Drugs / Riociguat
Riociguat
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | ADEMPAS | — | 2018-01-11 | fda.gov ↗ |
| Approved | EU (EMA) | Adempas | — | 2014-03-27 | europa.eu ↗ |
| Approved | US (FDA) | ADEMPAS | — | 2013-10-08 | fda.gov ↗ |
Trials 45
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 111 trials | ||||||
| Phase 1 | NCT04776499 | Mar 2021 → Feb 2022 | — | Maastricht University | Completed | No outcome recorded |
| Phase 1 | NCT04211272 | Jan 2020 → Apr 2021 | — | Actelion | Completed | No outcome recorded |
| Phase 1 | NCT03389321 | Jan → Feb 2018 | — | Actelion | Completed | No outcome recorded |
| Phase 1 | NCT02556268 | Feb → Dec 2016 | — | Bayer | Completed | No outcome recorded |
| Phase 1 | NCT02159326 | Jun 2014 → Mar 2015 | — | Bayer | Completed | No outcome recorded |
| Phase 1 | NCT02159313 | Jun → Sep 2014 | — | Bayer | Completed | No outcome recorded |
| Phase 1 | NCT01489488 | Jan → Apr 2012 | — | Bayer | Completed | No outcome recorded |
| Phase 1 | NCT04366622 | Apr 2010 → Apr 2011 | — | Bayer | Completed | No outcome recorded |
| Phase 1 | NCT04364464 | Feb 2010 → Mar 2011 | — | Bayer | Completed | No outcome recorded |
| Phase 1 | NCT00680654 | Oct 2008 → Aug 2009 | pulmonary hypertension | Bayer | Completed | No outcome recorded |
| Phase 1 | NCT00640315 | Aug 2008 → Sep 2009 | chronic obstructive pulmonary disease, pulmonary hypertension | Bayer | Completed | No outcome recorded |
| Phase 216 trials · 1 met primary · 6 missed | ||||||
| Phase 2 | NCT05339087 | Oct 2022 → Jul 2025 | pulmonary arterial hypertension, systemic sclerosis | Heidelberg University | Terminated | Met primary Stop: Business |
| Phase 2 | NCT05762146 | Sep 2022 → Feb 2024 | ischemic stroke | Maastricht University | Unknown | No outcome recorded |
| Phase 2 | NCT03409588 | Jun 2018 → Jan 2026 | venous thromboembolism | University of Colorado, Denver | Completed | No outcome recorded |
| Phase 2 | NCT02633397 | Apr 2017 → May 2022 | sickle cell disease | Mark Gladwin | Completed | No outcome recorded |
| Phase 2 | NCT02744339 | Mar 2016 → Aug 2020 | diastolic heart failure, pulmonary hypertension | Medical University of Vienna | Completed | No outcome recorded |
| Phase 2 | NCT02283762 | Jan 2015 → Dec 2017 | systemic sclerosis | Bayer | Completed | Missed primary |
| Phase 2 | NCT02170025 | Sep 2014 → Jan 2017 | cystic fibrosis | Bayer | Terminated | Missed primary |
| Phase 2 | NCT02138825 | Jun 2014 → May 2016 | idiopathic interstitial pneumonia | Bayer | Terminated | Missed primary |
| Phase 2 | NCT01926847 | Oct 2013 → Jun 2014 | Raynaud disease | Bayer | Completed | No outcome recorded |
| Phase 2 | NCT01165931 | May 2012 → Jan 2013 | coronary artery disorder | Bayer | Withdrawn | No outcome recorded |
| Phase 2 | NCT01065051 | Nov 2010 → Jan 2011 | left ventricular failure, pulmonary hypertension | Bayer | Terminated | No outcome recorded |
| Phase 2 | NCT01179334 | Aug 2010 → Jun 2012 | pulmonary hypertension | Bayer | Completed | Missed primary |
| Phase 2 | NCT01172756 | Jul 2010 → Oct 2012 | left ventricular failure, pulmonary hypertension | Bayer | Terminated | Missed primary Stop: Enrollment |
| Phase 2 | NCT01065454 | Apr 2010 → Jun 2012 | left ventricular failure, pulmonary hypertension | Bayer | Completed | Missed primary |
