Drugs / Mavorixafor

Regulatory milestones approvals, filings & regulatory actions · 2 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved EU (EMA) Xolremdi 2026-04-27 europa.eu
Approved US (FDA) XOLREMDI 2024-04-26 fda.gov

Trials 15 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 17 trials
Phase 1 NCT06858696 Feb 2025 → Jan 2026 liver disorder X4 Pharmaceuticals Completed No outcome recorded
Phase 1 NCT06914869 Feb → May 2025 X4 Pharmaceuticals Completed No outcome recorded
Phase 1 NCT04274738 Apr 2020 → Oct 2022 Waldenstrom macroglobulinemia X4 Pharmaceuticals Completed No outcome recorded
Phase 1 NCT02823405 Sep 2016 → Mar 2018 melanoma X4 Pharmaceuticals Completed No outcome recorded
Phase 1 NCT02680782 Jan → Feb 2016 X4 Pharmaceuticals Terminated No outcome recorded
Phase 1 NCT00361101 Oct 2005 → Aug 2006 HIV infectious disease Genzyme, a Sanofi Company Completed No outcome recorded
Phase 1 NCT00063804 ? → Oct 2006 HIV infectious disease National Institute of Allergy and Infectious Diseases (NIAID) Completed No outcome recorded
Phase 1/25 trials
Phase 1/2 NCT04154488 Oct 2021 → Aug 2024 neutropenia X4 Pharmaceuticals Completed No outcome recorded
Phase 1/2 NCT05103917 Jul 2021 → Nov 2022 triple-negative breast carcinoma Abbisko Therapeutics Co, Ltd Unknown No outcome recorded
Phase 1/2 NCT02923531 Dec 2016 → Aug 2018 clear cell renal carcinoma X4 Pharmaceuticals Terminated No outcome recorded
Phase 1/2 NCT02667886 Apr 2016 → Apr 2022 clear cell renal carcinoma X4 Pharmaceuticals Completed No outcome recorded
Phase 1/2 NCT00089466 Nov 2004 → Jun 2006 HIV infectious disease National Institute of Allergy and Infectious Diseases (NIAID) Completed No outcome recorded
Phase 21 trial
Phase 2 NCT03005327 Dec 2016 → Jun 2022 WHIM syndrome X4 Pharmaceuticals Completed No outcome recorded
Phase 32 trials
Phase 3 NCT06056297 Jun 2024 → Sep 2027 expected neutropenia X4 Pharmaceuticals Recruiting No outcome recorded
Phase 3 NCT03995108 Oct 2019 → Dec 2025 WHIM syndrome X4 Pharmaceuticals Completed No outcome recorded

Evidence & citations 10 cited values

Every value below carries the sentence it was read from. 17 sources stand behind the page.

FieldValueCited text
Known as mavorixafor Mavorixafor is an oral small molecule selective antagonist of the CXCR4 receptor that increases mobilization and trafficking of white blood cells from the bone marrow.” PMID 32870250 Dec 2020
7

Mavorixafor (X4P-001) is an oral, selective, allosteric CXCR4 inhibitor” PMID 33507454 Jan 2021

NCT04154488

NCT06056297

NCT03995108

NCT04274738

NCT06858696

NCT06914869

Known as AMD070 “This study will test the safety and anti-HIV activity of eight different doses of the HIV entry inhibitor AMD11070 (also known as AMD070) in HIV infected patients.” NCT00089466
1

NCT00063804

Known as AMD11070 “AMD070 (also known as AMD11070) is designed to block HIV from entering cells and may be effective in treating patients who have developed resistance to or are unable to take...” NCT00063804
2

NCT00361101

NCT00089466

Known as Cxcr4 inhibitor x4p-001 ChEMBL registry synonym — accepted as the source's own label CHEMBL518924
Known as X4P-001 “Mavorixafor (X4P-001) is an oral, selective, allosteric CXCR4 inhibitor” PMID 33507454 Jan 2021
4

NCT02680782

NCT02823405

NCT05103917

NCT02667886

Known as Xolremdi ChEMBL registry synonym — accepted as the source's own label CHEMBL518924
Action Inhibit “AMD070 binds to the chemokine receptor CXCR4, inhibiting membrane fusion and viral entry.” NCT00063804
Modality Small molecule “Mavorixafor is an oral small molecule selective antagonist of the CXCR4 receptor that increases mobilization and trafficking of white blood cells from the bone marrow.” PMID 32870250 Dec 2020
Route Oral “AMD070 is an oral CXCR4 antagonist” PMID 17452489 Apr 2007
Target CXCR4 “AMD070 binds to the chemokine receptor CXCR4, inhibiting membrane fusion and viral entry.” NCT00063804