Drugs / Berubicin
Berubicin
Trials 7
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 14 trials | ||||||
| Phase 1 | NCT05082493 | Dec 2023 | malignant glioma | WPD Pharmaceuticals Sp. z o.o. | Withdrawn | No outcome recorded Stop: Business |
| Phase 1 | NCT00527410 | Oct 2006 → Dec 2008 | neoplastic meningitis | Biogen | Terminated | No outcome recorded Stop: Business |
| Phase 1 | NCT00512460 | Sep 2006 → Mar 2010 | brain neoplasm, leukemia, lymphoma, neoplastic meningitis | M.D. Anderson Cancer Center | Terminated | No outcome recorded |
| Phase 1 | NCT00526812 | Nov 2005 → Dec 2008 | glioma | Biogen | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT04915404 | Dec 2022 → Dec 2023 | glioblastoma | WPD Pharmaceuticals Sp. z o.o. | Terminated | No outcome recorded Stop: Business |
| Phase 22 trials · 1 missed | ||||||
| Phase 2 | NCT04762069 | May 2021 → Apr 2026 overdue | adult glioblastoma | CNS Pharmaceuticals, Inc. | Active not recruiting | Missed primary |
| Phase 2 | NCT00538343 | Oct 2007 → Dec 2008 | metastatic malignant neoplasm in the brain | Biogen | Terminated | No outcome recorded Stop: Business |
News releases announcing trial results or a regulatory action · 25
| Date | Issuer | Release |
|---|---|---|
| 2025-03-25 | CNS Pharmaceuticals, Inc. | Results CNS Pharmaceuticals Announces Primary Analysis of Berubicin in Second Line Treatment of Glioblastoma Multiforme cnspharma.com ↗
Berubicin showed clinically relevant outcomes comparable to Lomustine across multiple endpoints, but not a statistically significant difference in overall survival, the primary endpoint. |
| 2024-11-25 | CNS Pharmaceuticals, Inc. | Results CNS Pharmaceuticals Presents Update from Ongoing Potentially Pivotal Study of Berubicin Compared with Lomustine in Adult Patients with Recurrent GBM (WHO Grade IV) After Failure of Standard First Line Therapy cnspharma.com ↗
The data presented at the SNO Annual Meeting include comparative demographics, disposition of patients, MGMT promoter methylation status and safety, showing that the balance between the randomized arms has been maintained through enrollment of 239 patients into the study. |
| 2023-12-18 | CNS Pharmaceuticals, Inc. | Results CNS Pharmaceuticals Announces Successful Interim Analysis of Efficacy and Safety Data in Potentially Pivotal Study of Berubicin cnspharma.com ↗
today announced the recommendation of the independent Data Safety Monitoring Board (DSMB) that the Company’s ongoing global, potentially pivotal trial of the investigational agent, Berubicin for the treatment of glioblastoma multiforme (GBM) continue without any modification. |
| 2023-11-22 | CNS Pharmaceuticals, Inc. | Results CNS Pharmaceuticals (NASDAQ: CNSP) Presents Updated Safety Data from Ongoing Potentially Pivotal Study Evaluating Berubicin in Advance of the Pre-Planned Interim Analysis of Efficacy cnspharma.com ↗
The data presented at the SNO Annual Meeting show the comparability of the patient demographics in the two arms of the study, and of the safety data for each therapeutic modality in treating recurrent GBM. |
| 2023-08-14 | CNS Pharmaceuticals, Inc. | Results CNS Pharmaceuticals (NASDAQ: CNSP) Presents Updated Results from On-Going Potentially Pivotal Study of Berubicin in Adult Patients with Recurrent GBM (WHO Grade IV) After Failure of Standard First Line Therapy cnspharma.com ↗
today announced the presentation of updated results from the on-going potentially pivotal study evaluating Berubicin, the Company’s novel anthracycline and the first anthracycline to appear to cross the blood-brain barrier, in a poster presentation at the 2023 SNO/ASCO CNS Cancer Conference, held August 10-12, 2023 in San Francisco, CA. |
| 2023-04-06 | CNS Pharmaceuticals, Inc. | Regulatory CNS Pharmaceuticals Receives Approval from Competent Authority and Central Ethics Committee in Italy for Potentially Pivotal Global Trial Evaluating Berubicin for the Treatment of GBM cnspharma.com ↗ |
| 2022-12-08 | CNS Pharmaceuticals, Inc. | Results CNS Pharmaceuticals Announces Preliminary Results from Ongoing Potentially Pivotal Trial Evaluating Berubicin for the Treatment of Recurrent Glioblastoma Multiforme (GBM) cnspharma.com ↗