| Phase 2 | NCT00694850 | Aug 2008 → Jul 2025 | pulmonary hypertension | Bayer | Completed | No outcome recorded |
| Phase 2 | NCT00454558 | Jan 2007 → Jul 2014 | pulmonary hypertension | Bayer | Completed | No outcome recorded |
| Phase 38 trials · 2 met primary | ||||||
| Phase 3 | NCT07644377 | Nov 2026 → Jan 2031 expected | chronic thromboembolic pulmonary hypertension | Assistance Publique - Hôpitaux de Paris | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT04062565 | Mar 2019 → Dec 2025 overdue | pulmonary arterial hypertension | University of Arizona | Recruiting | No outcome recorded |
| Phase 3 | NCT02562235 | Oct 2015 → Mar 2020 overdue | pulmonary arterial hypertension | Bayer | Active not recruiting | No outcome recorded |
| Phase 3 | NCT02007629 | Feb 2014 → Dec 2016 | pulmonary arterial hypertension | Bayer | Completed | No outcome recorded |
| Phase 3 | NCT00910429 | Jul 2009 → Aug 2019 | pulmonary hypertension | Bayer | Completed | No outcome recorded |
| Phase 3 | NCT00863681 | Mar 2009 → Aug 2019 | pulmonary arterial hypertension | Bayer | Completed | No outcome recorded |
| Phase 3 | NCT00855465 | Feb 2009 → Jun 2012 | pulmonary hypertension | Bayer | Completed | Met primary |
| Phase 3 | NCT00810693 | Dec 2008 → May 2012 | pulmonary hypertension | Bayer | Completed | Met primary |
| Phase 47 trials · 2 met primary | ||||||
| Phase 4 | NCT06715280 | Jul 2024 → Jul 2026 overdue | chronic thromboembolic pulmonary hypertension | Chinese University of Hong Kong | Recruiting | No outcome recorded |
| Phase 4 | NCT04954742 | Apr 2022 → Aug 2025 | chronic thromboembolic pulmonary hypertension, pulmonary arterial hypertension | Heidelberg University | Terminated | Met primary Stop: Business |
| Phase 4 | NCT02891850 | Jan 2017 → Jan 2020 | pulmonary arterial hypertension | Bayer | Completed | Met primary |
| Phase 4 | NCT02759419 | Jun 2016 → Sep 2025 | pulmonary arterial hypertension | Bayer | Completed | No outcome recorded |
| Phase 4 | NCT03809156 | Apr 2016 → Dec 2020 | pulmonary hypertension | University of Calgary | Unknown | No outcome recorded |
| Phase 4 | NCT02191137 | Sep 2014 → Jul 2016 | pulmonary arterial hypertension | Bayer | Completed | No outcome recorded |
| Phase 4 | NCT02024386 | Jan 2014 → Dec 2015 | altitude sickness, pulmonary hypertension | Richard Moon | Completed | No outcome recorded |
| Phase not applicable2 trials | ||||||
| — | NCT05750446 | Jun 2023 → Feb 2024 | migraine without aura | Danish Headache Center | Completed | No outcome recorded |
| — | NCT05582811 | Oct 2022 → Jun 2023 | headache disorder | Danish Headache Center | Completed | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT01784562 | — | pulmonary hypertension | Bayer | No longer available | No outcome recorded |
| Comparator or background therapy10 trials | ||||||
| Phase 1 | NCT00855660 Comparator | Mar → Dec 2009 | — | Bayer | Completed | No outcome recorded |
| Phase 2 | NCT04600492 Comparator | Oct 2020 → Sep 2023 | pulmonary hypertension | National Hospital Organization Okayama Medical Center | Unknown | No outcome recorded |
| Phase 2 | NCT03273257 Comparator | Aug 2018 → May 2020 | chronic thromboembolic pulmonary hypertension | International CTEPH Association | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT02915835 Comparator | Sep 2016 → Jul 2018 | scleroderma | Dinesh Khanna, MD, MS | Completed | No outcome recorded |
