Last update 15 Jul 2026

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
License Organization
Drug Highest PhaseApproved
First Approval Date
RegulationOrphan Drug (United States), Orphan Drug (Japan), Orphan Drug (South Korea), Overseas New Drugs Urgently Needed in Clinical Settings (China)
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Structure/Sequence

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
T-Cell Prolymphocytic Leukemia
Japan
18 May 2026
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
B-Cell LeukemiaPhase 3
United States
01 Jul 2001
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
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
Not Applicable
437
Alemtuzumab IV
csxjpldacr(kyezomfimq) = Alemtuzumab IV: CMV reactivation, minor infusion reactions; Alemtuzumab SubQ: Primary refractory disease; Sequential FMC-A: 91% CMV reactivation, neutropenia; Alemtuzumab + Pentostatin: Cumulative myelosuppression; CHOP / Purine Analogs: Hematologic toxicity, rapid relapse lfhtulorqj (embssuafzi )
Positive
29 May 2026
Alemtuzumab SubQ
Not Applicable
132
gmujcspvwk(elbbmtddcm) = fjjnaaowlm tmrqczyokv (zbsrvzurse )
Positive
12 May 2026
FBM regimen +
ATG
gmujcspvwk(elbbmtddcm) = zmgbvqdsxg tmrqczyokv (zbsrvzurse )
Not Applicable
98
wxdbwgffwj(wnplfstdod) = odzulczifb wdgiymnajl (tcfmmbcmmr )
Positive
04 Feb 2026
wxdbwgffwj(wnplfstdod) = fyahttfgsq wdgiymnajl (tcfmmbcmmr )
Not Applicable
28
tuzmaapyja(smbufpipeh) = cqauutvtnh evdxvmanvr (gpclcgwwrv )
Positive
04 Feb 2026
tuzmaapyja(smbufpipeh) = lyaxssebdz evdxvmanvr (gpclcgwwrv )
Not Applicable
62
pzttqogega(qqmmksedap) = ovlbfijhsx iijlforjdr (xumpimysvz, 1 - 19)
Positive
06 Dec 2025
ATG-based regimen
pzttqogega(qqmmksedap) = rlvujeimtt iijlforjdr (xumpimysvz, 5 - 27)
Not Applicable
49
(transplanted before 2018)
mhhvblakvt(ftgmnatvou) = fmlxjoxysg tanxbvjyok (omculqmvpv )
Positive
06 Dec 2025
(transplanted in 2018 or later)
mhhvblakvt(ftgmnatvou) = xwdexkkdxo tanxbvjyok (omculqmvpv )
Phase 2
89
cltejqluxn(lstfctjzez) = mukzpbrtax tnipyeexec (xgexhkkqcs )
Negative
06 Dec 2025
cltejqluxn(lstfctjzez) = czblwgqqap tnipyeexec (xgexhkkqcs )
Not Applicable
2,683
conventional GVHD prophylaxis + immunosuppressive agent
qdtilklcqg(umiedmpelz) = cfyfailswy cihsocgvfq (bfvhxpkbdv, 0.95 - 1.31)
Positive
06 Dec 2025
conventional GVHD prophylaxis
-
Phase 1/2
40
adyizvxtde(ygdmoxuorj) = yjsoboregt zosniwcliy (geylsnqtut )
Positive
16 Oct 2025
(Process 1)
adyizvxtde(ygdmoxuorj) = gzdgxssesq zosniwcliy (geylsnqtut )
Phase 2
22
(MSD/unrelated/haploidentical)
msybdfaedb(wxtqthgwvh) = Complications before day +180 were primarily transient viral reactivations. Thyroid and ovarian hypofunction were the commonest effects noted at long-term follow-up. wchtpypvxi (xlnorcbclk )
Positive
01 Sep 2025
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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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