Macitentan Clinical Trials

Size	Price	Qty
5mg	USD 147
25mg	USD 370

Clinical Trials

Numerous clinical trials evaluate macitentan across Phase 1 through Phase 4 in healthy cohorts and patient populations, with recruitment statuses ranging from recruiting and active to completed, withdrawn, or terminated. Primary indications under investigation include pulmonary arterial hypertension, combined pre- and post-capillary pulmonary hypertension, heart failure with preserved ejection fraction, glioblastoma, cardiac allograft vasculopathy, and lung transplant rejection. Supported by commercial sponsors such as Actelion and Janssen alongside academic institutions like the University of California, Los Angeles and the University of Giessen, these studies assess the drug's pharmacokinetics, safety, and therapeutic efficacy.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05946811	WITHDRAWN	Pulmonary Embolism	University of Maryland, Baltimore	2024-05-01	PHASE3
NCT07147114	RECRUITING	Combined Pre- and Post-capillary Pulmonary Hypertension; CpcPH; HFmrEF; HFpEF; Group 2 Pulmonary Hypertension	Gachon University Gil Medical Center	2025-11-24	PHASE4
NCT07392281	RECRUITING	Non-Coronary Obstructive Angina	China-Japan Friendship Hospital	2025-09-01	EARLY_PHASE1
NCT05179876	RECRUITING	Hypertension, Pulmonary	Actelion	2022-05-04	PHASE3
NCT06811831	RECRUITING	Coronary Microvascular Angina; Macitentan	China-Japan Friendship Hospital	2024-11-01	EARLY_PHASE1
NCT05140525	TERMINATED	CTEPH	Dr Sudarshan Rajagopal	2025-01-27	PHASE3
NCT04273945	ACTIVE_NOT_RECRUITING	Pulmonary Arterial Hypertension	Actelion	2020-06-30	PHASE3
NCT04780932	COMPLETED	Thromboembolic Pulmonary Hypertension; Chronic Disease; Inoperable Disease	Assistance Publique - Hôpitaux de Paris	2021-06-14	PHASE2; PHASE3
NCT02932410	COMPLETED	Pulmonary Arterial Hypertension	Actelion	2017-10-24	PHASE3
NCT05167825	COMPLETED	Pulmonary Arterial Hypertension	Janssen Pharmaceutical K.K.	2022-11-14	PHASE3
NCT03362047	COMPLETED	Pulmonary Arterial Hypertension (PAH)	University of Giessen	2018-03-01	PHASE2
NCT06553937	COMPLETED	PAH	Humanis Saglık Anonim Sirketi	2024-05-10	PHASE1
NCT06553924	COMPLETED	PAH	Humanis Saglık Anonim Sirketi	2024-05-14	PHASE1
NCT05731492	WITHDRAWN	Arterial Hypertension, Pulmonary	Actelion	2024-03-14	PHASE1
NCT05731492	Recruiting	Arterial Hypertension Pulmonary	Actelion	2024-03-14	Phase 1
NCT03422328	COMPLETED	Pulmonary Arterial Hypertension; Chronic Thromboembolic Pulmonary Hypertension	Actelion	2018-04-05	PHASE3
NCT04271475	TERMINATED	Chronic Thromboembolic Pulmonary Hypertension	Actelion	2020-07-07	PHASE3
NCT05373108	COMPLETED	Cardiac Allograft Vasculopathy	University of California, Los Angeles	2022-05-19	PHASE4
NCT05167825	Recruiting	Pulmonary Arterial Hypertension	Janssen Pharmaceutical K.K.	2022-11-14	Phase 3
NCT05433675	COMPLETED	Healthy	Actelion	2022-06-22	PHASE1
NCT05392530	COMPLETED	Healthy	Actelion	2022-05-25	PHASE1
NCT03904693	COMPLETED	Pulmonary Arterial Hypertension (PAH) (WHO Group 1 PH)	Actelion	2019-07-29	PHASE3
NCT05433675	Completed	Healthy	Actelion	2022-06-22	Phase 1
NCT05236231	COMPLETED	Healthy	Actelion	2022-02-04	PHASE1
NCT05392530	Completed	Healthy	Actelion	2022-05-25	Phase 1
NCT05373108	Completed	Cardiac Allograft Vasculopathy	University of California Los Angeles\|American Heart Association\|Janssen LP	2022-05-19	Phase 4
NCT02060721	COMPLETED	Chronic Thromboembolic Pulmonary Hypertension	Actelion	2015-02-03	PHASE2
NCT03775421	TERMINATED	Congenital Heart Disease With Fontan Circulation	Actelion	2019-04-11	PHASE3
NCT03714815	TERMINATED	Heart Failure With Preserved Ejection Fraction and Pulmonary Vascular Disease	Actelion	2018-12-07	PHASE2
NCT04963439	COMPLETED	Healthy	Actelion	2021-07-08	PHASE1
NCT04540744	COMPLETED	Healthy	Janssen Research & Development, LLC	2021-04-30	PHASE1
NCT03153137	COMPLETED	Congenital Heart Disease	Actelion	2017-08-14	PHASE3
NCT04211272	COMPLETED	Healthy	Actelion	2020-01-14	PHASE1
NCT03153111	COMPLETED	Heart Failure With Preserved Ejection Fraction	Actelion	2017-07-11	PHASE2
NCT04500808	COMPLETED	Healthy	Janssen Pharmaceutical K.K.	2020-07-21	PHASE1
