Drug Profile

Opaganib - RedHill Biopharma

Alternative Names: ABC-294640; YELIVA

Latest Information Update: 27 Mar 2025

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At a glance

Originator Apogee Biotechnology Corporation
Developer Apogee Biotechnology Corporation; Medical University of South Carolina; RedHill Biopharma; University of Louisville
Class Adamantanes; Amides; Anti-inflammatories; Antihypoglycaemics; Antineoplastics; Antirheumatics; Antithrombotics; Antivirals; Chlorobenzenes; Obesity therapies; Pyridines; Small molecules
Mechanism of Action Sphingosine kinase 2 inhibitors

Orphan Drug Status

Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

Yes - Neuroblastoma; Cholangiocarcinoma
New Molecular Entity Yes
Available For Licensing Yes - Cancer; Inflammation

Phase II/III COVID-19 pneumonia
Phase II Cholangiocarcinoma; Prostate cancer
Preclinical Acute radiation syndrome; COVID 2019 infections; Ebola virus infections; Influenza A virus infections; Obesity; Radiation injuries; Renal fibrosis; SARS-CoV-2 acute respiratory disease; Type 2 diabetes mellitus
Suspended Liver cancer
No development reported Cancer; Inflammatory bowel diseases; Osteoarthritis; Rheumatoid arthritis; Solid tumours
Discontinued Multiple myeloma

13 Mar 2025 Expanded access programme for Cholangiocarcinoma in USA is no longer available (NCT03414489)
04 Feb 2025 Phase-II clinical trials in Prostate cancer (Combination therapy, Metastatic disease, Hormone refractory) (PO)
10 Dec 2024 Pharmacodynamics data from a preclinical study in Acute radiation syndrome released by RedHill Biopharma

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