The purpose behind the pipeline
Our team of experts across the entire spectrum of drug development powers solutions designed to impact patients’ lives.
The safety and efficacy of the following investigational compounds or investigational uses of marketed products have not been established. These uses have not been approved by the U.S. Food and Drug Administration or other regulatory authorities unless otherwise noted.
BioLineRx’s focused pipeline includes novel compounds with best-in-class potential to meet areas of unmet need for patients with cancer and rare diseases.
PRE-CLINICAL
PHASE 1
PHASE 2
PHASE 3
APPROVED
Motixafortide BL-8040
Stem cell mobilizationMultiple Myeloma
Approved
2023 FDA Approved
U.S. Food and Drug Administration approved APHEXDA™ (motixafortide) in 2023.
Sickle Cell Disease
Phase 1
Clinical partner*
BioLineRx is advancing a Phase 1 clinical trial that will evaluate the safety and feasibility of motixafortide as monotherapy and in combination with natalizumab (VLA-4 inhibitor) to mobilize CD34+ hematopoietic stem cells (HSCs) for gene therapy in patients with sickle cell disease (SCD).
OncologyPancreatic Cancer
Phase 2
Clinical partner*, **
Motixafortide is also being evaluated in a randomized Phase 2 trial in combination with a checkpoint inhibitor and chemotherapy as a first-line therapy in metastatic pancreatic cancer.
AGI-134
OncologySolid Tumors
Other/BL-5010
Skin Lesions
Approved
Product rights
2016 CE Mark Approved
* Investigator-initiated study
** Trial being conducting with Libtayo®
Motixafortide
Our lead asset, motixafortide, is an innovative, high-affinity CXCR4 inhibitor. This novel agent leverages the expression of the CXCR4 receptor in a variety of cell populations, including hematopoietic stem cells, immune cells, and cancer cells, making it potentially applicable to multiple indications, such as stem cell mobilization and anti-tumor therapy.
