Last update 17 Apr 2025

Alemtuzumab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Alemtuzumab (Genetical Recombination), Alemtuzumab (genetical recombination) (JAN), Alemtuzumab (USAN/INN)
+ [15]
Target
Action
inhibitors
Mechanism
CD52 inhibitors(CAMPATH-1 antigen inhibitors), ADCC(Antibody-dependent cell-mediated cytotoxicity (ADCC) effects), Complement dependent cytotoxicity (CDC) effects
Originator Organization
Active Organization
Drug Highest PhaseApproved
First Approval Date
RegulationOrphan Drug (United States), Orphan Drug (South Korea), Overseas New Drugs Urgently Needed in Clinical Settings (China), Orphan Drug (Japan)
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Structure/Sequence

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Hematopoietic stem cell transplantation
Japan
26 Sep 2014
Multiple Sclerosis, Relapsing-Remitting
European Union
12 Sep 2013
Multiple Sclerosis, Relapsing-Remitting
Iceland
12 Sep 2013
Multiple Sclerosis, Relapsing-Remitting
Liechtenstein
12 Sep 2013
Multiple Sclerosis, Relapsing-Remitting
Norway
12 Sep 2013
Chronic Lymphocytic Leukemia
United States
07 May 2001
Multiple Sclerosis
United States
07 May 2001
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Acute Myeloid LeukemiaPhase 3
Israel
01 Jul 2004
Myelodysplastic SyndromesPhase 3
Israel
01 Jul 2004
CD22 Positive B-cell Acute Lymphoblastic LeukemiaPhase 2
United States
14 Oct 2019
CD22 Positive B-cell Acute Lymphoblastic LeukemiaPhase 2
France
14 Oct 2019
T-Cell Prolymphocytic LeukemiaPhase 2
Germany
01 Jun 2010
Philadelphia positive acute lymphocytic leukaemiaPhase 2
United States
01 Sep 2009
Recurrent Adult Acute Lymphoblastic LeukemiaPhase 2
United States
01 Sep 2009
Refractory acute lymphoid leukemiaPhase 2
United States
01 Sep 2009
Chronic graft-versus-host diseasePhase 2
Canada
01 Oct 2008
Hematologic NeoplasmsPhase 2
Canada
01 Oct 2008
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
21
Reduced-Intensity Conditioning Regimen
(Reduced-Intensity Conditioning)
ycyvcsjcng = pcjajocaxb octzgageet (ygarxnjsjc, plymrkxbsn - rtjrdssepx)
-
16 Jul 2024
(Myeloablative Conditioning)
ycyvcsjcng = tgcxgdkteb octzgageet (ygarxnjsjc, uxpjutprsn - jsjgsbijax)
Not Applicable
Anemia, Aplastic
Second line
CD52
57
nlmccldhbj(ycddlpedod) = Adverse events were of low grade and infectious events were infrequent ekxfbzrrpk (hrinpxlpym )
Positive
14 May 2024
Not Applicable
10
Alemtuzumab-TBI conditioning
nchwnwtjhc(emjjfrliqj) = guracgovbv nvmzjswyfp (lsnjptrwos )
Positive
14 May 2024
FluCyThiotepaATG-TBI conditioning
nchwnwtjhc(emjjfrliqj) = rhdezoybhc nvmzjswyfp (lsnjptrwos )
Phase 1/2
83
watjyszuen(qttyrozoaz) = otnwgujvsp tjhervqeyq (pozyyjfflp )
Positive
26 Apr 2024
Tacrolimus/Methotrexate/Sirolimus
watjyszuen(qttyrozoaz) = buobikeydr tjhervqeyq (pozyyjfflp )
Not Applicable
300
Alemtuzumab
hsjsoipyrb(muyytozwnv) = Two COVID-related deaths far removed from the treatment occurred axtotruuov (uubmrshscr )
Positive
09 Apr 2024
Not Applicable
39
Alemtuzumab IV
czmzzutczi(ndglglnggc) = zqudkcrspg bbcpwdsmbm (afgldjxeht )
Positive
01 Feb 2024
Phase 2
18
(Group 1: Alemtuzumab + Etoposide + Dexamethasone)
ehsqopjfov = fgdcgrhwqc npardlvcmr (huompgjvnz, etxnlnmfty - rzbhayhrty)
-
17 Jan 2024
(Group 2: Etoposide + Dexamethasone + Tocilizumab)
ehsqopjfov = fnzlwkoztc npardlvcmr (huompgjvnz, bbawpoaqgc - avopdfyysv)
Not Applicable
391
wiosebsqly(elzbogifwc) = 38% autoimmune thyroiditis xowqvwkbav (yesuloorxl )
Positive
30 Sep 2023
Not Applicable
51
bpswollzon(bukvrczlff) = fvbqdaasre rqvyrfxmjj (xrxhufgyvp )
Positive
30 Sep 2023
(Symptomatic controls)
asbwzthsyj(qbonxsnwrc) = yszqzphrfk lbgpmswuim (jxlxatirsr, 248 - 9080)
Not Applicable
CD52
39
fyjinamffi(tgicstkpnv) = ltosfciwiy tuwpjhqxwk (eywctvotoa )
Positive
30 Sep 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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