Riociguat API CAS 625115-55-1

Riociguat API powder is the first soluble guanylate cyclase (sGC) activator on the market. Clinically, it is mainly used to treat chronic thromboembolic pulmonary hypertension (CTEPH) and arterial pulmonary hypertension (PAH), in which arterial pulmonary hypertension mainly refers to idiopathic or hereditary arterial pulmonary hypertension and connective tissue-related arterial pulmonary hypertension. According to relevant data, it can significantly improve the exercise tolerance, hemodynamic parameters and cardiac function of patients, and prolong the time to clinical deterioration (in PATENT research).

What is the pharmacological action of Riociguat API Powder?

The core pharmacological action of Riociguat API Powder is to directly activate sGC and enhance its sensitivity to nitric oxide (NO), thereby increasing the level of intracellular cyclic guanosine phosphate (cGMP), achieving pulmonary vasodilation and improving hemodynamics. Studies have shown that its pharmacological action has dual mechanisms:
1. Direct activation: As a direct agonist of sGC, Riocguat powder can bind to the heme binding site of sGC without relying on nitric oxide (NO) to directly activate the enzyme and promote the transformation of GTP into cGMP. This mechanism is particularly important in the pathological state of NO deficiency or NO signal pathway damage.
2. Enhancement of NO sensitivity: After BAY 63-2521 binds to sGC, it can change the conformation of the enzyme and significantly enhance its sensitivity to endogenous NO, so that NO can effectively activate sGC at a low concentration, resulting in a "synergistic amplification" effect.
Through the above dual mechanisms, Riocguat significantly increased the intracellular cGMP level. As the second messenger, cGMP activates cGMP-dependent protein kinase (PKG), which leads to: the decrease of calcium influx in pulmonary vascular smooth muscle cells and vasodilation; Inhibit the proliferation and migration of vascular smooth muscle cells; Improve vascular endothelial function; Reduce pulmonary vascular resistance (PVR).

What is the latest research progress of Riociguat API powder?

The latest research progress of Riociguat API powder mainly focuses on the following directions: Based on the approved indications of pulmonary hypertension (PAH) and chronic thromboembolic pulmonary hypertension (CTEPH), a number of studies in 2024-2025 explored its optimal application strategies in specific populations, including the combined treatment with balloon pulmonary angioplasty (BPA), the comparison of curative effects in different treatment sequences, and the heart failure (HFpEF) complicated with pulmonary artery aiming at ejection fraction. Among them, the follow-up analysis of RACE test (2025) shows that BPA may be better than Riociguat alone in improving right ventricular function, while Phase II studies such as DYNAMIC initially suggest that BZY 632521 powder can improve hemodynamics in patients with PH-HFpEF, but the clinical benefit is not clear.

What are the side effects of Riociguat API powder?

The common side effects of Riociguat API powder include headache (about 30%-40%), dyspepsia (such as nausea, diarrhea, constipation, the incidence rate is about 20%), dizziness and hypotension (the incidence rate is about 10%-15%). These reactions mostly occur in the initial stage of treatment and are mostly mild to moderate, and can be gradually relieved or tolerated with the extension of time. Special attention should be paid to the risk of severe hypotension (especially when combined with vasodilators) and the increased risk of bleeding (such as epistaxis and gastrointestinal bleeding, the incidence rate is about 10%). In addition, it has the risk of teratogenesis, and it is forbidden during pregnancy, and women of childbearing age need strict contraception; Abnormal liver function (about 5%-10%) and anemia (about 7%) also need regular monitoring. Rare but serious adverse reactions that need to be vigilant include pulmonary artery bleeding and worsening of pulmonary vein occlusion. Therefore, when using it, it is necessary to evaluate blood pressure, liver function and hemoglobin level regularly, and stop in time and do further examination if there is persistent headache, severe hypotension or bleeding tendency.

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FAQ:

Q1: Can Riociguat improve systemic microcirculation?
It mainly acts on pulmonary vascular system, and the evidence of improving systemic microcirculation (such as skin, muscle and viscera) is insufficient, so it is not recommended to improve systemic microcirculation disorder.
Q2: What are the storage conditions of Riociguat API?
It should be sealed and stored at 2-8℃ in cold storage, dark and dry conditions to avoid contact with strong acid, alkali and oxidant. It should be used in a dry environment as soon as possible after opening to prevent moisture absorption and degradation.
Q3: What is the stability of Riocguat API powder?
Under the specified storage conditions, it is usually stable, and the validity period is generally 2-3 years (specifically, according to the COA label). It is suggested that the stability should be inspected regularly, and the use should be stopped in case of color change and caking.

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