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Drug

Macitentan

Approved · FDA / EMA
Late-stage development

Also known as Opsumit, Opsynvi, Macitentanum.

RxNorm1442132ChEMBLCHEMBL2103873UNIIZ9K9Y9WMVL
3
Active clinical trials
5
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

A Prospective, Open-label, Platform Study for Long-term Follow-up of Participants Using Study Intervention in Pulmonary Hypertension Parent Studies

Clinical trial2026-07-06Results expected Q1 2027 · ClinicalTrials.gov

Approval: MACITENTAN (ANDA211000)

Regulatory2026-06-08FDA

Approval: MACITENTAN (ANDA211187)

Regulatory2026-06-08FDA

A Multicenter, Open-label, Phase III Study to Assess the Efficacy, Safety, and Pharmacokinetics of Macitentan in Japanese Pediatric Patients (>=3 Months to <15 Years) With Pulmonary Arterial Hypertension

Clinical trial2026-05-07Results posted · ClinicalTrials.gov

A Multicenter, Open-label, Randomized, Study With Single-arm Extension Period to Assess the Pharmacokinetics, Safety and Efficacy of Macitentan Versus Standard of Care in Children With Pulmonary Arterial Hypertension

Clinical trial2026-03-13Results posted · ClinicalTrials.gov

Prospective, Multi-center, Double-blind, Randomized, Active-controlled, Triple-dummy, Parallel-group, Group-sequential, Adaptive Phase 3 Clinical Study to Compare the Efficacy and Safety of Macitentan and Tadalafil Monotherapies With the Corresponding Fixed Dose Combination in Subjects With Pulmonary Arterial Hypertension (PAH), Followed by an Open-label Treatment Period With Macitentan and Tadalafil Fixed Dose Combination Therapy

Clinical trial2025-12-19Results posted · ClinicalTrials.gov

Effects of Combination Medical Therapy Followed by Balloon Pulmonary Angioplasty on Right Ventricular-PA Coupling and Hemodynamics in Chronic Thromboembolic Pulmonary Hypertension

Clinical trial2025-10-21Results expected Q4 2026 · ClinicalTrials.gov

A Phase 3, Prospective, Multicenter, Double-blind, Double-dummy, Randomized, Active-controlled, Parallel-group, Group-sequential, Adaptive, Event-driven Study to Compare Efficacy, Safety, and Tolerability of Macitentan 75 mg Versus Macitentan 10 mg in Patients With Pulmonary Arterial Hypertension, Followed by an Open-label Treatment Period With Macitentan 75 mg

Clinical trial2025-10-07Primary completion · ClinicalTrials.gov

Approval: Macitentan Accord (EMA)

Regulatory2025-09-24EMA

Approval: Macitentan AccordPharma (EMA)

Regulatory2025-09-24EMA

Initial Dual Oral coMbination Therapy Versus Standard-of-care Initial Oral Monotherapy Prior to Balloon Pulmonary Angioplasty in Patients With Inoperable Chronic Thromboembolic Pulmonary hyperTension

Clinical trial2025-07-03Completed · ClinicalTrials.gov

A Multi-center, Double-blind, Placebo-controlled Phase 2b Study to Evaluate the Efficacy and Safety of Macitentan in Subjects With Heart Failure With Preserved Ejection Fraction and Pulmonary Vascular Disease

Clinical trial2025-03-30Results posted · ClinicalTrials.gov

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Macitentan
Aliases & brands
OpsumitOpsynviMacitentanum
RxNorm CUI
1442132
ChEMBL ID
CHEMBL2103873
UNII
Z9K9Y9WMVL
Regulatory jurisdictions
emafda

Regulatory timeline

5 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Approval / market entry confirmed across FDA and EMA (2025-09-24 → 2026-06-08)
Earliest approval
2013-12-20
Latest approval
2026-06-08
Authorities
FDA · EMA
Total events
5
fdaU.S. Food and Drug Administration· 2 events
2026-06-08ApprovalMulti-authority
Approval: MACITENTAN (ANDA211187)
Evidence ↗
2026-06-08ApprovalMulti-authority
Approval: MACITENTAN (ANDA211000)
Evidence ↗
emaEuropean Medicines Agency· 3 events
2025-09-24ApprovalMulti-authority
Approval: Macitentan AccordPharma (EMA)
Indication: AdultsMacitentan AccordPharma, as monotherapy or in combination, is indicated for the long-term treatmentof pulmonary arterial hypertension (PAH) in adult patients of WHO… Show full indication

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)

Evidence ↗
2025-09-24ApprovalMulti-authority
Approval: Macitentan Accord (EMA)
Indication: 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… Show full indication

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).&nbsp;

Evidence ↗
2013-12-20Approval
Approval: Opsumit (EMA)
Indication: Adults&nbsp;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… Show full indication

Adults&nbsp;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.

