BAY 3389934 / Bayer - LARVOL DELTA

Clinical Insights from the First Human Study of BAY 3389934: A Dual Factor IIa/Xa Inhibitor (ISTH 2026) - "These results underscore its potential as an innovative treatment of sepsis-induced coagulopathy. Table or Figure Upload (1) Figure 1: Scatterplot of plasma concentration of BAY 3389934 vs. values of aPTT[s] by study intervention (Part A and B) Page 2 DOI*10.1016/j.rpth.2026.103617"

Clinical • First-in-human • Hematological Disorders • Infectious Disease • Septic Shock

A Study to Learn About How Safe BAY3389934 is and How it Affects Blood Clotting When Given Alone or With Aspirin in Healthy Participants (clinicaltrials.gov) - P1 | N=16 | Recruiting | Sponsor: Bayer

New P1 trial • Thrombosis

A Study to Assess the Safety and Effects of Different Doses of an Investigational Drug, BAY 3389934, in Healthy Japanese Volunteers. (clinicaltrials.gov) - P1 | N=16 | Completed | Sponsor: Bayer | Recruiting ➔ Completed

Trial completion • Infectious Disease • Septic Shock

A Study to Assess the Safety and Effects of Different Doses of an Investigational Drug, BAY 3389934, in Healthy Japanese Volunteers. (clinicaltrials.gov) - P1 | N=16 | Recruiting | Sponsor: Bayer | Trial completion date: Jan 2026 ➔ Jun 2026 | Trial primary completion date: Jan 2026 ➔ Jun 2026

Trial completion date • Trial primary completion date • Infectious Disease • Septic Shock

A Study to Learn About How Safe BAY 3389934 is, Its Suitable Dose, and How it Affects the Participants With Sepsis Induced Coagulopathy (clinicaltrials.gov) - P1 | N=36 | Recruiting | Sponsor: Bayer | Suspended ➔ Recruiting

Enrollment open • Hematological Disorders • Infectious Disease • Septic Shock

A Study to Learn About How Safe BAY 3389934 is, Its Suitable Dose, and How it Affects the Participants With Sepsis Induced Coagulopathy (clinicaltrials.gov) - P1 | N=36 | Recruiting | Sponsor: Bayer | Suspended ➔ Recruiting | Trial completion date: May 2026 ➔ Feb 2027 | Trial primary completion date: Mar 2026 ➔ Dec 2026

Enrollment open • Trial completion date • Trial primary completion date • Hematological Disorders • Infectious Disease • Septic Shock

Treatment with a Novel Small Molecule Dual Factor IIa/Xa Inhibitor Protects Against Coagulopathy and Organ Dysfunction in a Baboon Model of Staphylococcus Aureus Sepsis (ASH 2024) - "Conclusion : In a model of sepsis-induced coagulopathy in baboons, the dual FIIa/Xa inhibitor BAY 3389934 reduced the hypercoagulable state strongly and protected from organ damage. Further studies are warranted to explore its full therapeutic potential in the treatment of sepsis-associated DIC."

Anesthesia • Hematological Disorders • Infectious Disease • Septic Shock

A Study to Assess the Safety and Effects of Different Doses of an Investigational Drug, BAY 3389934, in Healthy Japanese Volunteers. (clinicaltrials.gov) - P1 | N=16 | Recruiting | Sponsor: Bayer | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Septic Shock

A Study to Assess the Safety and Effects of Different Doses of an Investigational Drug, BAY 3389934, in Healthy Japanese Volunteers. (clinicaltrials.gov) - P1 | N=16 | Not yet recruiting | Sponsor: Bayer

New P1 trial • Infectious Disease • Septic Shock

A Study to Learn About How Safe BAY 3389934 is, Its Suitable Dose, and How it Affects the Participants With Sepsis Induced Coagulopathy (clinicaltrials.gov) - P1 | N=32 | Suspended | Sponsor: Bayer | Recruiting ➔ Suspended

Trial suspension • Hematological Disorders • Infectious Disease • Septic Shock

Pharmacological profile of BAY 3389934 – a novel rapidly cleared dual FIIa/Xa inhibitor (ISTH 2025) - "When administered as constant infusion over 6h together with LPS to simulate a gram- sepsis in rabbits, it reduced the hypercoagulable state and the consumption of fibrinogen and platelets. In a baboon model mimicking a gram+ infection by systemic exposure to heat-inactivated Staphylococcus aureus, constant infusion of BAY 3389934 resulted in strong reduction of organ damage biomarkers in addition to the reduced DIC parameters without increasing the bleeding risk."

Cardiovascular • Hematological Disorders • Infectious Disease • Septic Shock • Thrombosis

Pharmacological profile of BAY 3389934 – a novel rapidly cleared dual FIIa/Xa inhibitor (ISTH 2025) - No abstract available

Cardiovascular • Venous Thromboembolism

Discovery of BAY 3389934 Hydrochloride: A Potent and Selective Small-Molecule Dual Factor IIa/Xa Inhibitor with Short Half-Life for the Acute Treatment of Sepsis-Induced Coagulopathy. (PubMed, J Med Chem) - "Herein, we describe the discovery of BAY 3389934 hydrochloride (31), a potent and highly selective, direct dual FIIa/Xa inhibitor, with high solubility suited for i.v. application. This small molecule acts as a metabolically soft active pharmaceutical ingredient (API) due to a labile carboxylic ester group, which is responsible for the desired short pharmacokinetic and pharmacological half-life (t1/2), resulting in a high controllability of the pharmacological action."

Journal • Hematological Disorders • Infectious Disease • Septic Shock

A Study to Learn About How Safe BAY 3389934 is, Its Suitable Dose, and How it Affects the Participants With Sepsis Induced Coagulopathy (clinicaltrials.gov) - P1 | N=32 | Recruiting | Sponsor: Bayer | Not yet recruiting ➔ Recruiting

Enrollment open • Hematological Disorders • Infectious Disease • Septic Shock

A Study to Learn About How Safe BAY 3389934 Is, Its Suitable Dose, and How It Affects the Participants with Sepsis Induced Coagulopathy (clinicaltrials.gov) - P1 | N=32 | Not yet recruiting | Sponsor: Bayer

New P1 trial • Hematological Disorders • Infectious Disease • Septic Shock