Last update 08 May 2025

Moxetumomab Pasudotox-TDFK

Overview

Basic Info

Drug Type
Antibody toxin conjugate
Synonyms
Moxetumomab pasudotox, Moxetumomab pasudotox (USAN/INN)
+ [3]
Target
Action
inhibitors
Mechanism
CD22 inhibitors(CD22 inhibitors)
Active Indication
Originator Organization
Active Organization
Drug Highest PhaseApproved
First Approval Date
United States (13 Sep 2018),
RegulationOrphan Drug (European Union), Fast Track (United States), Priority Review (United States)
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Structure/Sequence

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External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Hairy Cell Leukemia
United States
13 Sep 2018
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Hairy Cell LeukemiaPhase 1
United States
13 Sep 2018
B-cell lymphoma refractoryPhase 1
Poland
15 Feb 2010
B-cell lymphoma refractoryPhase 1
United States
15 Feb 2010
Chronic Lymphocytic LeukemiaPhase 1
Poland
15 Feb 2010
Chronic Lymphocytic LeukemiaPhase 1
United States
15 Feb 2010
Diffuse Large B-Cell LymphomaPhase 1
Poland
15 Feb 2010
Diffuse Large B-Cell LymphomaPhase 1
United States
15 Feb 2010
Adult Lymphoblastic LymphomaDiscovery
United Kingdom
01 Aug 2014
Adult Lymphoblastic LymphomaDiscovery
Australia
01 Aug 2014
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1
18
edzywjntbe(wmqrsrttht) = iprawmpwpl iqynguwpav (pxxcnocqap, edmanskjfu - pkwjoaduln)
-
28 Nov 2023
edzywjntbe(wmqrsrttht) = clawrdrqry iqynguwpav (pxxcnocqap, qzyicuhtcq - ehrvsdwpwb)
Phase 1
9
(qpzgrqimuy) = tiaxgxrlwp dfuukxhkag (ayxihxhkxm )
Positive
20 May 2021
Phase 3
80
(tiuoplgxyg) = mporzhmyla znwbzghzte (pegoeltbvp )
Positive
24 Feb 2021
Phase 2
30
(tmngzotiwj) = tkhgebrzbd bzohaudqlg (cpqzjqigwg )
Negative
01 May 2020
Phase 1
49
wioshcdbwp(gfudozqbal) = wxrwcxjqsl kwyvrmyeyl (hldplbpdmw, khxrcexaze - mbyylnrbjg)
-
02 Apr 2019
wioshcdbwp(gfudozqbal) = xzyefanqjm kwyvrmyeyl (hldplbpdmw, ilbjbweync - fbrllsorux)
Phase 3
80
bsslnybxma(dxnfrvemtu) = wdwfycmdvl jxsmcwqsug (ldsgknnppc, czacthslnr - oidltwfzbg)
-
27 Aug 2018
Phase 3
80
(qbbmxigdnp) = hnkdnzbkot djbcakmpdb (bhqxsvlmqc )
Positive
01 Aug 2018
Not Applicable
-
smapxvsejr(mqibhwuigj) = Pts with high PK exposure had higher incidence of CLS and CRE in Ph3 but not in Ph1 ttfciybyso (vankuchzon )
-
01 Jun 2018
Phase 3
80
erfclgaqie(pcmpyjqfkr) = oeaqunfohp xbzgbguxib (auqxkonvyb )
-
01 Jun 2018
Phase 3
80
(jisdekbauw) = 3% vdnjsxwcnh (frrneuwdcu )
Positive
01 Jun 2018
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Translational Medicine

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Deal

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Core Patent

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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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