Riociguat

Generic Name: Riociguat

Brand Names: Adempas

Drug Type: Small Molecule

Chemical Formula: C_₂₀H_₁₉FN_₈O_₂

CAS Number: 625115-55-1

Unique Ingredient Identifier: RU3FE2Y4XI

Background: Riociguat is a soluble guanylate cyclase (sGC) agonist approved in the USA, Europe and several other regions for patients with group I PAH (pulmonary arterial hypertension) in WHO FC II or III; and for the treatment of patients with inoperable CTEPH (chronic thromboembolic pulmonary hypertension), or persistent/recurrent PH (pulmonary hypertension) after pulmonary endarterectomy in WHO FC II or III. Riociguat is marketed under the brand Adempas® by Bayer HealthCare Pharmaceuticals. Treatment with riociguat costs USD $7,500 for 30 days of treatment.

Indication: Riociguat is indicated for the treatment of adults with persistent/recurrent chronic thromboembolic pulmonary hypertension (CTEPH), (WHO Group 4) after surgical treatment, or inoperable CTEPH, to improve exercise capacity and WHO functional class.

Riociguat is indicated for the treatment of adults with pulmonary arterial hypertension (PAH), (WHO Group 1), to improve exercise capacity, WHO functional class and to delay clinical worsening. Efficacy was shown in patients on Riociguat monotherapy or in combination with endothelin receptor antagonists or prostanoids. Studies establishing effectiveness included predominately patients with WHO functional class II–III and etiologies of idiopathic or heritable PAH (61%) or PAH associated with connective tissue diseases (25%).

Associated Conditions: Chronic Thromboembolic Pulmonary Hypertension (CTEPH), Pulmonary Arterial Hypertension (PAH)

Clinical Trials

Pricing Dynamics of Rare Disease Drugs: How Prevalence and Patient Numbers Shape Market Access

2 months ago

• New research reveals a clear inverse relationship between disease rarity and drug pricing, with payers willing to pay premium prices for treatments targeting smaller patient populations, particularly for ultra-rare conditions. • Despite historically accepting higher prices for orphan drugs, healthcare systems are increasingly scrutinizing clinical data, negotiating rebates, and setting budget impact thresholds as more rare disease treatments enter the market. • In France's dual pricing system, orphan drug manufacturers face unique challenges, as comparative clinical benefit assessments are difficult without comparator drugs and establishing accurate patient population sizes becomes increasingly complex as prevalence decreases.

EMA Recommends Approval for New Cancer Treatments and Vaccines

4 months ago

• The European Medicines Agency (EMA) has recommended eight new products for EU-wide approval, expanding treatment options for various conditions. • Several cancer treatments have received positive recommendations, potentially offering new hope for patients with different types of malignancies. • A new antiparasitic combination has been endorsed for use in non-EU markets, addressing a critical need in regions affected by parasitic infections. • The EMA is also reviewing new safety information regarding Leqembi, an Alzheimer's disease treatment, ensuring ongoing monitoring of its benefit-risk profile.

Drug Development Updates

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