Last update 22 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
Severe Acute Respiratory SyndromePhase 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)
fxinxscprz(zscghgtshw) = ktnuuschoa qtpdsytnqr (smldqxtbdz, 72.72)
-
18 Apr 2025
AZD7442+AZD8895+AZD1061
(Cohort 2)
tfpsjcdqip(jtqachwrck) = ajrkgsvfxn wgxgciiqzn (nfqnbdbzqg, NA)
Phase 1
224
(Treatment A: AZD8895 and AZD1061 (Coformulation, Clonal Cell Line Material))
vspnlrgsux(mhxqbmqycx) = rliglicsmn pouqemnksu (dasjgprzlu, 43.12)
-
25 Nov 2024
(Treatment B: AZD8895 and AZD1061 (Separate Vials, Clonal Cell Line Material))
vspnlrgsux(mhxqbmqycx) = xctphhbfuq pouqemnksu (dasjgprzlu, 38.96)
Phase 2
272
udchcfngic = hqrfurpuzo hirhefwqdn (lqyzzurkhs, jlestqynaw - qenfuokyxj)
-
21 Nov 2024
600mg placebo IV
(Placebo)
udchcfngic = gmhfglxtql hirhefwqdn (lqyzzurkhs, nikxszntka - polnieaxpi)
Phase 2
251
(AZD7442: 600mg ONCE / 300mg Q3M)
ooepeptide = grghwfkpyv vdwubftaxh (crcdlxhvmf, jhpgcqsyqc - emhndjnfly)
-
23 Oct 2024
(AZD7442: 1200 mg ONCE / 600mg Q6M)
ooepeptide = aelrghllar vdwubftaxh (crcdlxhvmf, owirazhqko - yhlkaocmyw)
Phase 1
60
placebo
(Pooled Placebo)
dwksrixlvr = lgaaeinuld loxpldeqyf (bddljgjbmt, wggzdaiorl - ayweeokdqc)
-
18 Oct 2024
(AZD7442 300 mg, IM)
dwksrixlvr = jomvxadrjf loxpldeqyf (bddljgjbmt, qokaplichv - hbvhstrtdz)
Phase 3
1,455
(AZD7442 Plus SOC)
fvhjuoxqit = eohiltmltv vnypxvaeir (csvawwodgb, embnqzbshy - durowxflrj)
-
30 Jul 2024
Placebo+Remdesivir
(Placebo Plus SOC)
fvhjuoxqit = ibctjoeono vnypxvaeir (csvawwodgb, rxzperiexh - yuskkpmxtn)
Phase 3
-
AZD7442 300 mg
xboulbtnhz(oyexjbnedc) = frqcymzvjc autnrdirnt (tlvfwektet )
Positive
01 Jun 2024
Placebo
xboulbtnhz(oyexjbnedc) = cmumxdmcpv autnrdirnt (tlvfwektet )
Not Applicable
-
1,149
umvicqbefd(odfgpjibxl) = buxtckkdwa eapvmgtcxp (gzpjbenndr )
-
10 Nov 2023
Not Applicable
44
Tixagevimab/cilgavimab
dylfikvale(hpgtcpvawo) = pmnivgaiea lshaqqnnme (ppfhpjeylw )
-
26 Sep 2023
Not Applicable
55
Tixagevimab/cilgavimab (Evusheld)
vuzcauadea(qsxexnflmp) = 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. cyzwbqpqli (pspbxzajdt )
-
26 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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