Drugs / VAD044
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT07800429 | Sep → Oct 2026 expected | — | Vaderis Therapeutics AG | Not yet recruiting | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT05406362 | Jul 2022 → Jan 2027 expected | hereditary hemorrhagic telangiectasia | Vaderis Therapeutics AG | Active not recruiting | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT07743671 | Sep 2026 → Jun 2028 expected | hereditary hemorrhagic telangiectasia | Vaderis Therapeutics AG | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2025-12-02 | Vaderis Therapeutics AG | Results Vaderis Therapeutics Announces The New England Journal of Medicine Publishes Engasertib Proof-of-Concept and Long-Term Extension Results vaderis.com ↗
Vaderis Therapeutics today announced that data from its randomized, double-blind, placebo-controlled, multi-center proof-of-concept study and long-term extension of engasertib (VAD044) in Hereditary Hemorrhagic Telangiectasia (HHT) have been published in The New England Journal of Medicine (NEJM). |
| 2024-11-17 | Vaderis Therapeutics AG | Regulatory Vaderis Receives FDA Fast Track Designation for VAD044 for the Treatment of Hereditary Hemorrhagic Telangiectasia vaderis.com ↗
Vaderis Therapeutics AG (Vaderis), a clinical stage biotechnology company focusing on treatments for rare diseases associated with vascular malformations, today 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). |
| 2024-08-27 | Vaderis Therapeutics AG | Results Vaderis Announces Positive Clinical Proof-of-Concept Trial in HHT vaderis.com ↗
Safety was the primary endpoint and VAD044 was similar to placebo as measured by both the frequency and severity of off-target adverse events (AEs). |
All press releases naming this drug 5 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-08-11 | Vaderis Therapeutics AG | Vaderis Therapeutics Announces Oversubscribed $152 Million Series B Financing and Initiation of the Global Phase 3 HEROIC Study of Engasertib for Hereditary Hemorrhagic Telangiectasia vaderis.com ↗ |
| 2025-12-02 | Vaderis Therapeutics AG | Vaderis Therapeutics Announces The New England Journal of Medicine Publishes Engasertib Proof-of-Concept and Long-Term Extension Results vaderis.com ↗ |
| 2024-11-17 | Vaderis Therapeutics AG | Vaderis Receives FDA Fast Track Designation for VAD044 for the Treatment of Hereditary Hemorrhagic Telangiectasia vaderis.com ↗ |
| 2024-11-05 | Vaderis Therapeutics AG | Vaderis Announces Acceptance of Abstract on VAD044 Proof-of-Concept Clinical Trial vaderis.com ↗ |
| 2024-08-27 | Vaderis Therapeutics AG | Vaderis Announces Positive Clinical Proof-of-Concept Trial in HHT vaderis.com ↗ |
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 5 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | VAD044 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05406362 ↗ |
| Known as | Engasertib | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07743671 ↗ |
| Action | Inhibit | “a new, allosteric, selective AKT inhibitor” PMID 41297007 ↗ Nov 2025 |
| Modality | Small molecule | — CHEMBL5314970 ↗ |
| Route | Oral | “we evaluated the safety and efficacy of oral engasertib” PMID 41297007 ↗ Nov 2025 |
| Target | AKT | “a new, allosteric, selective AKT inhibitor” PMID 41297007 ↗ Nov 2025 |