Drug

Mavorixafor

As of the edition of 20 October 2026, Mavorixafor is a small molecule: marketed, first approved in 2024 (US); acts on CXCR4; US protection ends in 2031.

Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.

The drug

Status
Marketed; latest approval 2026
Kind
Small molecule
Brand name
Xolremdi
First approved
26 April 2024 (US)
Approvals on record
2 in 2 regions
Holder of the most recent approval
Norgine B.V.; 2 holders in all
Registered trials
15, 2 stopped early
Disease areas
Cancer; Immune system; Urinary and reproductive; Blood and lymph; Infections; Digestive system

US protection

US protection ends in 2031.

The last listed US exclusivity ends in 2031. The application that gives this date is held by X4 Pharmaceuticals.

This is the US only, and it is not the date generics or biosimilars can enter.

The exact date and the listings behind it

In the product

2 listings count towards this date. The exact date and each listing are in the product.

See the exact date and the 2 listings behind itRequest access. Nothing is shown until you do.

Companies that need a new molecule because of this drug

2 companies on route B because of this drug.

Companies on route B for this drug

In the product

2 companies are on route B because of Mavorixafor.

Target

GeneProteinUniProt
CXCR4C-X-C chemokine receptor type 4P61073

Registered trials

PhaseTrialsCompletedActiveStopped early
Phase 17601
Phase 26401
Phase 32110
All trials15

Who has held its approvals

CompanyRoleYears
X4 PharmaceuticalsOriginator and Lead sponsor of trials2016 to now