Evidence ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

50 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
50
registered trials across all phases
LATEST COMPLETION 2025
3
Active studies
2
Recruiting
29
Late-stage (III+)
33
Completed
14
Discontinued
PHASE DISTRIBUTIONn = 50
Phase 112Phase 29Phase 2 / 32Phase 322Phase 45

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Impact of Endothelin-1 on the Development of Cardiac Allograft Vasculopathy in Heart Transplant Recipients: Endothelin Receptor Antagonism and Vasomotor Function

CompletedPH IVUniversity of California, Los Angelesn=192023

Potential Therapy With MACITENTAN in the Treatment of Chronic Lung Allograft Dysfunction (CLAD) After Lung Transplantation

WithdrawnPH IVUniversity of California, Los Angeles2019

A Prospective, Multicenter, Single-arm, Open-label, Phase 4 Study to Evaluate the Effects of Macitentan on Right vEntricular Remodeling in Pulmonary ArterIal hypeRtension Assessed by Cardiac Magnetic Resonance Imaging

CompletedPH IVActelionn=892019

A Randomized, Double-blind, Placebo-controlled, Prospective, Multicenter, Parallel Group Study to Assess the Safety and Efficacy of Macitentan in Patients With Portopulmonary Hypertension

CompletedPH IVActelionn=852018

Prospective, Multicenter, Open-label Study Evaluating the Effects of First-line Oral Combination Therapy of Macitentan and Tadalafil in Patients With Newly Diagnosed Pulmonary Arterial Hypertension (OPTIMA).

TerminatedPH IVActelionn=462018

Recent completions

Trials that read out recently, adding to the completed evidence base.

A Multicenter, Open-label, Randomized, Study With Single-arm Extension Period to Assess the Pharmacokinetics, Safety and Efficacy of Macitentan Versus Standard of Care in Children With Pulmonary Arterial Hypertension

CompletedPH IIIActelionn=1652025

Initial Dual Oral coMbination Therapy Versus Standard-of-care Initial Oral Monotherapy Prior to Balloon Pulmonary Angioplasty in Patients With Inoperable Chronic Thromboembolic Pulmonary hyperTension

CompletedPH II/IIIAssistance Publique - Hôpitaux de Parisn=962025

A Multicenter, Open-label, Phase III Study to Assess the Efficacy, Safety, and Pharmacokinetics of Macitentan in Japanese Pediatric Patients (>=3 Months to <15 Years) With Pulmonary Arterial Hypertension

CompletedPH IIIJanssen Pharmaceutical K.K.n=72025

Prospective, Multi-center, Double-blind, Randomized, Active-controlled, Triple-dummy, Parallel-group, Group-sequential, Adaptive Phase 3 Clinical Study to Compare the Efficacy and Safety of Macitentan and Tadalafil Monotherapies With the Corresponding Fixed Dose Combination in Subjects With Pulmonary Arterial Hypertension (PAH), Followed by an Open-label Treatment Period With Macitentan and Tadalafil Fixed Dose Combination Therapy

CompletedPH IIIActelionn=1872024

Untersuchung Des Einflusses PAH-spezifischer Medikation Auf Die rechtsventrikuläre Funktion Bei Patienten Mit Pulmonaler Arterieller Hypertonie (PAH) Unter Basalen Bedingungen

CompletedPH IIUniversity of Giessenn=72024

mUlticenter, Single-arM, Open-laBel, Long-teRm Safety Study With macitEntan in Patients With puLmonary Arterial Hypertension previousLy Treated With mAcitentan in Clinical Studies

CompletedPH IIIActelionn=1512023
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.