Drug Profile

Macitentan - Johnson & Johnson Innovative Medicine

Alternative Names: ACT-064992; Actelion-1; JNJ-67896062; JNJ-67896062-AAA; JNJ-67896062-AAA-G004; OPSUMIT; Opsumit; Zependo

Latest Information Update: 13 Aug 2025

Price :

$50 ^*

Note:

Adis is an information provider. We do not sell or distribute actual drugs.
Final gross price and currency may vary according to local VAT and billing address.
Your purchase entitles you to full access to the information contained in our drug profile at the time of purchase.
A link to download a PDF version of the drug profile will be included in your email receipt.

At a glance

Originator Actelion Pharmaceuticals
Developer Actelion Pharmaceuticals; Johnson & Johnson Innovative Medicine; Nippon Shinyaku
Class Antifibrotics; Antihypertensives; Antineoplastics; Bromobenzenes; Cardiovascular therapies; Heart failure therapies; Pyrimidines; Skin disorder therapies; Small molecules; Sulfonamides
Mechanism of Action Endothelin A receptor antagonists; Endothelin B receptor antagonists

Orphan Drug Status

Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

Yes - Pulmonary hypertension; Idiopathic pulmonary fibrosis; Pulmonary arterial hypertension
New Molecular Entity Yes

Marketed Pulmonary arterial hypertension
Phase III Eisenmenger complex; Pulmonary hypertension
Phase II Heart failure
Discontinued Congenital heart defects; Glioblastoma; Idiopathic pulmonary fibrosis; Portal hypertension; Skin ulcer

03 Jul 2025 Janseen completes a phase II/III IMPACT-CTEPH trial in Pulmonary hypertension (Combination therapy, In adults, In the elderly), In France (PO) (NCT04780932)
28 May 2025 No recent reports of development identified for phase-I development in Pulmonary-hypertension(In adolescents, In children, In infants) in Japan (PO, Tablet)
05 Mar 2025 Janssen Pharmaceutical completes a phase I trial in Pulmonary hypertension (In infants, In children, In adolescents) in Japan (PO) (NCT05167825)

If your organization or you do not have a subscription, try one of the following:

Contacting your organization’s admin about adding this content to your AdisInsight subscription
Buying a PDF version of any individual profile
Request a free trial (opens in a new window)

If your organization has a subscription, there are several access options, even while working remotely:

Working within your organization’s network
Login with username/password or try to access via your institution
Persisted access using your organization’s identifier stored in your user browser for 90 days

For assistance, contact us at asktheexpert.adisinsight@springer.com