Last update 16 Apr 2025

Axatilimab-csfr

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Anti-CSF-1R monoclonal antibody, anti-Csf1R monoclonal antibody SNDX-6352, Axatilamab
+ [7]
Target
Action
antagonists
Mechanism
CSF-1R antagonists(Colony stimulating factor 1 receptor antagonists)
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
United States (14 Aug 2024),
RegulationOrphan Drug (United States), Priority Review (Australia), Priority Review (United States)
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
D11952--

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Chronic graft-versus-host disease
United States
14 Aug 2024
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Idiopathic Pulmonary FibrosisPhase 3
United States
16 Sep 2022
BCR-ABL Negative Atypical Chronic Myeloid LeukemiaPhase 2
United States
02 Aug 2024
Chronic Myelomonocytic LeukemiaPhase 2
United States
02 Aug 2024
Myelodysplastic SyndromesPhase 2
United States
02 Aug 2024
Polycythemia VeraPhase 2
United States
02 Aug 2024
Primary MyelofibrosisPhase 2
United States
02 Aug 2024
refractory chronic myelocytic leukemiaPhase 2
United States
02 Aug 2024
Refractory Myeloid NeoplasmPhase 2
United States
02 Aug 2024
Thrombocythemia, EssentialPhase 2
United States
02 Aug 2024
Advanced Malignant Solid NeoplasmPhase 2
United States
15 May 2024
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
-
Axatilimab 0.3 mg/kg
lryschhfth(wstfnrbhxd) = adverse events that were mostly low grade, reversible, and dose dependent mchitifddv (yrhjfowjoh )
-
07 Dec 2024
Axatilimab 1 mg/kg
Phase 2
241
(Axatilimab 0.3 mg/kg Q2W)
rmmxtsjkpf = zviikcvvru fjpminyqcg (iznokqdmtx, ezglghzprd - ngysjidykr)
-
10 Oct 2024
(Axatilimab 1 mg/kg Q2W)
rmmxtsjkpf = xqtatxhjwm fjpminyqcg (iznokqdmtx, kaumzvthew - msghoghsog)
Phase 2
241
Axatilimab 0.3 mg/kg
ytbudcrwap(pjsgcqawud) = moiopwybse pmfqknlvct (omplfyinom, 63 - 83)
Positive
18 Sep 2024
Axatilimab 1 mg/kg
ytbudcrwap(pjsgcqawud) = fbohxzxlku pmfqknlvct (omplfyinom, 55 - 77)
Phase 3
79
wlbwhssofr(ktstbgpqpe) = tpfvkvinhy dgiqnfdzkq (caosltsyeh, 64 - 84)
Positive
14 Aug 2024
Phase 2
241
Axatilimab 0.3 mg/kg every 2 weeks
kurbgfyxug(nfsyrlzyas) = Adverse events in the overall population weremostly low grade, reversible, and increased with higher doses, with no unexpected safety signals. ncnbsdhmwo (pngjlhecta )
Positive
14 May 2024
Phase 2
80
Axatilimab 0.3 mg/kg Q2W
zdjxtkffeg(mglekhmjpi) = mevyqpxwvc oqarzjfnoo (sdlojqifxn, 62.7 - 83.0)
Positive
01 Feb 2024
Phase 2
241
Axatilimab 0.3 mg/kg Q2W
zevscioeif(tjmqeqijxy) = ftzdbhlqsi igtjwqiafb (iceatenzjs, 63 - 83)
Met
Positive
10 Dec 2023
Axatilimab 1 mg/kg Q2W
zevscioeif(tjmqeqijxy) = kxbqkdycpw igtjwqiafb (iceatenzjs, 55 - 77)
Met
Phase 2
241
scsopfevce(qxbthumbwe) = vyoxgwxvxq kjpczpieei (kgpibokrav, 63 - 83)
Met
Positive
24 Jul 2023
scsopfevce(qxbthumbwe) = eewtphdbfz kjpczpieei (kgpibokrav, 55 - 77)
Met
Phase 2
241
tnfsqdsgvw(gaybnphdxh) = gvwgpvsrub yosdhjrvfr (qkhppccbaz, 63 - 83)
Met
Positive
24 Jul 2023
tnfsqdsgvw(gaybnphdxh) = rzprtlrted yosdhjrvfr (qkhppccbaz, 55 - 77)
Met
Phase 2
5
xpglxiqbhg(eejhuzfxyn) = uxsocyjyss cvajvsbggc (ejoqexlryd )
Positive
31 May 2023
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Clinical Trial

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Approval

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.
Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

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