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Drug ReportsRiociguat
Adempas(riociguat)
Adempas, Riociguat (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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YTD
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FDA approval date
EMA approval date
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Study first post date
Last update post date
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Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
respiratory tract diseasesD012140
cardiovascular diseasesD002318
Trade Name
FDA
EMA
Adempas, Riociguat
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
ADEMPASBayerN-204819 RX2013-10-08
5 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
adempasNew Drug Application2023-01-31
Indications
FDA
EMA
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Riociguat, Adempas, Bayer Hlthcare
106621882034-02-18DS, DPU-2834, U-2835
112035932034-02-18DS, DPU-2834, U-2835
71730372026-12-04DS, DP
ATC Codes
C: Cardiovascular system drugs
C02: Antihypertensives
C02K: Other antihypertensives in atc
C02KX: Antihypertensives for pulmonary arterial hypertension
C02KX05: Riociguat
HCPCS
No data
Clinical
Clinical Trials
64 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
HypertensionD006973EFO_0000537I10212871240
Pulmonary hypertensionD006976EFO_0001361I27.20213761037
Pulmonary arterial hypertensionD0000810291146618
Familial primary pulmonary hypertensionD065627I27.011338
Altitude sicknessD000532EFO_1000782T70.2911
SarcoidosisD012507EFO_0000690D80-D8911
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Chronic diseaseD002908111
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Systemic sclerodermaD012595EFO_0000717M34.033
Diffuse sclerodermaD045743EFO_000040433
Left ventricular dysfunctionD01848733
Ventricular dysfunctionD01875433
Interstitial lung diseasesD017563HP_0006530J84.8922
Lung diseasesD008171HP_0002088J98.4112
FibrosisD00535511
Cystic fibrosisD003550EFO_0000390E8411
PneumoniaD011014EFO_000310611
Pulmonary fibrosisD01165811
Show 17 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients44
Drug interactionsD00434722
Renal insufficiencyD051437HP_0000083N1911
Chronic obstructive pulmonary diseaseD029424EFO_0000341J44.911
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Sleep apnea syndromesD012891HP_0010535G47.311
Respiratory aspirationD053120EFO_100183911
HeadacheD006261HP_0002315R5111
Migraine disordersD008881EFO_0003821G4311
Migraine without auraD020326EFO_0005296G43.011
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameRiociguat
INNriociguat
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 classguanaline cyclase activators
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Structure (InChI/SMILES or Protein Sequence)
COC(=O)N(C)c1c(N)nc(-c2nn(Cc3ccccc3F)c3ncccc23)nc1N
Identifiers
PDB
CAS-ID625115-55-1
RxCUI
ChEMBL IDCHEMBL2107834
ChEBI ID76018
PubChem CID
DrugBankDB08931
UNII IDRU3FE2Y4XI (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
£
Adempas Merck & Co
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Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 2,458 documents
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Safety
Black-box Warning
Black-box warning for: Adempas
Adverse Events
Top Adverse Reactions
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15,940 adverse events reported
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