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Drug

Riociguat

Approved · EMA
ClassSoluble guanylate cyclase positive allosteric modulatorEmerging researchLate-stage development

Also known as Adempas, Riociguatum.

1
Research papers
5
Active clinical trials
4
Protein targets
3
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Update of EULAR recommendations for the treatment of systemic sclerosis.

Research2016-11-09Annals of the rheumatic diseases

Approval: Adempas (EMA)

Regulatory2014-03-27EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Riociguat
Aliases & brands
AdempasRiociguatum
RxNorm CUI
1439816
ChEMBL ID
CHEMBL2107834
ATC codes
C02KX05
UNII
RU3FE2Y4XI
Primary mechanism
Soluble guanylate cyclase positive allosteric modulator
Regulatory jurisdictions
emamhra

Pharmacology & targets

4 targets

Known molecular targets and mechanisms supported by curated pharmacology databases.

POSITIVE ALLOSTERIC MODULATORSoluble guanylate cyclase positive allosteric modulator
POSITIVE ALLOSTERIC MODULATORSoluble guanylate cyclase positive allosteric modulator
POSITIVE ALLOSTERIC MODULATORSoluble guanylate cyclase positive allosteric modulator
POSITIVE ALLOSTERIC MODULATORSoluble guanylate cyclase positive allosteric modulator

Regulatory timeline

3 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2014-03-27
Latest approval
2014-03-27
Authorities
EMA · MHRA
Total events
3
emaEuropean Medicines Agency· 2 events
2026-07-20CHMP positive opinion
CHMP positive opinion: Riociguat Accord (EMA)

Indication: Treatment of Chronic thromboembolic pulmonary hypertension (CTEPH) in adults and treatment of Pulmonary arterial hypertension (PAH) in adults and children from 6 years of age.

Evidence ↗
2014-03-27Approval
Approval: Adempas (EMA)
Indication: Chronic thromboembolic pulmonary hypertension (CTEPH) Adempas is indicated for the treatment of adult patients with WHO Functional Class (FC) II to III with inoperable CTEPH,Show full indication

Chronic thromboembolic pulmonary hypertension (CTEPH) Adempas is indicated for the treatment of adult patients with WHO Functional Class (FC) II to III with inoperable CTEPH, persistent or recurrent CTEPH after surgical treatment, to improve exercise capacity. Pulmonary arterial hypertension (PAH) AdultsAdempas, as monotherapy or in combination with endothelin receptor antagonists, is indicated for the treatment of adult patients with pulmonary arterial hypertension (PAH) with WHO Functional Class (FC) II to III to improve exercise capacity. Efficacy has been shown in a PAH population including aetiologies of idiopathic or heritable PAH or PAH associated with connective tissue disease. PaediatricsAdempas is indicated for the treatment of PAH in paediatric patients aged less than 18 years of age and body weight ? 50 kg with WHO Functional Class (FC) II to III in combination with endothelin receptor antagonists.

Evidence ↗
mhraMedicines and Healthcare products Regulatory Agency· 1 event
2016-08-08Safety communicationSafety
Drug Safety Update: Riociguat (Adempas): not for use in patients with pulmonary hypertension associated with idiopathic interstitial pneumonias
Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Contains public sector information from the Medicines and Healthcare products Regulatory Agency (MHRA) licensed under the Open Government Licence (OGL v3).

Clinical trials

48 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
48
registered trials across all phases
LATEST COMPLETION 2026
5
Active studies
4
Recruiting
20
Late-stage (III+)
32
Completed
11
Discontinued
PHASE DISTRIBUTIONn = 48
Phase 110Phase 218Phase 38Phase 48Phase N / A4

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Recent completions

Trials that read out recently, adding to the completed evidence base.

Research activity

1 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Most influential

Update of EULAR recommendations for the treatment of systemic sclerosis.

Annals of the rheumatic diseases · 2017 · 708 cites
Recent papers

Update of EULAR recommendations for the treatment of systemic sclerosis.

Annals of the rheumatic diseases · 2017 · 708 cites
Journals, researchers & institutions
Top journals
  • Annals of the rheumatic diseases1
Leading researchers
  • Allanore Y1
  • Avouac J1
  • Becker M1
  • Clements P1
  • Cutolo M1
  • Czirjak L1
  • Damjanov N1
  • Del Galdo F1
Leading institutions
free-text, unnormalised
  • Basel University1
  • Central Manchester NHS Foundation Trust1
  • Cochin Hospital1
  • Department of Rheumatology and Clinical Immunology1
  • Ghent University Hospital1
  • Hamburg Centre for Pediatric and Adolescence Rheumatology1

Related drugs

1 matches

Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).

Studied across 7 of the same disease areas as Riociguat in the shared literature.

7 shared diseases1 shared paper
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.