Drugs / 5-(4-((2S,5S)-5-(4-CHLOROBENZYL)-2-METHYLMORPHOLINO)PIPERIDIN-1-YL)-1H-1,2,4-TRIAZOL-3-AMINE
5-(4-((2S,5S)-5-(4-CHLOROBENZYL)-2-METHYLMORPHOLINO)PIPERIDIN-1-YL)-1H-1,2,4-TRIAZOL-3-AMINE
Small molecule targets CHIT1 via inhibition
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT05030857 | Sep → Nov 2021 | — | Lakefront Biotherapeutics NV | Completed | No outcome recorded |
| Phase 1 | NCT04971746 | Jul 2021 → May 2022 | — | Lakefront Biotherapeutics NV | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT06205121 | Mar 2024 → Aug 2027 expected | pulmonary sarcoidosis | Molecure S.A. | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 13
| Date | Issuer | Release |
|---|---|---|
| 2026-07-24 | Molecure S.A. | Results Molecure Receives Positive IDMC Recommendation to Continue the KITE Clinical Trial Without Changes to the Study Protocol (OATD-01 Development Program) molecure.com ↗
The positive recommendation was issued following the IDMC’s review of the complete safety and efficacy dataset specified for the interim analysis in 30 patients and confirms that these results warrant continuation of the study with no modifications. |
| 2024-05-21 | Molecure S.A. | Regulatory Molecure receives approval to initiate a Phase II clinical trial (KITE) for OATD-01 for the treatment of pulmonary sarcoidosis in selected countries of the European Union and Norway molecure.com ↗
Obtaining regulatory approvals in Denmark, France, Greece, Germany, and Norway enables the conduct of the Phase II clinical trial of OATD-01 in these countries. |
| 2024-02-09 | Molecure S.A. | Regulatory Molecure has submitted a new application for approval to conduct a Phase II clinical trial for clinical candidate OATD-01 in the countries of the European Union and Norway molecure.com ↗
Molecure has resubmitted an application for approval to conduct a Phase II clinical trial for OATD-01 in Denmark, France, Greece, Germany and Norway. |
| 2023-09-09 | Molecure S.A. | Regulatory Molecure submits application to the European Medicines Agency (EMA) to initiate a phase II clinical trial in the European Union and Norway to investigate OATD-01 for the treatment of pulmonary sarcoidosis molecure.com ↗
Molecure S.A. (“Molecure”, GPW ticker: MOC), clinical stage biotechnology company developing first-in-class small molecule drug candidates that directly modulate unexplored protein and RNA targets to treat multiple incurable diseases, has applied to the European Medicines Agency (EMA) for permission to initiate a phase II study for OATD-01, a first-in-class and potentially disease-modifying chitotriosidase 1 (CHIT1) inhibitor. |
| 2023-07-22 | Molecure S.A. | Regulatory The U.S. Food and Drug Administration Gives the Green Light to Molecure’s Flagship Program – Phase II Clinical Testing of OATD-01 is Ready for Launch molecure.com ↗
This IND will allow the company to conduct phase II clinical testing of OATD-01, the first-ever chitotriosidase 1 (CHIT1) inhibitor with disease-modifying potential. |
| 2023-06-22 | Molecure S.A. | Regulatory Molecure Files an Investigational New Drug (IND) application for lead clinical candidate OATD-01 with U.S. FDA ahead of a planned Phase 2 pulmonary sarcoidosis study molecure.com ↗ |
| 2020-09-10 | Molecure S.A. | Results OncoArendi Therapeutics has received the final report from the phase Ib clinical trial of innovative drug candidate OATD-01 molecure.com ↗
the report confirms the OATD-01 safety profile which justifies further clinical development of this experimental drug |
| 2020-04-20 | Molecure S.A. | Results OncoArendi Therapeutics has completed a Phase Ib clinical trial with an innovative small molecule experimental drug – OATD-01. Further analyses of the data from the study will lead to the final report and advancing to phase II clinical trials in patients molecure.com ↗
OncoArendi Therapeutics announces the end of the clinical part of phase Ib trial (multiple ascending dose (MAD)) of the OATD-01 compound after confirming the tolerability of the tested doses and achieving the estimated pharmacodynamic effect. |
| 2019-01-11 | Molecure S.A. | Regulatory Clinical trials of the OATD-01 molecule will enter the next phase molecure.com ↗ |
| 2018-10-31 | Molecure S.A. | Regulatory Submission of the application for the approval to initiate Phase 1b clinical trial for OATD-01 molecure.com ↗
On October 30, 2018, OncoArendi Therapeutics has requested the German State Institute for Medicines and Medical Devices [BfArM] to start a phase 1b clinical trial for the OATD-01 compound |
| 2018-05-21 | Molecure S.A. | Results ATS 2018, 18 – 23 May, San Diego, USA molecure.com ↗
Poster: OATD-01, a Dual Chitinase Inhibitor, Significantly Ameliorates Pulmonary Fibrosis in the Bleomycin-Induced Mouse Model |
| 2017-10-09 | Molecure S.A. | Regulatory OncoArendi Therapeutics to Begin the Phase 1 Clinical Evaluation of its Novel Class of Medicines molecure.com ↗
OncoArendi Therapeutics has been granted permission from the German Federal Institute for Drugs and Medical Devices (BfArM) to begin the first-in-human clinical evaluation of its novel drug candidate. |
| 2017-07-07 | Molecure S.A. | Regulatory OncoArendi Therapeutics announced today that it has filed a Clinical Trial Application (CTA) molecure.com ↗ |
All press releases naming this drug 20 releases
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 4 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | 5-(4-((2S,5S)-5-(4-CHLOROBENZYL)-2-METHYLMORPHOLINO)PIPERIDIN-1-YL)-1H-1,2,4-TRIAZOL-3-AMINE | ChEMBL registry synonym — accepted as the source's own label CHEMBL4788866 ↗ |
| Known as | GLP 4716 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4788866 ↗ |
| Known as | GLPG4716 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05030857 ↗ |
| Known as | OAT 889 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4788866 ↗ |
| Known as | OATD-01 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06205121 ↗ |
| Action | Inhibit | “OATD-01 is an oral inhibitor of chitinase-1 (CHIT1)” NCT06205121 ↗ |
| Modality | Small molecule | — CHEMBL4788866 ↗ |
| Route | Oral | “participants will receive GLPG4716 tablets once daily in fasted state” NCT05030857 ↗ |
| Target | CHIT1 | “inhibitor of chitinase-1 (CHIT1)” NCT06205121 ↗ |