAH) in adult patients of WHO Functional Class (FC) II to III (seesection 5.1)Paediatric populationMacitentan AccordPharma, as monotherapy or in combination, is indicated for the long-term treatmentof pulmonary arterial hypertension (PAH) in paediatric patients aged less than 18 years andbodyweight ≥ 40 kg with WHO Functional Class (FC) II to III (see section 5.1)

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EMA9/24/2025

Macitentan Accord

AdultsMacitentan Accord as monotherapy is indicated for the long-term treatment of pulmonary arterialhypertension (PAH) in adult patients of WHO Functional Class (FC) II to III (see section 5.1). Paediatric populationMacitentan Accord as monotherapy is indicated for the long-term treatment of pulmonary arterialhypertension (PAH) in paediatric patients aged less than 18 years and bodyweight ≥ 40 kg with WHOFunctional Class (FC) II to III (see section 5.1).

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EMA12/20/2013

Opsumit

Adults Opsumit, as monotherapy or in combination, is indicated for the long-term treatment of pulmonary arterial hypertension (PAH) in adult patients of WHO Functional Class (FC) II to III. Paediatric populationOpsumit, as monotherapy or in combination, is indicated for the long-term treatment of pulmonary arterial hypertension (PAH) in paediatric patients aged less than 18 years and bodyweight ≥ 40 kg with WHO Functional Class (FC) II to III. Opsumit, as monotherapy or in combination, is indicated for the long-term treatment of pulmonary arterial hypertension (PAH) in paediatric patients aged 2 years to less than 18 years with WHO Functional Class (FC) II to III.

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Drug Science
Mechanism of action & safety profile
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