Clinical Trials

Multiple clinical trials sponsored by Actelion evaluate MRE-269 (ACT-333679) across Phase 1 through Phase 3. Early-phase trials in healthy volunteers assessed cardiodynamics, drug-drug interactions, pharmacokinetics, safety, and tolerability, with most completed. Several advanced Phase 2 and Phase 3 trials evaluating therapeutic efficacy and safety in pulmonary arterial hypertension and pulmonary hypertension are currently active but non-recruiting.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT04175600 Active not recruiting
Hypertension Pulmonary
Actelion
 2020-01-16 Phase 3
NCT03492177 Active not recruiting
Pulmonary Arterial Hypertension
Actelion
 2018-07-23 Phase 2
NCT03496506 COMPLETED
Healthy Subjects
Actelion
 2018-03-05 PHASE1
NCT03496506 Completed
Healthy Subjects
Actelion
 2018-03-05 Phase 1
NCT02791815 Completed
Healthy Subjects
Actelion
 2016-07 Phase 1
NCT02770222 COMPLETED
Healthy Subjects
Actelion
 2016-06 PHASE1
NCT02770222 Completed
Healthy Subjects
Actelion
 2016-06 Phase 1
NCT02206204 COMPLETED
Cardiodynamics; Safety; Tolerability; Pharmacokinetics
Actelion
 2012-06 PHASE1

(data from https://clinicaltrials.gov, updated on 2024-05-22)

Check the MRE-269 (ACT-333679) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

MRE-269 selectively binds to and activates the human prostacyclin (IP) receptor with 130-fold greater affinity over other prostanoid receptor subtypes, stimulating intracellular cyclic AMP signaling to promote vascular smooth muscle relaxation. This targeted vasodilation and anti-remodeling action reduces elevated pulmonary artery pressure, directly supporting its clinical evaluation for treating pulmonary arterial hypertension and related hypertensive pulmonary conditions.

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.