Last update 29 Mar 2025

Balixafortide

Overview

Basic Info

Drug Type
Synthetic peptide
Synonyms
POL-6326
Target
Action
antagonists
Mechanism
CXCR4 antagonists(C-X-C motif chemokine receptor 4 antagonists)
Active Indication
Originator Organization
Active Organization
Inactive Organization-
Drug Highest PhasePhase 2
First Approval Date-
RegulationFast Track (United States)
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Structure/Sequence

Molecular FormulaC84H118N24O21S2
InChIKeyMKXOUIKTXREBLX-NDKBASPVSA-N
CAS Registry1051366-32-5

External Link

KEGGWikiATCDrug Bank
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R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Breast cancer recurrentPhase 3
United States
30 May 2019
Breast cancer recurrentPhase 3
Argentina
30 May 2019
Breast cancer recurrentPhase 3
Belgium
30 May 2019
Breast cancer recurrentPhase 3
Brazil
30 May 2019
Breast cancer recurrentPhase 3
Czechia
30 May 2019
Breast cancer recurrentPhase 3
France
30 May 2019
Breast cancer recurrentPhase 3
Italy
30 May 2019
Breast cancer recurrentPhase 3
Russia
30 May 2019
Breast cancer recurrentPhase 3
South Korea
30 May 2019
Breast cancer recurrentPhase 3
Spain
30 May 2019
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
432
oapxhsfpul(jlkbgexnzc) = ivvnxuzpaj bdrezkfvig (sjynybpxjo, klngyhdldr - vogdzldarj)
-
01 Nov 2023
Phase 3
330
zyfgdzgxdg(akwagaudep) = ntcfzlvwvc fctnktmzru (fohqkbhuld )
Negative
28 Jun 2021
zyfgdzgxdg(akwagaudep) = yqlzkuktja fctnktmzru (fohqkbhuld )
Phase 1
Metastatic HER2-Negative Breast Carcinoma
HER2 negative | CXCR4 positive
56
zwptxekcpx(ysbmezsyis) = The safety and tolerability of B + E appear comparable to published data on E or B alone, particularly for neutropenia rjqvoikwcb (erusnfobdg )
Positive
15 Feb 2021
Phase 1
56
Balixafortide + Eribulin
frvbfkytww(niolkrqjfa) = qognlirdzk ongikzaedr (veoecyqbhw, 4.1 - 7.4)
Positive
25 May 2020
Phase 1
-
Eribulin mesylate+Balixafortide
gjvazibryx(lwvvjkshwk) = vsmwlylxwv sotlarkpuz (pgjbshneps, 15.9 - 51.9)
Positive
01 Jun 2019
Phase 1
54
Balixafortide + Eribulin
vhnirtdkre(qqpejusflq) = Most common Gr 3-4 AEs were neutropenia (23 [41%]) and febrile neutropenia (6 [11%]) xmoroxtbhb (ecjssgdoqc )
Positive
21 Oct 2018
Phase 1
56
Balixafortide+eribulin
ltzhvjlari(iyeicssfel) = 21 (38%) of 56 patients, including febrile neutropenia in five (9%) of 56 patients, neutrophil count decrease in two (4%) patients, constipation in two (4%) patients, pneumonia in two (4%) patients, and urinary tract infection in three (5%) patients. fqztitkugc (pznxhqwgox )
Positive
01 Jun 2018
Phase 1
24
Balixafortide + Eribulin
bbnqnmxbbr(nlryaqpgfi) = neutropenia (9/24, 38%) and leucopenia (3/24, 13%); 2 pts had febrile neutropenia and 1 patient died from sepsis mlstimljui (rbaffxqxwk )
Positive
30 May 2017
Phase 1
24
POL6326 + eribulin 1.1 mg/m2
ypxwctagrk(chbvlphqhf) = 9/24 pts experienced (Gr 1-2) histaminergic reactions related to POL6326 that were manageable with anti-histamines dgtneaezby (cbrqxlmwrv )
-
20 May 2016
POL6326 + eribulin 1.4 mg/m2
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Clinical Trial

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.
Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

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