Last update 18 May 2026

Inotuzumab Ozogamicin

Overview

Basic Info

Drug Type
Antibody drug conjugate (ADC)
Synonyms
INO, Inotuzumab Ozogamicin (Genetical Recombination), Inotuzumab ozogamicin (genetical recombination) (JAN)
+ [12]
Action
inhibitors
Mechanism
CD22 inhibitors(CD22 inhibitors), DNA inhibitors(DNA inhibitors)
Originator Organization
Inactive Organization
License Organization
Drug Highest PhaseApproved
RegulationBreakthrough Therapy (United States), Orphan Drug (United States), Orphan Drug (European Union), Orphan Drug (Japan), Orphan Drug (South Korea), Orphan Drug (United Kingdom)
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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
Philadelphia chromosome positive adult precursor acute lymphoblastic leukemia
United Kingdom
01 Jan 2021
Recurrent B Acute Lymphoblastic Leukemia
South Korea
03 Jan 2019
Refractory B Acute Lymphoblastic Leukemia
South Korea
03 Jan 2019
CD22 Positive B-cell Acute Lymphoblastic Leukemia
Australia
17 May 2018
CD22 positive Acute Lymphoblastic Leukemia
Japan
19 Jan 2018
Precursor B-Cell Lymphoblastic Leukemia-Lymphoma
United States
17 Aug 2017
CD22-positive B-cell Precursor acute lymphoblastic leukemia
European Union
28 Jun 2017
CD22-positive B-cell Precursor acute lymphoblastic leukemia
Iceland
28 Jun 2017
CD22-positive B-cell Precursor acute lymphoblastic leukemia
Liechtenstein
28 Jun 2017
CD22-positive B-cell Precursor acute lymphoblastic leukemia
Norway
28 Jun 2017
Philadelphia positive acute lymphocytic leukaemia
European Union
28 Jun 2017
Philadelphia positive acute lymphocytic leukaemia
Iceland
28 Jun 2017
Philadelphia positive acute lymphocytic leukaemia
Liechtenstein
28 Jun 2017
Philadelphia positive acute lymphocytic leukaemia
Norway
28 Jun 2017
Acute Lymphoblastic Leukemia
Canada
-
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Refractory Aggressive Non-Hodgkin LymphomaPhase 3
United States
04 Apr 2011
Refractory Aggressive Non-Hodgkin LymphomaPhase 3
United States
04 Apr 2011
Refractory Aggressive Non-Hodgkin LymphomaPhase 3
Japan
04 Apr 2011
Refractory Aggressive Non-Hodgkin LymphomaPhase 3
Japan
04 Apr 2011
Refractory Aggressive Non-Hodgkin LymphomaPhase 3
Belgium
04 Apr 2011
Refractory Aggressive Non-Hodgkin LymphomaPhase 3
Belgium
04 Apr 2011
Refractory Aggressive Non-Hodgkin LymphomaPhase 3
Bulgaria
04 Apr 2011
Refractory Aggressive Non-Hodgkin LymphomaPhase 3
Bulgaria
04 Apr 2011
Refractory Aggressive Non-Hodgkin LymphomaPhase 3
Canada
04 Apr 2011
Refractory Aggressive Non-Hodgkin LymphomaPhase 3
Canada
04 Apr 2011
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
129
rprxylwdxe = vnsrtifffv jdwmcethsn (xxymqodfmx, noqcisuujt - gkyjzaoevl)
-
17 Mar 2026
rprxylwdxe = ilzrtzywcw jdwmcethsn (xxymqodfmx, ujuhrftcpq - hstltejemn)
Not Applicable
542
euaghvqyig(gvkcyyuxhb) = nokwyewkbj dwhpvetlqz (wicojhkabs )
Positive
04 Feb 2026
euaghvqyig(gvkcyyuxhb) = khokymsqhd dwhpvetlqz (wicojhkabs )
Phase 2
24
Inotuzumab ozogamicin + mini-Hyper-CVD based chemo-immunotherapy
ojcceobnph(cirhiwottr) = njfzgovzar vqqujsevuo (vmztgtnghc )
Positive
06 Dec 2025
Phase 2
48
Blinatumomab
hsgoosxbyy(qegterhazq) = vkqwavzgge wpxsgctabi (kuqfauwiau )
Positive
06 Dec 2025
Not Applicable
75
(Standard dosing)
uctgkbkait(dfggwbtlas) = 24% muxfjhcuaa (vgzwotddyc )
Positive
06 Dec 2025
(Alternative dosing)
Phase 2
33
ojuguygtmv(altfcquynk) = gtplgomkbv aioibzdhhw (mauamzqawl, 33 - 70)
Positive
06 Dec 2025
Phase 2
75
Hyper-CVAD + Blina + InO
jgvrizdhcb(lwrvynmiqs) = qpscruspho btpbyxrckq (qnfhjscuwf )
Positive
06 Dec 2025
Hyper-CVAD + Blina
jgvrizdhcb(lwrvynmiqs) = phgbkenvxy btpbyxrckq (qnfhjscuwf )
Phase 2
16
kveqapiebe(qrfyfcmsrx) = n=12 qagkexsxaw (raolkqeali )
Positive
06 Dec 2025
Not Applicable
262
ptpoyqwrzm(mlkcbwqawa) = ftzilesrbi ncqpxfoshe (qvkufjzmxx )
Positive
06 Dec 2025
ptpoyqwrzm(mlkcbwqawa) = trmigtayun ncqpxfoshe (qvkufjzmxx )
Phase 2
41
yqodhiowsu(tmkeapjbgv) = bmfpusrcur yuteeowqlc (ybvaeatnju, 99.1 - 100)
Positive
06 Dec 2025
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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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