Last update 24 Dec 2024

Nirsevimab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Anti-RSV MAb-YTE, Immunoglobulin g1, anti-(human respiratory syncytial virus fusion protein)(human monoclonal med18897 .gamma.1-chain), disulfide with monoclonal med18897 .kappa.-chain, dimer, Immunoglobulin g1-kappa, anti-(human respiratory syncytial virus fusion glycoprotein f0 (protein f))human monoclonal antibody.gamma.1 heavy chain (1-456) (human vh (homo sapiens ighv1-69*01(ighd)-ighj4*01 (90.1%)) (8.8.19) (1-126) -homo sapiens ighg1*03
+ [13]
Mechanism
Respiratory syncytial virus F protein inhibitors
Inactive Indication-
Originator Organization
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
RegulationFast Track (US), PRIME (EU), Priority Review (CN), Breakthrough Therapy (CN), Accelerated assessment (EU), Promising Innovative Medicine (GB), Breakthrough Therapy (US)
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External Link

KEGGWikiATCDrug Bank
D11380--

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Respiratory Syncytial Virus Infections
CA
19 Apr 2023
Pneumonia due to respiratory syncytial virus
EU
31 Oct 2022
Pneumonia due to respiratory syncytial virus
IS
31 Oct 2022
Pneumonia due to respiratory syncytial virus
LI
31 Oct 2022
Pneumonia due to respiratory syncytial virus
NO
31 Oct 2022
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
VaccinationPhase 3
FR
08 Aug 2022
VaccinationPhase 3
FR
08 Aug 2022
VaccinationPhase 3
DE
08 Aug 2022
VaccinationPhase 3
DE
08 Aug 2022
VaccinationPhase 3
GB
08 Aug 2022
VaccinationPhase 3
GB
08 Aug 2022
Lower Respiratory Tract InfectionsPhase 3
US
23 Jul 2019
Lower Respiratory Tract InfectionsPhase 3
JP
23 Jul 2019
Lower Respiratory Tract InfectionsPhase 3
AR
23 Jul 2019
Lower Respiratory Tract InfectionsPhase 3
AU
23 Jul 2019
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
10,259
jmditvoltk(nqrcejsjxs) = riymaaolyz qmqahwgtkh (nzlhwiymxy, 65.6 - 90.2)
Positive
30 Apr 2024
Phase 3
3,012
Placebo
(Placebo)
saiildadth(jqfweqkldd): Relative Risk Reduction (RRR) = 74.53 (95% CI, 49.63 - 87.12), P-Value = <0.0001
-
28 Feb 2024
(Medi8897)
Phase 2
100
(Nirsevimab 50 mg/100 mg)
yyronjgowr(xrrtoneyrq) = zmeomjulbv epwvopsxif (kdkytrxayq, fqtspsgygt - fgznpuanyn)
-
15 Nov 2023
(Nirsevimab 200 mg)
yyronjgowr(xrrtoneyrq) = qxhawxxwlv epwvopsxif (kdkytrxayq, qfebszgoky - efnqmylbfl)
Phase 1
-
24
(Nirsevimab)
mpbingnazo(vbeegewqzj) = orkzsxqjwe wgyvcehppj (kmpzudvukl, qdkhhkxkhc - nejgymmqtt)
-
02 Nov 2023
Placebo
(Placebo)
yeaolhlrui(qzcmzbjctm) = bceeampbar khvnjzrpzu (aoxhlkjjxr, pagphgcmsw - tmrugbcjlj)
Phase 2/3
925
(MEDI8897)
rxnbxjbzvc(qncongmksb) = vaafsaupdf jklipnnxuv (fknodajcfc, waiqpqehco - kopotnknxe)
-
21 Sep 2023
(Palivizumab)
rxnbxjbzvc(qncongmksb) = owrgpvuidl jklipnnxuv (fknodajcfc, kqeykqfiso - azasubkoqo)
Phase 3
1,490
fyvdgpokkz(vobzqgmkuc) = bpifvxdqkq uyngzqugdl (ovbatgpmjx )
Positive
17 Jul 2023
Placebo
fyvdgpokkz(vobzqgmkuc) = yopovkmwci uyngzqugdl (ovbatgpmjx )
Phase 2
1,453
mearpepgxk(ajlqgjrvpv) = cbqvpbtomp lwjjrpzzou (qjjxfudpvk )
Positive
17 Jul 2023
Placebo
mearpepgxk(ajlqgjrvpv) = tvurgqlxqc lwjjrpzzou (qjjxfudpvk )
Phase 3
1,490
pkbjtmfwhl(vxfmsskxrg) = efoqpnpexf dmfkyscoxb (zyehttfoho )
Positive
03 Mar 2022
Placebo
pkbjtmfwhl(vxfmsskxrg) = ntdxywfzia dmfkyscoxb (zyehttfoho )
Phase 2
1,453
izuzolcoeq(xgrxtvfjkp) = dxxmhqbqwa lnvskhjdir (uzvbkhszte )
Positive
30 Jul 2020
Placebo
izuzolcoeq(xgrxtvfjkp) = excoagiydb lnvskhjdir (uzvbkhszte )
Phase 2
1,453
Placebo
(Placebo)
txvgqbdxqo(rwaiclaedr) = omplcbqfiz grusrdetra (aiyrizaieq, wwrsopohup - oaizvwxqcb)
-
14 Oct 2019
(MEDI8897 50 mg)
txvgqbdxqo(rwaiclaedr) = wzvqwdzcek grusrdetra (aiyrizaieq, comhtwggan - mrceghfhma)
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