X
API Suppliers
0
US DMFs Filed
0
CEP/COS Certifications
0
JDMFs Filed
0
Other Certificates
0
Other Suppliers
0
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
EDQM
0
USP
0
JP
0
Other Listed Suppliers
0
0
Details:
ABC294640 (Opaganib) is a proprietary, bimodal release, once-daily oral pill formulation, which is investigated for the treatment of Ebola virus disease.
Lead Product(s): Opaganib
Therapeutic Area: Infections and Infectious Diseases Product Name: ABC294640
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: United States Army Medical Research Institute of Infectious Diseases
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 03, 2023
Details:
ABC294640 (opaganib) is an orally administered, selective inhibitor of sphingosine kinase-2 (SK2) with suggested anti-inflammatory, anticancer, radioprotective and antiviral activity. It is currently being investigated for acute nuclear radiation syndrome.
Lead Product(s): Opaganib
Therapeutic Area: Trauma (Emergency, Injury, Surgery) Product Name: ABC294640
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 15, 2023
Details:
Opaganib a new chemical entity, is an orally administered, first-in-class proprietary selective inhibitor of sphingosine kinase-2 (SK2) with suggested anti-inflammatory, anticancer, radioprotective and antiviral activity.
Lead Product(s): Opaganib
Therapeutic Area: Trauma (Emergency, Injury, Surgery) Product Name: Undisclosed
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 17, 2022
Details:
Opaganib a new chemical entity, is an orally administered, first-in-class proprietary selective inhibitor of sphingosine kinase-2 (SK2) with suggested anti-inflammatory, anticancer, radioprotective and antiviral activity.
Lead Product(s): Opaganib
Therapeutic Area: Trauma (Emergency, Injury, Surgery) Product Name: Yeliva
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 14, 2022
Details:
USPTO grants new method of use patent for the inhibition of a disease caused by a coronavirus in patients having pneumonia and receiving supplemental oxygen at a fraction of inspired oxygen (FiO2) up to and including 60%.
Lead Product(s): Opaganib
Therapeutic Area: Infections and Infectious Diseases Product Name: Yeliva
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 19, 2022
Details:
Yeliva (opaganib (ABC294640), a new chemical entity, is a proprietary, rst-in-class, orally-administered, investigational sphingosine kinase-2 (SK2) selective inhibitor, with suggested dual anti-inammatory and antiviral activity.
Lead Product(s): Opaganib
Therapeutic Area: Infections and Infectious Diseases Product Name: Yeliva
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 12, 2022
Details:
The partnership with Kukbo also includes a right of first offer for RedHill's late-stage clinical assets, opaganib, RHB-107 (upamostat) and Talicia®, for one or more of the territories of South Korea, Japan, Indonesia, Vietnam, Thailand and/or Malaysia.
Lead Product(s): Opaganib
Therapeutic Area: Infections and Infectious Diseases Product Name: Yeliva
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Kukbo Co.
Deal Size: $7.1 million Upfront Cash: $1.5 million
Deal Type: Licensing Agreement March 15, 2022
Details:
In a prespecified analysis of Phase 2/3 study patients with positive PCR at screening, Yeliva (opaganib) improved the median time to viral RNA clearance by at least 4 days also showed 62% reduction in mortality seen in a post-hoc analysis.
Lead Product(s): Opaganib
Therapeutic Area: Infections and Infectious Diseases Product Name: Yeliva
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 13, 2022
Details:
Under the terms of agreement, RedHill has agreed to grant Kukbo a right of first offer, for a period of six months, for a license of late-stage clinical assets, opaganib, RHB-107 (upamostat)1 and Talicia®, for one or more of the territories.
Lead Product(s): Opaganib
Therapeutic Area: Infections and Infectious Diseases Product Name: Yeliva
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Kukbo Co. Ltd.
Deal Size: $10.0 million Upfront Cash: Undisclosed
Deal Type: Private Placement November 08, 2021
Details:
Opaganib, a new chemical entity, is a proprietary, first-in-class, orally-administered, sphingosine kinase-2 (SK2) selective inhibitor, with dual anti-inflammatory and antiviral activity that acts on the viral cause and inflammatory effect of COVID-19.
Lead Product(s): Opaganib
Therapeutic Area: Infections and Infectious Diseases Product Name: Yeliva
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 04, 2021
Details:
While preliminary top-line data of the study efficacy endpoints showed consistent trends in favor of the opaganib arm, the study endpoints did not achieve statistical significance.
