Drugs / Motixafortide

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved US (FDA) APHEXDA 2023-09-08 fda.gov

Trials 22 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 15 trials
Phase 1 NCT06442761 Nov 2024 → Jan 2028 expected sickle cell disease St. Jude Children's Research Hospital Recruiting No outcome recorded
Phase 1 NCT06547112 Oct 2024 → Jul 2025 plasma cell myeloma Washington University School of Medicine Completed No outcome recorded
Phase 1 NCT05618301 Jul 2023 → Jun 2025 sickle cell disease Washington University School of Medicine Completed No outcome recorded
Phase 1 NCT05293171 Jun 2021 → Jun 2022 BioLineRx, Ltd. Completed No outcome recorded
Phase 1 NCT02073019 Aug 2014 → Jul 2015 hemopoietic proliferation BioLineRx, Ltd. Completed No outcome recorded
Phase 1/25 trials
Phase 1/2 NCT03154827 Jan 2018 → Apr 2020 acute myeloid leukemia BioLineRx, Ltd. Terminated No outcome recorded
Phase 1/2 NCT03281369 Oct 2017 → Oct 2025 digestive system carcinoma Hoffmann-La Roche Completed No outcome recorded
Phase 1/2 NCT03193190 Jul 2017 → Feb 2025 pancreatic adenocarcinoma Hoffmann-La Roche Completed No outcome recorded
Phase 1/2 NCT02115672 Nov 2014 → Nov 2016 chronic myeloid leukemia Sheba Medical Center Withdrawn No outcome recorded
Phase 1/2 NCT01010880 Oct 2008 → Jul 2010 plasma cell myeloma Biokine Therapeutics Ltd Completed No outcome recorded
Phase 29 trials
Phase 2 NCT07392970 Jul 2026 → Aug 2028 expected acute myeloid leukemia Washington University School of Medicine Not yet recruiting No outcome recorded
Phase 2 NCT04543071 Nov 2020 → Jun 2028 expected pancreatic adenocarcinoma Gulam Manji Recruiting No outcome recorded
Phase 2 NCT02763384 Dec 2016 → Feb 2022 T-cell acute lymphoblastic leukemia, T-lymphoblastic lymphoma Washington University School of Medicine Terminated No outcome recorded
Phase 2 NCT02907099 Dec 2016 → Oct 2023 pancreatic adenocarcinoma M.D. Anderson Cancer Center Completed No outcome recorded
Phase 2 NCT02826486 Sep 2016 → Sep 2022 pancreatic adenocarcinoma BioLineRx, Ltd. Completed No outcome recorded
Phase 2 NCT02639559 Mar 2016 → Apr 2018 Hodgkins lymphoma, acute lymphoblastic leukemia, acute myeloid leukemia, chronic myeloid leukemia +2 Washington University School of Medicine Completed No outcome recorded
Phase 2 NCT02462252 Oct 2015 → Nov 2020 aplastic anemia, myelodysplastic syndrome BioLineRx, Ltd. Completed No outcome recorded
Phase 2 NCT02502968 Sep 2015 → Jul 2018 acute myeloid leukemia Dr. Petra Tschanter Unknown No outcome recorded
Phase 2 NCT01838395 Apr 2013 → Mar 2016 acute myeloid leukemia BioLineRx, Ltd. Completed No outcome recorded
Phase 32 trials
Phase 3 NCT06514508 Dec 2025 → Dec 2026 expected plasma cell myeloma Guangzhou Gloria Biosciences Co., Ltd. Recruiting No outcome recorded
Phase 3 NCT03246529 Mar 2018 → Dec 2020 overdue plasma cell myeloma BioLineRx, Ltd. Active not recruiting No outcome recorded
Phase 41 trial
Phase 4 NCT07101445 Sep 2025 → Dec 2026 expected plasma cell myeloma Emory University Recruiting No outcome recorded
Also used as a comparator or background therapy in 1 trial
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 1 NCT06506461 Background Mar 2025 → Dec 2029 expected sickle cell disease St. Jude Children's Research Hospital Recruiting No outcome recorded

Evidence & citations 11 cited values

Every value below carries the sentence it was read from. 26 sources stand behind the page.

FieldValueCited text
Known as Motixafortide “the CXCR4 antagonist BL-8040 (motixafortide) with pembrolizumab and chemotherapy in metastatic PDAC (NCT02826486).” PMID 32451495 May 2020
9

“Study to Investigate the Effect of BL-8040 (Motixafortide) on the QTc Interval in Healthy Subjects” NCT05293171

NCT07101445

NCT06442761

NCT06514508

NCT04543071

NCT06506461

NCT07392970

NCT05618301

NCT06547112

Known as 4F-benzoyl-TN14003 “BKT140 (4F-benzoyl-TN14003) is a highly selective and unique CXCR4 antagonist.” NCT01010880
Known as BKT-140 BKT-140 drug substance is a highly selective CXCR4 antagonist.” NCT01010880
1

NCT01010880

Known as BL-8040 ClinicalTrials.gov intervention name — accepted as the source's own label NCT02502968
13

NCT02907099

NCT03246529

NCT02073019

NCT02763384

NCT03193190

NCT03154827

NCT03281369

NCT02639559

NCT02826486

NCT05293171

NCT02115672

NCT01838395

NCT02462252

Known as Motixafortida ChEMBL registry synonym — accepted as the source's own label CHEMBL5095030
Known as T140 ChEMBL registry synonym — accepted as the source's own label CHEMBL5095030
Known as TF 14016 ChEMBL registry synonym — accepted as the source's own label CHEMBL5095030
Action Inhibit “BKT140 (4F-benzoyl-TN14003) is a highly selective and unique CXCR4 antagonist.” NCT01010880
Modality Peptide “Motixafortide is a novel cyclic-peptide CXCR4 inhibitor with extended in vivo activity.” PMID 37069359 Apr 2023
Route Subcutaneous “BKT140 will be injected S.C once at dose of 0.03, 0.1, 0.3, 0.9 mg/kg” NCT01010880
Target CXCR4 “BKT140 (4F-benzoyl-TN14003) is a highly selective and unique CXCR4 antagonist.” NCT01010880