Clinical Trials

Riociguat is evaluated across numerous clinical trials ranging from Phase I through Phase IV for cardiovascular and pulmonary conditions, specifically pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension, as well as exploratory indications like systemic scleroderma and migraine. Sponsored by academic institutions and pharmaceutical entities, these studies encompass recruitment statuses from not yet recruiting to completed.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07644377 NOT_YET_RECRUITING
CTEPH
Assistance Publique - Hôpitaux de Paris
 2026-10-01 PHASE3
NCT05825417 ACTIVE_NOT_RECRUITING
Pulmonary Arterial Hypertension
Sheffield Teaching Hospitals NHS Foundation Trust
 2023-06-14 PHASE4
NCT06922240 RECRUITING
Chronic Thromboembolic Pulmonary Hypertension
Suqiao Yang
 2025-03-21 PHASE3
NCT06715280 RECRUITING
Chronic Thromboembolic Pulmonary Hypertension
Chinese University of Hong Kong
 2024-07-25 PHASE4
NCT05140525 TERMINATED
CTEPH
Dr Sudarshan Rajagopal
 2025-01-27 PHASE3
NCT04062565 RECRUITING
Pulmonary Arterial Hypertension
University of Arizona
 2019-03-25 PHASE3
NCT02759419 COMPLETED
Hypertension, Pulmonary
Bayer
 2016-06-16 PHASE4
NCT04954742 TERMINATED
Primary Pulmonary Arterial Hypertension; Chronic Thromboembolic Pulmonary Hypertension
Heidelberg University
 2022-04-13 PHASE4
NCT05339087 TERMINATED
Pulmonary Vascular Disorder; Primary Pulmonary Hypertension; Systemic Sclerosis; Other Systemic Involvement of Connective Tissue
Heidelberg University
 2022-10-24 PHASE2
NCT00694850 COMPLETED
Hypertension, Pulmonary
Bayer
 2008-08-02 PHASE2
NCT05762146 UNKNOWN
Ischemic Stroke, Acute
Maastricht University
 2022-09-05 PHASE2
NCT05750446 COMPLETED
Migraine Without Aura
Danish Headache Center
 2023-06-01
NCT04600492 UNKNOWN
Hypertension, Pulmonary
National Hospital Organization Okayama Medical Center
 2020-10-16 PHASE2
NCT05582811 COMPLETED
Headache
Danish Headache Center
 2022-10-26
NCT05750446 Not yet recruiting
Migraine Without Aura
Danish Headache Center
 2023-04-01 Not Applicable
NCT06180096 COMPLETED
Pulmonary Arterial Hypertension
Humanis Saglık Anonim Sirketi
 2023-03-07 PHASE1
NCT03074539 COMPLETED
Chronic Thromboembolic Pulmonary Hypertension; Sleep Disordered Breathing
Medical University of Vienna
 2017-02-01
NCT05582811 Completed
Headache
Danish Headache Center
 2022-10-26 Not Applicable
NCT02633397 COMPLETED
Sickle Cell Disease
Mark Gladwin
 2017-04-11 PHASE2
NCT04776499 COMPLETED
Drug Drug Interaction; Safety Issues
Maastricht University
 2021-03-18 PHASE1
NCT04813926 Active not recruiting
Pulmonary Arterial Hypertension
Bayer|Xcenda LLC
 2021-07-16 --
NCT04780932 Recruiting
Thromboembolic Pulmonary Hypertension|Chronic Disease|Inoperable Disease
Assistance Publique - Hôpitaux de Paris|Janssen LP
 2021-06-14 Phase 2|Phase 3
NCT04211272 COMPLETED
Healthy
Actelion
 2020-01-14 PHASE1
NCT03809156 UNKNOWN
Pulmonary Hypertension
University of Calgary
 2016-04-26 PHASE4
NCT02744339 COMPLETED
Hypertension, Pulmonary; Heart Failure With Normal Ejection Fraction
Medical University of Vienna
 2016-03 PHASE2
NCT03273257 TERMINATED
Chronic Thromboembolic Pulmonary Hypertension; CTEPH
International CTEPH Association
 2018-08-17 PHASE2
NCT02562235 ACTIVE_NOT_RECRUITING
Hypertension, Pulmonary
