TheraRadar
Data updated: May 26, 2026

MOZOBIL (plerixafor)

Trial Activity: Declining 14 active trials
Oncology Approved 2008-12-15

Mozobil helps patients with non-Hodgkin's lymphoma or multiple myeloma by moving stem cells from the bone marrow into the bloodstream. It is used alongside filgrastim to prepare these patients for stem cell collection and a subsequent autologous transplant. This process ensures that enough hematopoietic stem cells are available in the peripheral blood for harvesting.

Source: FDA Label • Sanofi • Hematopoietic Stem Cell Mobilizer
Jump to: Indications Approvals Trials Competitors Similar Safety Patents

How MOZOBIL Works

This drug works by blocking the CXCR4 chemokine receptor, which prevents it from binding to its ligand, SDF-1α. Since this receptor-ligand pair normally anchors stem cells within the bone marrow matrix, inhibiting their interaction allows the cells to move into the circulating blood. This results in an increase of circulating hematopoietic progenitor cells available for collection.

Source: FDA Label

Development Insights

M.D. Anderson Cancer Center conducting 6 trials (7%)
139 indications explored (Broad Platform)
→ multiple myeloma (15 trials)
→ sickle cell disease (7 trials)
→ non-hodgkin's lymphoma (5 trials)
1
Indication
--
Phase 3 Trials
1
Priority Reviews
17
Years on Market

Details

Status
Prescription
First Approved
2008-12-15
Revenue
$7M (Q4-2025)

Pro Metrics

Patent cliff and revenue data

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Routes
SUBCUTANEOUS
Dosage Forms
SOLUTION

Companies

Sanofi
Active Ingredient: PLERIXAFOR

MOZOBIL Approval History

2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
12 FDA actions from 2008 to 2023
Sep 2023 SUPPL
Label · Labeling
FDA Letter Label
Aug 2020 SUPPL
Label · Labeling
FDA Letter Label
May 2019 SUPPL
Label · Labeling
FDA Letter Label

What MOZOBIL Treats

2 indications

MOZOBIL is approved for 2 conditions since its original approval in 2008. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Non-Hodgkin's Lymphoma
  • Multiple Myeloma
Source: FDA Label

MOZOBIL Competitive Set

Pro

Three rings of competition based on shared molecular targets and treated indications.

Direct competitors

1

Same target(s) AND same indication — head-to-head.

APHEXDA
AYRMID PHARMA
2023 1 indic.

MoA expansion candidates

1

Same target(s), different indications — where else is this mechanism being explored?

XOLREMDI
X4 PHARMS
2024 1 indic.

Indication competitors

10

Same indication, different mechanism — what else might this patient receive?

IDELALISIB
NATCO
2026 3 indic.
OZILTUS
AMNEAL PHARMS
2025 4 indic.
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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

What's emerging in MOZOBIL's indications

See all emerging drugs →

Phase 3 candidates targeting molecules with no FDA-approved drug, in indications MOZOBIL treats. First-in-class if their pivotal trials read out positive.

Tiragolumab MTIG7192A / RG6058 ~ Mixed — Ph3 readout
Hoffmann-La Roche
TIGIT · monoclonal antibody (anti-TIGIT) · 10 Phase 3 trials
Ceralasertib AZD6738 ~ Mixed — Ph3 readout
AstraZeneca
ATR · small-molecule ATR kinase inhibitor · 2 Phase 3 trials

Drugs Similar to MOZOBIL

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BICNU
CARMUSTINE
2 shared
AVET LIFESCIENCES
Shared indications:
Multiple MyelomaNon-Hodgkin's Lymphoma
CARMUSTINE
CARMUSTINE
2 shared
MEITHEAL
Shared indications:
Multiple MyelomaNon-Hodgkin's Lymphoma
APHEXDA
MOTIXAFORTIDE ACETATE
1 shared
AYRMID PHARMA
Shared indications:
Multiple Myeloma
View all 20 similar drugs Pro
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Clinical Trial Registry

