Last reviewed 2026-04-23 · How we verify

Tinzaparin (Leo)

Aalborg University Hospital · Phase 3 active Small molecule

Tinzaparin (Leo) is a Low molecular weight heparin Small molecule drug developed by Aalborg University Hospital. It is currently in Phase 3 development for Prophylaxis and treatment of deep vein thrombosis and pulmonary embolism, Prophylaxis and treatment of atrial fibrillation for stroke prevention. Also known as: Innohep (Leo).

Tinzaparin is a low molecular weight heparin that acts as an anticoagulant by inhibiting factor Xa and thrombin.

Tinzaparin is a low molecular weight heparin that acts as an anticoagulant by inhibiting factor Xa and thrombin. Used for Prophylaxis and treatment of deep vein thrombosis and pulmonary embolism, Prophylaxis and treatment of atrial fibrillation for stroke prevention.

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	Tinzaparin (Leo)
Also known as	Innohep (Leo)
Sponsor	Aalborg University Hospital
Drug class	Low molecular weight heparin
Target	Factor Xa, Thrombin
Modality	Small molecule
Therapeutic area	Cardiovascular
Phase	Phase 3

Mechanism of action

Tinzaparin exerts its anticoagulant effect by binding to antithrombin III, which accelerates the inhibition of factor Xa and thrombin. This leads to a decrease in the formation of blood clots and an increase in the dissolution of existing clots.

Approved indications

Prophylaxis and treatment of deep vein thrombosis and pulmonary embolism
Prophylaxis and treatment of atrial fibrillation for stroke prevention

Common side effects

Hemorrhage
Thrombocytopenia
Nausea
Vomiting
Abdominal pain

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:

Tinzaparin (Leo) CI brief — competitive landscape report
Tinzaparin (Leo) updates RSS · CI watch RSS
Aalborg University Hospital portfolio CI

Frequently asked questions about Tinzaparin (Leo)

What is Tinzaparin (Leo)?

Tinzaparin (Leo) is a Low molecular weight heparin drug developed by Aalborg University Hospital, indicated for Prophylaxis and treatment of deep vein thrombosis and pulmonary embolism, Prophylaxis and treatment of atrial fibrillation for stroke prevention.

How does Tinzaparin (Leo) work?

Tinzaparin is a low molecular weight heparin that acts as an anticoagulant by inhibiting factor Xa and thrombin.

What is Tinzaparin (Leo) used for?

Tinzaparin (Leo) is indicated for Prophylaxis and treatment of deep vein thrombosis and pulmonary embolism, Prophylaxis and treatment of atrial fibrillation for stroke prevention.

Who makes Tinzaparin (Leo)?

Tinzaparin (Leo) is developed by Aalborg University Hospital (see full Aalborg University Hospital pipeline at /company/aalborg-university-hospital).

Is Tinzaparin (Leo) also known as anything else?

Tinzaparin (Leo) is also known as Innohep (Leo).

What drug class is Tinzaparin (Leo) in?

Tinzaparin (Leo) belongs to the Low molecular weight heparin class. See all Low molecular weight heparin drugs at /class/low-molecular-weight-heparin.

What development phase is Tinzaparin (Leo) in?

Tinzaparin (Leo) is in Phase 3.

What are the side effects of Tinzaparin (Leo)?

Common side effects of Tinzaparin (Leo) include Hemorrhage, Thrombocytopenia, Nausea, Vomiting, Abdominal pain.

What does Tinzaparin (Leo) target?

Tinzaparin (Leo) targets Factor Xa, Thrombin and is a Low molecular weight heparin.

Drug class: All Low molecular weight heparin drugs
Target: All drugs targeting Factor Xa, Thrombin
Manufacturer: Aalborg University Hospital — full pipeline
Therapeutic area: All drugs in Cardiovascular
Indication: Drugs for Prophylaxis and treatment of deep vein thrombosis and pulmonary embolism
Indication: Drugs for Prophylaxis and treatment of atrial fibrillation for stroke prevention
Also known as: Innohep (Leo)

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