Recent Updates
Recently added Catalysts

plerixafor GZ316455

Phase 2FDA approved 2008

Lymphoma | Small molecule | Oncology |Sanofi|Trials Updated: Mar 30, 2016

plerixafor GZ316455 development status

FDA approval Dec 15, 2008 as Mozobil
Approval holderGenzyme
ApplicationNDA022311
Highest phase Phase 2
Registered trials 2 across 1 sponsor since Aug 2014

Label indication Mozobil is indicated in combination with filgrastim to mobilize hematopoietic stem cells (HSCs) to the peripheral blood for collection and subsequent autologous transplantation in patients with non-Hodgkin's lymphoma (NHL) or multiple myeloma (MM). FDA label

plerixafor GZ316455 target and mechanism

Molecular targetCXCR4
Target classPartial Agonist
ModalitySmall molecule

Also known as Mozobil

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials2
Total Enrollment46

FDA Designations

No designations recorded

plerixafor GZ316455 clinical trials

plerixafor GZ316455 · 2 trials · 2 indications

Phase 2 2
NCT02221492Plerixafor Plus Granulocyte Colony-Stimulating Factor For Mobilization And Collection Of Peripheral Hematopoietic Stem Cells In Japanese Participants With Non-Hodgkin LymphomaLymphoma
COMPLETED32 Analytics
NCT02221479Plerixafor Plus Granulocyte Colony-stimulating Factor (G-CSF) For Mobilization And Collection Of Peripheral Hematopoietic Stem Cells In Japanese Participants With Multiple MyelomaMultiple Myeloma
COMPLETED14 Analytics
PHASE2COMPLETED
Plerixafor Plus Granulocyte Colony-Stimulating Factor For Mobilization And Collection Of Peripheral Hematopoietic Stem Cells In Japanese Participants With Non-Hodgkin Lymphoma
LymphomaUnlock trial analytics
PHASE2COMPLETED
Plerixafor Plus Granulocyte Colony-stimulating Factor (G-CSF) For Mobilization And Collection Of Peripheral Hematopoietic Stem Cells In Japanese Participants With Multiple Myeloma
Multiple MyelomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Proportion of participants who achieve a collection of greater than or equal to 5 x10^6 cells/kg CD34+ cells in less than or equal to 4 days of apheresis
Day 5 to Day 8 of the apheresis/treatment period
Proportion of participants who achieve a collection of greater than or equal to 6 x10^6 cells/kg CD34+ cells in less than or equal to 2 days of apheresis
Day 5 to Day 8 of the apheresis/treatment period

Secondary Endpoints

Proportion of participants who achieve a collection of a minimum target of 2 x10^6 cells/kg CD34+ cells in less than or equal to 4 days of apheresis
Day 5 to Day 8 of the apheresis/treatment period
Number of days of apheresis to collect 5 x10^6 cells/kg CD34+ cells
Day 5 to Day 8 of the apheresis/treatment period
Number of days of apheresis to collect 2 x10^6 cells/kg CD34+ cells
Day 5 to Day 8 of the apheresis/treatment period
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
granulocyte colony-stimulating factor aloneACTIVE_COMPARATORG-CSF administered up to 8 days
granulocyte colony-stimulating factor plus plerixaforEXPERIMENTALG-CSF administered up to 8 days (Day 1 to Day 8) and plerixafor administered for 4 days (Day 4 to Day 7)
Granulocyte colony-stimulating factor (G-CSF) aloneACTIVE_COMPARATORG-CSF administered up to 8 days
G-CSF plus plerixaforEXPERIMENTALG-CSF administered up to 8 days (Day 1 to Day 8) and plerixafor administered for 4 days (Day 4 to Day 7)

Interventions

NameTypeDescription
plerixafor GZ316455DRUGPharmaceutical form:vial Route of administration: subcutaneous injection
FilgrastimDRUGPharmaceutical form:vial Route of administration: subcutaneous injection
Unlock Study Design Details

Eligibility Criteria

Age Range20 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites12

Inclusion criteria: * Age 20 to 75. * Japanese participants with histological or pathological diagnosis of NHL. * First or second complete response (CR) or partial response (PR). Exclusion criteria: * Leukemia participants. * Myelodysplastic syndrome (MDS) participants. * Less than 2 weeks since ...

