API Suppliers
0
US DMFs Filed
0
CEP/COS Certifications
0
JDMFs Filed
0
Other Certificates
0
Other Suppliers
0
0
USA (Orange Book)
0
Europe
0
Canada
0
Australia
0
South Africa
0
Uploaded Dossiers
0
U.S. Medicaid
0
Annual Reports
0
0
USFDA Orange Book Patents
0
USFDA Exclusivities
0
Blog #PharmaFlow
0
News
0
EDQM
0
USP
0
JP
0
Other Listed Suppliers
0
0
Details:
The net proceeds will be used for the research and development of RTA 744 (berubicin HCl). It is a novel anthracycline used for serious brain and CNS oncology indications including glioblastoma multiforme (GBM), an aggressive and incurable form of brain cancer.
Lead Product(s): Berubicin Hydrochloride
Therapeutic Area: Oncology Product Name: RTA 744
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Alliance Global Partners
Deal Size: $4.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering January 29, 2024
Details:
Berubicin HCl is a cytotoxic anthracycline topoisomerase II inhibitor isolated from cultures of Streptomyces peucetius var. caesius. It is under phase 2 clinical development for the treatment of glioblastoma multiforme.
Lead Product(s): Berubicin Hydrochloride
Therapeutic Area: Oncology Product Name: Berubicin
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 17, 2024
Details:
RTA 744 (berubicin hydrochloride) is an anthracycline, which is designed to utilize natural processes to induce deoxyribonucleic acid (DNA) damage in targeted cancer cells, which is investigated for glioblastoma multiforme.
Lead Product(s): Berubicin Hydrochloride
Therapeutic Area: Oncology Product Name: RTA 744
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 11, 2023
Details:
RTA 744 (berubicin hydrochloride) is an anthracycline, which is designed to utilize natural processes to induce deoxyribonucleic acid (DNA) damage in targeted cancer cells by interfering with the action of topoisomerase II, a critical enzyme enabling cell proliferation.
Lead Product(s): Berubicin Hydrochloride
Therapeutic Area: Oncology Product Name: RTA 744
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 07, 2023
Details:
Berubicin hydrochloride is an anthracycline, which is designed to utilize natural processes to induce deoxyribonucleic acid (DNA) damage in targeted cancer cells by interfering with the action of topoisomerase II, a critical enzyme enabling cell proliferation.
Lead Product(s): Berubicin Hydrochloride
Therapeutic Area: Oncology Product Name: RTA 744
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 03, 2023
Details:
RTA 744 (berubicin hydrochloride) is an anthracycline, an anticancer agent effective against more types of cancer. Product induces DNA damage in targeted cancer cells by interfering with the action of topoisomerase II, a critical enzyme enabling cell proliferation.
Lead Product(s): Berubicin Hydrochloride
Therapeutic Area: Oncology Product Name: RTA 744
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 25, 2023
Details:
RTA 744 (berubicin hydrochloride) is an anthracycline, an anticancer agent effective against more types of cancer. Product induces DNA damage in targeted cancer cells by interfering with the action of topoisomerase II, a critical enzyme enabling cell proliferation.
Lead Product(s): Berubicin Hydrochloride
Therapeutic Area: Oncology Product Name: RTA 744
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 10, 2023
Details:
RTA 744 (berubicin hydrochloride) is an anthracycline, an anticancer agent effective against more types of cancer. Product induces DNA damage in targeted cancer cells by interfering with the action of topoisomerase II, a critical enzyme enabling cell proliferation.
Lead Product(s): Berubicin Hydrochloride
Therapeutic Area: Oncology Product Name: RTA 744
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 06, 2023
Details:
Berubicin hydrochloride is an anthracycline, which is designed to utilize natural processes to induce deoxyribonucleic acid (DNA) damage in targeted cancer cells by interfering with the action of topoisomerase II, a critical enzyme enabling cell proliferation.
Lead Product(s): Berubicin Hydrochloride
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 09, 2023
Details:
Berubicin hydrochloride is an anthracycline, which is designed to utilize natural processes to induce deoxyribonucleic acid (DNA) damage in targeted cancer cells by interfering with the action of topoisomerase II, a critical enzyme enabling cell proliferation.
Lead Product(s): Berubicin Hydrochloride
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 07, 2023
Details:
RTA 744 (berubicin hydrochloride) is an anthracycline, an anticancer agent effective against more types of cancer. Product induces DNA damage in targeted cancer cells by interfering with the action of topoisomerase II, a critical enzyme enabling cell proliferation.
Lead Product(s): Berubicin Hydrochloride
Therapeutic Area: Oncology Product Name: RTA 744
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 12, 2023
Details:
Berubicin (RTA 744), is an anthracycline, a class of anticancer agents that are among the most powerful chemotherapy drugs and effective against more types of cancer than any other class of chemotherapeutic agents.
Lead Product(s): Berubicin Hydrochloride
Therapeutic Area: Oncology Product Name: RTA 744
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 08, 2022
Details:
Berubicin (RTA 744), is a novel anthracycline and the first anthracycline to appear to cross the bloodbrain barrier. Berubicin is currently being evaluated in a potentially pivotal global study evaluating its efficacy and safety in the treatment of GBM.
Lead Product(s): Berubicin Hydrochloride
Therapeutic Area: Oncology Product Name: RTA 744
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 02, 2022
Details:
Results from the trial will compare RTA 744 (berubicin) to a current standard of care (Lomustine), with a 2 to 1 randomization of patients to receive either Berubicin or Lomustine.
