Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Riociguat immediate release · 1 trial · 1 indication
Marker of bone resorption
Area under the plasma concentration vs time curve (AUC) from zero to 7 hours after single (first) dose for riociguat and its metabolite M-1 (BAY60-4552)
AUC(0-7) at steady state
Maximum drug concentration in plasma after single dose administration for riociguat and its metabolite M-1 (BAY60-4552)
Maximum drug concentration in plasma at steady state during a dosage interval for riociguat and its metabolite M-1 (BAY60-4552)
| Arm | Type | Description |
|---|---|---|
| Riociguat | ACTIVE_COMPARATOR | Subjects received multiple doses of riociguat (thrice a day) with concomitant administration of ranitidine (once daily) for 14 days |
| Placebo | PLACEBO_COMPARATOR | Subjects received placebo (thrice a day) with concomitant administration of ranitidine (once daily) for 14 days |
| Name | Type | Description |
|---|---|---|
| Riociguat (Adempas, BAY63-2521) immediate release tablet of 2.5 mg | DRUG | Riociguat administered in a dose of 2.5 mg (single tablet), thrice daily, over 14 days. |
| Placebo | DRUG | Placebo administered as a single tablet, thrice daily, over 14 days. |
Inclusion Criteria: * Healthy male white subjects * 18 to 45 years of age * BMI between 18 and 28 kg/m2 * Subjects who are able to understand and follow instructions and who are able to participate in the study for the entire period Exclusion Criteria: * Relevant deviation from the normal range i...
Riociguat immediate release is an investigational small molecule developed by Bayer AG. In the clinical program described, it was studied in healthy male volunteers in Germany to evaluate its effect on bone metabolism, a pharmacology and clinical study rather than a treatment study in a specific disease population.
Riociguat immediate release targets the soluble guanylate cyclase subunits GUCY1B1, GUCY1A2, and GUCY1A1. It acts as a positive allosteric modulator of these subunits, meaning it binds to and enhances the activity of the enzyme complex rather than blocking it.
Riociguat immediate release is made by Bayer AG, which trades on the OTC market under the ticker BAYRY. Bayer is the developer of the riociguat immediate release tablet formulation.
Riociguat immediate release is in Phase 1 development. The single recorded trial for this asset is a completed Phase 1 study, and the drug remains investigational rather than approved for the pharmacology and clinical uses studied.
Riociguat immediate release has been studied in one completed Phase 1 trial, NCT00855660, titled Effect of Riociguat on Bone Metabolism. That trial enrolled 17 healthy male volunteers aged 18 years and older in Germany and used a randomized, double-blind, placebo-controlled design.
Yes. Riociguat immediate release is also known as Adempas and BAY63-2521, and it is identified as the immediate release tablet formulation of 2.5 mg. These names refer to the same small molecule developed by Bayer AG.