engasertib (VAD044) / Vaderis - LARVOL DELTA

Effect of a Known P-glycoprotein (P-gp) Inhibitor, Itraconazole, on the Pharmacokinetics (PK) of Engasertib (clinicaltrials.gov) - P1 | N=27 | Not yet recruiting | Sponsor: Vaderis Therapeutics AG

New P1 trial

A Trial to Assess the Efficacy and Safety of Engasertib in Participants With Moderate to Severe Hereditary Hemorrhagic Telangiectasia (HHT) (clinicaltrials.gov) - P3 | N=240 | Recruiting | Sponsor: Vaderis Therapeutics AG | Not yet recruiting ➔ Recruiting

Enrollment open • Hematological Disorders

A Trial to Assess the Efficacy and Safety of Engasertib in Participants With Moderate to Severe Hereditary Hemorrhagic Telangiectasia (HHT) (clinicaltrials.gov) - P3 | N=240 | Not yet recruiting | Sponsor: Vaderis Therapeutics AG

New P3 trial • Hematological Disorders

POC study: Assess Safety and Efficacy of VAD044 in HHT Patients (clinicaltrials.gov) - P1/2 | N=75 | Active, not recruiting | Sponsor: Vaderis Therapeutics AG | Trial completion date: Dec 2025 ➔ Jan 2027 | Trial primary completion date: Mar 2025 ➔ Jan 2027

Trial completion date • Trial primary completion date • Hematological Disorders

A Randomized, Placebo-Controlled, Multicenter Proof-of-Concept (POC) Study to Assess the Safety and Efficacy of the Novel Allosteric AKT Inhibitor, VAD044, in Adults with Hereditary Hemorrhagic Telangiectasia (HHT) (ASH 2024) - P1/2 | "These results support continued development of VAD044—the first-ever novel therapy being developed specifically for HHT—to address the major unmet need for patients with HHT. An open-label extension trial is ongoing."

Clinical • Anemia • Cardiovascular • CNS Disorders • Diabetes • Gastroenterology • Hematological Disorders • ALK1 • ENG

POC study: Assess Safety and Efficacy of VAD044 in HHT Patients (clinicaltrials.gov) - P1/2 | N=75 | Active, not recruiting | Sponsor: Vaderis Therapeutics AG | Recruiting ➔ Active, not recruiting | Phase classification: P1 ➔ P1/2 | Trial completion date: May 2024 ➔ Dec 2025 | Trial primary completion date: Mar 2024 ➔ Mar 2025

Enrollment closed • Phase classification • Trial completion date • Trial primary completion date • Hematological Disorders

Vaderis Receives FDA Fast Track Designation for VAD044 for the Treatment of Hereditary Hemorrhagic Telangiectasia (PRNewswire) - "Vaderis Therapeutics AG...announces that the US Food and Drug Administration (FDA) has designated the allosteric AKT-inhibitor VAD044 a Fast Track product for the treatment of Hereditary Hemorrhagic Telangiectasia (HHT)."

Fast track • Genetic Disorders

Assess Safety and Efficacy of VAD044 in HHT Patients (clinicaltrials.gov) - P1 | N=80 | Recruiting | Sponsor: Vaderis Therapeutics AG | Trial completion date: Dec 2024 ➔ May 2024 | Trial primary completion date: Sep 2024 ➔ Mar 2024

Trial completion date • Trial primary completion date • Hematological Disorders

Assess Safety and Efficacy of VAD044 in HHT Patients (clinicaltrials.gov) - P1 | N=80 | Recruiting | Sponsor: Vaderis Therapeutics AG | Not yet recruiting ➔ Recruiting

Enrollment open • Hematological Disorders

Assess Safety and Efficacy of VAD044 in HHT Patients (clinicaltrials.gov) - P1 | N=80 | Not yet recruiting | Sponsor: Vaderis Therapeutics AG

New P1 trial • Hematological Disorders