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Ventavis

Meshalkin Research Institute of Pathology of Circulation · Phase 2 active Small molecule ✓ Verified May 2026

Ventavis is a Small molecule drug developed by Meshalkin Research Institute of Pathology of Circulation. It is currently in Phase 2 development for Pulmonary arterial hypertension.

Ventavis is a medication used to treat conditions such as pulmonary arterial hypertension, scleroderma, and Raynaud's phenomenon, where blood vessels are constricted and blood flow is impaired. It works as a prostanoid IP receptor agonist, a type of small molecule that activates the prostacyclin receptor.

Likelihood of approval
13.3% vs 15.3% industry baseline
If approved by FDA: likely 2031–2034
Steps remaining: Phase 3 → NDA/BLA submission
Confidence: Medium
Why this estimate
  • Baseline phase 2 → approval rate +15.3pp
    Industry-wide phase 2 drugs reach approval ~15.3% 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 2031–2034
EMA EU 2032–2035 +0.7 yr
MHRA GB 2032–2035 +0.7 yr
Health Canada CA 2032–2036 +0.9 yr
TGA AU 2032–2036 +1.2 yr
PMDA JP 2032–2036 +1.5 yr
NMPA CN 2033–2037 +2.3 yr
MFDS KR 2032–2036 +1.4 yr
CDSCO IN 2032–2037 +1.8 yr
ANVISA BR 2033–2037 +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 nameVentavis
SponsorMeshalkin Research Institute of Pathology of Circulation
TargetProstacyclin receptor, Prostaglandin D2 receptor, Prostaglandin E2 receptor EP1 subtype
ModalitySmall molecule
Therapeutic areaCardiovascular
PhasePhase 2

Approved indications

Common side effects

No common side effects on file.

Key clinical trials

Primary sources

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

SourceUsed for
ClinicalTrials.govTrial 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:

Frequently asked questions about Ventavis

What is Ventavis?

Ventavis is a Small molecule drug developed by Meshalkin Research Institute of Pathology of Circulation, indicated for Pulmonary arterial hypertension.

What is Ventavis used for?

Ventavis is indicated for Pulmonary arterial hypertension.

Who makes Ventavis?

Ventavis is developed by Meshalkin Research Institute of Pathology of Circulation (see full Meshalkin Research Institute of Pathology of Circulation pipeline at /company/meshalkin-research-institute-of-pathology-of-circulation).

What development phase is Ventavis in?

Ventavis is in Phase 2.

What does Ventavis target?

Ventavis targets Prostacyclin receptor, Prostaglandin D2 receptor, Prostaglandin E2 receptor EP1 subtype.

Related

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