Delving into the Latest Updates on Motixafortide with Synapse

Overview

Basic Info

Drug Type

Synthetic peptide

Synonyms

Motixafortide Acetate, 莫替福肽, 4F-BENZOYL-TN14003

+ [7]

Target

CXCR4

Action

antagonists

Mechanism

CXCR4 antagonists(C-X-C motif chemokine receptor 4 antagonists)

Therapeutic Areas

NeoplasmsImmune System DiseasesHemic and Lymphatic Diseases+ [4]

Active Indication

Multiple MyelomaPancreatic Ductal CarcinomaPancreatic Cancer+ [1]

Inactive Indication

Acute Lymphoblastic LeukemiaAcute Myeloid LeukemiaAcute Promyelocytic Leukemia+ [13]

Originator Organization

Biokine Therapeutics Ltd.

Active Organization

BioLineRx Ltd.

Genfleet Therapeutics (Shanghai), Inc.

Ayrmid Pharma Limited

+ [2]

Inactive Organization

Washington University School of Medicine

The University of Texas MD Anderson Cancer Center

Biokine Therapeutics Ltd.

License Organization

Guangzhou Gloria Biosciences Co., Ltd.

Genfleet Therapeutics (Shanghai), Inc.

Gamida Cell Ltd.

+ [4]

Drug Highest PhaseApproved

First Approval Date

United States (08 Sep 2023),

Multiple Myeloma

RegulationOrphan Drug (United States), Orphan Drug (European Union)

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Structure/Sequence

Molecular FormulaC97H144FN33O19S2

InChIKeyJJVZSYKFCOBILL-KZGZZEQFSA-N

CAS Registry664334-36-5

Sequence Code 528941150

Source: *****

This is a pilot phase I study evaluating the effect of motixafortide on determination of measurable residual disease (MRD) level in patients with acute myeloid leukemia (AML) who have completed induction treatment. Consenting and eligible patients will undergo standard of care (SOC) bone marrow and peripheral blood assessments with SOC MRD assays, followed by a single injection of motixafortide. Ten to 14 hours after injection, the patient will undergo peripheral blood collection for the same applicable MRD tests

Start Date31 Mar 2026

Sponsor / Collaborator

Washington University School of Medicine

[+1]

NCT06514508

/ RecruitingPhase 3

A Phase Ⅲ, Randomized, Double-Blinded Study Evaluating the Safety and Efficacy of Combination Treatment of Motixafortide and G-CSF as Compared to Placebo and G-CSF for the Mobilization of Hematopoietic Stem Cells for Autologous Transplantation in Subjects With Multiple Myeloma

This is a randomized, double-blinded, placebo-controlled, multi-center phase Ⅲ bridging clinical study designed to evaluate the efficacy, safety, and pharmacokinetic and pharmacodynamic profiles of Motixafortide (BL-8040) + G-CSF vs placebo + G-CSF mobilized hematopoietic stem cells for autologous transplantation in Chinese patients with multiple myeloma.

Start Date01 Dec 2025

Sponsor / Collaborator

Guangzhou Gloria Biosciences Co., Ltd.

NCT07101445

/ RecruitingPhase 4IIT

Prevent Allergic Reactions to Aphexda With Dexamethasone (PARADE)

This phase IV trial compares the effect of premedication regimens with methylprednisolone versus dexamethasone for the prevention of allergic reaction to motixafortide in patients with multiple myeloma (MM) undergoing stem cell mobilization. MM patients that receive an autologous stem cell transplantation (ASCT) have better outcomes. However, not all MM patients are able to have a successful stem cell mobilization and collection which is needed to proceed to ASCT. The addition of motixafortide prior to stem cell mobilization has allowed more MM patients to collect the needed number of stem cells to proceed to ASCT. However, motixafortide does produce systemic and injection site reactions in many patients. The optimal medication regimen to prevent reactions remains unknown. A premedication regimen with dexamethasone prior to motixafortide decreases the incidence of reactions in many patients and is considered the standard of care regimen for the prevention of systemic and injection site reactions to motixafortide in patients with MM undergoing stem cell mobilization. Dexamethasone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen side effects/allergic reactions. However, dexamethasone is associated with other side effects like headache, difficulty sleeping, high blood glucose, high blood pressure, mood changes, fluid retention, and infection, among others. A premedication regimen with methylprednisolone prior to motixafortide may work better to decrease the incidence of reactions to motixafortide in patients with MM undergoing stem cell mobilization. Methylprednisolone is in a class of medications called corticosteroids. It works to decrease side effects/allergic reactions by changing the way the immune system works. Giving methylprednisolone may be safe, tolerable and/or more effective than dexamethasone as part of a premedication regimen for the prevention of allergic reaction to motixafortide in patients with MM undergoing stem cell mobilization.

