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Adempas

Phase 2

Chronic Thromboembolic Disease (CTED) | Small molecule | Other |Bayer AG|Last Updated: Feb 5, 2026

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment10

FDA Designations

No designations recorded

Clinical trial landscape

Adempas · 1 trial · 2 indications

Phase 2 1
NCT03409588Treatment of Exercise-Induced Pulmonary Vascular Dysfunction After Pulmonary Thromboendarterectomy or Balloon Pulmonary AngioplastyChronic Thromboembolic Disease (CTED)
COMPLETED10 Analytics
PHASE2COMPLETED
Treatment of Exercise-Induced Pulmonary Vascular Dysfunction After Pulmonary Thromboendarterectomy or Balloon Pulmonary Angioplasty
Chronic Thromboembolic Disease (CTED)
NCT0340958810
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Study Endpoints

Primary Endpoints

Change in mean pulmonary arterial pressure
Baseline and 3 months

Measurements include mPAP (mean pulmonary arterial pressure) measured by right heart catheterization (RHC)

Change in cardiac output
Baseline and 3 months

Measurements include CO (cardiac output) mPAP/CO slope measured by right heart catheterization (RHC)

Change in Pulmonary artery compliance
Baseline and 3 months

Measurements include Pulmonary artery compliance measured by right heart catheterization (RHC)

Secondary Endpoints

Change in 6 minute walk test
Baseline and 3 months
Change in New York Heart Association (NYHA) functional class
Baseline and 3 months
Change in the University of California San Diego (UCSD) shortness of Breath Score
Baseline and 3 months
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Study DrugEXPERIMENTALRiociguat (Adempas) 0.5mg to 2.5 mg three time daily - oral medication

Interventions

NameTypeDescription
AdempasDRUGAfter obtaining baseline data, patients will be placed on oral riociguat at a dose of 0.5 mg TID which will be up titrated over two months to a maximum dose of 2.5 mg TID or maximum tolerated dose. After 3 months from onset of riociguat initiation, the University of California San Diego (UCSD) shortness of breath score, 6 Minute Walk Test (6MWD), and resting/exercise Right Heart Catheterization (RHC) will be repeated.
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Eligibility Criteria

Age Range18 Years to 100 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Adult patients who underwent PTE or BPA for Chronic thromboembolic pulmonary hypertension (CTEPH) at least six months prior to screening and report ongoing subjective exercise limitation, * able to give consent * able to perform a exercise protocol Exclusion Criteria: * Pati...

Countries:United States
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Frequently asked questions about Adempas

What is Adempas used for?

Adempas is a small molecule being studied for the treatment of Chronic Thromboembolic Disease (CTED), a condition involving exercise-induced pulmonary vascular dysfunction after pulmonary thromboendarterectomy or balloon pulmonary angioplasty. It is currently in Phase 2 clinical development and is not approved for this indication.

Who makes Adempas?

Adempas is developed by Bayer AG, a multinational pharmaceutical company. The company's stock is traded under the ticker symbol BAYRY on the OTC market. Bayer is conducting clinical trials to evaluate the drug's safety and efficacy in patients with Chronic Thromboembolic Disease.

What phase is Adempas in?

Adempas is in Phase 2 clinical development for Chronic Thromboembolic Disease (CTED). A Phase 2 trial has been completed, and the drug remains investigational for this condition. It has not received regulatory approval for this use.

What clinical trials is Adempas in?

Adempas has one completed Phase 2 clinical trial registered as NCT03409588, titled "Treatment of Exercise-Induced Pulmonary Vascular Dysfunction After Pulmonary Thromboendarterectomy or Balloon Pulmonary Angioplasty." The trial enrolled 10 participants in the United States and evaluated the drug in patients with Chronic Thromboembolic Disease.

Is Adempas FDA approved?

Adempas is not FDA approved for Chronic Thromboembolic Disease (CTED). It is an investigational drug currently in Phase 2 clinical development for this condition. The completed Phase 2 trial was uncontrolled and not randomized or double-blinded, and further studies would be needed to support regulatory approval.