Drugs / AGMB-129
Trials 4
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT07118878 | Aug → Sep 2025 | Crohn disease | Agomab Therapeutics NV | Completed | No outcome recorded |
| Phase 1 | NCT06397508 | Apr → May 2024 | — | Agomab Therapeutics NV | Completed | No outcome recorded |
| Phase 1 | NCT05937386 | Aug → Sep 2023 | — | Agomab Therapeutics NV | Completed | No outcome recorded |
| Phase 21 trial · 1 met primary | ||||||
| Phase 2 | NCT05843578 | Aug 2023 → Jun 2026 | Crohn disease | Agomab Therapeutics NV | Completed | Met primary |
News releases announcing trial results or a regulatory action · 5
| Date | Issuer | Release |
|---|---|---|
| 2026-06-23 | Agomab Spain S.L.U. | Regulatory Agomab Announces Design of NOV-ERA Phase 2b Study with Ontunisertib in Fibrostenosing Crohn’s Disease agomab.com ↗
The protocol has been submitted to the FDA and has cleared central Institutional Review Board (IRB) approval in the U.S. |
| 2025-11-17 | Agomab Spain S.L.U. | Results Agomab Announces Positive Topline Phase 2a Data for Ontunisertib in Fibrostenosing Crohn’s Disease agomab.com ↗ |
| 2025-03-10 | Agomab Spain S.L.U. | Results Agomab Announces Positive Topline Phase 2a Interim Results for AGMB-129 in Fibrostenosing Crohn’s Disease agomab.com ↗ |
| 2023-10-05 | Agomab Spain S.L.U. | Regulatory Agomab Receives FDA Fast Track Designation for AGMB-129 in Fibrostenosing Crohn’s Disease and Starts STENOVA Phase 2a Clinical Trial agomab.com ↗
Agomab Therapeutics NV (‘Agomab’) today announced that it received Fast Track Designation from the U.S. Food and Drug Administration (FDA) for AGMB -129 for the potential treatment of Fibrostenosing Crohn’s Disease (FSCD). |
| 2023-02-02 | Agomab Spain S.L.U. | Results Agomab Reports Positive Phase 1 Results with AGMB-129, a GI-restricted ALK5 Inhibitor for Fibrostenosing Crohn’s Disease agomab.com ↗
Agomab Therapeutics NV (‘Agomab’) today announced positive clinical results from its Phase 1 study evaluating AGMB-129, an oral gastro-intestinal (GI)-restricted small molecule kinase inhibitor of ALK5 (TGFbRI or ALK5), intended for the treatment of Fibrostenosing Crohn’s Disease (FSCD). |
All press releases naming this drug 7 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 4 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | AGMB-129 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05843578 ↗ |
| Known as | Ontunisertib | “The objective of this clinical trial is to evaluate the safety, pharmacokinetics, and pharmacodynamics of AGMB-129 (Ontunisertib) in patients with Crohn's disease and...” NCT05843578 ↗ |
| Route | Oral | “Oral capsule” NCT05843578 ↗ |