Start Date24 Sep 2025

Sponsor / Collaborator

Emory University

[+2]

100 Clinical Results associated with Motixafortide

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100 Translational Medicine associated with Motixafortide

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100 Patents (Medical) associated with Motixafortide

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68

Literatures (Medical) associated with Motixafortide

01 Jul 2025·BIOMEDICAL CHROMATOGRAPHY

Development and Validation of the LC–MS/MS Method and Its Application for Pharmacokinetic Studies for the Simultaneous Estimation of Motixafortide and Filgrastim in rat Plasma

Article

Author: Shaik, Afzal B. ; Mary K, Lurdhu ; Podila, Naresh ; Chimakurthy, Jithendra

ABSTRACT:

Introduction:

Motixafortide, a CXCR4 antagonist, and filgrastim, a granulocyte colony‐stimulating factor, have shown significant potential in enhancing hematopoietic stem cell mobilization and improving cancer treatment outcomes when used in combination. However, critical challenges persist due to the absence of analytical methods and the necessity for reliable quantification of both drugs in biological matrices. This research aims to address these gaps by developing and validating a liquid chromatography–tandem mass spectrometry method for the simultaneous quantification of motixafortide and filgrastim in rat plasma.

Experiment:

An isocratic mobile phase with acetonitrile and buffer was employed for separation, following protein precipitation with acetonitrile, using a C18 Waters X‐Terra RP‐18 column (150x4.6 mm,3.5 μm). Liquid chromatography–tandem mass spectrometry with an internal standard employs multiple reaction monitoring in electrospray ionization (positive ion mode) to monitor the transitions. The method was validated according to USFDA guidelines, assessing parameters such as selectivity, matrix effect, linearity, precision, accuracy, lower limit of quantification, and stability.

Results:

This method was successfully applied in pharmacokinetic studies, ensuring reliable and accurate quantification of co‐administered motixafortide and filgrastim. These findings significantly contribute to optimizing therapeutic protocols and enhancing treatment outcomes for cancer patients.

03 Apr 2025·EXPERT OPINION ON THERAPEUTIC PATENTS

Small molecule and peptide CXCR4 antagonists. A patent review from 2019 to 2024

Review

Author: Wilson, Lawrence J. ; Liotta, Dennis C. ; Tahirovic, Yesim A. ; Geng, Jiafeng ; Sahin, Zafer

INTRODUCTION:

The chemokine receptor CXCR4 has been under intense study due to the central role it plays in immune system regulation and the pathology of human disease. Although the first CXCR4 drug plerixafor emerged over a decade ago (2007), recently the first peptide (motixafortide, 2023) and the first oral small molecule (mavorixafor, 2024) CXCR4 antagonists became FDA approved.

AREAS COVERED:

This article describes patent documents published during the period of 2019 through 2024 for both small molecule and peptides. This IP includes few new chemotypes, with most being extensions of existing structural classes. There is also less significant IP covering peptide-based therapeutics than those covering small molecules. Notably, multiple therapeutic uses have also emerged. Patents were searched from SciFinder (CAS) and Google Patents with the term CXCR4 antagonists. Patents were selected according to whether they fit into the classification of small molecules or peptides.

