Opsumit
(Macitentan)ApprovedSmall molecule
Johnson & JohnsonMacitentan is used to treat pulmonary arterial hypertension, a condition where blood pressure in the lungs becomes dangerously high, making it hard for the heart to pump blood through them.[2] Opsumit is currently approved and in use across 10 indications[4].[1]
Opsumit is one of 277 small molecule programs targeting Cardiovascular Disease. It is currently in Approved.
10
Indications
48
Total Trials
2
Active Trials
276
Competitors
1
FDA Application
NDA/BLA/ANDA regulatory filings
9
Patents
Pipeline
Status by Indication[4][1]
Indication
Competition
Competitive Landscape
198 competitors in Heart Failure
#DrugCompanyPhaseTrials
1Opsumit
Johnson & JohnsonApproved
Bayer Aspirin
BayerPreclinical
Medrol
PfizerPreclinical
Brethine
SanofiPreclinical
Amidate
PfizerPreclinical
Adriamycin
PfizerPreclinical
Savaysa
Daiichi SankyoPreclinical
Xifaxan
SSalix
Preclinical
Oraverse
LLife Extension Foundation Inc.
Preclinical
Xylocaine
MMEDRx USA, Inc.
Preclinical
Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.
Timeline
Expected Milestones
Clinical
Trials by Indication[1]
Pulmonary Arterial Hypertension11 trials
Show 8 more trials
Pulmonary Hypertension5 trials
Show 2 more trials
Macitentan in Pulmonary Hypertension of Sickle Cell Disease
Terminated·—·Phase 2·NCT02651272·4 enrolled
Chronic Thromboembolic Pulmonary Hypertension5 trials
Show 2 more trials
Adult4 trials
Show 1 more trial
Vascular Disease2 trials
18 more indications
PAH2 trials
Systemic Sclerosis2 trials
MPA2 trials
Lung Transplantation1 trial
Idiopathic Pulmonary Fibrosis1 trial
Female1 trial
Concentration1 trial
Eisenmenger syndrome1 trial
Efficacy and Safety1 trial
Fontan1 trial
Hypertension, Pulmonary1 trial
CTEPH1 trial
Unspecified1 trial
Regulatory
FDA Approval Timeline[5]
Oct 18, 2013
OPSUMIT
NDA NDA204410
Sources
References
- [1]
- [2]MedlinePlus Drug Information — Opsumit drug information. U.S. National Library of Medicine, National Institutes of Health.
- [3]
- [4]Open Targets Platform — Drug–disease associations for Macitentan. EMBL-EBI & Wellcome Sanger Institute.
- [5]
- [6]
- [7]
Details
Drug Info
Quick Facts
- Mechanism of Action
- Endothelin Receptor, ET-A/ET-B Antagonist[3]
- Modality
- Small molecule[3]
- Highest Phase
- Approved[1]
- Company
Patent Landscape[6]
Patent Cliff
Mar 11, 2027
Earliest patent expiration — generic entry possible after this date
Patent #Expires
7094781*PEDJun 5, 2026
10946015Sep 11, 2026
10946015*PEDMar 11, 2027
9265762May 29, 2027
9265762*PEDNov 29, 2027