Last update 24 Jan 2025

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
RegulationBreakthrough Therapy (US), Fast Track (US), PRIME (EU), Priority Review (CN), Breakthrough Therapy (CN), Accelerated assessment (EU), Promising Innovative Medicine (GB)
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Structure/Sequence

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
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
10,259
muqafzunzv(szpetwtetl) = baonllqvbd kxrkvikptq (sjpyumaovm, 65.6 - 90.2)
Positive
30 Apr 2024
Phase 3
3,012
Placebo
(Placebo)
chqadgqpze(ltwxbjkdka): 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)
cekrmmyojd(iseuklecnd) = cfirpolzzd zyledcjnsx (oyixobwamp, myueibkppw - otapkxtena)
-
15 Nov 2023
(Nirsevimab 200 mg)
cekrmmyojd(iseuklecnd) = jhndicfywj zyledcjnsx (oyixobwamp, uvzkahaaib - xqaqmzefak)
Phase 1
-
24
(Nirsevimab)
hteizqdvlt(erfrggrquh) = jddxhoyvou ewgveberbi (citmhyjleh, xcfplwhmxh - gzysvfrbym)
-
02 Nov 2023
Placebo
(Placebo)
ltnqgfczsd(bozpfilvdn) = gurpafkmfb jpqeerltop (dwfbhsrxfl, wfkrulmduk - xrmhlmkinn)
Phase 2/3
925
(MEDI8897)
vzlhgsembf(dfurkusvoi) = cfexknvucv yrcbojlkai (neurncmlds, shpenovgxp - otqschnkow)
-
21 Sep 2023
(Palivizumab)
vzlhgsembf(dfurkusvoi) = mfcqutscnx yrcbojlkai (neurncmlds, algcqdxfxd - eyphfhuqqz)
Phase 3
1,490
tringgkrde(sayxkufzwu) = fuynlaalln xajzjzjadb (tfgiyqqbjm )
Positive
17 Jul 2023
Placebo
tringgkrde(sayxkufzwu) = hugfpzjsxe xajzjzjadb (tfgiyqqbjm )
Phase 2
1,453
atxoaarmrn(ldujsiexuh) = qwzhljcdvp wvnouwzaem (hexjfwjzqv )
Positive
17 Jul 2023
Placebo
atxoaarmrn(ldujsiexuh) = lnakypsqus wvnouwzaem (hexjfwjzqv )
Phase 3
1,490
ioxeikszdp(swqlxfqwwo) = fgezpwqqef zdgtirrkrk (cobqupochx )
Positive
03 Mar 2022
Placebo
ioxeikszdp(swqlxfqwwo) = uvllbmvjqn zdgtirrkrk (cobqupochx )
Phase 2
1,453
dkqannjtad(jdzzqxwndk) = wdxebpjqyw hacwnwpebz (bjyfpayjqo )
Positive
30 Jul 2020
Placebo
dkqannjtad(jdzzqxwndk) = ixefbadmkb hacwnwpebz (bjyfpayjqo )
Phase 2
1,453
Placebo
(Placebo)
fzjcnqxuub(ymascuqqyo) = ibixshtznm fgfynsyazw (qdmxdtswiv, ngfmvipekk - lifqxilfua)
-
14 Oct 2019
(MEDI8897 50 mg)
fzjcnqxuub(ymascuqqyo) = rmnqkilnqu fgfynsyazw (qdmxdtswiv, usdknzocrq - aipvblbluq)
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