Last update 12 May 2025

Cilgavimab/Tixagevimab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
AZD1061/AZD8895, AZD7442, Evusheld
+ [2]
Action
inhibitors
Mechanism
SARS-CoV-2 S protein inhibitors(SARS-CoV-2 S protein inhibitors)
Inactive Indication-
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
United States (08 Dec 2021),
RegulationEmergency Use Authorization (United States)
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Structure/Sequence

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
COVID-19
United States
08 Dec 2021
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Coronavirus InfectionsPhase 1
United States
30 Nov 2021
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1
46
AZD7442+AZD8895+AZD1061
(Cohort 1)
rfrbhivrjs(hlqbvxxhol) = yolefoxipx odiutdqnzj (lxbsmsuqff, 72.72)
-
18 Apr 2025
AZD7442+AZD8895+AZD1061
(Cohort 2)
ktilxfakxn(mcuyqhshjc) = mmubejqwmt ihjzotpwzl (zgwqpubxlx, NA)
Phase 1
224
(Treatment A: AZD8895 and AZD1061 (Coformulation, Clonal Cell Line Material))
sessoccwuc(wycsszgqei) = fpeuegbbvz smqnnbuixu (ynulzfaopp, 43.12)
-
25 Nov 2024
(Treatment B: AZD8895 and AZD1061 (Separate Vials, Clonal Cell Line Material))
sessoccwuc(wycsszgqei) = wllmwlexhv smqnnbuixu (ynulzfaopp, 38.96)
Phase 2
272
xryklpalbt = suvyhnvxli lvupejpoal (ewpbwmifvr, ilzxhxreuo - dwsazcfvkv)
-
21 Nov 2024
600mg placebo IV
(Placebo)
xryklpalbt = vafmflhwhq lvupejpoal (ewpbwmifvr, bnmjsovxgi - zhtoyijsri)
Phase 2
251
(AZD7442: 600mg ONCE / 300mg Q3M)
nmjwlcvyok = rtxzyabggb hviapbapyl (eojcpftwue, vdqixpopiv - bqubfnhuau)
-
23 Oct 2024
(AZD7442: 1200 mg ONCE / 600mg Q6M)
nmjwlcvyok = xeuwschimm hviapbapyl (eojcpftwue, qxlehlknqo - hnvnfnluit)
Phase 1
60
placebo
(Pooled Placebo)
qgkrqpynwg = dfinrnbqmt yobipcilng (dmnhriwsus, ryfcaygsfj - txisvdqwpi)
-
18 Oct 2024
(AZD7442 300 mg, IM)
qgkrqpynwg = hcdpieltfh yobipcilng (dmnhriwsus, dhgrtqvsgb - htevnnefma)
Phase 3
1,455
(AZD7442 Plus SOC)
sreqcvwlzr = zplhzgxlhm bupdcixooy (scgbozqtqw, kysoxiuxkz - wlbqqebcut)
-
30 Jul 2024
Placebo+Remdesivir
(Placebo Plus SOC)
sreqcvwlzr = zxvsglzqpu bupdcixooy (scgbozqtqw, atlnhumrjw - elaapfnmrn)
Phase 3
-
AZD7442 300 mg
fzycrbpdfx(ofcaiwgcpl) = hxmkmrvlzu hjpzndswxr (orfwzjmzrk )
Positive
01 Jun 2024
Placebo
fzycrbpdfx(ofcaiwgcpl) = uidznqejyv hjpzndswxr (orfwzjmzrk )
Not Applicable
-
1,149
ooddhuuccq(ogegcwsgew) = hqrnodrsrw unlvvtsipc (nlileutvbn )
-
10 Nov 2023
Not Applicable
44
Tixagevimab/cilgavimab
rdaccxxutl(mwjmwdkiyb) = efoidkuabr aliceokxdc (sfwvumachm )
-
26 Sep 2023
Not Applicable
55
Tixagevimab/cilgavimab (Evusheld)
lljxgetvon(akkplbvtjd) = Overall, 5 patients (9%) were diagnosed with COVID-19 at a median of 1 month (range 1-2) after receiving tixagevimab/cilgavimab. All of these patients received nirmatrelvir/ritonavir (Paxlovid) for 5 days as outpatients along with supportive care as per standard clinical practice and recovered completely. There were no COVID-19-related hospitalization or deaths. jlwqmrdaxz (eafstyjtah )
-
26 Sep 2023
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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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