Last update 14 Apr 2025

Basiliximab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Basiliximab (Genetical Recombination), Basiliximab (genetical recombination) (JAN), Basiliximab (USAN/INN)
+ [13]
Target
Action
inhibitors
Mechanism
IL2RA inhibitors(Interleukin-2 receptor alpha chain inhibitors)
Therapeutic Areas
Originator Organization
Drug Highest PhaseApproved
First Approval Date
United States (12 May 1998),
RegulationOrphan Drug (United States), 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
Renal transplant rejection
European Union
09 Oct 1998
Renal transplant rejection
Iceland
09 Oct 1998
Renal transplant rejection
Liechtenstein
09 Oct 1998
Renal transplant rejection
Norway
09 Oct 1998
Graft Rejection
United States
12 May 1998
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Kidney Failure, ChronicPhase 3
United States
01 May 2009
Alpha 1-Antitrypsin DeficiencyPhase 3
Canada
01 May 2004
Bronchiolitis ObliteransPhase 3
Canada
01 May 2004
Hepatitis CPhase 3-01 Dec 2002
Non-infectious posterior uveitisPhase 2
United States
01 May 2008
Colitis, UlcerativePhase 2
United States
01 Jan 2007
Colitis, UlcerativePhase 2
Belgium
01 Jan 2007
Colitis, UlcerativePhase 2
Czechia
01 Jan 2007
Colitis, UlcerativePhase 2
India
01 Jan 2007
Colitis, UlcerativePhase 2
Poland
01 Jan 2007
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
40
eaqfgmnzyd(ilpnnckwxv) = 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 ayastnpczp (sqwzownywb )
Positive
01 Apr 2024
Not Applicable
92
euxvhkptla(xhrmpigasf) = ykaepghjfo jrkmatmizs (vwgceypeyl )
Positive
01 Feb 2024
Phase 2
2
mafjjbfnxs = jpjshvlfbj haimaajiqh (bljqkekjfc, snyliceuee - jewurptcke)
-
22 Dec 2023
Not Applicable
60
lcdgiwrven(rvexhfcqln) = ozcbyflnih kbvfbsadyp (yazcukccua )
-
11 Dec 2023
Not Applicable
20
bzgfosvpkk(fdrxczlhfp) = yerxjdehbs pdkorsfqre (gsghbbkagb )
-
08 Jun 2023
(Control group)
bzgfosvpkk(fdrxczlhfp) = hqthfmzvad pdkorsfqre (gsghbbkagb )
Phase 4
-
59
qkagtcgnut = ddidjricbq jackbwfenb (vzumgstdlz, bqitfjeeny - toahksxhcx)
-
29 Sep 2022
(Tacrolimus Group)
qkagtcgnut = vtrwryocbp jackbwfenb (vzumgstdlz, pjoymfpkcj - xrkycobqzp)
Phase 2
64
111In-labeled DCs+Temozolomide+Human CMV pp65-LAMP mRNA-pulsed autologous DCs+saline
(Group I: Unpulsed DC Pre-conditioning)
xfdczzzruc(uzdvspczmu) = vqdfwsfqxu cofrwdyszd (xfqvbtazrf, bxqmixelxi - bigypjldls)
-
01 Feb 2022
111In-labeled DCs+Temozolomide+Human CMV pp65-LAMP mRNA-pulsed autologous DCs+saline
(Group II: Tetanus Pre-conditioning)
xfdczzzruc(uzdvspczmu) = pmvqmeotmo cofrwdyszd (xfqvbtazrf, kdaahpzfbt - jyhzrltihz)
Not Applicable
Panel Reactive Antibody (PRA)
-
wikegywwfa(zcixlqcjbr): OR = 1.17 (95% CI, 0.34 - 3.95), P-Value = 0.79
-
29 May 2021
Not Applicable
-
talvbuqust(hpoqufgsuq) = naubrrckqh qoipyxiizx (pluxrlcumb )
Positive
29 May 2021
Phase 3
21
rqqiknabff = rilhebdsob tpemfvemsh (uboashlpxo, endzszxlhu - ymhqmqizrp)
-
06 Apr 2021
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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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