Data updated: May 26, 2026
RIOCIGUAT
Cardiovascular
Approved 2022-09-01
1
Indication
--
Phase 3 Trials
3
Years on Market
Details
- Status
- None (Tentative Approval)
- First Approved
- 2022-09-01
- Routes
- ORAL
- Dosage Forms
- TABLET
RIOCIGUAT Approval History
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
10 FDA actions from 2022 to 2026
May 2026 SUPPL
Update · REMS
What RIOCIGUAT Treats
1 FDA approvalsOriginally approved for its first indication in 2022 .
- Other (1)
Other
(1 approval)- • Approved indication (Sep 2022)Letter
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Clinical Trial Registry
10 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05140525 EPIPHANY | Pro00105903 | Ph 3 | recruiting | Effects of Combination Medical Therapy Followed by BPA on Right Ventricular-PA Coupling and Hemodynamics in CTEPH |
| NCT04954742 RIVERII | 2020-06RCT | Ph 4 | terminated | Effects of Riociguat on RIght VEntricular Size and Function in PAH and CTEPH |
| NCT06922240 RED-HEART | BRWEP2024W112030108 | Ph 3 | recruiting | Riociguat-Discontinue Effects on Right HEART in CTEPH (RED-HEART) |
| NCT04211272 | CR108727 2019-004001-27, 67896062PAH1003 | Ph 1 | completed | A 2-part Study to Investigate the Effect of Macitentan in Healthy Male Participants |
| NCT05825417 PHoenix | STH21653 MR/W026279/1, 325120 | Ph 4 | recruiting | Pulmonary Hypertension: Intensification and Personalisation of Combination Rx |
| NCT02633397 results posted | PRO15110016 | Ph 2 | completed | A Multi-Center Study of Riociguat in Patients With Sickle Cell Diseases |
| NCT03273257 results posted | PEA Bridging Study | Ph 2 | terminated | Riociguat in Patients With Operable CTEPH Prior to Pulmonary Endarterectomy (PEA Bridging Study) |
| NCT02744339 DYNAMIC | RIO-40400 2014-003055-60 | Ph 2 | completed | Pharmacodynamic Effects of Riociguat in Pulmonary Hypertension and Heart Failure With Preserved Ejection Fraction |
| NCT02915835 RESCUE results posted | BAY63-2521 | Ph 2 | completed | Riociguat in Scleroderma Associated Digital Ulcers |
| NCT02024386 results posted | Pro00049150 | Ph 4 | completed | Efficacy Study of Riociguat and Its Effects on Exercise Performance and Pulmonary Artery Pressure at High Altitude |
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
RIOCIGUAT FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.