Product Description
Opaganib, a first-in-class new chemical entity, is a sphingosine kinase-2 (SK2) selective inhibitor in oral pill form, with proposed dual anti-inflammatory and antiviral activity. Opaganib's unique mechanism is host-targeted and therefore expected to be effective against emerging viral variants. (Sourced from: https://www.redhillbio.com/our-programs/pipeline/opaganib/covid-19/default.aspx)
Mechanisms of Action: SK2 Inhibitor
Novel Mechanism: Yes
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: Orphan Drug - Neuroblastoma *
Approval Status: Not Approved
Approved Countries: None
Approved Indications: None
Known Adverse Events: None
Company: RedHill Biopharma
Company Location: Europe
Company Founding Year: 2009
Additional Commercial Interests: Kukbo
Clinical Description
Countries in Clinic:
Active Clinical Trial Count:
Recent & Upcoming Milestones
- Clinical Outcomes Reported - RedHill Biopharma presented P2 COVID-19 results on 2024-09-03 for Opaganib
- Clinical Outcomes Reported - RedHill Biopharma presented P0 General Diabetes|Obesity results on 2024-08-19 for Opaganib
- Clinical Outcomes Reported - RedHill Biopharma presented P3 Fibrosis results on 2024-02-20 for Opaganib
Highest Development Phases
Phase 3: Pneumonia|COVID-19
Phase 2: Sarcoma, Kaposi|COVID-19|Diffuse Large B-Cell Lymphoma|Pneumonia|Coronavirus Infections|Multiple Myeloma|Hepatocellular Carcinoma|Cholangiocarcinoma|Prostate Cancer|Klatskin Tumor
Phase 1: Pancreatic Cancer
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
NCT04435106 |
0123-20- SZMC | N/A |
Completed |
Coronavirus Infections|Severe Acute Respiratory Syndrome |
2020-05-01 |
2020-06-22 |
Primary Endpoints|Treatments |
|
NCT03414489 |
Yeliva ® | N/A |
No longer available |
Cholangiocarcinoma|Klatskin Tumor |
None |
2025-03-19 |
Treatments|Trial Status |
|
NCT01488513 |
ABC-101 | P1 |
Completed |
Pancreatic Cancer |
2014-08-01 |
2019-03-19 |
Treatments |
|
ACTRN12624001458527 |
DARO-LIPID | P2 |
Recruiting |
Prostate Cancer |
2027-06-25 |
2025-07-26 |
Treatments |
|
NCT02939807 |
ABC-106 | P2 |
Withdrawn |
Hepatocellular Carcinoma |
2023-09-30 |
50% |
2019-09-13 |
Patient Enrollment|Start Date|Trial Status |
NCT04207255 |
Pro00095537 | P2 |
Completed |
Prostate Cancer |
2023-08-31 |
2024-09-26 |
Patient Enrollment|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
|
NCT03377179 |
ABC-108 | P2 |
Completed |
Cholangiocarcinoma|Klatskin Tumor |
2022-06-21 |
15% |
2022-07-13 |
|
NCT04502069 |
Opaganib-RHB | P2 |
Withdrawn |
COVID-19|Pneumonia |
2021-02-01 |
51% |
2020-08-12 |
Patient Enrollment|Primary Endpoints|Treatments|Trial Status |
NCT04414618 |
COVID-19 | P2 |
Completed |
Pneumonia|Coronavirus Infections |
2020-11-26 |
43% |
2022-03-22 |
Primary Endpoints|Treatments |
NCT02229981 |
ABC-102 | P2 |
Withdrawn |
Diffuse Large B-Cell Lymphoma|Sarcoma, Kaposi |
2019-06-01 |
2019-03-20 |
Treatments |
|
NCT02757326 |
ABC-103 | P2 |
Terminated |
Multiple Myeloma |
2019-05-01 |
68% |
2021-06-19 |
Primary Endpoints|Treatments |
2020-002677-95 |
- | P3 |
Completed |
Pneumonia|COVID-19 |
2021-07-22 |
2022-03-13 |
||
NCT04467840 |
ABC-201 | P3 |
Completed |
Pneumonia|COVID-19 |
2021-07-18 |
23% |
2021-07-21 |
Primary Completion Date|Primary Endpoints |