Drugs / zelenirstat
zelenirstat
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT06613217 | Mar 2025 → Mar 2026 overdue | acute myeloid leukemia | Pacylex Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 1 | NCT04836195 | Sep 2021 → Oct 2024 | B-cell non-Hodgkin lymphoma | Pacylex Pharmaceuticals | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 16
| Date | Issuer | Release |
|---|---|---|
| 2024-04-21 | Pacylex Pharmaceuticals | Results Pacylex Pharmaceuticals CEO Presents Zelenirstat for Acute Myeloid Leukemia at the World Orphan Drug Congress pacylex.com ↗
Zelenirstat prolonged progression free and overall survival in Phase 1 solid tumor patients receiving the RP2D, compared to those receiving lower doses. |
| 2024-04-08 | Pacylex Pharmaceuticals | Results Zelenirstat Disrupts Oxidative Phosphorylation in Cancer Cells at AACR 2024 pacylex.com ↗
A poster will be presented describing the Company’s Phase 1 study safety results and efficacy signals, as well as evidence for profound disruption of Complex I formation in mitochondria of cancer cell with concomitant loss of oxidative phosphorylation. |
| 2024-01-17 | Pacylex Pharmaceuticals | Results Phase 1 Safety and Efficacy Results for Zelenirstat in Colorectal and other Cancers pacylex.com ↗
Zelenirstat prolonged progression free and overall survival in Phase 1 solid tumor patients receiving the RP2D. |
| 2023-12-03 | Pacylex Pharmaceuticals | Results Pacylex Pharmaceuticals Reports Safety and Efficacy Results from Its Phase 1 First-In-Human Study of Zelenirstat (PCLX-001) pacylex.com ↗
A recommended Phase 2 dose for expansion studies was established. |
| 2023-10-03 | Pacylex Pharmaceuticals | Results Zelenirstat Shows Potent in vitro Radiosensitization in Human Glioblastoma Models pacylex.com ↗
Zelenirstat was more effective than clinically used radiosensitizers, which generally augment the effects of radiation by 10% to 30%, increasing the effects of radiation by 40% - 140%; |
| 2023-06-13 | Pacylex Pharmaceuticals | Results Pacylex Pharmaceuticals Presents New Data on the Mechanism of Action of Myristoylation Inhibition pacylex.com ↗
MISS-91 predicts multiple cancers that are sensitive to PCLX-001, a first-in-class small molecule NMT inhibitor, including both hematologic and solid tumors, at concentrations at which normal tissues would be insensitive. |
| 2023-05-07 | Pacylex Pharmaceuticals | Results Pacylex Pharmaceuticals Reports a Potential Drug Sensitivity Gene Signature and the Effects of Myristoylation Inhibition on Angiogenesis and Cancer Cell Migration at American Association of Cancer Research (AACR) 2023. pacylex.com ↗
New data demonstrating that PCLX-001, a proprietary, potent, N-myristoyltransferase (NMT) inhibitor reduces angiogenesis, cell migration/invasion, and thus potentially cancer metastasis, will also be presented. |
| 2022-11-22 | Pacylex Pharmaceuticals | Regulatory Pacylex Granted FDA Fast Track Designation for PCLX-001 for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia pacylex.com ↗
We are happy to announce that the U.S. Food and Drug Administration (FDA) has granted PCLX-001 Fast Track Designation for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML). |
| 2022-11-04 | Pacylex Pharmaceuticals | Regulatory Pacylex Announces FDA Clearance of IND Application for PCLX-001 to Treat Acute Myeloid Leukemia pacylex.com ↗
Pacylex , a clinical-stage NMT inhibitor company developing first-in-class therapies for leukemia, lymphoma, and solid tumor cancers, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for PCLX-001 for the treatment of acute myeloid leukemia (AML). |
| 2022-10-27 | Pacylex Pharmaceuticals | Results Pacylex Pharmaceuticals announces progress on early phase clinical trials of PCLX-001 in patients pacylex.com ↗
The drug is a once-per-day capsule that has been dosed in 16 solid tumor and non-Hodgkin lymphoma patients to date without any dose limiting toxicities. |
| 2022-10-14 | Pacylex Pharmaceuticals | Regulatory Pacylex Announces Orphan Drug Designation Granted to PCLX-001 for the Treatment of Acute Myeloid Leukemia pacylex.com ↗
Pacylex today announced that the U.S. Food and Drug Administration (FDA) granted PCLX-001 Orphan Drug Designation for “treatment of patients with acute myeloid leukemia.” |
| 2022-04-08 | Pacylex Pharmaceuticals | Results Pacylex Presents Evidence Supporting Advancement of PCLX-001 for Treatment of AML at AACR 2022 pacylex.com ↗
This investigation included the association of N-myristoyl transferase (NMT) expression levels with AML patient survival and the in vitro and in vivo demonstration of AML cell killing and tumor reduction with PCLX-001, a proprietary, potent, NMT inhibitor in clinical investigation in Non-Hodgkin’s Lymphoma (NHL) and solid tumor cancer patients. |
| 2022-03-14 | Pacylex Pharmaceuticals | Results First Clinical Experience with an N-myristoyltransferase (NMT) inhibitor in a patient published pacylex.com ↗
Pacylex is excited to announce the publication in the journal Current Oncology of data from the first patient. |
| 2021-12-13 | Pacylex Pharmaceuticals | Results Pacylex Presented Initial Clinical Experience with PCLX-001 in Patients at ASH 2021 pacylex.com ↗
This update included the design of the first clinical trial with PCLX-001 in Non-Hodgkin’s Lymphoma and solid tumor patients and an update on the first dose cohort. |
| 2021-03-11 | Pacylex Pharmaceuticals | Regulatory Health Canada Approves PCLX-001 Phase I Clinical Trial pacylex.com ↗
A No Objection Letter has been received from Health Canada on March 8, 2021, opening the way for a planned Phase 1 Trial of PCLX-001 in relapsed/refractory B-cell Non-Hodgkin Lymphoma and advanced solid malignancies. |
| 2020-06-08 | Pacylex Pharmaceuticals | Results Pacylex presents at 2019 Biotech Showcase pacylex.com ↗
In the presentation and interview, Dr. Weickert reported animal results demonstrating efficacy of PCLX-001 against various leukemias and lymphomas as well as against solid tumor cancers. |
All press releases naming this drug 27 releases
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 4 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | zelenirstat | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06613217 ↗ |
| Known as | CCI-002 | ChEMBL registry synonym — accepted as the source's own label CHEMBL3357685 ↗ |
| Known as | DDD 86481 | ChEMBL registry synonym — accepted as the source's own label CHEMBL3357685 ↗ |
| Known as | PCLX-001 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04836195 ↗ |
| Action | Inhibit | “Cancer cell treatments with the first-in-class NMTI PCLX-001 (zelenirstat), which is undergoing human phase 1/2a trials in advanced lymphoma and solid tumors, recapitulated...” PMID 38715059 ↗ May 2024 |
| Modality | Small molecule | — CHEMBL3357685 ↗ |
| Route | Oral | “Zelenirstat will be administered orally, once daily, on 28-day cycles, at the same time each day.” NCT06613217 ↗ |