Lead Product(s): Berubicin Hydrochloride
Therapeutic Area: Oncology Product Name: RTA 744
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: The University of Texas MD Anderson Cancer Center
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 23, 2022
Details:
The induction of apoptosis and DNA damage by Berubicin (RTA 744) was significantly higher than that of doxorubicin in all tested cancer cells, demonstrating Berubicin's greater potential potency and consistently higher cytotoxicity in GBM cell lines than Dox.
Lead Product(s): Berubicin Hydrochloride
Therapeutic Area: Oncology Product Name: RTA 744
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 08, 2022
Details:
RTA 744 (berubicin) is an anthracycline, a class of anticancer agents that are among the most powerful chemotherapy drugs and effective against more types of cancer than any other class of chemotherapeutic agents.
Lead Product(s): Berubicin Hydrochloride
Therapeutic Area: Oncology Product Name: RTA 744
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 18, 2022
Details:
RTA 744 (berubicin) is a novel anthracycline and the first anthracycline to appear to cross the blood-brain barrier currently being evaluated in a potentially pivotal global study evaluating its efficacy and safety in the treatment of GBM.
Lead Product(s): Berubicin Hydrochloride
Therapeutic Area: Oncology Product Name: RTA 744
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 28, 2022
Details:
Berubicin is a novel anthracycline and first anthracycline to appear to cross the blood-brain barrier currently being evaluated in a potentially pivotal global study evaluating its efficacy and safety in the treatment of GBM.
Lead Product(s): Berubicin Hydrochloride
Therapeutic Area: Oncology Product Name: RTA 744
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 06, 2022
Details:
Berubicin is a novel anthracycline and the first anthracycline to appear to cross the blood-brain barrier, is currently in development for the treatment of a number of serious brain and CNS oncology indications.
Lead Product(s): Berubicin Hydrochloride
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 09, 2022
Details:
Berubicin is a novel anthracycline and the first anthracycline to appear to cross the bloodbrain barrier currently being evaluated in a potentially pivotal global study evaluating its efficacy and safety in the treatment of GBM.
Lead Product(s): Berubicin Hydrochloride
Therapeutic Area: Oncology Product Name: RTA 744
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 02, 2021
Details:
Berubicin is a novel anthracycline and the first anthracycline to appear to cross the bloodbrain barrier currently being evaluated in a global potentially pivotal study evaluating its efficacy and safety.
Lead Product(s): Berubicin Hydrochloride
Therapeutic Area: Oncology Product Name: RTA 744
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 11, 2021
Details:
Berubicin is novel anthracycline and first anthracycline to appear to cross blood-brain barrier used as anticancer agents that are among most powerful chemotherapy drugs and effective against more types of cancer than any other class of chemotherapeutic agents.
Lead Product(s): Berubicin Hydrochloride
Therapeutic Area: Oncology Product Name: RTA 744
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 30, 2021
Details:
Berubicin is currently in development for the treatment of a number of serious brain and CNS oncology indications.
Lead Product(s): Berubicin Hydrochloride
Therapeutic Area: Oncology Product Name: RTA 744
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 01, 2021
Details:
Berubicin is a second-generation anthracycline candidate for the treatment of a number of Central Nervous System Cancers, including Glioblastoma Multiforme (GBM) and Malignant Gliomas.
Lead Product(s): Berubicin Hydrochloride
Therapeutic Area: Oncology Product Name: RTA 744
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 27, 2021
Details:
The Company plans to evaluate the efficacy of Berubicin in a Phase 2 Trial for adults with GBM who have failed first-line therapy and commence the trial within the first quarter of 2021, pending the FDA's acceptance of the Company's filing.
Lead Product(s): Berubicin Hydrochloride
Therapeutic Area: Oncology Product Name: RTA 744
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 17, 2020
Details:
The Company plans to submit an Investigational New Drug (IND) application to the U.S. Food & Drug Administration (FDA), which includes a novel clinical trial designed to build on the encouraging results observed in a prior Phase 1.
Lead Product(s): Berubicin Hydrochloride
Therapeutic Area: Oncology Product Name: RTA 744
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 09, 2020
Details:
Company plans to file an Investigational New Drug Application ("IND") and initiate its Phase 2 U.S. clinical trial for Berubicin on its anticipated timeline.
Lead Product(s): Berubicin Hydrochloride
Therapeutic Area: Oncology Product Name: RTA 744
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 29, 2020
Details:
Company's European manufacturer, BSP Pharmaceuticals S.p.A, has begun the manufacturing process for Berubicin Drug Product, its lead drug candidate for the treatment of glioblastoma multiforme, an aggressive form of brain cancer currently considered incurable.
Lead Product(s): Berubicin Hydrochloride
Therapeutic Area: Oncology Product Name: RTA 744
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: BSP Pharmaceuticals S.p.A
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 09, 2020
Details:
IAG, a leading medical imaging company, will work closely with CNS during the Berubicin clinical trials to provide critical imaging services, its proprietary platform DYNAMIKA and imaging data analysis.
Lead Product(s): Berubicin Hydrochloride
Therapeutic Area: Oncology Product Name: RTA 744
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: CNS Pharmaceuticals
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership September 24, 2020
Details:
As previously announced, the Company implemented a dual-track drug product manufacturing strategy and engaged U.S.-based Pharmaceutics International, Inc. ("Pii") and Italy-based BSP Pharmaceuticals S.p.A. ("BSP") for the production of Berubicin.
Lead Product(s): Berubicin Hydrochloride
Therapeutic Area: Oncology Product Name: RTA 744
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 03, 2020
Details:
The company has taken significant strides in designing Phase 2 clinical trials for Berubicin and anticipates submitting an Investigational New Drug application (IND) to the U.S. Food and Drug Administration (FDA) this year and initiating clinical trials in early 2021.
Lead Product(s): Berubicin Hydrochloride
Therapeutic Area: Oncology Product Name: RTA 744
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 25, 2020