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.
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
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/04/10 | Phase 3 | Recruiting | Suqiao Yang | ||
2024/12/04 | Phase 4 | Recruiting | |||
2023/12/22 | Phase 1 | Completed | Humanis Saglık Anonim Sirketi | ||
2023/04/24 | Phase 4 | Recruiting | |||
2023/03/09 | Phase 2 | Recruiting | |||
2023/03/01 | Not Applicable | Completed | |||
2022/10/17 | Not Applicable | Completed | |||
2022/04/21 | Phase 2 | Active, not recruiting | |||
2021/12/01 | Phase 3 | Recruiting | Dr Sudarshan Rajagopal | ||
2021/07/08 | Phase 4 | Active, not recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Bayer HealthCare Pharmaceuticals Inc. | 50419-253 | ORAL | 2 mg in 1 1 | 9/9/2021 | |
| Bayer HealthCare Pharmaceuticals Inc. | 50419-252 | ORAL | 1.5 mg in 1 1 | 9/9/2021 | |
| Bayer HealthCare Pharmaceuticals Inc. | 50419-251 | ORAL | 1 mg in 1 1 | 9/9/2021 | |
| Bayer HealthCare Pharmaceuticals Inc. | 50419-250 | ORAL | .5 mg in 1 1 | 9/9/2021 | |
| Bayer HealthCare Pharmaceuticals Inc. | 50419-254 | ORAL | 2.5 mg in 1 1 | 9/9/2021 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 3/27/2014 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| ADEMPAS FILM-COATED TABLET 2.0mg | SIN14681P | TABLET, FILM COATED | 2.00mg | 11/24/2014 | |
| ADEMPAS FILM-COATED TABLET 1.0mg | SIN14679P | TABLET, FILM COATED | 1mg | 11/24/2014 | |
| ADEMPAS FILM-COATED TABLET 0.5mg | SIN14678P | TABLET, FILM COATED | 0.50mg | 11/24/2014 | |
| ADEMPAS FILM-COATED TABLET 1.5mg | SIN14680P | TABLET, FILM COATED | 1.50mg | 11/24/2014 | |
| ADEMPAS FILM-COATED TABLET 2.5mg | SIN14682P | TABLET, FILM COATED | 2.50mg | 11/24/2014 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| ADEMPAS riociguat 2.5 mg film-coated tablet blister pack | 207596 | Medicine | A | 4/14/2014 | |
| ADEMPAS riociguat 1 mg film-coated tablet blister pack | 207599 | Medicine | A | 4/14/2014 | |
| ADEMPAS riociguat 1.5 mg film-coated tablet blister pack | 207597 | Medicine | A | 4/14/2014 | |
| ADEMPAS riociguat 2 mg film-coated tablet blister pack | 207598 | Medicine | A | 4/14/2014 | |
| ADEMPAS riociguat 0.5 mg film-coated tablet blister pack | 207595 | Medicine | A | 4/14/2014 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| SANDOZ RIOCIGUAT | 02533561 | Tablet - Oral | 1 MG | 4/29/2024 | |
| ADEMPAS | Bayer Inc | 02412810 | Tablet - Oral | 2.5 MG | 9/25/2013 |
| ADEMPAS | Bayer Inc | 02412799 | Tablet - Oral | 1.5 MG | 9/25/2013 |
| SANDOZ RIOCIGUAT | 02533588 | Tablet - Oral | 1.5 MG | 4/29/2024 | |
| SANDOZ RIOCIGUAT | 02533618 | Tablet - Oral | 2.5 MG | 4/29/2024 | |
| ADEMPAS | Bayer Inc | 02412764 | Tablet - Oral | 0.5 MG | 9/25/2013 |
| ADEMPAS | Bayer Inc | 02412772 | Tablet - Oral | 1 MG | 9/25/2013 |
| ADEMPAS | Bayer Inc | 02412802 | Tablet - Oral | 2 MG | 9/25/2013 |
| SANDOZ RIOCIGUAT | 02533596 | Tablet - Oral | 2 MG | 4/29/2024 | |
| SANDOZ RIOCIGUAT | 02533545 | Tablet - Oral | 0.5 MG | 4/29/2024 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| ADEMPAS 1,5 mg comprimidos recubiertos con pelicula | 113907007 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Uso Hospitalario | Commercialized | |
| ADEMPAS 2,5 mg comprimidos recubiertos con pelicula | 113907013 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Uso Hospitalario | Commercialized | |
| ADEMPAS 2,5 MG COMPRIMIDOS RECUBIERTOS CON PELICULA | 13907013IP | COMPRIMIDO RECUBIERTO CON PELÍCULA | Uso Hospitalario | Commercialized | |
| ADEMPAS 0,5 mg comprimidos recubiertos con pelicula | 113907001 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Uso Hospitalario | Not Commercialized | |
| ADEMPAS 2 mg comprimidos recubiertos con pelicula | 113907010 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Uso Hospitalario | Commercialized | |
| ADEMPAS 1 mg comprimidos recubiertos con pelicula | 113907004 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Uso Hospitalario | Commercialized | |
| ADEMPAS 2 MG COMPRIMIDOS RECUBIERTOS CON PELICULA | 13907010IP | COMPRIMIDO RECUBIERTO CON PELÍCULA | Uso Hospitalario | Commercialized | |
| ADEMPAS 1,5 MG COMPRIMIDOS RECUBIERTOS CON PELICULA | 113907007IP | COMPRIMIDO RECUBIERTO CON PELÍCULA | Uso Hospitalario | Commercialized | |
| ADEMPAS 1 MG COMPRIMIDOS RECUBIERTOS CON PELICULA | 113907004IP | COMPRIMIDO RECUBIERTO CON PELÍCULA | Uso Hospitalario | Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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