Drugs / ABC294640

Trials 9

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 11 trial · 1 met primary
Phase 1 NCT01488513 Aug 2011 → Aug 2014 malignant pancreatic neoplasm RedHill Biopharma Limited Completed Met primary
Phase 1/23 trials
Phase 1/2 NCT04502069 Aug 2020 → Feb 2021 COVID-19, respiratory tract infectious disorder RedHill Biopharma Limited Withdrawn No outcome recorded
Phase 1/2 NCT02757326 Dec 2016 → May 2019 plasma cell myeloma RedHill Biopharma Limited Terminated No outcome recorded Stop: Business
Phase 1/2 NCT02229981 Jul 2014 → Jun 2019 Kaposi's sarcoma, diffuse large B-cell lymphoma RedHill Biopharma Limited Withdrawn No outcome recorded Stop: Enrollment
Phase 23 trials · 1 met primary
Phase 2 NCT04207255 Mar 2020 → Aug 2023 prostate cancer Medical University of South Carolina Completed No outcome recorded
Phase 2 NCT02939807 Sep 2019 → Sep 2023 hepatocellular carcinoma Medical University of South Carolina Withdrawn No outcome recorded
Phase 2 NCT03377179 Mar 2018 → Jun 2022 hilar cholangiocarcinoma RedHill Biopharma Limited Completed Met primary
Phase 2/31 trial · 1 missed
Phase 2/3 NCT04467840 Aug 2020 → Jul 2021 COVID-19, pneumonia RedHill Biopharma Limited Completed Missed primary
Phase not stated1 trial
— NCT03414489 — hilar cholangiocarcinoma RedHill Biopharma Limited No longer available No outcome recorded
Comparator or background therapy1 trial
Phase 2 NCT04414618 Comparator Jul → Nov 2020 Coronaviridae infectious disease RedHill Biopharma Limited Completed No outcome recorded

News releases announcing trial results or a regulatory action · 58

DateIssuerRelease
2026-06-09 RedHill Biopharma Limited Regulatory RedHill's Opaganib Receives FDA Rare Pediatric Disease Designation for Neuroblastoma in Addition to Current Orphan Drug Designation redhillbio.com ↗
RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has granted rare pediatric disease (RPD) designation to opaganib for treatment of neuroblastoma (NB).
2026-04-22 RedHill Biopharma Limited Results RedHill's Opaganib Enhances Efficacy of Neuroblastoma Chemo Combination and Augment Anti-Tumor Immunity in Triple-Negative Breast Cancer in Preclinical Studies - New Data Presented at AACR 2026 redhillbio.com ↗
New preclinical data, independently presented in two posters at the 2026 American Association for Cancer Research (AACR) Annual Meeting, show positive effects of opaganib[1] as potential add-on therapy in models of neuroblastoma (NB) and triple-negative breast cancer (TNBC)
2025-12-15 RedHill Biopharma Limited Results RedHill Biopharma's Positive Opaganib Results Indicate Reduction in Venetoclax Resistant Cells redhillbio.com ↗
New in vivo study shows adding opaganib, a potent SPHK2 inhibitor, to venetoclax reduces CLL cell (CD19⁺, CD5⁺) counts by 50% compared to controls
2025-04-16 RedHill Biopharma Limited Results RedHill Biopharma's Positive Opaganib Weight Loss & Diabetes Data Published: Signals Potential $100B Market Disruption redhillbio.com ↗
Opaganib's positive results, newly published in the journal Diabetes, Metabolic Syndrome and Obesity, demonstrated weight loss and improved metabolic markers on par with semaglutide in preclinical models
2024-12-10 RedHill Biopharma Limited Results Radioprotective Activity of RedHill's Opaganib for GI-ARS Confirmed in New RNCP/NIAID Study - Discussions Ongoing with U.S. Government on Advanced Development redhillbio.com ↗
2024-09-03 RedHill Biopharma Limited Results New Peer-Reviewed Publication of Opaganib Phase 2/3 Data Shows 62% Reduction in COVID-19 Mortality redhillbio.com ↗
2024-08-26 RedHill Biopharma Limited Regulatory RedHill's Opaganib Granted Orphan Drug Designation by the FDA for Childhood Cancer, Neuroblastoma redhillbio.com ↗
RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan-drug designation to opaganib for treatment of neuroblastoma, a type of childhood cancer that develops from immature nerve cells and accounts for 15% of all pediatric cancer-related deaths.
2024-08-19 RedHill Biopharma Limited Results RedHill Announces Positive Obesity and Diabetes Results with Opaganib redhillbio.com ↗
2024-02-20 RedHill Biopharma Limited Results RedHill's Opaganib Protects Against Radiation-Induced Lung Inflammation and Fibrosis - New Publication redhillbio.com ↗
2023-12-20 RedHill Biopharma Limited Results RedHill and U.S. Army Announce Opaganib and RHB-107 Combinations with Remdesivir Show Distinct Synergistic Effect Against Ebola redhillbio.com ↗
2023-10-03 RedHill Biopharma Limited Results RedHill and U.S. Army Announce Opaganib's Ebola Virus Disease Survival Benefit in U.S. Army-Funded In-Vivo Study redhillbio.com ↗
2022-11-17 RedHill Biopharma Limited Results RedHill Biopharma Announces Positive New Data with Opaganib for Nuclear Radiation Injury redhillbio.com ↗
Positive in vivo results from a new study of opaganib in radiation-induced hematologic and renal toxicity reaffirms opaganib's potential protective impact on hematological and kidney function following total body irradiation (TBI)

All press releases naming this drug 103 releases

DateIssuerRelease
Show all 103 releases opens the full record — a long page

Evidence & citations 7 cited values

Every value below carries the sentence it was read from. 11 sources stand behind the page.

FieldValueCited text
Known as ABC294640 ClinicalTrials.gov intervention name — accepted as the source's own label NCT02939807 ↗
4

NCT03377179 ↗

NCT02229981 ↗

NCT03414489 ↗

NCT01488513 ↗

Known as Opaganib ClinicalTrials.gov intervention name — accepted as the source's own label NCT02757326 ↗
4

NCT04207255 ↗

NCT04414618 ↗

NCT04502069 ↗

NCT04467840 ↗

Known as Yeliva “This program is designed to provide access to ABC294640 (Yeliva ®) for treatment of cholangiocarcinoma (CCA) prior to approval by the local regulatory agency.” NCT03414489 ↗
Action Inhibit “sphingosine kinase-2 inhibitor ABC294640” NCT01488513 ↗
Modality Small molecule — CHEMBL2158685 ↗
Route Oral “Patients receive sphingosine kinase-2 inhibitor ABC294640 orally (PO) twice daily (BID) on days 1-28.” NCT01488513 ↗
Target SPHK2 “selective SphK2 inhibition” NCT04414618 ↗