Drugs / Orziloben
Orziloben
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial | ||||||
| Phase 2 | NCT05919680 | Jan 2024 → Jun 2025 overdue | intestinal failure–associated liver disease | NorthSea Therapeutics B.V. | Recruiting | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 1 | NCT05181085 Comparator | Nov 2021 → May 2022 | intestinal failure–associated liver disease, short bowel syndrome | NorthSea Therapeutics B.V. | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2026-03-03 | NorthSea Therapeutics B.V. | Regulatory NorthSea Therapeutics Announces Achievement of Key Regulatory Milestones for Orziloben northseatherapeutics.com ↗
today announced that the U.S. Food and Drug Administration (FDA) and the European Medicines Agency’s (EMA) Committee for Orphan Medicinal Products (COMP) have granted Orphan Drug Designations (ODD) to orziloben (NST-6179) for the treatment of intestinal failure associated liver disease (IFALD). |
All press releases naming this drug 3 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-03-31 | NorthSea Therapeutics B.V. | NorthSea Therapeutics Bolsters Board, as Orziloben Moves into Late-stage Development northseatherapeutics.com ↗ |
| 2026-03-03 | NorthSea Therapeutics B.V. | NorthSea Therapeutics Announces Achievement of Key Regulatory Milestones for Orziloben northseatherapeutics.com ↗ |
| 2024-02-22 | NorthSea Therapeutics B.V. | NorthSea Therapeutics Initiates Phase 2A Trial of Orziloben (NST-6179) in Intestinal Failure-Associated Liver Disease (IFALD) northseatherapeutics.com ↗ |
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 | Orziloben | “A Phase 2a, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Orziloben (NST-6179) in Subjects...” NCT05919680 ↗ |
| Known as | NST-6179 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05919680 ↗ |
| Known as | Orzilobene | ChEMBL registry synonym — accepted as the source's own label CHEMBL5314534 ↗ |
| Modality | Small molecule | “orally administered, fully synthetic medium chain fatty acid (MCFA) analogue” NCT05181085 ↗ |
| Route | Oral | “orally administered” NCT05181085 ↗ |