MedPath

Riociguat

Generic Name
Riociguat
Brand Names
Adempas
Drug Type
Small Molecule
Chemical Formula
C20H19FN8O2
CAS Number
625115-55-1
Unique Ingredient Identifier
RU3FE2Y4XI

Overview

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.

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)

FDA Approved Products

Adempas
Manufacturer:Bayer HealthCare Pharmaceuticals Inc.
Route:ORAL
Strength:1.5 mg in 1 1
Approved: 2021/09/09
NDC:50419-252
Adempas
Manufacturer:Bayer HealthCare Pharmaceuticals Inc.
Route:ORAL
Strength:2.5 mg in 1 1
Approved: 2021/09/09
NDC:50419-254
Adempas
Manufacturer:Bayer HealthCare Pharmaceuticals Inc.
Route:ORAL
Strength:2 mg in 1 1
Approved: 2021/09/09
NDC:50419-253
Adempas
Manufacturer:Bayer HealthCare Pharmaceuticals Inc.
Route:ORAL
Strength:1 mg in 1 1
Approved: 2021/09/09
NDC:50419-251
Adempas
Manufacturer:Bayer HealthCare Pharmaceuticals Inc.
Route:ORAL
Strength:.5 mg in 1 1
Approved: 2021/09/09
NDC:50419-250

Singapore Approved Products

ADEMPAS FILM-COATED TABLET 2.0mg
Manufacturer:Bayer AG, Leverkusen ( Mfg of bulk product,Pri&SecPackaging,QC & Stability Storage Testing)
Form:TABLET, FILM COATED
Strength:2.00mg
Online:Yes
Approved: 2014/11/24
Approval:SIN14681P
ADEMPAS FILM-COATED TABLET 1.0mg
Manufacturer:Bayer AG, Leverkusen ( Mfg of bulk product,Pri&SecPackaging,QC & Stability Storage Testing)
Form:TABLET, FILM COATED
Strength:1mg
Online:Yes
Approved: 2014/11/24
Approval:SIN14679P
ADEMPAS FILM-COATED TABLET 0.5mg
Manufacturer:Bayer AG, Leverkusen ( Mfg of bulk product,Pri&SecPackaging,QC & Stability Storage Testing)
Form:TABLET, FILM COATED
Strength:0.50mg
Online:Yes
Approved: 2014/11/24
Approval:SIN14678P
ADEMPAS FILM-COATED TABLET 1.5mg
Manufacturer:Bayer AG, Leverkusen ( Mfg of bulk product,Pri&SecPackaging,QC & Stability Storage Testing)
Form:TABLET, FILM COATED
Strength:1.50mg
Online:Yes
Approved: 2014/11/24
Approval:SIN14680P
ADEMPAS FILM-COATED TABLET 2.5mg
Manufacturer:Bayer AG, Leverkusen ( Mfg of bulk product, Pri& Sec packaging,QC &Stability storage testing)
Form:TABLET, FILM COATED
Strength:2.50mg
Online:Yes
Approved: 2014/11/24
Approval:SIN14682P

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