Clinical Trials

Multiple clinical trials ranging from Phase 1 to Phase 3 have evaluated Opaganib (ABC294640) across various oncology and infectious disease indications, including cholangiocarcinoma, hepatocellular carcinoma, prostate cancer, multiple myeloma, diffuse large B-cell lymphoma, and COVID-19 pneumonia. Sponsored by commercial entities, academic institutions, and federal bodies, these studies reflect varying recruitment outcomes, encompassing completed, terminated, and withdrawn trials.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT02939807 WITHDRAWN
Carcinoma, Hepatocellular
Medical University of South Carolina
 2019-09-30 PHASE2
NCT04207255 COMPLETED
Prostate Cancer
Medical University of South Carolina
 2020-03-27 PHASE2
NCT03377179 COMPLETED
Cholangiocarcinoma; Cholangiocarcinoma Non-resectable; Cholangiocarcinoma, Perihilar; Cholangiocarcinoma, Extrahepatic; Cholangiocarcinoma, Intrahepatic
RedHill Biopharma Limited
 2018-03-07 PHASE2
NCT04467840 COMPLETED
COVID-19; Lung Infection
RedHill Biopharma Limited
 2020-08-21 PHASE2; PHASE3
NCT04502069 WITHDRAWN
COVID-19; Lung Infection
RedHill Biopharma Limited
 2020-08 PHASE1; PHASE2
NCT04414618 COMPLETED
Coronavirus Infections
RedHill Biopharma Limited
 2020-07-02 PHASE2
NCT02939807 Withdrawn
Carcinoma Hepatocellular
Medical University of South Carolina|National Cancer Institute (NCI)|Apogee Biotechnology Corporation
 2019-09-30 Phase 2
NCT02229981 WITHDRAWN
Diffuse Large B Cell Lymphoma; Kaposi Sarcoma
RedHill Biopharma Limited
 2014-07 PHASE1; PHASE2
NCT02757326 TERMINATED
Multiple Myeloma
RedHill Biopharma Limited
 2016-12-13 PHASE1; PHASE2
NCT03377179 Completed
Cholangiocarcinoma|Cholangiocarcinoma Non-resectable|Cholangiocarcinoma Perihilar|Cholangiocarcinoma Extrahepatic|Cholangiocarcinoma Intrahepatic
RedHill Biopharma Limited
 2018-03-07 Phase 2
NCT02757326 Terminated
Multiple Myeloma
RedHill Biopharma Limited|Apogee Biotechnology Corporation|Duke University|National Cancer Institute (NCI)
 2016-12-13 Phase 1|Phase 2
NCT01488513 COMPLETED
Pancreatic Cancer; Unspecified Adult Solid Tumor, Protocol Specific
RedHill Biopharma Limited
 2011-08 PHASE1
NCT02229981 Withdrawn
Diffuse Large B Cell Lymphoma|Kaposi Sarcoma
RedHill Biopharma Limited|Louisiana State University Health Sciences Center in New Orleans|Apogee Biotechnology Corporation
 2014-07 Phase 1|Phase 2
NCT01488513 Completed
Pancreatic Cancer|Unspecified Adult Solid Tumor Protocol Specific
RedHill Biopharma Limited|Apogee Biotechnology Corporation|Medical University of South Carolina|FDA Office of Orphan Products Development|National Cancer Institute (NCI)
 2011-08 Phase 1

(data from https://clinicaltrials.gov, updated on 2025-04-27)

Check the Opaganib (ABC294640) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Opaganib (ABC294640) selectively binds to and inhibits sphingosine kinase-2 (SphK2), blocking the phosphorylation of sphingosine to sphingosine-1-phosphate (S1P) and disrupting intracellular bioactive lipid signaling. This enzymatic inhibition suppresses downstream pro-survival pathways to induce cell cycle arrest and apoptosis, providing the pharmacological basis for its clinical evaluation in solid tumors such as cholangiocarcinoma as well as severe viral infections including COVID-19.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.