Preliminary results showcase updated patient population profile and safety |
| 2022-06-23 | CNS Pharmaceuticals, Inc. | Regulatory CNS Pharmaceuticals Receives Approval from U.S. FDA for Protocol Amendment to Ongoing Potentially Pivotal Global Trial Evaluating Berubicin for the Treatment of GBM cnspharma.com ↗ |
| 2022-04-28 | CNS Pharmaceuticals, Inc. | Regulatory CNS Pharmaceuticals Receives Approval from Ethics Committee and Competent Authority in Spain for Potentially Pivotal Study of Berubicin for the Treatment of Glioblastoma Multiforme (GBM) cnspharma.com ↗ |
| 2022-04-06 | CNS Pharmaceuticals, Inc. | Regulatory CNS Pharmaceuticals Receives Approval from France Ethics Committee and Competent Authority for Potentially Pivotal Study of Berubicin for the Treatment of Glioblastoma Multiforme (GBM) cnspharma.com ↗ |
| 2022-04-05 | CNS Pharmaceuticals, Inc. | Regulatory CNS Pharmaceuticals Receives Approval from Competent Authority of Switzerland for Potentially Pivotal Study of Berubicin for the Treatment of Glioblastoma Multiforme (GBM) cnspharma.com ↗
today announced it has received approval from Swissmedic, the Swiss Agency for Therapeutic Products, for the Company’s potentially pivotal study of Berubicin for the treatment of recurrent glioblastoma multiforme (GBM). |
| 2021-12-02 | CNS Pharmaceuticals, Inc. | Regulatory CNS Pharmaceuticals Receives Approval from Switzerland Ethics Committee for its Potentially Pivotal Study of Berubicin for the Treatment of Glioblastoma Multiforme (GBM) cnspharma.com ↗
today announced it has received approval from swissethics, the umbrella organization of the cantonal Ethics Committees (EC) in Switzerland, for the Company’s potentially pivotal study of Berubicin |
| 2021-07-12 | WPD Pharmaceuticals Sp. z o.o. | Regulatory WPD Pharmaceuticals’ Licensor Receives FDA Fast Track Designation for Berubicin for the Treatment of Recurrent Glioblastoma Multiforme; WPD Poland Arranges Loans wpdpharmaceuticals.com ↗
WPD Pharmaceuticals’ Licensor Receives FDA Fast Track Designation for Berubicin for the Treatment of Recurrent Glioblastoma Multiforme; WPD Poland Arranges Loans |
| 2021-06-29 | CNS Pharmaceuticals, Inc. | Regulatory FDA Grants Fast Track Designation to CNS Pharmaceuticals for Berubicin for the Treatment of Recurrent Glioblastoma Multiforme cnspharma.com ↗
CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) (“CNS” or the “Company”), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers in the brain and central nervous system, today announced that the U.S. Food and Drug Administration (FDA) granted Fast Track Designation for its lead investigational drug, Berubicin, for the treatment of patients with recurrent glioblastoma multiforme (GBM). |
| 2021-02-18 | WPD Pharmaceuticals Sp. z o.o. | Regulatory WPD and CNS Pharmaceuticals Announce Positive Opinion of the Polish Central Ethics Committee for the WPD-201 Study and Central IRB Study Level Approval for the CNS-201 Study wpdpharmaceuticals.com ↗
today announced that WPD Pharmaceuticals received a positive opinion of the Lower Silesian Medical Chamber Ethics Committee in Wrocław, Poland for its planned upcoming Berubicin clinical trial in adults with Glioblastoma Muliforme (GBM) under the WPD-201 Clinical Trial Protocol. |
| 2021-02-18 | CNS Pharmaceuticals, Inc. | Regulatory WPD and CNS Pharmaceuticals Announce Positive Opinion of the Polish Central Ethics Committee for the WPD-201 Study and Central IRB Study Level Approval for the CNS-201 Study cnspharma.com ↗
WPD Pharmaceuticals received a positive opinion of the Lower Silesian Medical Chamber Ethics Committee in Wrocław, Poland for its planned upcoming Berubicin clinical trial in adults with Glioblastoma Muliforme (GBM) under the WPD-201 Clinical Trial Protocol. |
| 2020-12-17 | CNS Pharmaceuticals, Inc. | Regulatory CNS Pharmaceuticals Announces FDA Approval of IND Application for its Brain Cancer Drug Candidate Berubicin cnspharma.com ↗
