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LMWH parnaparin subcutaneously

IRCCS Azienda Ospedaliero-Universitaria di Bologna · Phase 3 active Small molecule

LMWH parnaparin subcutaneously is a Low-molecular-weight heparin (LMWH) Small molecule drug developed by IRCCS Azienda Ospedaliero-Universitaria di Bologna. It is currently in Phase 3 development for Thromboembolism prophylaxis and treatment, Deep vein thrombosis prevention and treatment, Pulmonary embolism prevention and treatment.

Parnaparin is a low-molecular-weight heparin (LMWH) that inhibits blood coagulation by enhancing the activity of antithrombin III against factors Xa and IIa.

Parnaparin is a low-molecular-weight heparin (LMWH) that inhibits blood coagulation by enhancing the activity of antithrombin III against factors Xa and IIa. Used for Thromboembolism prophylaxis and treatment, Deep vein thrombosis prevention and treatment, Pulmonary embolism prevention and treatment.

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 nameLMWH parnaparin subcutaneously
SponsorIRCCS Azienda Ospedaliero-Universitaria di Bologna
Drug classLow-molecular-weight heparin (LMWH)
TargetAntithrombin III (indirect target); Coagulation factors Xa and IIa
ModalitySmall molecule
Therapeutic areaCardiovascular
PhasePhase 3

Mechanism of action

Parnaparin works by potentiating antithrombin III-mediated inactivation of coagulation factors, particularly factor Xa (more than factor IIa), thereby preventing thrombin generation and fibrin clot formation. This anticoagulant effect is used to prevent and treat thromboembolism. The subcutaneous route provides predictable pharmacokinetics with a longer half-life compared to unfractionated heparin.

Approved indications

Common side effects

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

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Frequently asked questions about LMWH parnaparin subcutaneously

What is LMWH parnaparin subcutaneously?

LMWH parnaparin subcutaneously is a Low-molecular-weight heparin (LMWH) drug developed by IRCCS Azienda Ospedaliero-Universitaria di Bologna, indicated for Thromboembolism prophylaxis and treatment, Deep vein thrombosis prevention and treatment, Pulmonary embolism prevention and treatment.

How does LMWH parnaparin subcutaneously work?

Parnaparin is a low-molecular-weight heparin (LMWH) that inhibits blood coagulation by enhancing the activity of antithrombin III against factors Xa and IIa.

What is LMWH parnaparin subcutaneously used for?

LMWH parnaparin subcutaneously is indicated for Thromboembolism prophylaxis and treatment, Deep vein thrombosis prevention and treatment, Pulmonary embolism prevention and treatment.

Who makes LMWH parnaparin subcutaneously?

LMWH parnaparin subcutaneously is developed by IRCCS Azienda Ospedaliero-Universitaria di Bologna (see full IRCCS Azienda Ospedaliero-Universitaria di Bologna pipeline at /company/irccs-azienda-ospedaliero-universitaria-di-bologna).

What drug class is LMWH parnaparin subcutaneously in?

LMWH parnaparin subcutaneously belongs to the Low-molecular-weight heparin (LMWH) class. See all Low-molecular-weight heparin (LMWH) drugs at /class/low-molecular-weight-heparin-lmwh.

What development phase is LMWH parnaparin subcutaneously in?

LMWH parnaparin subcutaneously is in Phase 3.

What are the side effects of LMWH parnaparin subcutaneously?

Common side effects of LMWH parnaparin subcutaneously include Bleeding, Thrombocytopenia, Injection site reactions, Elevated transaminases.

What does LMWH parnaparin subcutaneously target?

LMWH parnaparin subcutaneously targets Antithrombin III (indirect target); Coagulation factors Xa and IIa and is a Low-molecular-weight heparin (LMWH).

Related

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