86 trials
Trial Sponsor ID Phase Status Title
NCT07585136 BDSTEM Ph 1 not yet recruiting Stem Cell Mobilization and Apheresis for Life-threatening Blood Disorders
NCT05088356 IRB-60439 NCI-2021-12228 Ph 1 active not recruiting Reduced Intensity Allogeneic HCT in Advanced Hematologic Malignancies w/T-Cell Depleted Graft
NCT02015013 140020 14-I-0020 Ph 2 recruiting Hematopoietic Stem Cell Mobilization in Idiopathic CD4 Lymphocytopenia Patients and Healthy Controls for the Study of T Cell Maturation and Trafficking in Murine Models
NCT06506461 SAGES1 U01HL163983 Ph 1 recruiting Gene Editing For Sickle Cell Disease
NCT06158828 ABCD-NK 202401147 Ph 1, Ph 2 recruiting Pilot Study of Memory-like Natural Killer (ML NK) Cells After TCRαβ T Cell Depleted Haploidentical Transplant in AML
NCT05470491 10000478 000478-C Ph 1, Ph 2 recruiting Trial of Allogeneic Reduced-Intensity, HLA-Haploidentical Allogeneic Hematopoietic Cell Bone Marrow Transplantation Followed by Graft-versus-Host-Disease (GVHD) Prophylaxis With Cyclophosphamide, Bortezomib and Maraviroc for Hematologic Malignancies ...
NCT01318317 results posted 09174 NCI-2011-00344, 09174 Ph 1, Ph 2 active not recruiting Genetically Engineered Lymphocyte Therapy After Peripheral Blood Stem Cell Transplant in Treating Patients With High-Risk, Intermediate-Grade, B-cell Non-Hodgkin Lymphoma
NCT06325709 10001580 001580-I Ph 1, Ph 2 recruiting Base Editing for Mutation Repair in Hematopoietic Stem & Progenitor Cells for X-Linked Chronic Granulomatous Disease
NCT05357482 10000539 000539-H Ph 1, Ph 2 active not recruiting Addition of JSP191 (C-kit Antibody) to Nonmyeloablative Hematopoietic Cell Transplantation for Sickle Cell Disease and Beta-Thalassemia
NCT06207799 2023-0448 NCI-2024-00110 Ph 2 recruiting Pre-transplant Purging and Post-transplant MRD-guided Maintenance Therapy With Elranatamab in Patients With High-risk Multiple Myeloma
NCT06414889 2023-0799 NCI-2024-04300 Ph 1 recruiting Protocol Title: Safety and Feasibility of Autologous CD34+ Hematopoietic Stem Cells Mobilization and Apheresis in Participants With RUNX1 Familial Platelet Disorder
NCT07188090 HSCT iRISID-2024-1641 JT 44251 Ph 2 recruiting Mozobil for Autologous Hematopoietic Stem Cell Transplantation
NCT02570542 15-193 Ph 2 active not recruiting Study of the Impact of CD34+ Cell Dose on Absolute Lymphocyte Count Following High-Dose Therapy and Autologous Stem Cell Transplantation for Relapsed and Refractory Diffuse Large B-cell Lymphoma (DLBCL)
NCT03746080 results posted IRB-46410 NCI-2018-02159, BRN0037 Ph 2 completed Whole Brain Radiation Therapy With Standard Temozolomide Chemo-Radiotherapy and Plerixafor in Treating Patients With Glioblastoma
NCT01526096 10-551-B Ph 1 completed Stem Cell Transplantation for Patients With Multiple Myeloma
NCT03055247 XCGD-MOBI 2015-002356-27 Ph 2 recruiting Combination of Ibuprofen, G-CSF and Plerixafor as Stem Cells Mobilization Regimen in Patients Affected by X-CGD
NCT03664830 PISMO 17426 Ph 1 active not recruiting Safety of Blood Stem Cell Mobilization With Plerixafor in Patients With Sickle Cell Disease
NCT03653247 003SCD101 Ph 1, Ph 2 completed A Study to Assess the Safety, Tolerability, and Efficacy of BIVV003 for Autologous Hematopoietic Stem Cell Transplantation in Patients With Severe Sickle Cell Disease