EXPERT OPINION:

In the last 5 years there has been significant advancement in CXCR4 antagonists as gauged by the FDA approval of two drugs. The search for second and third generation compounds will be the focus of future efforts with new uses and better properties which likely could come from some of the IP described herein.

01 Nov 2024·LEUKEMIA

CXCR4 as a therapeutic target in acute myeloid leukemia

Review

Author: Chlubek, Dariusz ; Bosiacki, Mateusz ; Barczak, Katarzyna ; Kupnicka, Patrycja ; Korbecki, Jan ; Baranowska-Bosiacka, Irena

Extensive research on the CXCL12-CXCR4 axis in acute myeloid leukemia (AML) has resulted in the incorporation of novel anti-leukemia drugs targeting this axis into therapeutic strategies. However, despite this progress, a comprehensive and up-to-date review addressing the role of the CXCL12-CXCR4 axis in AML's oncogenic processes is lacking. In this review, we examine its molecular aspects influencing cancer progression, such as its impact on autonomous proliferation, apoptotic regulation, chemoresistance mechanisms, and interactions with non-leukemic cells such as MSCs and T_reg cells. Additionally, we explore clinical implications, including prognosis, correlation with WBC count, blast count in the bone marrow and peripheral blood, as well as its association with FLT3-ITD, NPM1 mutations, and FAB classification. Finally, this paper extensively discusses drugs that specifically target the CXCL12-CXCR4 axis, including plerixafor/AMD3100, ulocuplumab, peptide E5, and motixafortide, shedding light on their potential therapeutic value in the treatment of AML.

106

News (Medical) associated with Motixafortide

09 Feb 2026

·www.biospace.com

Ayrmid Appoints ACA Pharma as Exclusive Distributor for Omisirge(R) across Greater China and Southeast Asia

ACA Pharma granted exclusive rights to register and distribute Omisirge across 15 markets, covering both FDA-approved Omisirge indications DUBLIN, IE / ACCESS Newswire / February 9, 2026 / Ayrmid, Ltd. ("Ayrmid" or the "Company"), the parent company of Gamida Cell Inc., today announced that it has appointed ACA Pharma as its exclusive distributor for Omisirge (Omidubicel-onlv) and granted ACA Pharma exclusive rights to seek registration and to distribute Omisirge across the following jurisdictions: Mainland China, Hong Kong SAR, Macau SAR, Mongolia, Brunei Darussalam, Cambodia, Indonesia, Lao PDR, Malaysia, Myanmar, Philippines, Singapore, Thailand, Vietnam and Timor-Leste. Under the terms of the agreement, ACA Pharma will hold exclusive rights to register and distribute Omisirge across the Territory; the parties will prioritize specific jurisdictions for regulatory and launch planning based on local requirements and commercial considerations. Initial efforts may focus on lighthouse centers in Macau and Singapore, with additional jurisdictions assessed over time. Dr. Joe Wiley, CEO and Chairman of Ayrmidcommented: "This agreement represents continued progress as we expand access for patients in existing and new territories. Omisirge represents an important advancement in cell therapy and we look forward to working with the team at ACA as we continue to advance our innovative therapies to help patients with serious unmet medical needs." Mike Zhou, CEO of ACA Pharmacommented: "This appointment reflects a shared commitment to responsibly expanding access to Omisirge for appropriate patients across Greater China and Southeast Asia. ACA Pharma's platform is built for complex specialty products-combining regulatory execution, hospital launch capability, and end-to-end distribution-while maintaining the highest standards for quality and patient safety." About Omisirge Omisirge is a nicotinamide-modified allogeneic hematopoietic progenitor cell therapy derived from cord blood. Omisirge is approved in the United States for: (1) adults and pediatric patients 12 years and older with hematologic malignancies planned for umbilical cord blood transplantation following myeloablative conditioning to reduce time to neutrophil recovery and incidence of infection; and (2) adults and pediatric patients 6 years of age and older with severe aplastic anemia following reduced-intensity conditioning. About Ayrmid Ltd. and Gamida Cell Ayrmid Ltd. is the parent company of Gamida Cell Inc., a pioneering cell therapy company developing novel treatments designed to turn cells into powerful therapeutics. Gamida Cell Inc. currently has two FDA approved products on the market in the US, namely Omisirge ® (please see the current full Prescribing Information, including boxed warning, here ) and APHEXDA ® (please see the current full Prescribing Information here ). Gamida Cell operates as a wholly owned subsidiary of Ayrmid Limited, a UK entity. For additional information, please visit or follow Gamida Cell on LinkedIn , X , Facebook or Instagram . Contacts: Media, Investors / Business Development: bd@ayrmid.com About ACA Pharma Founded in 1997, ACA Pharma is a U.S.-headquartered company specializing in fast-track registrations, early access programs, and end-to-end commercialization for innovative medicines and medical devices worldwide. The company is best known for its Macau Fast-Track platform for medicines and Hong Kong Fast-Track pathway for advanced devices, which can enable market entry in as little as 30-90 days in Macau and approximately three months in Hong Kong. These hubs then serve as launchpads to bridge into mainland China via the Greater Bay Area and other national pilot zones, with the real-world evidence generated supporting accelerated national approvals - particularly for products addressing unmet medical need, clinically urgent conditions, or rare diseases. Learn more at This information is provided by RNS, the news service of the London Stock Exchange. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact rns@lseg.com or visit . SOURCE: Ayrmid Pharma Ltd View the original press release on ACCESS Newswire

