ADEMPAS (riociguat)
Adempas treats adults with specific types of high blood pressure in the lungs, including pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension. It helps patients who have persistent symptoms after surgery for blood clots or those with conditions that cannot be treated surgically. This medication is used to improve a patient's ability to exercise and perform daily tasks while also helping to delay the worsening of their condition.
How ADEMPAS Works
This drug works by targeting an enzyme called soluble guanylate cyclase, which serves as the receptor for nitric oxide in the heart and lungs. It uses a dual approach to increase the production of a signaling molecule that triggers vasodilation and regulates vascular inflammation and fibrosis. By both sensitizing the enzyme to existing nitric oxide and stimulating it directly, the medication helps restore signaling pathways that are often impaired in pulmonary hypertension.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2013-10-08
- Patent Cliff
- 2034
- Routes
- ORAL
- Dosage Forms
- TABLET
ADEMPAS Approval History
What ADEMPAS Treats
2 indicationsADEMPAS is approved for 2 conditions since its original approval in 2013. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Chronic Thromboembolic Pulmonary Hypertension
- Pulmonary Arterial Hypertension
ADEMPAS Boxed Warning
EMBRYO-FETAL TOXICITY Adempas is contraindicated for use during pregnancy because it may cause fetal harm based on animal data [see Contraindications (4.1) , Warnings and Precautions (5.1) , and Use in Specific Populations (8.1) ]. Females of reproductive potential: Confirm negative pregnancy status before the start of treatment. Use effective contraception prior to initiation of treatment, during treatment, and for one month after treatment with Adempas [see Dosage and Administration (2.3) , Wa...
WARNING: EMBRYO-FETAL TOXICITY Adempas is contraindicated for use during pregnancy because it may cause fetal harm based on animal data [see Contraindications (4.1) , Warnings and Precautions (5.1) , and Use in Specific Populations (8.1) ]. Females of reproductive potential: Confirm negative pregnancy status before the start of treatment. Use effective contraception prior to initiation of treatment, during treatment, and for one month after treatment with Adempas [see Dosage and Administration (2.3) , Warnings and Precautions (5.1) ,and Use in Specific Populations (8.3) ] . When pregnancy is detected, discontinue Adempas as soon as possible [see Warnings and Precautions (5.1) ] . WARNING: EMBRYO-FETAL TOXICITY See full prescribing information for complete boxed warning. • Based on animal data Adempas may cause fetal harm if used during pregnancy. ( 4.1 , 5.1 , 8.1 ) • Females of reproductive potential: Confirm negative pregnancy status before the start of treatment. Use effective contraception prior to initiation of treatment, during treatment, and for one month after treatment with Adempas. ( 2.3 , 5.1 8.6 ) • When pregnancy is detected, discontinue Adempas as soon as possible ( 5.1 )
ADEMPAS Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in ADEMPAS's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications ADEMPAS treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to ADEMPAS
3 of 18FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
11 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03409588 | 17-2349 | Ph 2 | completed | Treatment of Exercise-Induced Pulmonary Vascular Dysfunction After Pulmonary Thromboendarterectomy or Balloon Pulmonary Angioplasty |
| 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 |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
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.
ADEMPAS FDA Label Details
Indications & Usage
FDA Label (PDF)ADEMPAS is indicated for the treatment of Chronic Thromboembolic Pulmonary Hypertension; Pulmonary Arterial Hypertension.
WARNING: EMBRYO-FETAL TOXICITY Adempas is contraindicated for use during pregnancy because it may cause fetal harm based on animal data [see Contraindications (4.1) , Warnings and Precautions (5.1) , and Use in Specific Populations (8.1) ]. Females of reproductive potential: Confirm negative pregnan...
ADEMPAS Patents & Exclusivity
Patents (4 active)
Pro Intelligence Preview
Deep insights for ADEMPAS
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2034
- • 175 active patents
Trial Analysis
- • 11 total trials
- • Stage: Stable
Competitive Landscape
- • 18 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment