Adempas

(Riociguat)

ApprovedSmall molecule

Riociguat is used to treat pulmonary hypertension, a condition where high blood pressure in the lungs makes it harder for the heart to pump blood. It helps relax blood vessels in the lungs to improve blood flow and reduce symptoms like shortness of breath and fatigue.[2] Adempas is currently approved and in use across 22 indications[4].[1]

Adempas is one of 448 small molecule programs targeting Coronary Artery Disease. It is currently in Approved.

Indications

Total Trials

Active Trials

447

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Coronary Artery DiseaseApproved

Migraine Without AuraActive, not recruiting

Raynaud DiseaseApproved

StrokeActive, not recruiting

Pulmonary HypertensionActive, not recruiting

Chronic Obstructive Pulmonary DiseaseActive, not recruiting

Left Ventricular Diastolic DysfunctionActive, not recruiting

HypertensionActive, not recruiting

Ulcer DiseaseApproved

Interstitial Lung DiseaseActive, not recruiting

Coronary Artery DiseaseApproved

Approved

Migraine Without AuraPreclinical

Active, not recruiting

Raynaud DiseaseApproved

Approved

StrokePhase 2

Active, not recruiting

Pulmonary HypertensionApproved

Active, not recruiting

Chronic Obstructive Pulmonary DiseasePhase 1

Active, not recruiting

Left Ventricular Diastolic DysfunctionPhase 2

Active, not recruiting

HypertensionApproved

Active, not recruiting

Ulcer DiseaseApproved

Approved

Interstitial Lung DiseasePhase 2

Active, not recruiting

Showing 10 of 21 indications

Competition

Competitive Landscape

566 competitors in Hypertension

#DrugCompanyPhaseTrials

Adempas

Bayer

Approved

54 2

Apresoline

Novartis

Preclinical

7 3

Benicar

Novartis

Preclinical

7 4

Zebeta

Teva

Preclinical

6 5

Aceon

Institut de Recherches Internationales Servier

Preclinical

5 6

Winrevair

Alphagan

Deltavit

HHyundai Pharmaceutical Co., LTD.

Preclinical

2 9

Avastin

BBio-Thera Solutions

Preclinical

1 10

Ultiva

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 3Recruiting

Hemodynamic

NCT05140525

Q1 2027

Post-ApprovalRecruiting

Itching

NCT06715280

Q3 2027

Phase 3Active, not recruiting

Hypertension, Pulmonary

NCT02562235

Q4 2027

Phase 3Recruiting

CTEPH

NCT06922240

Clinical

Trials by Indication[1]

Pulmonary Hypertension8 trials

Pharmacodynamic Effects of Riociguat in Pulmonary Hypertension and Heart Failure With Preserved Ejection Fraction

Completed·MMedical University of Vienna·Phase 2·NCT02744339·118 enrolled

Riociguat for Sarcoidosis Associated Pulmonary Hypertension

Unknown status·UUniversity of Cincinnati·Phase 4·NCT02625558·60 enrolled

Pulmonary Hypertension: Intensification and Personalisation of Combination Rx

Recruiting·SSheffield Teaching Hospitals NHS Foundation Trust·Phase 4·NCT05825417·40 enrolled

Show 5 more trials

An Open Multiple Dose Titration Study In Patients With Pulmonary Hypertension

Completed· Bayer logo

Bayer·Phase 2·NCT00454558·75 enrolled

Interaction Study in Patients With Pulmonary Hypertension and Stable Treatment of Sildenafil 20 mg TID

Completed· Bayer logo

Bayer·Phase 1·NCT00680654·7 enrolled

A Study to Test the Effects of Riociguat in Patients With Pulmonary Hypertension Associated With Left Ventricular Systolic Dysfunction

Completed· Bayer logo

Bayer·Phase 2·NCT01065454·202 enrolled

Efficacy and Safety of Riociguat in Patients With Symptomatic Pulmonary Hypertension (PH) Associated With Idiopathic Interstitial Pneumonias (IIP)

Terminated· Bayer logo

Bayer·Phase 2·NCT02138825·147 enrolled

EXPERT, EXPosurE Registry RiociguaT in Patients With Pulmonary Hypertension

Completed· Bayer logo

Bayer··NCT02092818·1,316 enrolled

Pulmonary Arterial Hypertension6 trials

BAY63-2521:Long-term Extension Study in Patients With Pulmonary Arterial Hypertension

Completed· Bayer logo

Bayer·Phase 3·NCT00863681·396 enrolled

A Study to Evaluate Efficacy and Safety of Oral BAY63-2521 in Patients With Pulmonary Arterial Hypertension (PAH)

Completed· Bayer logo

Bayer·Phase 3·NCT00810693·445 enrolled

A Study to Learn About How Well Riociguat Works, How Safe it is and How it is Used Under Real World Conditions in Patients in the United States Who Are Receiving Riociguat for High Blood Pressure in the Arteries That Carry Blood From the Heart to the Lungs (Pulmonary Arterial Hypertension, PAH)

Completed· Bayer logo

Bayer··NCT04813926·500 enrolled

Show 3 more trials

Measuring Outcomes In Patients With Pulmonary Arterial Hypertension Not on Active Treatment (MOTION)

Completed· Bayer logo

Bayer·Phase 4·NCT02191137·75 enrolled

Upfront Combination Pulmonary Arterial Hypertension Therapy

Unknown status·UUniversity of Calgary·Phase 4·NCT03809156·20 enrolled

Prospective, Non-interventional, Multi-center, Post-authorization Safety Study of Riociguat for Pulmonary Arterial Hypertension (PAH)

Completed· Bayer logo

Bayer··NCT02428985·882 enrolled

Chronic Thromboembolic Pulmonary Hypertension5 trials

Sleep-Disordered Breathing in Chronic Thromboembolic Pulmonary Hypertension

Completed·MMedical University of Vienna·N/A·NCT03074539·50 enrolled

Riociguat Versus Balloon Pulmonary Angioplasty in Non-operable Chronic thromboEmbolic Pulmonary Hypertension

Completed·AAssistance Publique - Hôpitaux de Paris·N/A·NCT02634203·105 enrolled

Prospective, Non-interventional, Multi-center Post-authorization Safety Study of Riociguat for Chronic Thromboembolic Pulmonary Hypertension (CTEPH )

Completed· Bayer logo

Bayer··NCT02117791·1,298 enrolled

Show 2 more trials

A Study to Understand the Treatment Patterns in Patients With Pulmonary Arterial Hypertension or Chronic Thromboembolic Pulmonary Hypertension During a Switch of Treatment to Adempas in Real-life Clinical Practice

Completed· Bayer logo

Bayer··NCT02545465·125 enrolled

BAY63-2521 - Long-term Extension Study in Patients With Chronic Thromboembolic Pulmonary Hypertension

Completed· Bayer logo

Bayer·Phase 3·NCT00910429·237 enrolled

CTEPH2 trials

Riociguat in Patients With Operable CTEPH Prior to Pulmonary Endarterectomy (PEA Bridging Study)

Terminated·IInternational CTEPH Association·Phase 2·NCT03273257·14 enrolled

Riociguat-Discontinue Effects on Right HEART in CTEPH (RED-HEART)

Recruiting·SSuqiao Yang·Phase 3·NCT06922240·68 enrolled

Hemodynamic2 trials

Effects of Combination Medical Therapy Followed by BPA on Right Ventricular-PA Coupling and Hemodynamics in CTEPH

Recruiting·DDr Sudarshan Rajagopal·Phase 3·NCT05140525·15 enrolled

Hemodynamic and Echocardiographic Assessment of Riociguat Effects on Myocardial Wall Contractility and Relaxation Kinetics

Terminated· Bayer logo

Bayer·Phase 2·NCT01065051·1 enrolled

27 more indications

Function2 trials

Effects of Riociguat on RIght VEntricular Size and Function in PAH and CTEPH

Terminated·HHeidelberg University·Phase 4·NCT04954742·30 enrolled

Study on the Safety of BAY 63-2521, How it is Tolerated and the Way the Body Absorbs, Distributes and Gets Rid of the Study Drug Given as a Single Oral Dose of 1 mg Tablet in Participants With Impaired Liver Function and Healthy Participants Matched for Age-, Gender-, and Weight

Completed· Bayer logo

Bayer·Phase 1·NCT04366622·32 enrolled

Sickle Cell Disease1 trial

A Multi-Center Study of Riociguat in Patients With Sickle Cell Diseases

Completed·MMark Gladwin·Phase 2·NCT02633397·130 enrolled

Headache1 trial

Effect of Riocigaut on Cerebral Vasodilation and Headache Induction in Healthy Volunteers

Completed·DDanish Headache Center·N/A·NCT05582811·15 enrolled

ART1 trial

A 2-part Study to Investigate the Effect of Macitentan in Healthy Male Participants

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT04211272·47 enrolled

Scleroderma1 trial

Riociguat in Scleroderma Associated Digital Ulcers

Completed·—·Phase 2·NCT02915835·17 enrolled

Treatment1 trial

Riociguat Clinical Effects Studied in Patients With Insufficient Treatment Response to Phosphodiesterase-5 Inhibitor

Completed· Bayer logo

Bayer·Phase 3·NCT02007629·61 enrolled

Efficacy1 trial

Efficacy Study of Riociguat and Its Effects on Exercise Performance and Pulmonary Artery Pressure at High Altitude

Completed·RRichard Moon·Phase 4·NCT02024386·28 enrolled

Stroke1 trial

Networked Drug REpurposing for Mechanism-based neuroPrOtection in Acute Ischaemic STROKE

Unknown status·MMaastricht University·Phase 2·NCT05762146·28 enrolled

Itching1 trial

Switching of Sildenafil to Riociguat in CTEPH Patients

Recruiting·—·Phase 4·NCT06715280·30 enrolled

Left ventricular diastolic dysfunction1 trial

A Study to Test the Effects of Riociguat in Patients With Pulmonary Hypertension Associated With Left Ventricular Diastolic Dysfunction

Terminated· Bayer logo

Bayer·Phase 2·NCT01172756·39 enrolled

TED1 trial

Bioequivalence Study of Riociguat 2.5 mg Film Coated Tablets and Adempas (Riociguat) 2.5 mg Film Coated Tablets

Completed·HHumanis Saglık Anonim Sirketi·Phase 1·NCT06180096·36 enrolled

Trial1 trial

THERAPY-HYBRID-BPA Trial

Unknown status·NNational Hospital Organization Okayama Medical Center·Phase 2·NCT04600492·72 enrolled

AIN1 trial

Riociguat rEplacing PDE-5i Therapy evaLuated Against Continued PDE-5i thErapy

Completed· Bayer logo

Bayer·Phase 4·NCT02891850·225 enrolled

Migraine1 trial

Effect of Riocigaut on Migraine Attack Induction in People With Migraine

Completed·DDanish Headache Center·N/A·NCT05750446·22 enrolled

Systemic Sclerosis1 trial

Efficacy and Safety of Riociguat in Patients With Systemic Sclerosis

Completed· Bayer logo

Bayer·Phase 2·NCT02283762·121 enrolled

Blood Pressure1 trial

Evaluation of the Pharmacodynamic Effect of the Combination of Sildenafil and Riociguat on Blood Pressure and Other Safety Parameters.

Completed· Bayer logo

Bayer·Phase 2·NCT01179334·18 enrolled

Chronic Obstructive Pulmonary Disease1 trial

Single Dose Study in Patients With Chronic Obstructive Pulmonary Disease (COPD) Associated Pulmonary Hypertension.

Completed· Bayer logo

Bayer·Phase 1·NCT00640315·23 enrolled

Renal Impairment1 trial

Study on the Safety of BAY 63-2521, How it is Tolerated and the Way the Body Absorbs, Distributes and Gets Rid of the Study Drug Given as a Single Oral Dose of 1 mg Tablet in Participants With Renal Impairment and Healthy Participants Matched for Age-, Gender-, and Weight

Completed· Bayer logo

Bayer·Phase 1·NCT04364464·40 enrolled

Interaction1 trial

Interaction With HIV Antiretroviral Agents

Completed· Bayer logo

Bayer·Phase 1·NCT02556268·40 enrolled

Tics1 trial

Clinical Study to Investigate Effect of Macitentan on Riociguat Pharmacokinetics

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT03389321·20 enrolled

Efficacy and Safety1 trial

A Study to Evaluate Efficacy and Safety of Oral BAY63-2521 in Patients With CTEPH.