NCT02678533 FancoMob P130103 2014-005264-14 Ph 1, Ph 2 completed Mobilization and Collection of Peripheral Blood Stem Cells in Patients With Fanconi Anemia Using G-CSF and Plerixafor
NCT02212535 DrepaMob HAO13017 2014-001650-42 Ph 1, Ph 2 completed Assessment of Tolerance of Mobilizing Peripheral Hematopoietic Stem Cells by Plerixafor in Sickle Cell Patients
NCT05445128 results posted 145-SCD-204 Ph 2 terminated Study of MGTA-145 and Plerixafor in Patients With Sickle Cell Disease
NCT02193191 13-229 Ph 1 completed Escalation of Plerixafor for Mobilization of CD34+ Hematopoietic Progenitor Cells and Evaluation of Globin Gene Transfer in Patients With Sickle Cell Disease
NCT01413100 STAT results posted 2533.00 NCI-2011-01190, 2533 Ph 2 completed Scleroderma Treatment With Autologous Transplant (STAT) Study
NCT04762875 results posted 145-ADS-202 Ph 2 terminated MGTA-145 + Plerixafor in the Mobilization of HSCs for Allogeneic Transplant in Hematologic Malignancies
NCT03182426 Pro00053082 Ph 1, Ph 2 completed Stem Cell Mobilization (Plerixafor) and Immunologic Reset in Type 1 Diabetes (T1DM)
NCT01331018 2097.00 NCI-2011-00202, RG9212015 Ph 1 terminated Gene Therapy for Fanconi Anemia
NCT03157804 FANCOLEN-1 2011-006100-12 Ph 1, Ph 2 completed Lentiviral-mediated Gene Therapy of Fanconi Anemia Patients Subtype A
NCT04177810 results posted J19113 IRB00225153, 5P01CA247886 Ph 2 completed Plerixafor and Cemiplimab in Metastatic Pancreatic Cancer
NCT03932864 145-HV-101 Ph 1 completed Study Assessing Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MGTA-145 in Healthy Volunteers as a Single Agent or in Combination With Plerixafor
NCT03240861 NYESO SCT 15-000511 NCI-2017-00896, Ribas NYESO SCT Cancer Ph 1 terminated Genetically Engineered PBMC and PBSC Expressing NY-ESO-1 TCR After a Myeloablative Conditioning Regimen to Treat Patients With Advanced Cancer
NCT03226691 results posted 170124 17-H-0124 Ph 1 completed Peripheral Blood Stem Cell Collection for Sickle Cell Disease (SCD) Patients
NCT01696461 results posted 09-PLEX Ph 2 completed A Phase II Study Evaluating the Safety and Efficacy of Subcutaneous Plerixafor
NCT02231879 results posted 140185 14-I-0185 Ph 2, Ph 3 completed Plerixafor Versus G-CSF in the Treatment of People With WHIM Syndrome
NCT04817345 ASPIRES2 Ph 2 withdrawn Peripheral Blood Stem Cell Collection From Patients With Sickle Cell Disease (SCD) Using Plerixafor
NCT01746173 results posted 12-388 Ph 2 terminated CHOEP + High Dose Therapy + Auto SCT for T-Cell Lymphoma
NCT03612466 2018-8787 7R01CA163870-06 Ph 1 withdrawn A Dose Finding Study of CycloSam® Combined With External Beam Radiotherapy
NCT04552743 results posted IRB-57056 BMT362 Ph 2 completed MGTA-145 + Plerixafor in the Mobilization of Hematopoietic Stem Cells for Autologous Transplantation in Multiple Myeloma
NCT00669669 results posted 2000.00 NCI-2013-00701, 8357 Ph 1, Ph 2 terminated O6-Benzylguanine-Mediated Tumor Sensitization With Chemoprotected Autologous Stem Cell in Treating Patients With Malignant Gliomas
NCT02703779 results posted 2015-IIT-BMT-MM-AutoSCT Ph 2 completed Exploratory Trial to Estimate Proportion of Patients With Tumor Cell Contaminated Leukapheresis Products With and Without Bortezomib With In-vivo Purging - Multiple Myeloma (MM)
