Mavorixafor
Trade name: Xolremdi
Small moleculeapprovedOrphan Drug FDAFast Track FDA
Approved
Apr 26, 2024
Clinical trial activity
15 trials · 8 clinical orgs · 2 marketing orgs
Phase 1
12
Phase 2
6
Phase 3
3
Phase 4
0
Earliest trial started Jul 7, 2003 (NCT00063804)
Timeline
2000s
- Jan 1, 2003
Earliest Phase 1 Sponsor(trial)
2010s
- Jan 1, 2016
X4 Pharmaceuticals — Earliest Phase 2 Sponsor(trial)
- Oct 10, 2018
Orphan Drug Designation
- Jan 1, 2019
X4 Pharmaceuticals — Earliest Phase 3 Sponsor(trial)
2020s
- Apr 26, 2024
X4 Pharmaceuticals — Earliest FDA Approval
- Apr 26, 2024
X4 PHARMS — Marketing Organization
- Apr 26, 2024
X4 Pharmaceuticals — NDA Organization
Indications
Approved for
Mechanism of action
- C-X-C chemokine receptor type 4ANTAGONIST
C-X-C chemokine receptor type 4 antagonist
Approval history
- approvedPriority reviewFast trackApr 26, 2024
Chemistry & pharmacology
Loading structure…
SMILES
NCCCCN(Cc1nc2ccccc2[nH]1)[C@H]1CCCc2cccnc21- Mol. weight
- 349.48 g/mol
- Lipinski Ro5
- Pass
- Rule of 3
- No
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Oral
- Availability
- Prescription Only
Oral
Yes
Parenteral
No
Topical
No
First in class
Sources
- ChEMBLCHEMBL518924 ↗
Also known as
- amd070
- amd070
- amd070
- amd 070
- amd-070
- amd-070
- amd11070
- amd11070
- amd11070
- amd 11070
- amd-11070
- n'-((1h-benzo(d)imidazol-2-yl)methyl)-n'-(5,6,7,8-tetrahydroquinolin-8-yl)butane-1,4-diamine
- x4p-001
- x4p-001
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT06858696 | Phase 1 | Feb 24, 2025 | X4 Pharmaceuticals |
| NCT06914869 | Phase 1 | Feb 18, 2025 | X4 Pharmaceuticals |
| NCT06056297 | Phase 3 | Feb 29, 2024 | X4 Pharmaceuticals |
| NCT05103917 | Phase 1/Phase 2 (Phase 2) | Jul 21, 2021 | Abbisko Therapeutics Co, Ltd |
| NCT04274738 | Phase 1 | Apr 30, 2020 | X4 Pharmaceuticals |
| NCT04154488 | Phase 1 | Dec 11, 2019 | X4 Pharmaceuticals |
| NCT03995108 | Phase 3 | Aug 31, 2019 | X4 Pharmaceuticals |
| NCT03005327 | Phase 2/Phase 3 (Phase 3) | Dec 1, 2016 | X4 Pharmaceuticals |
| NCT02923531 | Phase 1/Phase 2 (Phase 2) | Sep 1, 2016 | X4 Pharmaceuticals |
| NCT02823405 | Phase 1 | Jun 1, 2016 | X4 Pharmaceuticals |
| NCT02680782 | Phase 1 | Jan 1, 2016 | Covance, X4 Pharmaceuticals |
| NCT02667886 | Phase 1/Phase 2 (Phase 2) | Jan 1, 2016 | X4 Pharmaceuticals |
| NCT00361101 | Phase 1 | Oct 1, 2005 | Genzyme |
| NCT00089466 | Phase 1/Phase 2 (Phase 2) | Nov 1, 2004 | AIDS Clinical Trials Group, National Institute of Allergy and Infectious Diseases (NIAID), University of Alabama, Birmingham |
| NCT00063804 | Phase 1 | Jul 7, 2003 | AIDS Clinical Trials Group, Johns Hopkins University, National Institute of Allergy and Infectious Diseases (NIAID) |
Showing 15 of 15 trials
Page 1 / 1
Organizations
Research & Development (8)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| X4 Pharmaceuticals | For profit | 11 | 11 | 3 | 2016 |
| AIDS Clinical Trials Group | Academic/Hospital | 2 | 0 | 2 | 2003 |
| National Institute of Allergy and Infectious Diseases (NIAID) | Government | 2 | 2 | 2 | 2003 |
| Abbisko Therapeutics Co, Ltd | For profit | 1 | 1 | 1 | 2021 |
| Covance | For profit | 1 | 0 | 1 | 2016 |
| Genzyme | For profit | 1 | 1 | 1 | 2005 |
| Johns Hopkins University | Academic/Hospital | 1 | 0 | 1 | 2003 |
| University of Alabama, Birmingham | Academic/Hospital | 1 | 0 | 1 | 2004 |
8 organizations
Page 1 / 1
Marketing (2)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| X4 PHARMS | For profit | MKTG | Apr 26, 2024 |
| X4 Pharmaceuticals | For profit | NDA | Apr 26, 2024 |