Cell TherapyLicense out/inDrug ApprovalClinical StudyAccelerated Approval

05 Feb 2026

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Ayrmid and Ariti Sign Distribution Agreement for Omisirge(R) in Greece and Cyprus

DUBLIN, IE / ACCESS Newswire / February 5, 2026 / Ayrmid, Ltd. ("Ayrmid" or the "Company"), the parent company of Gamida Cell Inc., today announced that it has entered into an exclusive distribution agreement with Ariti S.A., a Greece based pharmaceutical company for the distribution of Omisirge (Omidubicel-onlv) in Greece and Cyprus. Under the terms of the agreement, Ariti will provide services to support early access schemes to Omisirge in the agreed territories, leveraging its established expertise in hematology and local market infrastructure. Dr. Joe Wiley, Chief Executive Officer and Chairman of Ayrmidccommented: "This agreement represents continued progress as we expand access for patients in existing and new territories. We look forward to working with the team at Ariti and we remain deeply committed to advancing innovative therapies to help patients with serious unmet medical needs." Mr. Serafeim Kyrkos, Chief Executive Officer of Ariti S.A.commented: "This collaboration brings together our broad expertise in hematology with Ayrmid's innovative therapies, including Omisirge, the only FDA approved cell therapy for allogenic transplant for hematologic malignancies and for the treatment of Severe Aplastic Anemia. For both companies, this represents a tremendous opportunity to support market access in Greece and Cyprus, while driving mutual growth in the haemato-oncology segment". About Omisirge Omisirge is a nicotinamide-modified allogeneic hematopoietic progenitor cell therapy derived from cord blood. Omisirge is approved in the United States for: (1) adults and pediatric patients 12 years and older with hematologic malignancies planned for umbilical cord blood transplantation following myeloablative conditioning to reduce time to neutrophil recovery and incidence of infection; and (2) adults and pediatric patients 6 years of age and older with severe aplastic anemia following reduced-intensity conditioning. About Ayrmid Ltd. and Gamida Cell Ayrmid Ltd. is the parent company of Gamida Cell Inc., a pioneering cell therapy company developing novel treatments designed to turn cells into powerful therapeutics. Gamida Cell Inc. currently has two FDA approved products on the market in the US, namely Omisirge ® (please see the current full Prescribing Information, including boxed warning, here ) and APHEXDA ® (please see the current full Prescribing Information here ). Gamida Cell operates as a wholly owned subsidiary of Ayrmid Limited, a UK entity. For additional information, please visit or follow Gamida Cell on LinkedIn , X , Facebook or Instagram . Contacts: Media, Investors / Business Development: bd@ayrmid.com About Ariti S.A. Ariti S.A., founded in 1985, is a well-established Greek healthcare company active in the pharmaceutical and medical sector. Over the past decades, the Company has built a strong track record in the exclusive representation, distribution and commercialization of pharmaceutical and healthcare products in Greece, in collaboration with reputable international partners. With extensive local expertise, Ariti leverages a solid commercial and regulatory infrastructure to support market access and broad product availability across Greece and Cyprus. Ariti also maintains an owned nationwide network of 10 chronic hemodialysis care units in Greece, strengthening its healthcare footprint and supporting its long-term commitment to improving patient outcomes. For additional information, please visit Ariti SA or follow Ariti SA on LinkedIn This information is provided by RNS, the news service of the London Stock Exchange. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact rns@lseg.com or visit . SOURCE: Ayrmid Pharma Ltd View the original press release on ACCESS Newswire

