Drug Profile

Bemcentinib - BerGenBio/Rigel Pharmaceuticals

Alternative Names: BGB 324; BGB-3234; R-428

Latest Information Update: 26 May 2025

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At a glance

Originator Rigel Pharmaceuticals
Developer BerGenBio; Haukeland University Hospital; Merck Sharp & Dohme; Oslo University Hospital; University of Leicester; University of Texas Health Science Center at San Antonio; University of Texas Southwestern Medical Center
Class Antifibrotics; Antineoplastics; Antivirals; Benzocycloheptenes; Cycloheptanes; Hepatoprotectants; Pyridazines; Pyrrolidines; Small molecules; Triazoles
Mechanism of Action Axl receptor tyrosine kinase inhibitors; Virus internalisation inhibitors

Orphan Drug Status

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

Yes - Acute myeloid leukaemia
New Molecular Entity Yes

Phase II/III COVID 2019 infections
Phase II Acute myeloid leukaemia; Malignant melanoma; Malignant-mesothelioma; Myelodysplastic syndromes; Non-small cell lung cancer; Triple negative breast cancer
Phase I/II Adenocarcinoma; Glioblastoma; Pancreatic cancer
Preclinical Adult respiratory distress syndrome; Influenza virus infections; Respiratory syncytial virus infections; Rhinovirus infections
No development reported Chronic myeloid leukaemia; Ebola virus infections; Idiopathic pulmonary fibrosis; Non-alcoholic steatohepatitis; Solid tumours; Zika virus infection

09 May 2025 BerGenBio ASA terminates a phase I/II trial in Non-small cell lung cancer (Combination therapy, First-line therapy, Late-stage disease, Metastatic disease) in United Kingdom, Italy, Greece, France, Poland, USA, Hungary, Spain (PO) due to lack of efficacy (NCT05469178)
17 Mar 2025 BeiGene plans a phase III trial for Chronic lymphocytic leukemia (Second line therapy or greater) in Argentina, Australia, Brazil, Canada, Czech republic, Germany, Italy, Japan, South Korea, Mexico, New Zealand, Poland, Sweden, Turkey and United Kingdom (Ref), (NCT06846671) (EUCT-2024-518893-15-00)
07 Jan 2025 Phase-I/II clinical trials in Adenocarcinoma (Combination therapy, Metastatic disease, Late-stage disease, Second-line therapy or greater) in USA (PO) (NCT06516887)

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