today announced that the Investigational New Drug (IND) application for its lead product candidate, Berubicin, for the treatment of Glioblastoma Multiforme (GBM) is now approved and in effect as filed with the US Food and Drug Administration (FDA). |
| 2020-11-17 | CNS Pharmaceuticals, Inc. | Regulatory CNS Pharmaceuticals Announces FDA Filing of IND for its Brain Cancer Drug Berubicin cnspharma.com ↗ |
| 2020-06-11 | CNS Pharmaceuticals, Inc. | Regulatory CNS Announces the FDA has Granted Orphan Drug Designation for Brain Cancer Drug Berubicin cnspharma.com ↗
the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for its lead product Berubicin for the treatment of malignant gliomas. |
| 2020-04-24 | WPD Pharmaceuticals Sp. z o.o. | Regulatory WPD Pharmaceuticals Announces FDA Application Under The Orphan Drug Act Was Submitted By License Partner for Brain Cancer Drug, Berubicin wpdpharmaceuticals.com ↗
WPD Pharmaceuticals Inc. (CSE: WBIO)(FSE: 8SV1) (the “Company” or “WPD”) a clinical stage pharmaceutical company is pleased to announced that its license partner, CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) ("CNS") filed an application with the U.S. Food and Drug Administration (“FDA”) under the Orphan Drug Act to receive Orphan Drug Designation (“ODD”) for its brain cancer drug candidate, Berubicin. |
| 2020-04-23 | CNS Pharmaceuticals, Inc. | Regulatory CNS Pharmaceuticals Announces Filing of FDA Orphan Drug Designation for Brain Cancer Drug Berubicin cnspharma.com ↗
CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) (“CNS” or the “Company”), a biotechnology company specializing in the development of novel treatments for brain tumors, today announced it has filed an application with the U.S. Food and Drug Administration (FDA) to receive Orphan Drug Designation (ODD) for its lead product Berubicin. |
| 2020-04-08 | WPD Pharmaceuticals Sp. z o.o. | Results WPD Pharmaceuticals Provides Corporate Update wpdpharmaceuticals.com ↗
WPD is pleased to announce that a patient from the Phase 1 clinical trial of its Berubicin drug for the treatment of glioblastoma multiforme (" GBM") remains cancer free. |
| 2020-03-13 | WPD Pharmaceuticals Sp. z o.o. | Results WPD Pharmaceuticals Announces Brain Cancer Patient From Berubicin Phase 1 Trial Remains Cancer Free wpdpharmaceuticals.com ↗
This initial trial was conducted in 2006 and as of February 2020, the patient has remained cancer free for over 13 years. |
| 2020-03-04 | WPD Pharmaceuticals Sp. z o.o. | Regulatory WPD Pharmaceuticals’ Brain Cancer Drug Received Positive FDA Pre-IND Guidance wpdpharmaceuticals.com ↗ |
| 2020-03-03 | CNS Pharmaceuticals, Inc. | Results CNS Pharmaceuticals Announces Brain Cancer Patient from Berubicin Phase 1 Trial Remains Cancer Free cnspharma.com ↗
This initial trial was conducted in 2006 and as of February 2020, the patient has remained cancer free for over 13 years. |
All press releases naming this drug 70 releases
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 8 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Berubicin | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05082493 ↗ |
| Known as | Berubicin HCl | “Berubicin intravenously infused will be administered at a dose of 7.1 mg/m2 as free base (equivalent to 7.5 mg/m2 Berubicin HCl) as a 2-hour intravenous (IV) infusion once...” NCT04915404 ↗1“Berubicin HCL - MTD phase” NCT05082493 ↗ |
| Known as | Berubicin Hydrochloride | “berubicin hydrochloride (RTA 744)” NCT00538343 ↗ |
| Known as | Berubicina | ChEMBL registry synonym — accepted as the source's own label CHEMBL2110580 ↗ |
| Known as | Berubicine | ChEMBL registry synonym — accepted as the source's own label CHEMBL2110580 ↗ |
| Known as | RTA 744 | “berubicin hydrochloride (RTA 744)” NCT00538343 ↗ |
| Known as | WP-744 | ChEMBL registry synonym — accepted as the source's own label CHEMBL2110580 ↗ |
| Action | Inhibit | “a cytotoxic anthracycline topoisomerase II inhibitor” NCT04762069 ↗ |
| Modality | Small molecule | “RTA 744 is a close chemical analogue of the well characterized anti-cancer agent doxorubicin.” NCT00526812 ↗ |
| Route | Intravenous | “you will receive RTA 744 through a needle in your vein over a 2-hour period” NCT00512460 ↗ |