Bayer
 2015-10-29 PHASE3
NCT02891850 COMPLETED
Pulmonary Arterial Hypertension
Bayer
 2017-01-11 PHASE4
NCT02634203 COMPLETED
Chronic Thromboembolic Pulmonary Hypertension
Assistance Publique - Hôpitaux de Paris
 2016-01-19
NCT00863681 COMPLETED
Hypertension, Pulmonary
Bayer
 2009-03-12 PHASE3
NCT00910429 COMPLETED
Pulmonary Hypertension
Bayer
 2009-07-01 PHASE3
NCT02915835 COMPLETED
Scleroderma; Digital Ulcers
Dinesh Khanna, MD, MS
 2016-09 PHASE2
NCT02625558 UNKNOWN
Sarcoidosis
University of Cincinnati
 2015-04 PHASE4
NCT03389321 COMPLETED
Healthy Subjects
Actelion
 2018-01-09 PHASE1
NCT03389321 Completed
Healthy Subjects
Actelion
 2018-01-09 Phase 1
NCT02283762 COMPLETED
Scleroderma, Systemic
Bayer
 2015-01-15 PHASE2
NCT02170025 TERMINATED
Cystic Fibrosis
Bayer
 2014-09-30 PHASE2
NCT02007629 COMPLETED
Hypertension, Pulmonary
Bayer
 2014-02-18 PHASE3
NCT02556268 COMPLETED
HIV-DDI
Bayer
 2016-02-23 PHASE1
NCT02191137 COMPLETED
Hypertension, Pulmonary
Bayer
 2014-09-23 PHASE4
NCT02094001 COMPLETED
Chronic Thromboembolic Pulmonary Hypertension
Ottawa Heart Institute Research Corporation
 2014-05 PHASE2
NCT02138825 TERMINATED
Idiopathic Interstitial Pneumonias / Hypertension,Pulmonary
Bayer
 2014-06-04 PHASE2
NCT02024386 COMPLETED
Hypertension, Pulmonary; Altitude Sickness
Richard Moon
 2014-01 PHASE4
NCT02159326 COMPLETED
Drug Interactions
Bayer
 2014-06 PHASE1
NCT02159313 COMPLETED
Healthy Volunteers
Bayer
 2014-06 PHASE1
NCT00454558 COMPLETED
Hypertension, Pulmonary
Bayer
 2007-01 PHASE2
NCT01926847 COMPLETED
Raynaud Disease
Bayer
 2013-10 PHASE2
NCT01165931 WITHDRAWN
Coronary Artery Disease
Bayer
 2012-05 PHASE2
NCT01172756 TERMINATED
Hypertension, Pulmonary; Ventricular Dysfunction, Left
Bayer
 2010-07 PHASE2
NCT00855465 COMPLETED
Pulmonary Hypertension
Bayer
 2009-02-23 PHASE3
NCT01065454 TERMINATED
Hypertension, Pulmonary; Ventricular Dysfunction, Left
Bayer
 2010-04-14 PHASE2
NCT01179334 COMPLETED
Pulmonary Hypertension
Bayer
 2010-08 PHASE2
NCT00810693 COMPLETED
Pulmonary Hypertension
Bayer
 2008-12-17 PHASE3
NCT01489488 COMPLETED
Pharmacology, Clinical
Bayer
 2012-01 PHASE1
NCT04366622 COMPLETED
Clinical Pharmacology
Bayer
 2010-04-14 PHASE1
NCT04364464 COMPLETED
Clinical Pharmacology
Bayer
 2010-02-19 PHASE1
NCT01065051 TERMINATED
Hypertension, Pulmonary; Ventricular Dysfunction, Left
Bayer
 2010-11 PHASE2
NCT00855660 COMPLETED
Pharmacology, Clinical
Bayer
 2009-03 PHASE1
NCT00640315 COMPLETED
Hypertension, Pulmonary; Pulmonary Disease, Chronic Obstructive
Bayer
 2008-08 PHASE1
NCT00680654 COMPLETED
Hypertension, Pulmonary
Bayer
 2008-10 PHASE1

(data from https://clinicaltrials.gov, updated on 2026-06-12)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Riociguat directly stimulates soluble guanylate cyclase independently of nitric oxide while also sensitizing the enzyme to endogenous nitric oxide, thereby increasing intracellular cGMP synthesis and promoting vascular smooth muscle relaxation. This enhancement of cGMP signaling attenuates pulmonary vascular tone and remodeling, demonstrating therapeutic efficacy in clinical trials targeting pulmonary arterial hypertension and chronic thromboembolic pulmonary 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>).

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