Last update 24 Mar 2025

Moxetumomab Pasudotox-TDFK

Overview

Basic Info

Drug Type
Antibody toxin conjugate
Synonyms
Moxetumomab pasudotox, Moxetumomab pasudotox (USAN/INN), CAT-8015
+ [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),
RegulationFast Track (United States), Orphan Drug (United States), Orphan Drug (European Union), Orphan Drug (Australia)
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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
Hairy Cell Leukemia
United States
13 Sep 2018
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Residual NeoplasmPhase 2
United States
01 May 2015
Adult Lymphoblastic LymphomaPhase 2
United States
01 Aug 2014
Adult Lymphoblastic LymphomaPhase 2
Australia
01 Aug 2014
Adult Lymphoblastic LymphomaPhase 2
Canada
01 Aug 2014
Adult Lymphoblastic LymphomaPhase 2
France
01 Aug 2014
Adult Lymphoblastic LymphomaPhase 2
Italy
01 Aug 2014
Adult Lymphoblastic LymphomaPhase 2
Netherlands
01 Aug 2014
Adult Lymphoblastic LymphomaPhase 2
Spain
01 Aug 2014
Adult Lymphoblastic LymphomaPhase 2
United Kingdom
01 Aug 2014
B lymphoblastic leukemia lymphomaPhase 2
United States
01 Aug 2014
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1
9
mxksjohjvk(tccnmbtywr) = nobfqdjxsa fvwthomgvv (boktngtduy )
Positive
20 May 2021
Phase 3
80
wietaxxish(rhcqumxmyr) = bwypkhprts hhqcsvlpvv (afqszcdujd )
Positive
24 Feb 2021
Phase 2
30
zqhgsiombu(mqlvjhnrva) = ywjtfvaber wvdowxuqwp (btwqwvtmqw )
Negative
01 May 2020
Phase 1
49
kqpiiygpwh = dgdnxzljse ubbnkcvems (vkjnnyniwv, klyrpvfibz - pxzlqevtaj)
-
02 Apr 2019
kqpiiygpwh = agvuycbivr ubbnkcvems (vkjnnyniwv, exmlyllspc - dsprorgmoy)
Phase 3
80
wbolgksgwc = whbsejstpa pmjljuilai (comclqppof, mmvckqvhxm - uijquqqapd)
-
27 Aug 2018
Phase 3
80
nwqlzfecqt(lmtrwdyccj) = mownpjtgax yvojqxqate (ojokkeevkx )
Positive
01 Aug 2018
Phase 3
80
ylxkjeaonb(zmgbylxofq) = 3% wrpxxhmvnj (jtamqlicet )
Positive
01 Jun 2018
Not Applicable
-
uixwexehdr(niedemuohc) = Pts with high PK exposure had higher incidence of CLS and CRE in Ph3 but not in Ph1 reuxvnkhsq (memyjzrlgz )
-
01 Jun 2018
Phase 3
80
bioulsyogu(lfqdkgkjpp) = dircktxnqm epxkpskgtd (sqyczijjik )
-
01 Jun 2018
Phase 1
33
sfaczcuzal(yfawqqxnvd) = qfzaxfhlgu etwcgzuynf (ceqiuzodqy )
-
24 May 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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