Opaganib

Generic Name: Opaganib

Brand Names: -

Drug Type: Small Molecule

Chemical Formula: C_₂₃H_₂₅ClN_₂O

CAS Number: 915385-81-8

Unique Ingredient Identifier: DRG21OQ517

Background: Opaganib, also known as ABC294640, is a selective sphingosine kinase-2 (SK2) inhibitor that is orally administered. This drug has potential anticancer, anti-inflammatory, and antiviral activities, with potential applications in oncology, inflammation, the gastrointestinal system, and COVID-19.

Associated Conditions: -

Associated Therapies: -

Clinical Trials

Treatment of COVID-19 With Opaganib in Patients With Pneumonia Requiring Oxygen

Phase 1

Withdrawn

Conditions: COVID-19
Lung Infection

Interventions: Drug: Opaganib

First Posted Date: 2020-08-06

Last Posted Date: 2020-08-11

Lead Sponsor: RedHill Biopharma Limited

Registration Number: NCT04502069

Locations: 🇮🇱
Shaare Zedek Medical Center, Jerusalem, Israel

Opaganib, a Sphingosine Kinase-2 (SK2) Inhibitor in COVID-19 Pneumonia

Phase 2

Completed

Conditions: COVID-19
Lung Infection

Interventions: Drug: Opaganib
Drug: Placebo

First Posted Date: 2020-07-13

Last Posted Date: 2023-10-19

Lead Sponsor: RedHill Biopharma Limited

Target Recruit Count: 475

Registration Number: NCT04467840

Locations: 🇬🇧
ABC-201 Site 251, Gillingham, United Kingdom
🇷🇺
ABC-201 Site 104, Tver, Russian Federation
🇧🇷
ABC-201 Site 403, São Paulo, Brazil

and more 54 locations

Compassionate Use of Opaganib in Patients With Coronavirus Disease 2019 (COVID-19)

Completed

Conditions: Coronavirus Infections

Interventions: Drug: Opaganib
Drug: Standard of Care

First Posted Date: 2020-06-17

Last Posted Date: 2020-06-17

Lead Sponsor: Shaare Zedek Medical Center

Target Recruit Count: 23

Registration Number: NCT04435106

Locations: 🇮🇱
Shaare-Zedek Medical Center, Jerusalem, Israel

A Study of Opaganib in Coronavirus Disease 2019 Pneumonia

Phase 2

Completed

Conditions: Coronavirus Infections

Interventions: Drug: Opaganib
Drug: Placebo

First Posted Date: 2020-06-04

Last Posted Date: 2022-03-21

Lead Sponsor: RedHill Biopharma Limited

Target Recruit Count: 42

Registration Number: NCT04414618

Locations: 🇺🇸
Memorial Hermann, Memorial City Medical Center, Houston, Texas, United States
🇺🇸
Henry Ford Hospital, Detroit, Michigan, United States
🇮🇱
Ziv Medical Center, Safed, Israel

and more 6 locations

Addition of Opaganib to Androgen Antagonists in Patients With mCRPC

Phase 2

Active, not recruiting

Conditions: Prostate Cancer

Interventions: Drug: Enzalutamide
Drug: Abiraterone
Drug: Opaganib

First Posted Date: 2019-12-20

Last Posted Date: 2024-06-25

Lead Sponsor: Medical University of South Carolina

Target Recruit Count: 67

Registration Number: NCT04207255

Locations: 🇺🇸
Medical University of South Carolina, Charleston, South Carolina, United States
🇺🇸
Emory University, Atlanta, Georgia, United States

Expanded Access for the Treatment of Advanced Cholangiocarcinoma With ABC294640 (Yeliva ®)

Conditions: Cholangiocarcinoma
Cholangiocarcinoma Non-resectable
Cholangiocarcinoma, Perihilar
Cholangiocarcinoma, Extrahepatic
Cholangiocarcinoma, Intrahepatic

First Posted Date: 2018-01-30

Last Posted Date: 2022-03-16

Lead Sponsor: RedHill Biopharma Limited

Registration Number: NCT03414489

A Study of ABC294640 (Yeliva ®) Alone and in Combination With Hydroxychloroquine Sulfate in Treatment of Patients With Advanced Cholangiocarcinoma

Phase 2

Completed

Conditions: Cholangiocarcinoma, Extrahepatic
Cholangiocarcinoma, Intrahepatic
Cholangiocarcinoma Non-resectable
Cholangiocarcinoma, Perihilar
Cholangiocarcinoma

Interventions: Drug: ABC294640
Drug: Hydroxychloroquine Sulfate 200 MG

First Posted Date: 2017-12-19

Last Posted Date: 2023-04-04

Lead Sponsor: RedHill Biopharma Limited

Target Recruit Count: 65

Registration Number: NCT03377179

Locations: 🇺🇸
MD Anderson Cancer Center, Houston, Texas, United States
🇺🇸
Emory University, Atlanta, Georgia, United States
🇺🇸
Huntsman Cancer Institute, University of Utah, Salt Lake City, Utah, United States

and more 1 locations

A Phase II Study of ABC294640 as Monotherapy in Patients With Advanced Hepatocellular Carcinoma

Phase 2

Withdrawn

Conditions: Carcinoma, Hepatocellular

Interventions: Drug: ABC294640

First Posted Date: 2016-10-20

Last Posted Date: 2019-09-12

Lead Sponsor: Medical University of South Carolina

Registration Number: NCT02939807

Locations: 🇺🇸
Medical University of South Carolina, Charleston, South Carolina, United States

ABC294640 (Opaganib) in Refractory / Relapsed Multiple Myeloma

Phase 1

Terminated

Conditions: Multiple Myeloma

Interventions: Drug: Opaganib

First Posted Date: 2016-05-02

Last Posted Date: 2021-06-18

Lead Sponsor: RedHill Biopharma Limited

Target Recruit Count: 13

Registration Number: NCT02757326

Locations: 🇺🇸
Duke University Medical Center, Durham, North Carolina, United States

Early Phase Evaluation of ABC294640 in Patients With Refractory/Relapsed Diffuse Large B-cell Lymphoma or Kaposi Sarcoma

Phase 1

Withdrawn

Conditions: Kaposi Sarcoma
Diffuse Large B Cell Lymphoma

Interventions: Drug: ABC294640

First Posted Date: 2014-09-03

Last Posted Date: 2017-12-07

Lead Sponsor: RedHill Biopharma Limited

Registration Number: NCT02229981

Locations: 🇺🇸
Louisiana State University Health Sciences Center, New Orleans, Louisiana, United States

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