NCT00667823	COMPLETED	Pulmonary Arterial Hypertension	Actelion	2008-10-17	PHASE3
NCT04235270	COMPLETED	Healthy	Janssen Research & Development, LLC	2020-01-17	PHASE1
NCT03809650	TERMINATED	Chronic Thromboembolic Pulmonary Hypertension (CTEPH)	Actelion	2019-01-08	PHASE3
NCT02554903	COMPLETED	Pulmonary Hypertension	Actelion	2016-03-28	PHASE2
NCT02651272	TERMINATED	Pulmonary Hypertension; Sickle Cell Disease	Boston University	2015-07	PHASE2
NCT02893176	WITHDRAWN	Lung Transplant Rejection	University of California, Los Angeles	2016-09	PHASE4
NCT02310672	COMPLETED	Pulmonary Arterial Hypertension	Actelion	2015-06-01	PHASE4
NCT02558231	COMPLETED	Pulmonary Arterial Hypertension	Actelion	2016-05-01	PHASE3
NCT02112487	COMPLETED	Pulmonary Arterial Hypertension	Actelion	2014-06-23	PHASE3
NCT02968901	TERMINATED	Pulmonary Arterial Hypertension	Actelion	2015-09-01	PHASE4
NCT03045666	UNKNOWN	Pulmonary Arterial Hypertension	Soroka University Medical Center	2017-04-15
NCT03389321	COMPLETED	Healthy Subjects	Actelion	2018-01-09	PHASE1
NCT01739400	TERMINATED	Pulmonary Arterial Hypertension	Actelion	2013-09-10	PHASE3
NCT03359291	COMPLETED	Healthy Subjects	Actelion	2017-11-03	PHASE1
NCT02382016	COMPLETED	Portopulmonary Hypertension	Actelion	2015-06-23	PHASE4
NCT03215966	COMPLETED	Healthy Subjects	Actelion	2017-08-07	PHASE1
NCT03236818	UNKNOWN	Pulmonary Arterial Hypertension	Amsterdam UMC, location VUmc	2013-05	PHASE4
NCT01743001	COMPLETED	Pulmonary Arterial Hypertension	Actelion	2013-05-21	PHASE3
NCT02254954	TERMINATED	Glioblastoma	Actelion	2015-01-08	PHASE1
NCT02021292	COMPLETED	Chronic Thromboembolic Pulmonary Hypertension	Actelion	2014-08-20	PHASE2
NCT01346930	WITHDRAWN	Idiopathic Pulmonary Fibrosis	Actelion	2011-07-31	PHASE2
NCT01499251	TERMINATED	Glioblastoma	Actelion	2012-01	PHASE1
NCT02476864	COMPLETED	Healthy Subjects	Actelion	2015-08	PHASE1
NCT01841762	COMPLETED	Pulmonary Arterial Hypertension	Actelion	2013-04-01	PHASE3
NCT02070991	COMPLETED	Pulmonary Hypertension	Actelion	2014-07-01	PHASE2
NCT01847014	TERMINATED	Pulmonary Arterial Hypertension	Actelion	2013-09-01	PHASE3
NCT02081690	TERMINATED	Pulmonary Arterial Hypertension	Actelion	2014-03-01	PHASE3
NCT01474122	TERMINATED	Digital Ulcers	Actelion	2011-12	PHASE3
NCT01474109	COMPLETED	Systemic Sclerosis; Ulcers	Actelion	2011-12	PHASE3
NCT00660179	COMPLETED	Pulmonary Arterial Hypertension	Actelion	2008-05	PHASE3
NCT02050802	COMPLETED	Healthy	Actelion	2011-08	PHASE1
NCT00903331	COMPLETED	Idiopathic Pulmonary Fibrosis	Actelion	2009-05	PHASE2

(data from https://clinicaltrials.gov, updated on 2024-03-08)

Check the Macitentan product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Macitentan is an orally active, non-peptide dual endothelin receptor antagonist that selectively binds endothelin A and endothelin B receptors with IC50 values of 0.5 nM and 391 nM, respectively, thereby preventing endothelin-1-induced intracellular calcium mobilization and vascular smooth muscle contraction. This competitive receptor blockade inhibits sustained vasoconstriction and cellular proliferation in the pulmonary vasculature, providing the therapeutic rationale for mitigating elevated pulmonary vascular resistance in conditions such as pulmonary arterial hypertension.

Appendix RUO and cGMP Quality Standards

Quality Dimension	RUO (Research Use Only)	cGMP (Current Good Manufacturing Practice)
Clinical Applicability	Prohibited in human clinical trials or medical diagnostics.	Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status	Non-regulated grade; exempt from drug manufacturing laws.	Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment	Unclassified analytical or research laboratories.	Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control	Basic purity and activity testing.	Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation	Basic equipment calibration; no process validation required.	Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance	Vendor self-declared without required formal QMS.	Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact	High risk of IND rejection if used as a critical raw material.	Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).