License out/inCell TherapyDrug ApprovalImmunotherapyBiosimilar

05 Feb 2026

·www.biospace.com

Ayrmid Pharma Ltd Announces Additional Positive Results for Omisirge(R) in Treating Severe Aplastic Anemia (SAA) Presented at TANDEM

Omisirge transplantation shows accelerated immune recovery in SAA New data presented at the 2026 TANDEM Meetings demonstrate that patients with SAA who received Omisirge experienced faster and more robust immune recovery compared with patients receiving alternative transplant graft sources Omisirge approved by FDA as First Cell Therapy to Treat Severe Aplastic Anemia Key Highlights of Data Presented at TANDEM: Rapid neutrophil recovery: Median time to neutrophil engraftment was 10 days following Omisirge transplantation. Faster recovery was associated with higher transplanted CD34⁺ cell doses Enhanced CD4⁺T-cell reconstitution: At six months post-transplant, CD4⁺ T-cell counts were significantly higher in Omisirge recipients compared with other transplant sources including matched and haploidentical donors. Higher CD4⁺ T-cell recovery correlated with more rapid neutrophil engraftment Accelerated NK-cell recovery: Natural killer (NK) cell reconstitution occurred early after transplant, with median NK-cell counts at days 30 and 100 exceeding those observed across all comparator graft sources Omisirge approved by the FDA on December 5, 2025 for SAA DUBLIN, IE / ACCESS Newswire / February 5, 2026 / Ayrmid Ltd. ("Ayrmid" or the "Company"), the parent company of Gamida Cell Inc., a leader in cell therapy innovation, today announced further positive interim clinical results for Omisirge (Omidubicel-onlv), its advanced stem cell transplant therapy for Severe Aplastic Anemia (SAA). The data showed that patients with SAA who received Omisirge transplants experienced faster and more robust immune recovery compared with patients receiving other transplant graft sources, including HLA-matched donor peripheral blood stem cells, haploidentical donors with post-transplant cyclophosphamide, standard cord blood, and combined cord/haploidentical transplants. The findings come from an ongoing single-center Phase II study conducted at the National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health (NIH) and were presented by investigators from NHLBI/NIH and collaborating institutions at the 2026 Transplantation & Cellular Therapy meetings of ASTCT ® and CIBMTR ® (TANDEM), taking place from February 4-7, 2026 in Salt Lake City, UT. Alternative donor hematopoietic cell transplantation (HCT) has historically been limited in SAA by delayed engraftment and high rates of graft rejection. Omisirge is a nicotinamide-expanded cord blood product designed to increase the number of hematopoietic stem and progenitor cells available for transplantation. Dr. Richard Childs of the National Heart, Lung, and Blood Institute (NHLBI) at the National Institutes of Health (NIH) commented: "In this study, we observed that Omisirge transplantation was associated with faster neutrophil engraftment and earlier recovery of key immune cell populations compared with historical transplant approaches in SAA. These findings suggest that enhanced stem cell dose may translate into improved early immune reconstitution in this high-risk patient population." Dr. Ronit Simantov, Chief Medical and Scientific Officer of Ayrmid commented: "These results highlight the significant potential of Omisirge as a transplant option for patients with SAA. The enhanced immune recovery observed following Omisirge transplantation may have important clinical implications for patients with SAA, including improved engraftment, reduced risk of graft rejection, and potentially lower susceptibility to infections in the post-transplant period. We remain deeply committed to advancing transformative therapies for patients with serious unmet medical needs." Omisirge is now approved for treatment in adults and pediatric patients 6 years of age and older with SAA following reduced intensity conditioning. The FDA approval of Omisirge was based on data from the 17-H-0091 study. About Severe Aplastic Anemia Severe Aplastic Anemia is a rare, life-threatening hematologic disorder in which the bone marrow fails to produce sufficient blood cells. Stem cell transplantation offers a potential cure; however, many patients lack a matched sibling donor. Ayrmid is advancing therapies to address this unmet medical need. About Ayrmid Ltd. and Gamida Cell Ayrmid Ltd. is the parent company of Gamida Cell Inc., a pioneering cell therapy company developing novel treatments designed to turn cells into powerful therapeutics. Gamida Cell Inc. currently has two FDA approved products on the market in the US, namely Omisirge ® (please see the current full Prescribing Information, including boxed warning, here ) and APHEXDA ® (please see the current full Prescribing Information here ). Gamida Cell operates as a wholly owned subsidiary of Ayrmid Limited, a UK entity. For additional information, please visit or follow Gamida Cell on LinkedIn , X , Facebook or Instagram . Contacts: Media, Investors / Business Development: bd@ayrmid.com This information is provided by RNS, the news service of the London Stock Exchange. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact rns@lseg.com or visit . SOURCE: Ayrmid Pharma Ltd View the original press release on ACCESS Newswire

