Adempas(riociguat)
Adempas (riociguat) is a small molecule pharmaceutical. Riociguat was first approved as Adempas on 2013-10-08. It is used to treat pulmonary hypertension in the USA. It has been approved in Europe to treat pulmonary hypertension.
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Commercial
Trade Name
FDA
EMA
Adempas (generic drugs available since 2022-09-01)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Riociguat
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| ADEMPAS | Bayer | N-204819 RX | 2013-10-08 | 5 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| adempas | New Drug Application | 2019-07-22 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| pulmonary hypertension | EFO_0001361 | D006976 | I27.20 |
Agency Specific
FDA
EMA
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HCPCS
No data
Clinical
Clinical Trials
57 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pulmonary hypertension | D006976 | EFO_0001361 | I27.20 | 2 | 8 | 6 | 4 | 5 | 25 |
| Pulmonary arterial hypertension | D000081029 | — | — | 1 | 1 | 1 | 3 | ||
| Familial primary pulmonary hypertension | D065627 | I27.0 | — | 1 | — | 1 | — | 2 | |
| Altitude sickness | D000532 | EFO_1000782 | T70.29 | — | — | — | 1 | — | 1 |
| Sarcoidosis | D012507 | EFO_0000690 | D80-D89 | — | — | — | 1 | — | 1 |
Indications Phases 3
No data
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Left ventricular dysfunction | D018487 | — | 3 | — | — | — | 3 | ||
| Systemic scleroderma | D012595 | EFO_0000717 | M34 | — | 2 | — | — | — | 2 |
| Cystic fibrosis | D003550 | EFO_0000390 | E84 | — | 1 | — | — | — | 1 |
| Idiopathic interstitial pneumonias | D054988 | — | 1 | — | — | — | 1 | ||
| Heart failure | D006333 | EFO_0003144 | I50 | — | 1 | — | — | — | 1 |
| Sickle cell anemia | D000755 | EFO_0000697 | D57 | — | 1 | — | — | — | 1 |
| Raynaud disease | D011928 | EFO_1001145 | I73.0 | — | 1 | — | — | — | 1 |
| Coronary artery disease | D003324 | I25.1 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | 4 | — | — | — | — | 4 | ||
| Drug interactions | D004347 | 2 | — | — | — | — | 2 | ||
| Chronic obstructive pulmonary disease | D029424 | EFO_0000341 | J44.9 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Sleep apnea syndromes | D012891 | EFO_0003877 | G47.3 | — | — | — | — | 1 | 1 |
| Headache | D006261 | HP_0002315 | R51 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | RIOCIGUAT |
| INN | riociguat |
| Description | Riociguat is a carbamate ester that is the methyl ester of {4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo[3,4-b]pyridin-3-yl]pyrimidin-5-yl}methylcarbamic acid. It is used for treatment of chronic thromboembolic pulmonary hypertension and pulmonary arterial hypertension It has a role as a soluble guanylate cyclase activator and an antihypertensive agent. It is a pyrazolopyridine, an aminopyrimidine, an organofluorine compound and a carbamate ester. |
| Classification | Small molecule |
| Drug class | guanaline cyclase activators |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | COC(=O)N(C)c1c(N)nc(-c2nn(Cc3ccccc3F)c3ncccc23)nc1N |
Identifiers
| PDB | — |
| CAS-ID | 625115-55-1 |
| RxCUI | 1439816 |
| ChEMBL ID | CHEMBL2107834 |
| ChEBI ID | 76018 |
| PubChem CID | 11304743 |
| DrugBank | DB08931 |
| UNII ID | RU3FE2Y4XI (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
Adempas - Merck Sharp & Dohme
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 1,976 documents
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Safety
Black-box Warning
Black-box warning for: Adempas
Adverse Events
Top Adverse Reactions
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837 adverse events reported
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