Completed· Bayer logo

Bayer·Phase 3·NCT00855465·262 enrolled

Interstitial Lung Disease1 trial

Impact of Multiple Doses of BAY63-2521 on Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Patients With Interstitial Lung Disease (ILD) Associated Pulmonary Hypertension (PH)

Completed· Bayer logo

Bayer·Phase 2·NCT00694850·22 enrolled

Cystic Fibrosis1 trial

Early Signs of Efficacy Study With Riociguat in Adult Homozygous Delta F508 Cystic Fibrosis Patients

Terminated· Bayer logo

Bayer·Phase 2·NCT02170025·21 enrolled

Vascular Disease1 trial

Efficacy and Safety of Riociguat in Incipient Pulmonary Vascular Disease as an Indicator for Early PAH

Terminated·HHeidelberg University·Phase 2·NCT05339087·35 enrolled

Postmenopausal Women1 trial

Microgynon Riociguat Drug Interaction Study in Healthy Postmenopausal Women

Completed· Bayer logo

Bayer·Phase 1·NCT02159326·31 enrolled

Hypertension, Pulmonary1 trial

Open-label, Individual Dose Titration Study to Evaluate Safety, Tolerability and Pharmacokinetics of Riociguat in Children From 6 to Less Than 18 Years of Age With Pulmonary Arterial Hypertension (PAH)

Active, not recruiting· Bayer logo

Bayer·Phase 3·NCT02562235·24 enrolled

Unspecified4 trials

Digital Flow Enhancement in Raynaud's Phenomenon With an sGC (Soluble Guanylate Cyclase) Stimulator

Completed· Bayer logo

Bayer·Phase 2·NCT01926847·23 enrolled

Coronary Vasomotor Response After Riociguat Exposure

Withdrawn· Bayer logo

Bayer·Phase 2·NCT01165931

Relative Bioavailability Study

Completed· Bayer logo

Bayer·Phase 1·NCT02159313·48 enrolled

Show 1 more trial

Relative Bioavailability and Food Effect Study

Completed· Bayer logo

Bayer·Phase 1·NCT01489488·32 enrolled

Regulatory

FDA Approval Timeline[5]

Oct 8, 2013

ADEMPAS

NDA NDA204819

Sources

References

[1]
ClinicalTrials.gov — 54 trial records for Riociguat. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Adempas drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Riociguat compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Riociguat. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA204819). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Adempas. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Bayer company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Soluble Guanylate Cyclase Positive Allosteric Modulator[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Bayer

Patent Landscape[6]

Patent Cliff

Dec 4, 2026

Earliest patent expiration — generic entry possible after this date

Patent #Expires

7173037Dec 4, 2026

12503469Feb 18, 2034

10662188Feb 18, 2034

11203593Feb 18, 2034

Adempas

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Q3 2027

Q4 2027

Trials by Indication[1]

Pulmonary Hypertension8 trials

Pulmonary Arterial Hypertension6 trials

Chronic Thromboembolic Pulmonary Hypertension5 trials

CTEPH2 trials

Hemodynamic2 trials

Function2 trials

Sickle Cell Disease1 trial

Headache1 trial

ART1 trial

Scleroderma1 trial

Treatment1 trial

Efficacy1 trial

Stroke1 trial

Itching1 trial

Left ventricular diastolic dysfunction1 trial

TED1 trial

Trial1 trial

AIN1 trial

Migraine1 trial

Systemic Sclerosis1 trial

Blood Pressure1 trial

Chronic Obstructive Pulmonary Disease1 trial

Renal Impairment1 trial

Interaction1 trial

Tics1 trial

Efficacy and Safety1 trial

Interstitial Lung Disease1 trial

Cystic Fibrosis1 trial

Vascular Disease1 trial

Postmenopausal Women1 trial

Hypertension, Pulmonary1 trial

Unspecified4 trials

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

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