NCT01753453 ARD12858 MOZ23510, 2011-004783-30 Ph 2 completed An Exploratory Safety Study to Investigate the Extent of Tumor Cell Mobilization (TCM) After Use of G-CSF Alone or G-CSF Plus Plerixafor in Multiple Myeloma (MM) Patients Who May be Poor Mobilizers of Stem Cells
NCT00822770 results posted 2007-0772 Ph 1, Ph 2 completed Plerixafor and Granulocyte Colony-stimulating Factor (G-CSF) With Busulfan, Fludarabine and Thymoglobulin
NCT03506802 NYSCT MM 17-001866 NCI-2018-00204, 17-001866 Ph 1 withdrawn TCR Genetically Engineered PBMC and PBSC After Melphalan Conditioning Regimen in Treating Participants With Relapsed and Refractory Multiple Myeloma
NCT00903968 results posted 08-273 Ph 1, Ph 2 completed Combination Plerixafor (AMD3100)and Bortezomib in Relapsed or Relapsed/Refractory Multiple Myeloma
NCT02931071 FANCOSTEM-1 2011-006197-88 Ph 2 completed Clinical Phase II Trial to Evaluate CD34+ Cells Mobilization and Collection in Patients With Fanconi Anemia for Subsequent Transduction With a Lentiviral Vector Carring FANCA Gene. FANCOSTEM-1
NCT03277209 1508016466 Ph 1 terminated To Assess the Safety of Continuous IV Administration of Plerixafor and Assess Impact on the Immune Microenvironment in Patients With Pancreatic, Ovarian and Colorectal Adenocarcinomas
NCT01146834 results posted 1005011049 X05324 Ph 3 completed Trial of Three Stem Cell Mobilization Regimens for Multiple Myeloma
NCT02790957 MOZOBL07740 3694/Ao/15 Ph 2 terminated Plerixafor in Diabetic Wound Healing
NCT02682953 HP-00064099 Ph 2 withdrawn Hyperbaric Oxygen Therapy for Hematopoietic Progenitor Cell Collection in Poor Mobilizers
NCT01160354 results posted 2009-0536 NCI-2012-01786 Ph 1, Ph 2 terminated Plerixafor and Clofarabine in Frontline Treatment of Elderly Patients With Acute Myelogenous Leukemia (AML)
NCT02179970 CAM-PLEX CAM-PLEX 2014-000117-31 Ph 1 completed To Assess the Safety of Continuous IV Administration of Plerixafor in Patients With Advanced Pancreatic, Ovarian and Colorectal Cancers

Showing 50 of 86 trials

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

MOZOBIL FDA Label Details

Indications & Usage

FDA Label (PDF)

MOZOBIL is indicated for the treatment of Non-Hodgkin's Lymphoma; Multiple Myeloma.

Pro Intelligence Preview

Deep insights for MOZOBIL

Revenue Insights

  • • Q4-2025: $7M
  • • Historical trend analysis

Patent Timeline

  • • Patent expiration dates
  • • Generic/biosimilar risk

Trial Analysis

  • • 89 total trials
  • • Stage: Declining

Competitive Landscape

  • • 20 similar drugs
  • • Same target/indication analysis
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Full approval history • All patents • Revenue trends • Competitor analysis

Data Sources

FDA Approval: NDA022311 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.

How We Calculate These Metrics

Trial Activity Stage

Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.

Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.

  • Growth: High proportion of early-phase trials (Phase 1/2), active development
  • Expansion: Significant Phase 3 activity, approaching or pursuing approvals
  • Mature: Substantial Phase 4 post-marketing studies
  • Stable: Mixed phase distribution, steady development
  • Declining: Low active trial ratio, reduced R&D investment