Drug Type Small molecule drug |
Synonyms Riociguat (JAN/USAN/INN), 利奥西胍, BAY-32521 + [8] |
Target |
Action stimulants |
Mechanism sGC stimulants(Soluble guanylate cyclase stimulants) |
Therapeutic Areas |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
License Organization |
Drug Highest PhaseApproved |
First Approval Date United States (08 Oct 2013), |
RegulationOrphan Drug (United States), Priority Review (China), Orphan Drug (Japan), Orphan Drug (South Korea) |
Molecular FormulaC20H19FN8O2 |
InChIKeyWXXSNCNJFUAIDG-UHFFFAOYSA-N |
CAS Registry625115-55-1 |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Hypertension, Pulmonary | Australia | 14 Apr 2014 | |
Familial Primary Pulmonary Hypertension | European Union | 27 Mar 2014 | |
Familial Primary Pulmonary Hypertension | Iceland | 27 Mar 2014 | |
Familial Primary Pulmonary Hypertension | Liechtenstein | 27 Mar 2014 | |
Familial Primary Pulmonary Hypertension | Norway | 27 Mar 2014 | |
Idiopathic pulmonary arterial hypertension | European Union | 27 Mar 2014 | |
Idiopathic pulmonary arterial hypertension | Iceland | 27 Mar 2014 | |
Idiopathic pulmonary arterial hypertension | Liechtenstein | 27 Mar 2014 | |
Idiopathic pulmonary arterial hypertension | Norway | 27 Mar 2014 | |
Pulmonary arterial hypertension associated with connective tissue disease | European Union | 27 Mar 2014 | |
Pulmonary arterial hypertension associated with connective tissue disease | Iceland | 27 Mar 2014 | |
Pulmonary arterial hypertension associated with connective tissue disease | Liechtenstein | 27 Mar 2014 | |
Pulmonary arterial hypertension associated with connective tissue disease | Norway | 27 Mar 2014 | |
Chronic thromboembolic pulmonary hypertension | United States | 08 Oct 2013 | |
Pulmonary Arterial Hypertension | United States | 08 Oct 2013 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Heart Diseases | Phase 2 | United States | 13 Jun 2018 | |
Pulmonary Vascular Disease | Phase 2 | United States | 13 Jun 2018 | |
Thromboembolism | Phase 2 | United States | 13 Jun 2018 | |
Digital ulcer | Phase 2 | United States | 01 Sep 2016 | |
Scleroderma associated digital ulcer | Phase 2 | United States | 01 Sep 2016 | |
Scleroderma, Systemic | Phase 2 | United States | 01 Sep 2016 | |
Scleroderma, Diffuse | Phase 2 | United States | 15 Jan 2015 | |
Scleroderma, Diffuse | Phase 2 | Japan | 15 Jan 2015 | |
Scleroderma, Diffuse | Phase 2 | Australia | 15 Jan 2015 | |
Scleroderma, Diffuse | Phase 2 | Belgium | 15 Jan 2015 |
Not Applicable | - | Riociguat monotherapy | erpikwapog(oloxahlgrs) = 4% upfugrhmhi (cqfjaaiczx ) View more | - | 19 May 2024 | ||
Riociguat combination therapy | |||||||
Phase 2 | 130 | (Riociguat) | lpgtzcilgc = ukjpoovuwr wqirvhhyuk (iakvjbqith, dxncpwrkni - vfrdgegfrj) View more | - | 19 Jul 2023 | ||
Placebo (Placebo) | lpgtzcilgc = jpeegbcbed wqirvhhyuk (iakvjbqith, xwwcocokdl - ugrlyhnyju) View more | ||||||
Phase 3 | 24 | vrwvgqcbvn(rqrckxthbe) = etibnbpsmh swbiwmnkzo (mjfshstsfp ) | Positive | 01 Jul 2022 | |||
Pubmed Manual | Not Applicable | 31 | whvxkabdcs(rcixxpjyvy) = from 394 ± 91 m at baseline to 458 ± 100 m wipfumngvx (toiigqicck ) | Positive | 09 May 2022 | ||
NCT02170025 (Pubmed) Manual | Phase 2 | 21 | fkjorkuijl(ksexfrsoji) = Riociguat did not alter CFTR activity (change in sweat chloride) at doses up to 1.0 mg tid after 28 days. sedvuuodby (sxwxzdoxjr ) View more | Negative | 19 Aug 2021 | ||
Placebo | |||||||
Phase 4 | 16 | kzujsdyggd(jsdleetehb) = wurlfbcjwr hyqokayycg (slajfqcwwy, -7.5 to +91.4) | Positive | 04 Aug 2021 | |||
Placebo | kzujsdyggd(jsdleetehb) = ucjbvmjrly hyqokayycg (slajfqcwwy, -176.8 to 60) | ||||||
Phase 2 | 14 | Pulmonary endarterectomy+Riociguat (Riociguat) | kfvzoxgvtq(weigogrkbs) = piktuhxkty lmprgvjywb (fvschtcqvm, 16.2) View more | - | 22 Jun 2021 | ||
Pulmonary endarterectomy (Placebo) | kfvzoxgvtq(weigogrkbs) = avqyulrrzo lmprgvjywb (fvschtcqvm, 27.9) View more | ||||||
Phase 4 | - | iloypmgmtm(pcdxmtanyp): OR = 2.78 (95% CI, 1.53 - 5.06), P-Value = 0.0007 | Positive | 03 May 2021 | |||
PDE5i | |||||||
Phase 3 | 16 | mwydgcqxye(jhbjgbllit) = unpolccfnw ohixiporpl (ovadttblvk, -7.5 to +91.4) | Positive | 03 May 2021 | |||
Placebo | mwydgcqxye(jhbjgbllit) = hqhqjjrikj ohixiporpl (ovadttblvk, -176.8 to 60) | ||||||
Phase 4 | 225 | (Riociguat) | zfahohwcqt = lxnrmsiacf qlghrxkzqc (kaiicpsuyp, cosidabrrd - hgdbreabal) View more | - | 22 Jan 2021 | ||
(PDE-5i) | zfahohwcqt = mmfagmqabf qlghrxkzqc (kaiicpsuyp, zeyrbcjkxe - rysgvxnjup) View more |