Drugs / LIXUDEBART
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT05939947 | Apr 2023 → Oct 2024 | cirrhosis of liver, fibrotic liver disease | Alentis Therapeutics AG | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT06047171 | Sep 2023 → Jun 2027 expected | rapidly progressive glomerulonephritis | Alentis Therapeutics AG | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2025-01-09 | Alentis Therapeutics AG | Results Alentis Announces Positive Topline Results from Two Studies of Lixudebart (ALE.F02) in Patients with ANCA-RPGN and Advanced Liver Fibrosis alentis.ch ↗
Alentis Therapeutics (“Alentis”), a clinical-stage biotechnology company developing treatments for Claudin-1 positive (CLDN1+) tumors and organ fibrosis, announced positive topline results from two clinical trials of lixudebart (ALE.F02), a monoclonal antibody targeting Claudin-1 (CLDN1), developed to reverse organ fibrosis. |
| 2024-05-29 | Alentis Therapeutics AG | Regulatory Alentis Receives FDA Orphan Drug Designation for Lixudebart to Treat Idiopathic Pulmonary Fibrosis alentis.ch ↗
Alentis Therapeutics (“Alentis”), the clinical-stage biotechnology company developing treatments for Claudin-1 positive (CLDN1+) tumors and organ fibrosis, announced today that the U.S. Food and Drug Administration (FDA) has granted lixudebart (ALE.F02) Orphan Drug designation for the treatment of Idiopathic Pulmonary Fibrosis (IPF). |
| 2023-04-26 | Alentis Therapeutics AG | Results ALENTIS THERAPEUTICS REPORTS POSITIVE TOPLINE RESULTS FROM PHASE 1 MULTIPLE-ASCENDING DOSE COHORTS STUDY alentis.ch ↗
The trial confirms ALE.F02’s good safety profile, exposure and target biological activity |
| 2023-01-09 | Alentis Therapeutics AG | Results Positive Results from Single Ascending Dose Phase 1 Study of ALE.F02 Targeting Claudin-1 alentis.ch ↗
The study found ALE.F02 to be well tolerated in healthy volunteers at all doses with a good safety profile and demonstrated initial evidence of on-target biological activity. |
All press releases naming this drug 6 releases
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | LIXUDEBART | ChEMBL registry synonym — accepted as the source's own label CHEMBL5314749 ↗ |
| Known as | ALE.F02 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06047171 ↗ |
| Modality | Monoclonal antibody | “ALE.F02 is an anti-Claudin-1 (CLDN1) monoclonal antibody (mAb)” NCT06047171 ↗ |
| Route | Intravenous | “Continuous intravenous (IV) infusion administered once every second week to a total of 3 doses.” NCT05939947 ↗ |
| Target | CLDN1 | “ALE.F02 is an anti-Claudin-1 (CLDN1) monoclonal antibody (mAb) to selectively target the non-tight junctions (TJ), exposed form of CLDN1.” NCT06047171 ↗ |