Clinical Trials

Numerous clinical trials evaluate selexipag across Phases 1 through 4, primarily focusing on pulmonary arterial hypertension alongside conditions such as thromboangiitis obliterans, non-healing wounds, and Raynaud's phenomenon. Sponsored by pharmaceutical entities including Actelion, Liquidia Technologies, Janssen-Cilag, and United Therapeutics, alongside academic centers like the University of Sao Paulo General Hospital, protocols encompass completed, active, withdrawn, and expanded access statuses. Across these phases, investigations assess pharmacokinetics, prostacyclin therapy transition regimens, safety, and tolerability in healthy volunteers and symptomatic patient cohorts.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07700303 NOT_YET_RECRUITING
Pulmonary Arterial Hypertension
University of Alberta
 2026-09-30
NCT05825417 ACTIVE_NOT_RECRUITING
Pulmonary Arterial Hypertension
Sheffield Teaching Hospitals NHS Foundation Trust
 2023-06-14 PHASE4
NCT07759804 NOT_YET_RECRUITING
Pulmonary Arterial Hypertension (PAH)
Liquidia Technologies, Inc.
 2026-09 PHASE4
NCT05179876 RECRUITING
Hypertension, Pulmonary
Actelion
 2022-05-04 PHASE3
NCT07694128 COMPLETED
Arterial Hypertension (PAH)
Humanis Saglık Anonim Sirketi
 2026-04-08 PHASE1
NCT06932198 COMPLETED
Pulmonary Arterial Hypertension (PAH)
Humanis Saglık Anonim Sirketi
 2025-01-09 PHASE1
NCT04175600 ACTIVE_NOT_RECRUITING
Hypertension, Pulmonary
Actelion
 2020-01-16 PHASE3
NCT04565990 COMPLETED
Hypertension, Pulmonary
Actelion
 2021-05-03 PHASE3
NCT04435782 TERMINATED
Pulmonary Arterial Hypertension
Actelion
 2021-07-07 PHASE4
NCT03942211 TERMINATED
Sarcoidosis-associated Pulmonary Hypertension
Actelion
 2021-02-26 PHASE2
NCT03689244 TERMINATED
Chronic Thromboembolic Pulmonary Hypertension
Actelion
 2019-01-23 PHASE3
NCT03492177 ACTIVE_NOT_RECRUITING
Pulmonary Arterial Hypertension
Actelion
 2018-07-23 PHASE2
NCT04589390 UNKNOWN
Pulmonary Hypertension; Schistosomiasis
University of Sao Paulo General Hospital
 2020-10-15 PHASE2
NCT04266756 COMPLETED
Healthy
Actelion
 2020-01-23 PHASE1
NCT03078907 COMPLETED
Pulmonary Arterial Hypertension
Actelion
 2017-11-08 PHASE4
NCT02558231 COMPLETED
Pulmonary Arterial Hypertension
Actelion
 2016-05-01 PHASE3
NCT03016468 WITHDRAWN
Pulmonary Arterial Hypertension
United Therapeutics
 2017-05 PHASE2
NCT03187678 COMPLETED
Pulmonary Arterial Hypertension
Actelion
 2017-12-04 PHASE3
NCT03496506 COMPLETED
Healthy Subjects
Actelion
 2018-03-05 PHASE1
NCT02471183 COMPLETED
Pulmonary Arterial Hypertension
Actelion
 2015-10-12 PHASE3
NCT02791815 COMPLETED
Healthy Subjects
Actelion
 2016-07 PHASE1
NCT02770222 COMPLETED
Healthy Subjects
Actelion
 2016-06 PHASE1
NCT02745860 COMPLETED
Healthy Subjects
Actelion
 2016-06 PHASE1
NCT02260557 COMPLETED
Raynaud's Phenomenon Secondary to Systemic Sclerosis
Actelion
 2014-10-31 PHASE2
NCT02882425 COMPLETED
Healthy Subjects
Actelion
 2015-01 PHASE1
NCT01106014 COMPLETED
Pulmonary Arterial Hypertension
Actelion
 2009-12-01 PHASE3
NCT02206295 COMPLETED
Bioequivalence
Actelion
 2012-09 PHASE1
NCT02206204 COMPLETED
Cardiodynamics; Safety; Tolerability; Pharmacokinetics
Actelion
 2012-06 PHASE1

(data from https://clinicaltrials.gov, updated on 2026-07-15)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Selexipag is an orally active, selective prostacyclin IP receptor agonist with a Ki value of 260 nM that selectively binds the human IP receptor to stimulate adenylate cyclase activity and elevate intracellular cyclic AMP levels. This downstream signaling cascade promotes vascular smooth muscle cell relaxation and suppresses proliferation, inducing potent pulmonary vasodilation directly relevant to the treatment and management of pulmonary arterial hypertension in clinical trials.

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>).

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Note: Technical data last updated: Sep 1, 2026.