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Thrombate III

Phase 2

Trauma Injury | Small molecule | Cardiovascular |Grifols, S.A.|Trials Updated: May 14, 2025

Thrombate III development status

Highest phase Phase 2
Registered trials 1 across 1 sponsor since Apr 2001

Thrombate III target and mechanism

ModalitySmall molecule

Also known as Thrombate infusion, Anti-thrombin III

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment314

FDA Designations

No designations recorded

Thrombate III clinical trials

Thrombate III · 1 trial · 3 indications

Phase 2 1
NCT05794165Antithrombin to Improve Thromboprophylaxis and Reduce the Incidence of Trauma-Related Venous ThromboembolismTrauma Injury
ENROLLING BY_INVITATION314 Analytics
PHASE2ENROLLING BY_INVITATION
Antithrombin to Improve Thromboprophylaxis and Reduce the Incidence of Trauma-Related Venous Thromboembolism
Trauma InjuryUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of participants with incidences of venous thromboembolism (VTE )
14 days post hospital admission
Number of participants with incidence of antifactor Xa (anti-FXa) of ≥0.2 IU/mL
14 days post hospital admission

Secondary Endpoints

Time taken to achieve anti-FXa of ≥0.2 IU/mL
14 days post hospital admission
Number of enoxaparin dose escalations
from the time of hospital admission to the time of hospital discharge or 30 days (whichever occurs first)
Number of incidences of participants with other thrombotic complications (arterial thrombosis, myocardial infarction, stroke)
from the time of hospital admission to the time of hospital discharge or 30 days (whichever occurs first)
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Thrombate infusionEXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
Thrombate infusionDRUGBolus intravenous infusion of Thrombate will be given to achieve antithrombin (AT) activity levels at 150% before the 3rd dose of Enoxaparin. The dose will be based on patient weight.
PlaceboDRUGNormal Saline will be given as one time IV before the 3rd dose of Enoxaparin. The dose will be based on patient weight.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: * Admission to trauma service * Polytraumatic injuries OR pelvic/long bone fracture * Planned admission to trauma ICU or step-down/SIMU setting (this includes STICU, SIMU/TIMU, BICU, and BIMU) * Informed consent obtained Exclusion Criteria: * Prisoners (defined as those direct...

Countries:United States
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Competitive Landscape -Trauma and Injury 11 trials (matched to "Trauma Injury")

No competing companies are currently tracked in active development for Trauma and Injury.
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Frequently asked questions about Thrombate III

What is Thrombate III used for in trauma injury?

Thrombate III is being studied in trauma injury to improve thromboprophylaxis and reduce the incidence of trauma-related venous thromboembolism. The Phase 2 trial enrolls adults aged 18 years and older in the United States. Thrombate III is not approved for this trauma injury use and remains investigational in this setting.

Who makes Thrombate III?

Thrombate III is developed by Grifols, S.A., which trades under the ticker GRFS. Grifols is the company sponsoring the clinical development program for Thrombate III in trauma injury, including the ongoing Phase 2 study of the drug in patients at risk of trauma-related venous thromboembolism.

What phase is Thrombate III in?

Thrombate III is in Phase 2 development for trauma injury. The single registered trial, NCT05794165, is a Phase 2 study that is currently enrolling by invitation. No completed trials of Thrombate III for this indication are listed, so the asset remains in clinical development rather than approved for trauma injury.

What clinical trials is Thrombate III in?

Thrombate III is being evaluated in NCT05794165, titled Antithrombin to Improve Thromboprophylaxis and Reduce the Incidence of Trauma-Related Venous Thromboembolism. This Phase 2 trial is enrolling by invitation, is randomized, double blind, and placebo controlled, and plans to enroll 314 participants aged 18 years and older in the United States.

Is Thrombate III the same as Thrombate infusion?

Yes, Thrombate infusion is another name for Thrombate III. Both names refer to the same Grifols, S.A. product being studied in the Phase 2 NCT05794165 trial for trauma injury, where the goal is to improve thromboprophylaxis and reduce trauma-related venous thromboembolism.

Is Thrombate III FDA approved for trauma injury?

Thrombate III is not approved for trauma injury. It is an investigational therapy in Phase 2 clinical development for that indication, studied in the enrolling-by-invitation trial NCT05794165. The trial is randomized, double blind, and placebo controlled, with a planned enrollment of 314 adults aged 18 years and older.