Last reviewed 2026-04-23 · How we verify

Riociguat Pill

University of Arizona · Phase 3 active Small molecule

Riociguat Pill is a Soluble guanylate cyclase stimulator Small molecule drug developed by University of Arizona. It is currently in Phase 3 development for Pulmonary arterial hypertension (PAH), Chronic thromboembolic pulmonary hypertension (CTEPH). Also known as: Adempas.

Riociguat is a soluble guanylate cyclase stimulator that increases cyclic GMP levels to promote vasodilation and reduce pulmonary vascular resistance.

Riociguat is a soluble guanylate cyclase stimulator that increases cyclic GMP levels to promote vasodilation and reduce pulmonary vascular resistance. Used for Pulmonary arterial hypertension (PAH), Chronic thromboembolic pulmonary hypertension (CTEPH).

Likelihood of approval

56.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

Baseline phase 3 → approval rate +58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
Cardiovascular Phase 3 risk -2.0pp
Modern cardiovascular outcome trials are large + long; many fail to beat aggressive standard-of-care.

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2028–2030	—
EMA	EU	2029–2031	+0.7 yr
MHRA	GB	2029–2031	+0.7 yr
Health Canada	CA	2029–2032	+0.9 yr
TGA	AU	2029–2032	+1.2 yr
PMDA	JP	2029–2032	+1.5 yr
NMPA	CN	2030–2033	+2.3 yr
MFDS	KR	2029–2032	+1.4 yr
CDSCO	IN	2029–2033	+1.8 yr
ANVISA	BR	2030–2033	+2.3 yr

Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).

Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.

At a glance

Generic name	Riociguat Pill
Also known as	Adempas
Sponsor	University of Arizona
Drug class	Soluble guanylate cyclase stimulator
Target	Soluble guanylate cyclase (sGC)
Modality	Small molecule
Therapeutic area	Cardiovascular
Phase	Phase 3

Mechanism of action

Riociguat directly activates soluble guanylate cyclase (sGC), an enzyme that produces cyclic GMP, a key signaling molecule in vascular smooth muscle cells. By increasing cGMP levels, riociguat promotes smooth muscle relaxation and vasodilation in the pulmonary vasculature, reducing right ventricular afterload and improving hemodynamics in pulmonary hypertension.

Approved indications

Pulmonary arterial hypertension (PAH)
Chronic thromboembolic pulmonary hypertension (CTEPH)

Common side effects

Hypotension
Headache
Dizziness
Dyspepsia

Key clinical trials

Trial to Evaluate Parenteral Treprostinil and Riociguat on Right Ventriculo-vascular Coupling and Morphology in Those With Advanced PAH (PHASE3)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Source	Used for
ClinicalTrials.gov	Trial enrolment, design, endpoints, results

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

Riociguat Pill CI brief — competitive landscape report
Riociguat Pill updates RSS · CI watch RSS
University of Arizona portfolio CI

Frequently asked questions about Riociguat Pill

What is Riociguat Pill?

Riociguat Pill is a Soluble guanylate cyclase stimulator drug developed by University of Arizona, indicated for Pulmonary arterial hypertension (PAH), Chronic thromboembolic pulmonary hypertension (CTEPH).

How does Riociguat Pill work?

Riociguat is a soluble guanylate cyclase stimulator that increases cyclic GMP levels to promote vasodilation and reduce pulmonary vascular resistance.

What is Riociguat Pill used for?

Riociguat Pill is indicated for Pulmonary arterial hypertension (PAH), Chronic thromboembolic pulmonary hypertension (CTEPH).

Who makes Riociguat Pill?

Riociguat Pill is developed by University of Arizona (see full University of Arizona pipeline at /company/university-of-arizona).

Is Riociguat Pill also known as anything else?

Riociguat Pill is also known as Adempas.

What drug class is Riociguat Pill in?

Riociguat Pill belongs to the Soluble guanylate cyclase stimulator class. See all Soluble guanylate cyclase stimulator drugs at /class/soluble-guanylate-cyclase-stimulator.

What development phase is Riociguat Pill in?

Riociguat Pill is in Phase 3.

What are the side effects of Riociguat Pill?

Common side effects of Riociguat Pill include Hypotension, Headache, Dizziness, Dyspepsia.

What does Riociguat Pill target?

Riociguat Pill targets Soluble guanylate cyclase (sGC) and is a Soluble guanylate cyclase stimulator.

Drug class: All Soluble guanylate cyclase stimulator drugs
Target: All drugs targeting Soluble guanylate cyclase (sGC)
Manufacturer: University of Arizona — full pipeline
Therapeutic area: All drugs in Cardiovascular
Indication: Drugs for Pulmonary arterial hypertension (PAH)
Indication: Drugs for Chronic thromboembolic pulmonary hypertension (CTEPH)
Also known as: Adempas

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing