Asset profile

Macitentan · Opsumit

Small molecule

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Approvedregulatory verdict

Evidence outlook

Approved: Pulmonary Hypertension (label: pulmonary arterial hypertension (WHO Group 1) in adults)

Regulatory approval supersedes design-level evidence grading; the trials behind approval are preserved below as the drug's evidence history.

track record: Partial signal

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Competitive landscape

6 competitors in this universe: 0 direct rivals (same mechanism and indication), 2 same-class, 4 same-indication.

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DrugStageModalityMechanismEvidence signalReported efficacygraded featured trials
Macitentan (Opsumit): this drugApprovedSmall moleculeEndothelin receptor (ETA/ETB, dual)
Aprocitentan (Tryvio)ApprovedSmall moleculeEndothelin receptor (ETA/ETB, dual)
Bosentan (Tracleer)ApprovedSmall moleculeEndothelin receptor (ETA/ETB, dual)
Levosimendan (Simdax)Phase 3Small moleculeCardiac troponin C (calcium sensitizer)
MosliciguatPhase 3Small moleculeSoluble guanylate cyclase
Fc-Relaxin Fusion Protein (TX45)Phase 2Protein / enzyme therapeuticRelaxin receptor (RXFP1) / relaxin
PF-07868489Phase 2Protein / enzyme therapeuticBone morphogenetic protein 9 (BMP9)
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Research adds each competitor's evidence grade and sourced trial results, aligned per race, so you can see who actually has the data.

Upcoming events

(2 total)

Estimated primary-completion dates from ClinicalTrials.gov. These are registry estimates, never confirmed readout dates; they can move as trials progress.

2027 (2)
January 2027 (1)
Phase 3Hypertension, PulmonaryRecruiting
Est. primary completion 2027-01-31 · NCT05179876 · CT.gov ↗
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August 2027 (1)
Phase 1Non-Coronary Obstructive AnginaRecruiting
Est. primary completion 2027-08-31 · NCT07392281 · CT.gov ↗
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All registered studies

Every ClinicalTrials.gov study of this drug's own program, grouped by indication and phase. Research unlocks the studies themselves: titles, statuses, dates and featured-trial cross-links.

Phase 3 (23)
Phase 2/3 (2)
Phase 2 (10)
Phase 1 (20)
Phase 4 (6)
Early phase / not applicable (2)
Appears in other studies (2)