Riociguat, CAS# 625115-55-1, was approved yesterday by the FDA for the treatment of thromboembolic pulmonary hypertension. Known as the brand name Adempas, Riociguat has proven in trials to be an efficacious treatment option for adults with both persistent and recurrent thromboembolic pulmonary hypertension. The patient population suffering from chronic (CTPH) or recurrent thromboembolic pulmonary hypertension is unique, and until now there have been no drug treatments to meet their specific needs. The use of Riociguat in studies was found to not only control pulmonary hypertension in patients after surgical treatment, but it also proved to help patients improve exercise capacity. While there is a black-box warning that applies to the potential harm for a pregnant woman who takes Riociguat, there were no glaring problems associated with Riociguat in clinical trials.
Patients with chronic or recurrent thromboembolic pulmonary hypertension are sometimes treated surgically with a procedure called a pulmonary endarterectomy. This surgery is extremely specialized, and only performed at a handful of surgical centers around the United States. With a mortality rate of 15 percent, patients with chronic pulmonary hypertension had no viable options for treatment until the approval of Riociguat. Marketed by Bayer, data from clinical trials of Riociguat has been overwhelmingly positive. Riociguat acts as a powerful oral stimulator of soluble guanylate cyclase (sGC), helping patients with this incurable form of hypertension to find symptom relief.
Chronic thromboembolic pulmonary hypertension, known also as “CTEPH” is a condition which is exacerbated by blood clots in the arteries of the lungs, leading to high blood pressure and significant strain on the hearts of patients. There are roughly 30,000 Americans suffering from CTEPH, as well as over 20,000 people with this dire condition in both Europe and Japan.
The Riociguat FDA approval is an exciting opportunity for research and development. LGM Pharma provides the Riociguat API for research and development purposes. Clients can be assured of continuous support throughout the R&D process, as well as quality API products.
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