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
PARTNERED
GLIX1
Solid tumorsGlioblastomaOther Cancers
In September 2025, BioLineRx announced a collaboration agreement to develop GLIX1, a first-in-class, oral, small molecule targeting DNA damage response in glioblastoma and other cancers. The Phase 1 trial is expected to recruit up to 30 patients with recurrent GBM with the objective setting a maximum tolerated dose (MTD) and/or a recommended dose based on safety, PK/PD and preliminary efficacy. First patients are expected in Q1 2026. Though clinical development will start with glioblastoma, GLIX1 has shown efficacy in numerous different cancer cell lines and BioLine will explore these additional indications in additional preclinical models.
Motixafortide
Solid tumorsPancreatic Cancer
Phase 2
*
Asia development and commercial rights
In July 2023, BioLineRx announced the initiation of a randomized Phase 2 clinical trial in patients with first-line metastatic pancreatic cancer with sponsor Columbia University. The trial is evaluating motixafortide in combination with PD-1 inhibitor cemiplimab and standard of care combination chemotherapy.
In October 2023, BioLineRx finalized an agreement that included Gloria Biosciences to develop and commercialize motixafortide across all indications in Asia. GloriaBio plans to initiate a large, randomized Phase 2 clinical trial in patients with first-line metastatic pancreatic cancer evaluating motixafortide in combination with PD-1 inhibitor zimberelimab and standard of care combination chemotherapy.
Stem cell mobilizationMultiple Myeloma
Approved
Approved in US
Asia development and commercial rights except Asia**
Bridging Study
Asia development and commercial rights except Asia**
Bridging Study
Asia development and commercial rightsAsia commercial rights
In November 2024, BioLineRx and Ayrmid Ltd., the parent company of Gamida Cell Ltd., announced that the companies entered into a license agreement for motixafortide (commercially sold in the U.S. as APHEXDA® ), BioLineRx’s FDA-approved stem cell mobilization agent. BioLineRx granted Ayrmid an exclusive license to develop and commercialize APHEXDA® (motixafortide) across all indications, excluding solid tumor indications, and in all territories other than Asia.
In October 2023, BioLineRx finalized an agreement that included Gloria Biosciences to develop and commercialize motixafortide across all indications in Asia. GloriaBio will lead a bridging study to support potential approval and commercialization of motixafortide in stem cell mobilization for autologous transplantation in patients with multiple myeloma in China.
Sickle Cell Disease
Phase 2
*
Phase 1
*
Asia development and commercial rights except Asia**
In November 2025, BioLineRx announced the final results of a clinical trial conducted at the Washington University School of Medicine that evaluated motixafortide - as a monotherapy and in combination with natalizumab (VLA-4 inhibitor) - for mobilizing CD34+ hematopoietic stem cells (HSCs) for gene therapy in patients with sickle cell disease (SCD). In the 10-subject study, motixafortide alone, and in combination, demonstrated encouraging collection yields and was found to be safe and well-tolerated. In both regimens, motixafortide mobilized enough HSCs generally required for an HSC-based gene therapy (16.5-20x106 CD34+ cells/kg).
In May 2024, BioLineRx announced a clinical trial collaboration with St. Jude Children’s Research Hospital, Inc. to advance a multi-center Phase 1 clinical trial evaluating the safety, tolerability, and feasibility of single-agent motixafortide for the mobilization and collection of CD34+ hematopoietic stem cells in 12 patients (aged 18 and older) with sickle cell disease. Through our APHEXDA® development and commercialization agreement with Ayrmid, Gamida Cell is leading this program.
* Investigator-initiated study
** Rights exclude solid-tumors
Studies in Planning
GLIX1
GLIX1 is a first-in-class oral agent that restores TET2 activity, a mechanism with broad applicability in the oncology space. By reactivating this pathway, GLIX1 promotes selective cancer-cell killing while sparing normal cells. While development will start in glioblastoma, additional cancer indications have been validated in preclinical studies and will continue to be advanced.
Motixafortide
Motixafortide is an innovative, high-affinity CXCR4 inhibitor. The 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.