Lead Product(s): Opaganib
Therapeutic Area: Infections and Infectious Diseases Product Name: Yeliva
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 14, 2021
Details:
Opaganib is a novel, host-targeted, dual antiviral and anti-inflammatory investigational pill in advanced clinical development for the treatment of severe COVID-19.
Lead Product(s): Opaganib
Therapeutic Area: Infections and Infectious Diseases Product Name: Yeliva
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 19, 2021
Details:
Opaganib is being evaluated as a treatment for COVID-19 pneumonia in a global Phase 2/3 study, which recently completed enrollment, and has demonstrated positive safety and efficacy signals in preliminary top-line data from the 40-patient U.S. Phase 2 study.
Lead Product(s): Opaganib
Therapeutic Area: Infections and Infectious Diseases Product Name: Yeliva
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 28, 2021
Details:
The global study of 475 patients in phase 2/3 of opaganib in severe COVID-19 has been approved in 10 countries and on June 6 completed the enrollment in up to 57 participating points.
Lead Product(s): Opaganib
Therapeutic Area: Infections and Infectious Diseases Product Name: Yeliva
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 21, 2021
Details:
Independent Data Safety Monitoring Board unanimously recommends continuation of the global Phase 2/3 study of orally-administered opaganib in severe COVID-19 pneumonia based on review of unblinded safety data from the first 255 treated patients.
Lead Product(s): Opaganib
Therapeutic Area: Infections and Infectious Diseases Product Name: Yeliva
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 09, 2021
Details:
New agreement further expands manufacturing capacity for orally-administered opaganib following positive top-line data from its Phase 2 COVID-19 study, progress with the ongoing global Phase 2/3 study, and amid the urgent need to address emerging viral strains.
Lead Product(s): Opaganib
Therapeutic Area: Infections and Infectious Diseases Product Name: Yeliva
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: RedHill Biopharma
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement January 28, 2021
Details:
Independent DSMB unanimously recommends continuation of the global Phase 2/3 study of orally-administered opaganib in severe COVID-19 based on review of unblinded safety data from 155 treated patients.
Lead Product(s): Opaganib
Therapeutic Area: Infections and Infectious Diseases Product Name: Yeliva
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 22, 2020
Details:
Opaganib, a novel, orally administered sphingosine kinase 2 (SK2) selective inhibitor, administered at 250mg/kg, showed a reduction of thrombosis (blood clotting) in an acute respiratory distress syndrome – a preclinical animal model designed to measure thrombotic risks.
Lead Product(s): Opaganib
Therapeutic Area: Infections and Infectious Diseases Product Name: ABC294640
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 15, 2020
Details:
The global Phase 2/3 study with opaganib (Yeliva®, ABC294640) in patients hospitalized with severe COVID-19 pneumonia has received a unanimous recommendation to continue, following a pre-scheduled safety review by an independent Data and Safety Monitoring Board.
Lead Product(s): Opaganib
Therapeutic Area: Infections and Infectious Diseases Product Name: Yeliva
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 19, 2020
Details:
U.S. Phase 2 study with opaganib (Yeliva®, ABC294640) in patients hospitalized with severe COVID-19 pneumonia has completed enrollment of the last patient in the study.
Lead Product(s): Opaganib
Therapeutic Area: Infections and Infectious Diseases Product Name: Yeliva
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 16, 2020
Details:
Notice of Allowance received for combination of RedHill’s novel orally administered investigational drugs, opaganib and RHB-107, for treatment of solid tumor cancers; patent expected to extend IP protection until 2036.
Lead Product(s): Opaganib,Upamostat
Therapeutic Area: Oncology Product Name: Yeliva
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 04, 2020
Details:
Collaborations with European and Canadian suppliers for large-scale ramp-up of opaganib manufacturing further strengthens manufacturing capabilities and capacity, in preparation for potential emergency use applications.
Lead Product(s): Opaganib
Therapeutic Area: Infections and Infectious Diseases Product Name: Yeliva
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Undisclosed
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement October 13, 2020
Details:
Collaborations with European and Canadian suppliers for large-scale ramp-up of opaganib manufacturing further strengthens manufacturing capabilities and capacity, in preparation for potential emergency use applications .