Countries:Japan
Unlock Eligibility Criteria

Competitive Landscape -Lymphoma 494 trials

Top 20 of 70 competitors

CompanyTickerTrialsLead PhaseDrugs
Regeneron Pharmaceuticals, Inc.REGN7PHASE3Odronextamab, REGN5837
Merck & Co., Inc.MRK22PHASE3Nemtabrutinib, Zilovertamab vedotin, Pembrolizumab Berahyaluronidase alfa, Pembrolizumab, MK-1045
Eli Lilly and CompanyLLY12PHASE3Pirtobrutinib, LY4152199, LY4584180
AstraZeneca PLCAZN20PHASE3Acalabrutinib, Surovatamig, AZD0486, AZD4512, AZD5492
Novartis AG Sponsored ADRNVS9PHASE3Tisagenlecleucel, Rapcabtagene autoleucel, PIT565, Tulmimetostat
Incyte CorporationINCY16PHASE3Tafasitamab, parsaclisib, Ruxolitinib
Gilead Sciences, Inc.GILD7PHASE3Axicabtagene Ciloleucel, KITE-753, KTE-X19, KITE-197, INT2104
AbbVie, Inc.ABBV14PHASE3Venetoclax, Epcoritamab, ABBV-319, ABBV-453, ABBV-525
Genmab A/S Sponsored ADRGMAB18PHASE3Epcoritamab
Johnson & JohnsonJNJ15PHASE3Ibrutinib, Bortezomib, JNJ-90009530, JNJ-80948543, JNJ-75348780
BeOne Medicines Ltd. Sponsored ADRONC21PHASE3Tacabrutideg, Zanubrutinib, Lenalidomide, Tislelizumab, Sonrotoclax
Bristol-Myers Squibb CompanyBMY19PHASE3Golcadomide, Lenalidomide, Lisocabtagene maraleucel, Nivolumab, CC-122
Pfizer Inc.PFE4PHASE3Brentuximab vedotin, Rituximab, Axitinib, Bosutinib, Crizotinib
Nurix Therapeutics, Inc.NRIX6PHASE3NX-5948, NX-1607, NX-2127
Grifols, S.A. Sponsored ADR Class BGRFS1PHASE3Xembify
ADC Therapeutics LtdADCT3PHASE3Loncastuximab tesirine
Cellectar Biosciences, Inc.CLRB3PHASE3Iopofosine I-131
HUTCHMED (China) Limited Sponsored ADRHCM2PHASE3HMPL-760
Nuvalent, Inc. Class ANUVL1PHASE3Neladalkib
Corvus Pharmaceuticals, Inc.CRVS2PHASE3Soquelitinib
Unlock Competitive Intelligence

Frequently asked questions about plerixafor GZ316455

What is plerixafor GZ316455 used for?

Plerixafor GZ316455 is used to mobilize and collect peripheral hematopoietic stem cells in patients with lymphoma and multiple myeloma. It is given with granulocyte colony-stimulating factor before stem cell collection. Sanofi is developing it, and it is in Phase 2 clinical development.

What does plerixafor GZ316455 target?

Plerixafor GZ316455 targets CXCR4, a chemokine receptor. It acts as a partial agonist at this receptor. By binding CXCR4, it helps release hematopoietic stem cells from the bone marrow into the bloodstream for collection.

Who makes plerixafor GZ316455?

Plerixafor GZ316455 is developed by Sanofi, which trades under the ticker SNY. Sanofi is the company responsible for its clinical development in lymphoma and multiple myeloma.

What phase is plerixafor GZ316455 in?

Plerixafor GZ316455 is in Phase 2 clinical development. It is investigational and has not been approved by the FDA. The Phase 2 trials have been completed, and no active trials are currently listed.

What clinical trials is plerixafor GZ316455 in?

Plerixafor GZ316455 has been studied in two completed Phase 2 trials. NCT02221492 evaluated it with G-CSF in Japanese participants with non-Hodgkin lymphoma, enrolling 32 patients. NCT02221479 evaluated it with G-CSF in Japanese participants with multiple myeloma, enrolling 14 patients.