| Phase 3 | NCT06922240 Comparator | Mar 2025 → Oct 2026 expected | chronic thromboembolic pulmonary hypertension | Suqiao Yang | Recruiting | No outcome recorded |
| Phase 3 | NCT05140525 Comparator | Jan 2025 → Mar 2026 | chronic thromboembolic pulmonary hypertension | Dr Sudarshan Rajagopal | Terminated | No outcome recorded |
| Phase 4 | NCT05825417 Comparator | Jun 2023 → Jan 2027 expected | pulmonary arterial hypertension | Sheffield Teaching Hospitals NHS Foundation Trust | Recruiting | No outcome recorded |
| Phase 4 | NCT02625558 Comparator | Apr 2015 → Apr 2018 | sarcoidosis | University of Cincinnati | Unknown | No outcome recorded |
| — | NCT03074539 Comparator | Feb 2017 → Dec 2022 | chronic thromboembolic pulmonary hypertension, sleep apnea syndrome | Medical University of Vienna | Completed | No outcome recorded |
| — | NCT02634203 Comparator | Jan 2016 → Jan 2020 | chronic thromboembolic pulmonary hypertension | Assistance Publique - Hôpitaux de Paris | Completed | No outcome recorded |
Press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2026-10-05 | Zydus Lifesciences Limited | Zydus, MSN partner to Launch First Generic of Adempas® (Riociguat Tablets) in the U.S. zyduslife.com ↗ |
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 57 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Riociguat | “Riociguat (Adempas,BAY63-2521)” NCT02159326 ↗ |
| Known as | Adempas | “Treatment A consists of a single oral dose (1 mg) of riociguat (Adempas) on Day 1.” NCT03389321 ↗28“Riociguat (Adempas, BAY63-2521) immediate release tablet of 2.5 mg” NCT00855660 ↗ “Riociguat (Adempas, BAY63-2521) 1.0 mg” NCT00640315 ↗ “Drug: Riociguat(Adempas,BAY63-2521)” NCT02159313 ↗ “Riociguat (Adempas, BAY 63-2521)” NCT04364464 ↗ “Riociguat (Adempas, BAY 63-2521)” NCT02556268 ↗ “Riociguat (Adempas, BAY63-2521).” NCT00694850 ↗ “Riociguat (Adempas, BAY 63-2521)” NCT04366622 ↗ “Riociguat (Adempas, BAY63-2521)” NCT00680654 ↗ “Riociguat (Adempas, BAY63-2521)” NCT01926847 ↗ “Riociguat (Adempas, BAY63-2521)” NCT02562235 ↗ |
| Known as | BAY63-2521 | “Single oral dose of 2.4 milligram (mg) riociguat (BAY63-2521) as pediatric high-concentration suspension” NCT01489488 ↗31“Riociguat (BAY 63-2521), a Stimulator of Soluble Guanylate Cyclase (sGC)” NCT05582811 ↗ “Riociguat (Adempas, BAY63-2521) immediate release tablet of 2.5 mg” NCT00855660 ↗ “Riociguat (Adempas, BAY63-2521) 1.0 mg” NCT00640315 ↗ “Drug: Riociguat(Adempas,BAY63-2521)” NCT02159313 ↗ “Riociguat (Adempas, BAY 63-2521)” NCT02556268 ↗ “Riociguat (Adempas, BAY63-2521).” NCT00694850 ↗ “Riociguat (Adempas, BAY 63-2521)” NCT04364464 ↗ “Riociguat (Adempas, BAY 63-2521)” NCT04366622 ↗ “Riociguat (Adempas, BAY63-2521)” NCT01926847 ↗ “Riociguat (Adempas, BAY63-2521)” NCT02283762 ↗ |
| Known as | MK-4836 | “Efficacy and Safety of Riociguat (MK-4836) in Incipient Pulmonary Vascular Disease” NCT05339087 ↗ |
| Action | Activate | “Bayer AG is developing riociguat, an oral sGC stimulator” PMID 19705340 ↗ Sep 2009 |
| Modality | Other / unclassified | “sGC stimulator Riociguat” NCT01926847 ↗ |
| Route | Oral | “patients received oral riociguat 1.0-2.5 mg t.i.d.” PMID 20530034 ↗ Jun 2010 |