Last reviewed 2026-06-03 · How we verify

Klexane and ASA

University of Helsinki · Phase 3 active Small molecule Under review

Klexane and ASA is a Low-molecular-weight heparin + antiplatelet agent Small molecule drug developed by University of Helsinki. It is currently in Phase 3 development for Thromboprophylaxis in acute coronary syndrome or post-acute coronary syndrome management, Prevention of venous thromboembolism in high-risk patients.

Klexane (enoxaparin) is a low-molecular-weight heparin that inhibits blood clotting factors, while ASA (acetylsalicylic acid) inhibits platelet aggregation, together providing dual anticoagulant and antiplatelet effects.

Klexane is a brand name for a medication that contains a low molecular weight sulfated dextran (LMW-SD). It has been studied in clinical trials for conditions such as type I diabetes and habitual abortion, often in combination with other medications like heparin, CellCept, or Rapamune.

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	Klexane and ASA
Sponsor	University of Helsinki
Drug class	Low-molecular-weight heparin + antiplatelet agent
Target	Factor Xa, thrombin (enoxaparin); cyclooxygenase (aspirin)
Modality	Small molecule
Therapeutic area	Cardiovascular
Phase	Phase 3

Mechanism of action

Enoxaparin works by potentiating antithrombin III to inactivate factor Xa and thrombin, preventing thrombus formation. Aspirin irreversibly inhibits cyclooxygenase, reducing thromboxane A2 production and platelet aggregation. The combination provides both anticoagulant and antiplatelet activity for enhanced thromboprophylaxis.

Approved indications

Thromboprophylaxis in acute coronary syndrome or post-acute coronary syndrome management
Prevention of venous thromboembolism in high-risk patients

Common side effects

Bleeding
Thrombocytopenia
Injection site reactions
Gastrointestinal bleeding

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.

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:

Klexane and ASA CI brief — competitive landscape report
Klexane and ASA updates RSS · CI watch RSS
University of Helsinki portfolio CI

Frequently asked questions about Klexane and ASA

What is Klexane and ASA?

Klexane and ASA is a Low-molecular-weight heparin + antiplatelet agent drug developed by University of Helsinki, indicated for Thromboprophylaxis in acute coronary syndrome or post-acute coronary syndrome management, Prevention of venous thromboembolism in high-risk patients.

How does Klexane and ASA work?

What is Klexane and ASA used for?

Klexane and ASA is indicated for Thromboprophylaxis in acute coronary syndrome or post-acute coronary syndrome management, Prevention of venous thromboembolism in high-risk patients.

Who makes Klexane and ASA?

Klexane and ASA is developed by University of Helsinki (see full University of Helsinki pipeline at /company/university-of-helsinki).

What drug class is Klexane and ASA in?

Klexane and ASA belongs to the Low-molecular-weight heparin + antiplatelet agent class. See all Low-molecular-weight heparin + antiplatelet agent drugs at /class/low-molecular-weight-heparin-antiplatelet-agent.

What development phase is Klexane and ASA in?

Klexane and ASA is in Phase 3.

What are the side effects of Klexane and ASA?

Common side effects of Klexane and ASA include Bleeding, Thrombocytopenia, Injection site reactions, Gastrointestinal bleeding.

What does Klexane and ASA target?

Klexane and ASA targets Factor Xa, thrombin (enoxaparin); cyclooxygenase (aspirin) and is a Low-molecular-weight heparin + antiplatelet agent.

Drug class: All Low-molecular-weight heparin + antiplatelet agent drugs
Target: All drugs targeting Factor Xa, thrombin (enoxaparin); cyclooxygenase (aspirin)
Manufacturer: University of Helsinki — full pipeline
Therapeutic area: All drugs in Cardiovascular
Indication: Drugs for Thromboprophylaxis in acute coronary syndrome or post-acute coronary syndrome management
Indication: Drugs for Prevention of venous thromboembolism in high-risk patients

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