Lead Product(s): Opaganib
Therapeutic Area: Infections and Infectious Diseases Product Name: Yeliva
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Undisclosed
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership October 13, 2020
Details:
The ongoing global Phase 2/3 study with orally-administered opaganib in patients with severe COVID-19 is approved in Italy, the UK, Russia, Israel, Mexico and Brazil; 16 clinical sites initiated globally to date.
Lead Product(s): Opaganib
Therapeutic Area: Infections and Infectious Diseases Product Name: Yeliva
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 22, 2020
Details:
Opaganib completely inhibited SARS-CoV-2 viral replication as measured after three days incubation in an in vitro model of human bronchial tissue, comparing favorably with remdesivir, the positive control in the study.
Lead Product(s): Opaganib
Therapeutic Area: Infections and Infectious Diseases Product Name: Yeliva
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 08, 2020
Details:
A global Phase 2/3 study in up to 270 patients hospitalized with severe COVID-19 pneumonia, and a U.S. Phase 2 study in up to 40 patients, are ongoing with opaganib, a novel sphingosine kinase-2 selective inhibitor with dual anti-inflammatory and anti-viral properties.
Lead Product(s): Opaganib
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Yeliva
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: State of Pennsylvania
Deal Size: $0.3 million Upfront Cash: Undisclosed
Deal Type: Funding September 03, 2020
Details:
The Phase 2/3 study is set to enroll up to 270 patients with severe COVID-19 pneumonia requiring hospitalization and treatment with supplemental oxygen. Subjects will be randomized at a 1:1 ratio to receive either opaganib or placebo, along with standard-of-care therapy.
Lead Product(s): Opaganib
Therapeutic Area: Infections and Infectious Diseases Product Name: Yeliva
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 06, 2020
Details:
RedHill Biopharma has initiated a global Phase 2/3 clinical study evaluating opaganib (Yeliva®) in patients hospitalized with severe SARS-CoV-2 infection (the cause of COVID-19) and pneumonia requiring treatment with supplemental oxygen.
Lead Product(s): Opaganib
Therapeutic Area: Infections and Infectious Diseases Product Name: Yeliva
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 30, 2020
Details:
The Ministry of Health of the Russian Federation has approved RedHill's Clinical Trial Authorization (CTA) application for a Phase 2/3 study evaluating opaganib (Yeliva®) in patients hospitalized with severe SARS-CoV-2 infection and pneumonia.
Lead Product(s): Opaganib
Therapeutic Area: Infections and Infectious Diseases Product Name: Yeliva
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 16, 2020
Details:
The Phase 2/3 multi-center, randomized, double-blind, parallel-arm, placebo-controlled study with opaganib aims to enroll 270 severe COVID-19 patients in up to 40 clinical sites across the UK, Italy, Russia and additional countries.
Lead Product(s): Opaganib
Therapeutic Area: Infections and Infectious Diseases Product Name: Yeliva
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 29, 2020
Details:
The multi-center, open-label Phase 1a/1b dose escalation study of CI-8993 in patients with relapsed / refractory solid tumors with the goal of identifying a recommended dose and schedule. Curis expects to initiate this study in the second half of 2020.
Lead Product(s): Opaganib
Therapeutic Area: Infections and Infectious Diseases Product Name: Yeliva
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 10, 2020
Details:
IND application for a Phase 2a clinical study evaluating RedHill's investigational drug, opaganib, in patients with confirmed moderate-to-severe SARS-CoV-2 infection (the cause of COVID-19).
Lead Product(s): Opaganib
Therapeutic Area: Infections and Infectious Diseases 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 May 08, 2020
Details:
Proposed study intended to evaluate the safety and efficacy of opaganib in up to 60 patients hospitalized with positive SARS-CoV-2 infection and pneumonia in the U.S.
Lead Product(s): Opaganib
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: IND EnablingProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 17, 2020
Details:
Opaganib was administered in addition to standard-of-care, including hydroxychloroquine background therapy, and was well tolerated.
Lead Product(s): Opaganib,Hydroxychloroquine Sulphate
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: UndisclosedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 14, 2020
Details:
Recruitment initiated in 2nd arm of Phase 1/2a study evaluating opaganib in combination with hydroxychloroquine in advanced cholangiocarcinoma.
Lead Product(s): Opaganib,Upamostat,Hydroxychloroquine Sulphate
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 11, 2020
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] 
Market Place
