Last reviewed 2026-04-22 · How we verify

(Arm Closed) Enoxaparin

University of Melbourne · Phase 3 active Small molecule

(Arm Closed) Enoxaparin is a Low-molecular-weight heparin (LMWH) Small molecule drug developed by University of Melbourne. It is currently in Phase 3 development for Venous thromboembolism prophylaxis, Acute coronary syndrome, Deep vein thrombosis treatment.

Enoxaparin is a low-molecular-weight heparin that inhibits blood clotting by enhancing the activity of antithrombin III against factors Xa and IIa.

Enoxaparin is a low-molecular-weight heparin that inhibits blood clotting by enhancing the activity of antithrombin III against factors Xa and IIa. Used for Venous thromboembolism prophylaxis, Acute coronary syndrome, Deep vein thrombosis 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 name	(Arm Closed) Enoxaparin
Sponsor	University of Melbourne
Drug class	Low-molecular-weight heparin (LMWH)
Target	Factor Xa and Factor IIa (via antithrombin III)
Modality	Small molecule
Therapeutic area	Cardiovascular
Phase	Phase 3

Mechanism of action

Enoxaparin works by potentiating antithrombin III, a natural anticoagulant, to inactivate clotting factors Xa and IIa in the coagulation cascade. This prevents thrombin generation and fibrin formation, reducing the risk of thromboembolism. It is administered subcutaneously and has more predictable pharmacokinetics than unfractionated heparin.

Approved indications

Venous thromboembolism prophylaxis
Acute coronary syndrome
Deep vein thrombosis treatment
Pulmonary embolism treatment

Common side effects

Bleeding
Thrombocytopenia
Injection site hematoma
Elevated transaminases

Key clinical trials

Australasian COVID-19 Trial (ASCOT) ADAptive Platform Trial (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:

(Arm Closed) Enoxaparin CI brief — competitive landscape report
(Arm Closed) Enoxaparin updates RSS · CI watch RSS
University of Melbourne portfolio CI

Frequently asked questions about (Arm Closed) Enoxaparin

What is (Arm Closed) Enoxaparin?

(Arm Closed) Enoxaparin is a Low-molecular-weight heparin (LMWH) drug developed by University of Melbourne, indicated for Venous thromboembolism prophylaxis, Acute coronary syndrome, Deep vein thrombosis treatment.

How does (Arm Closed) Enoxaparin work?

Enoxaparin is a low-molecular-weight heparin that inhibits blood clotting by enhancing the activity of antithrombin III against factors Xa and IIa.

What is (Arm Closed) Enoxaparin used for?

(Arm Closed) Enoxaparin is indicated for Venous thromboembolism prophylaxis, Acute coronary syndrome, Deep vein thrombosis treatment, Pulmonary embolism treatment.

Who makes (Arm Closed) Enoxaparin?

(Arm Closed) Enoxaparin is developed by University of Melbourne (see full University of Melbourne pipeline at /company/university-of-melbourne).

What drug class is (Arm Closed) Enoxaparin in?

(Arm Closed) Enoxaparin 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 (Arm Closed) Enoxaparin in?

(Arm Closed) Enoxaparin is in Phase 3.

What are the side effects of (Arm Closed) Enoxaparin?

Common side effects of (Arm Closed) Enoxaparin include Bleeding, Thrombocytopenia, Injection site hematoma, Elevated transaminases.

What does (Arm Closed) Enoxaparin target?

(Arm Closed) Enoxaparin targets Factor Xa and Factor IIa (via antithrombin III) and is a Low-molecular-weight heparin (LMWH).

Drug class: All Low-molecular-weight heparin (LMWH) drugs
Target: All drugs targeting Factor Xa and Factor IIa (via antithrombin III)
Manufacturer: University of Melbourne — full pipeline
Therapeutic area: All drugs in Cardiovascular
Indication: Drugs for Venous thromboembolism prophylaxis
Indication: Drugs for Acute coronary syndrome
Indication: Drugs for Deep vein thrombosis treatment

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