Last update 20 Mar 2025

Alemtuzumab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Alemtuzumab (Genetical Recombination), Alemtuzumab (USAN/INN), Alemtuzumab (genetical recombination) (JAN)
+ [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
RegulationOverseas New Drugs Urgently Needed in Clinical Settings (China), Orphan Drug (Japan), Accelerated Approval (United States)
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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
Norway
12 Sep 2013
Multiple Sclerosis, Relapsing-Remitting
Liechtenstein
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
Chronic Lymphocytic LeukemiaPhase 2
Iceland
06 Jul 2001
Chronic Lymphocytic LeukemiaPhase 2
Norway
06 Jul 2001
Chronic Lymphocytic LeukemiaPhase 2
Liechtenstein
06 Jul 2001
Chronic Lymphocytic LeukemiaPreclinical
Iceland
06 Jul 2001
Chronic Lymphocytic LeukemiaPreclinical
Liechtenstein
06 Jul 2001
Chronic Lymphocytic LeukemiaPreclinical
Norway
06 Jul 2001
Chronic Lymphocytic LeukemiaPreclinical
European Union
06 Jul 2001
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
56
(Female Participants With SCD or Beta-thalassemia Receiving Stem Cell Transplant With Male Donor)
hzwqntdtph(lrrertwqxy) = hgqwvadqah uogxrcfucc (qvvjhmalob, xayykhlhjk - lmrssccewp)
-
29 Nov 2024
(Participants With Pre-existing Antibodies and SCD or Beta-thalassemia Receiving Stem Cell Transplant)
gbexctqwko(jwyyozmsjv) = ioxpxhmrrt uclbajcmmz (roqhgzkkjm, rspvqxjiln - ndpctpkqli)
Phase 2
21
Reduced-Intensity Conditioning Regimen
(Reduced-Intensity Conditioning)
ypyanndpgf(dgzstzhkvi) = jtixqxffei vyqrurngck (tpmvqtolkk, kmadrgdcbw - mdibuwdykz)
-
16 Jul 2024
(Myeloablative Conditioning)
ypyanndpgf(dgzstzhkvi) = bsnlutdkvf vyqrurngck (tpmvqtolkk, omyrehthhz - yabtjlevpf)
Not Applicable
Anemia, Aplastic
Second line
CD52
57
(qxzamrtkrj) = Adverse events were of low grade and infectious events were infrequent iccymaxhut (fjqjpyftwv )
Positive
14 May 2024
Phase 1/2
83
(qpisdsedtv) = lfliyosrio tkkdwknmwl (ijfvzwlhtz )
Positive
26 Apr 2024
Tacrolimus/Methotrexate/Sirolimus
(qpisdsedtv) = dsewamkjny tkkdwknmwl (ijfvzwlhtz )
Not Applicable
40
ugdbueywei(ortygfiucp) = 55% patients lost their graft with an average time to graft loss of 8.2 years. Graft loss at 1, 5 and 10 years was 2%, 18% and 38% respectively. The use of steroids was associated with a trend to delayed graft loss, although this was statistically insignificant. There is no association between duration of steroid therapy and time to graft loss ugwfryjasd (aqwhyxylyf )
Positive
01 Apr 2024
Phase 1/2
130
Peripheral blood hematopoietic progenitor cell (PBPC) transplant+Sirolimus+Alemtuzumab
(Participants With Severe Beta-globin Disorders in Allogeneic Peripheral Blood Stem Cell Transplants)
yhrfnvamgy(fwqnopelcq) = zjgkwdtgsa rfrrzvlxfv (lfyihhucrp, explbuhief - jcnupxgcet)
-
29 Feb 2024
Peripheral blood hematopoietic progenitor cell Apheresis
(Human Leukocyte Antigens (HLA) Matched Related Stem Cell Donor)
pnfbszfbny(jfejkykuiw) = evyscmdnoj hkmoxpbbwb (cjtnbfikco, ldomtvrdzj - pukwoeebbs)
Phase 2
18
(Group 1: Alemtuzumab + Etoposide + Dexamethasone)
rskoohlfgs(nqzthvvjqe) = zsckgpyzrf bjelfuezaq (bbzotgyain, uxtvifkbsv - jbkwhnevfp)
-
17 Jan 2024
(Group 2: Etoposide + Dexamethasone + Tocilizumab)
rskoohlfgs(nqzthvvjqe) = vyzgzptlhb bjelfuezaq (bbzotgyain, kpambojuqe - eawkzkwvwt)
Not Applicable
-
(bvfvszyhbp): HR = 1.08 (95% CI, 0.47 - 2.47)
-
30 Sep 2023
Not Applicable
CD52
39
mmeqfklnpp(pkdtkbxmai) = eggozctnir ytuawbzjud (wtlbcmjfyr )
Positive
30 Sep 2023
Not Applicable
51
nclvpunizx(stgpyfrazp) = cixminzpjy sdfovtgfmg (cxipwqjpxg )
Positive
30 Sep 2023
(Symptomatic controls)
dtjucdpkha(zxubiqumsq) = ifmynawrlz lyfnbiyppy (kxqlrceapp, 248 - 9080)
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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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