Clinical Trials
Multiple clinical trials evaluate therapeutic interventions for pulmonary arterial hypertension, idiopathic pulmonary arterial hypertension, and chronic left ventricular failure across Phase 2, Phase 3, combined Phase 2/Phase 3, and non-phased protocols. These studies are sponsored by academic institutions—including Amsterdam UMC, University of Cincinnati, University of Zurich, and Heidelberg University—and industry sponsors such as Acceleron Pharma, United Therapeutics, and Bayer. Recruitment statuses across these protocols include actively recruiting, completed, and withdrawn.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT05493371 | Recruiting | Idiopathic Pulmonary Arterial Hypertension |
Amsterdam UMC location VUmc |
2023-03-01 | Phase 2 |
| NCT04451850 | Recruiting | Pulmonary Arterial Hypertension |
University of Cincinnati |
2021-06-01 | -- |
| NCT03496207 | Completed | Pulmonary Arterial Hypertension |
Acceleron Pharma Inc. a wholly-owned subsidiary of Merck & Co. Inc. Rahway NJ USA |
2018-06-13 | Phase 2 |
| NCT02999906 | Withdrawn | Pulmonary Arterial Hypertension |
United Therapeutics |
2017-10 | Phase 3 |
| NCT02755298 | Completed | Hypertension Pulmonary |
University of Zurich |
2016-10 | Phase 2|Phase 3 |
| NCT02482402 | Withdrawn | Chronic Left Ventricular Failure|Pulmonary Hypertension |
Heidelberg University|Bayer |
2015-02 | Phase 2 |
(data from https://clinicaltrials.gov, updated on 2024-05-22)
Compliance for Clinical Use
Mechanism and Biochemical Profile
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>).