NDAORALTABLET
Approved
Oct 2013
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
26
Data completeness
7/8 — Comprehensive
ADEMPAS (riociguat) by Bayer is guanylate cyclase stimulators [moa]. Approved for soluble guanylate cyclase stimulator [epc]. First approved in 2013.
Drug data last refreshed 16h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ADEMPAS (riociguat) is an oral soluble guanylate cyclase stimulator approved by the FDA in October 2013 for the treatment of pulmonary hypertension. It works by directly stimulating soluble guanylate cyclase, a key enzyme in the nitric oxide signaling pathway, leading to pulmonary vasodilation and improved hemodynamics. The drug addresses a critical unmet need in a chronic, progressive disease requiring long-term management.
$598MPart D
Peak7.4 years to LOEThe product is at peak commercial performance with 44,483 Part D claims in 2023, indicating stable demand and a mature commercial infrastructure supporting the brand.
Mechanism of Action
Guanylate Cyclase Stimulators
Pharmacologic Class:
Soluble Guanylate Cyclase Stimulator
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (26)
Efficacy and Safety of Riociguat in Incipient Pulmonary Vascular Disease as an Indicator for Early PAH
Started Oct 2022
35 enrolled
Pulmonary Vascular DisorderPrimary Pulmonary HypertensionSystemic Sclerosis+1 more
Effects of Riociguat on RIght VEntricular Size and Function in PAH and CTEPH
Started Apr 2022
30 enrolled
Primary Pulmonary Arterial HypertensionChronic Thromboembolic Pulmonary Hypertension
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)
Started Jul 2021
500 enrolled
Pulmonary Arterial Hypertension
THERAPY-HYBRID-BPA Trial
Started Oct 2020
72 enrolled
Hypertension, Pulmonary
Riociguat rEplacing PDE-5i Therapy evaLuated Against Continued PDE-5i thErapy
Started Jan 2017
225 enrolled
Pulmonary Arterial Hypertension
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.