Clinical ResultCell TherapyImmunotherapyPhase 2Drug Approval

100 Deals associated with Motixafortide

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External Link

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB14939

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Multiple Myeloma	United States	Ayrmid Pharma Limited	08 Sep 2023

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Hematologic Neoplasms	Phase 3	Italy	BioLineRx Ltd.	13 May 2019
Pancreatic Ductal Carcinoma	Phase 2	China	BioLineRx Ltd.	28 Jun 2022
Pancreatic Ductal Carcinoma	Phase 2	China	Genfleet Therapeutics (Shanghai), Inc.	28 Jun 2022
Adult Lymphoblastic Lymphoma	Phase 2	United States	Washington University School of Medicine	02 Dec 2016
Precursor T-cell lymphoblastic lymphoma	Phase 2	United States	Washington University School of Medicine	02 Dec 2016
Refractory T Acute Lymphoblastic Leukemia	Phase 2	United States	Washington University School of Medicine	02 Dec 2016
Metastatic Pancreatic Cancer	Phase 2	United States	BioLineRx Ltd.	01 Sep 2016
Metastatic Pancreatic Cancer	Phase 2	Israel	BioLineRx Ltd.	01 Sep 2016
Metastatic Pancreatic Cancer	Phase 2	South Korea	BioLineRx Ltd.	01 Sep 2016
Metastatic Pancreatic Cancer	Phase 2	Spain	BioLineRx Ltd.	01 Sep 2016

