Drugs / mocravimod
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 22 trials | ||||||
| Phase 2 | NCT01294774 | Feb 2011 → Oct 2012 | subacute cutaneous lupus erythematosus | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT01375179 | Dec 2010 → May 2012 | ulcerative colitis | Novartis Pharmaceuticals | Terminated | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT05429632 | Jun 2022 → May 2027 expected | acute myeloid leukemia | Priothera SAS | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 10
| Date | Issuer | Release |
|---|---|---|
| 2026-03-02 | Priothera SAS | Results Clinical assessment of mocravimod as a victim of drug–drug interactions via CYP3A4 metabolism and transporters priothera.com ↗
The PK of mocravimod and mocravimod-phosphate were bioequivalent with or without co-administration of multiple doses of itraconazole and a moderate interaction is observed when co-administered with cyclosporin. |
| 2023-11-27 | Priothera SAS | Regulatory Priothera – US FDA grants Orphan Drug Designation to mocravimod to improve the outcome of allogeneic hematopoietic stem cell transplantation (allo-HSCT) in patients with hematologic malignancies priothera.com ↗
Priothera Ltd., a Phase 3 clinical stage biotechnology company pioneering the development of its S1P receptor modulator compound mocravimod, today announced that the US Food and Drug Administration (FDA) has granted Orphan Drug designation (ODD) to mocravimod for the “ treatment to improve outcome following hematopoietic stem cell transplantation in hematologic malignancies ”. |
| 2023-02-28 | Priothera SAS | Regulatory Priothera cleared to begin Japanese arm of pivotal Phase III study with mocravimod in patients with Acute Myeloid Leukemia undergoing allogeneic Hematopoietic Cell Transplant priothera.com ↗
Priothera, a late-clinical stage biotechnology company pioneering the development of its S1P receptor modulator compound mocravimod, today announced that it received clearance from the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan for the pivotal global MO-TRANS Phase 3 study evaluating mocravimod in Acute Myeloid Leukemia (AML) patients undergoing allogeneic hematopoietic cell transplant (HCT). |
| 2022-11-15 | Priothera SAS | Results Priothera – Positive mocravimod Phase Ib clinical data published in Transplantation and Cellular Therapy priothera.com ↗
The study found that mocravimod can safely be added to standard treatment regimens in patients with hematological malignancies requiring allo-HCT. |
| 2022-06-24 | Priothera SAS | Results Priothera – Clinical Mocravimod Data in Hematological Malignancies Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplant (aHSCT) Presented at the 2022 European Hematology Association (EHA) Congress priothera.com ↗
The study showed that in the Phase 1b/2a study mocravimod was safe and well tolerated with promising overall survival. |
| 2022-06-01 | Priothera SAS | Regulatory Priothera Receives Fast Track Designation for mocravimod in Combination with Allogeneic Hematopoietic Stem Cell Transplant (HSCT) for Post Remission Therapy of Acute Myeloid Leukemia (AML) Patients priothera.com ↗
Priothera, a late-clinical stage biotechnology company pioneering the development of its S1P receptor modulator compound , mocravimod , today announce s that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation (FTD) for mocravimod in combination with a llogeneic H ematopoietic S tem C ell T ransplant (HSCT) for post remission therapy of Acute Myeloid Leukemia (AML) p atients . |
| 2022-04-25 | Priothera SAS | Results Priothera to present an abstract at the TANDEM Meetings / Transplantation & Cellular Therapy Meetings of ASTCT™ and CIBMTR – April 23-26 2022 priothera.com ↗
KRP203 shows promising early clinical outcome with a limited number of relapses, acute and chronic GVHD. |
| 2022-04-25 | Priothera SAS | Regulatory Priothera Receives FDA clearance of Investigational New Drug (IND) priothera.com ↗
the U.S. Food and Drug Administration (FDA) has provided clearance to proceed with the Company’s Investigational New Drug (IND) application to begin its pivotal Phase 2b/3 study of mocravimod (named MO-TRANS). |
| 2022-04-11 | Priothera SAS | Regulatory Priothera Receives First Regulatory Approvals to Start a Global Pivotal Study with Mocravimod in Acute Myeloid Leukemia Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplant priothera.com ↗
Priothera Ltd, a late-clinical stage biotechnology company pioneering the development of its S1P receptor modulator mocravimod, today announces it has received the two first European country approvals from the Swiss and French national health authorities (Swissmedic and ANSM) to begin its planned pivotal study of mocravimod. |
| 2022-03-03 | Priothera SAS | Regulatory Priothera – FDA and EMA Grant Orphan Drug Designation to mocravimod for the treatment of Acute Myeloid Leukemia (AML) in patients undergoing allogeneic hematopoietic stem cell transplantation (HSCT) priothera.com ↗
The orphan drug designations we received for mocravimod from both the FDA and EMA are important milestones towards addressing the urgent, unmet needs of AML patients. |
All press releases naming this drug 14 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 | mocravimod | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05429632 ↗ |
| Known as | KRP-203 HYDROCHLORIDE | ChEMBL registry synonym — accepted as the source's own label CHEMBL2137148 ↗ |
| Known as | KRP203 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01375179 ↗ |
| Known as | KRP203 HCl | ChEMBL registry synonym — accepted as the source's own label CHEMBL2137148 ↗ |
| Known as | MOCRAVIMOD HYDROCHLORIDE | ChEMBL registry synonym — accepted as the source's own label CHEMBL2137148 ↗ |
| Action | Activate | “Sphingosine 1-phosphate receptor Edg-1 agonist” CHEMBL2137148 ↗ |
| Modality | Small molecule | — CHEMBL2137148 ↗ |
| Route | Oral | “3 mg of mocravimod orally once per day for 12 months” NCT05429632 ↗ |
| Target | S1PR1 | “Sphingosine 1-phosphate receptor Edg-1 agonist” CHEMBL2137148 ↗ |