drug · small molecule
MACITENTAN
Marketedupdated 3mo agoby $JNJ JOHNSON & JOHNSON🔗 ChEMBL
Approvedcommunity read0 votes
🐶 often sniffed alongside
top 2Small molecule drug with a maximum clinical stage of Approval (across all indications), with 4 approved and 6 investigational indications.
targets
Endothelin receptor, ET-A/ET-B
all catalysts(1)
Trials studying MACITENTAN
- phase3Outcome Study Assessing a 75 Milligrams (mg) Dose of Macitentan in Patients With Pulmonary Arterial Hypertension
- phase3A Study of Macitentan in Japanese Pediatric Participants With Pulmonary Arterial Hypertension
- phase3A Study Providing Treatment Access in Participants With Pulmonary Hypertension Completing a Parent Study and Having no Other Option
- phase3A Study to Assess Whether Macitentan Delays Disease Progression in Children With Pulmonary Arterial Hypertension (PAH)
- phase3Clinical Study to Compare the Efficacy and Safety of Macitentan and Tadalafil Monotherapies With the Corresponding Fixed-dose Combination Therapy in Subjects With Pulmonary Arterial Hypertension (PAH)
- phase3Effects of Combination Medical Therapy Followed by BPA on Right Ventricular-PA Coupling and Hemodynamics in CTEPH
- phase3Initial Dual Oral Combination Therapy Versus Standard-of-care Initial Oral Monotherapy Prior to Balloon Pulmonary Angioplasty in Patients With Inoperable Chronic Thromboembolic Pulmonary Hypertension
- phase3A Study to Evaluate Efficacy and Safety of Macitentan 75 mg in Inoperable or Persistent/Recurrent Chronic Thromboembolic Pulmonary Hypertension
Patent cliff
source: FDA Orange Bookfirst barrier falls
Sep 11, 2026
22 days
Earliest of all listed patents + FDA exclusivities. Generic / biosimilar entry typically only becomes possible AFTER both patent and exclusivity barriers expire.
patents (10)
- Oct 18, 2029patentUS 8268847*PED3.2y
- Apr 18, 2029method-of-use (U-1446)US 82688472.7y
- Apr 4, 2029patentUS 8367685*PED2.6y
- Oct 4, 2028formulationUS 83676852.1y
- Nov 29, 2027patentUS 9265762*PED1.3y
- May 29, 2027formulationUS 9265762282d
- Mar 11, 2027patentUS 10946015*PED203d
- Sep 11, 2026formulationUS 1094601522d
- Jun 5, 2026patentUS 7094781*PED
- Dec 5, 2025compositionUS 7094781
FDA exclusivities (2)
- Aug 28, 2028PEDPediatric (6mo bonus)2.0y
- Feb 28, 2028M-187Method (3y)1.5y
News(1)
- After missed endpoint, Gossamer and Chiesi pull the plug on PAH drug collaborationAfter signing a deal worth up to $486 million with Italian biopharma Chiesi to develop its pulmonary arterial hypertension (PAH) candidate seralutinib in 2024, Gossamer Bio has ended the collaborat…fiercebiotech · 23d ago
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