Product Description
Motixafortide (formerly known as BL-8040/BKT140) is a novel selective inhibitor of the CXCR4 chemokine receptor. CXCR4, is a well validated therapeutic target that is involved in the mobilization and trafficking of hematopoietic stem cells, immune cells and cancer cells from the bone marrow and the lymph nodes to the peripheral blood. Motixafortide is being developed as a platform for several indications including mobilization of hematopoietic stem cells (HSCs) for autologous transplantations, treatment of solid tumors, and other hematological malignancies. (Sourced from: https://www.biolinerx.com/pipeline/bl-8040/overview)
Mechanisms of Action: CXCR4 Inhibitor
Novel Mechanism: No
Modality: Peptide/Protein
Route of Administration: Subcutaneous
FDA Designation: Orphan Drug - Pancreatic Cancer *
Approval Status: Approved
Approved Countries: None
Approved Indications: None
Known Adverse Events: None
Company: BioLineRx
Company Location: MODI-IN L3 7177871
Company CEO:
Additional Commercial Interests: GenFleet Therapeutics (Australia)
Clinical Description
Countries in Clinic: China, Germany, Hungary, Italy, Japan, Korea, Spain, United States
Active Clinical Trial Count: 9
Recent & Upcoming Milestones
- Clinical Outcomes Reported - BioLineRx announced they will present P1 Anemia, Sickle Cell results in 2H25 for Motixafortide
- Clinical Outcomes Reported - BioLineRx presented P2 Pancreatic Cancer results on 2025-05-31 for Motixafortide
- Clinical Outcomes Reported - BioLineRx presented P1 Anemia, Sickle Cell results on 2024-12-07 for Motixafortide
Highest Development Phases
Phase 3: Hematopoietic Stem Cell Transplant|Multiple Myeloma
Phase 2: Adenocarcinoma|Pancreatic Cancer
Phase 1: Anemia, Sickle Cell
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
NCT04543071 |
AAAS9513 | P2 |
Recruiting |
Adenocarcinoma|Pancreatic Cancer |
2028-06-01 |
12% |
2025-03-12 |
|
2024-511953-23-00 |
BL-8040.SCM.301 | P3 |
Active, not recruiting |
Hematopoietic Stem Cell Transplant|Multiple Myeloma |
2028-09-30 |
2025-05-02 |
Treatments |
|
NCT05618301 |
NCT05618301 | P1 |
Completed |
Anemia, Sickle Cell |
2025-06-24 |
12% |
2025-07-09 |
Primary Endpoints |
NCT06547112 |
NCT06547112 | P1 |
Completed |
Multiple Myeloma |
2025-07-23 |
50% |
2025-08-30 |
|
NCT06514508 |
GLS-020-31 | P3 |
Not yet recruiting |
Multiple Myeloma |
2026-08-31 |
9% |
2024-07-24 |
Primary Endpoints|Treatments |
NCT03246529 |
GENESIS | P3 |
Active, not recruiting |
Multiple Myeloma |
2020-12-22 |
12% |
2024-02-09 |
Primary Endpoints|Study Completion Date|Treatments |
NCT06442761 |
SCDSTEMM | P1 |
Recruiting |
Anemia, Sickle Cell |
2028-01-01 |
12% |
2025-09-10 |
Primary Completion Date|Primary Endpoints|Start Date|Study Completion Date|Treatments |
NCT03193190 |
Morpheus-Pancreatic Cancer | P2 |
Completed |
Pancreatic Cancer|Adenocarcinoma |
2025-02-27 |
12% |
2025-04-19 |
Patient Enrollment|Primary Completion Date|Primary Endpoints|Study Completion Date |
2018-004372-36 |
BL-8040 with pembrolizumab for treatment of pancreatic cancer - The COMBAT Study | P2 |
Active, not recruiting |
Pancreatic Cancer |
2021-10-05 |
2022-03-13 |
Treatments |
Recent News Events
Date |
Type |
Title |
|---|---|---|
|
11/18/2025 |
News Article |
BioLineRx to Report Third Quarter 2025 Results on November 24, 2025 |
|
10/28/2025 |
News Article |
Gamida Cell Presents Positive Initial Results on Treating Severe Aplastic Anemia (SAA) with Omidubicel |
|
10/06/2025 |
News Article |
Exicure Highlights Recent Achievements and Near-term Strategic Priorities |
|
08/25/2025 |
News Article |
Ayrmid Ltd. Announces FDA Acceptance and Priority Review for Omidubicel for the Treatment of Severe Aplastic Anemia (SAA) |