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


Tandem Meetings ASTCT and CIBMTR2026	Not Applicable	Multiple Myeloma	138	Plerixafor + double dose G-CSF (Multiple Myeloma)	cuqhxqgzps(vjsjyehnch) = no grade ≥2 adverse reactions occurred with plerixafor, whereas motixafortide was associated with injection-site reactions (grade ≥2, 29.4%; including grade 3, 25%) and grade ≥2 allergic reactions. oceaifpmts (sbjdlbwmsa ) View more	Positive	04 Feb 2026
				Motixafortide +G-CSF (Multiple Myeloma)
Tandem Meetings ASTCT and CIBMTR2026	Not Applicable	Multiple Myeloma	70	Motixafortide + G-CSF	mwspqscltl(zjffifjizs) = ozvgolbmdk fafbtzppqs (ajbebyuplj )	Positive	04 Feb 2026
				Motixafortide + G-CSF (quadruplet therapy)	gmecwtxyzb(bqbbttykfj) = qqckgolqfw rvpnhteirb (ocakojvfoy ) View more
Tandem Meetings ASTCT and CIBMTR2026	Not Applicable	Multiple Myeloma	70	Motixafortide	gtciepvtue(qjolrhfyxg) = Incidence of LISR without dexamethasone premedication was similar at 68% compared to 77% with, while incidence of SISR was 42% and 23%, respectively. nqvulanvky (lsjvfjgybx ) View more	Negative	04 Feb 2026
ASH2025	Not Applicable	Anemia, Sickle Cell	10	Motixafortide	wgahcxtlsz(opjhnwqdfy) = The most common adverse events were induration at the injection site (92%), pruritus with rash or hives (88%), and local or generalized pain (62%, narcotics used in 41%). There were 2 instances of lip swelling and fever, but no cases of anaphylaxis. Two patients required prolonged hospitalization for pain management, one attributed to VOE. ohmnyuqaai (tcarojzzwd )	Positive	06 Dec 2025
NCT06547112 (ASH2025)	Phase 2	Multiple Myeloma	20	Motixafortide + G-CSF (standard dosing)	uqgclbrhhe(krttgzoaoe) = Following enhanced premeds, injection site reactions (e.g. pain, erythema, edema) of any grade occurred in 40% of patients (35% Grade 1, 5% Grade 3) relative to historical rates of 95.5% with single-agent premed and 80% with combination premeds; while systemic reactions (e.g. pruritis, flushing, rash) occurred in 40% of patients (30% Grade 1, 10% Grade 2) relative to historical rates of 90.9% with single-agent premed and 20% with combination premeds. qulgaktowc (iiiiukkndf )	Positive	06 Dec 2025
				Motixafortide + G-CSF (early dosing)
NCT04543071 (CheMo4METPANC, ASCO2025) Manual	Phase 2	Pancreatic adenocarcinoma metastatic	11	Motixafortide + cemiplimab + gemcitabine + nab-paclitaxel	zngnbivbqr(icgvbrvpzz) = xbmuqcozlu yoeohcefww (tzdwjsccyo ) View more	Positive	30 May 2025
NCT02502968 (BLAST trial, EHA2025)	Phase 2	Acute Myeloid Leukemia Consolidation CXCR4	128	Motixafortide	hvnsgdyghl(pmmfajkxoo) = qnxyldcmmc aqbavbevxo (cvafmgbgjx ) View more	Negative	14 May 2025
				Placebo	hvnsgdyghl(pmmfajkxoo) = cnpznctehg aqbavbevxo (cvafmgbgjx )
NCT02907099 (P328, CTgov)	Phase 2	Pancreatic adenocarcinoma metastatic \| Metastatic Pancreatic Cancer	20	BL-8040+Pembrolizumab	pknugszltx = yutczowter efhqwbaxce (nxslemxhoy, grvorptdft - nfgfdzuxzb) View more	-	19 Feb 2025
NCT03154827 (CTgov)	Phase 1/2	Acute Myeloid Leukemia	1	BL-8040+Atezolizumab	ykanekqwkv(bvskiavaot) = yknqwxkxwd oxhtmbfgrv (asecddmvbm, htljkjacap - jvunlffmwh) View more	-	05 Sep 2024
NCT02826486 (COMBAT/KEYNOTE-202 \| COMBAT, CTgov)	Phase 2	Pancreatic adenocarcinoma metastatic \| Metastatic Pancreatic Cancer	80	BL-8040+Pembrolizumab (Cohort 1: BL-8040 + Pembrolizumab)	ujjuafsgfv = ztcizuaigu tpotphrugs (tyltirwylo, kunwdeeleb - deamlveleb) View more	-	28 Aug 2024
				BL-8040+Pembrolizumab (Cohort 2: BL-8040 + Pembrolizumab + Chemotherapy)	ujjuafsgfv = bzrzlwouzx tpotphrugs (tyltirwylo, wiiqjjypdw - vmpuqkpedr) View more

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Motixafortide

Overview

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Biosimilar

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