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] |
Target |
Mechanism Respiratory syncytial virus F protein inhibitors |
Therapeutic Areas |
Inactive Indication- |
Originator Organization |
Active Organization |
Inactive Organization |
Drug Highest PhaseApproved |
First Approval Date EU (31 Oct 2022), |
RegulationBreakthrough Therapy (US), Fast Track (US), PRIME (EU), Priority Review (CN), Breakthrough Therapy (CN), Accelerated assessment (EU), Promising Innovative Medicine (GB) |
Indication | Country/Location | Organization | Date |
---|---|---|---|
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 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Vaccination | Phase 3 | FR | 08 Aug 2022 | |
Vaccination | Phase 3 | FR | 08 Aug 2022 | |
Vaccination | Phase 3 | DE | 08 Aug 2022 | |
Vaccination | Phase 3 | DE | 08 Aug 2022 | |
Vaccination | Phase 3 | GB | 08 Aug 2022 | |
Vaccination | Phase 3 | GB | 08 Aug 2022 | |
Lower Respiratory Tract Infections | Phase 3 | US | 23 Jul 2019 | |
Lower Respiratory Tract Infections | Phase 3 | JP | 23 Jul 2019 | |
Lower Respiratory Tract Infections | Phase 3 | AR | 23 Jul 2019 | |
Lower Respiratory Tract Infections | Phase 3 | AU | 23 Jul 2019 |
Not Applicable | 10,259 | muqafzunzv(szpetwtetl) = baonllqvbd kxrkvikptq (sjpyumaovm, 65.6 - 90.2) View more | 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 View more | - | 28 Feb 2024 | ||
(Medi8897) | |||||||
Phase 2 | 100 | (Nirsevimab 50 mg/100 mg) | cekrmmyojd(iseuklecnd) = cfirpolzzd zyledcjnsx (oyixobwamp, myueibkppw - otapkxtena) View more | - | 15 Nov 2023 | ||
(Nirsevimab 200 mg) | cekrmmyojd(iseuklecnd) = jhndicfywj zyledcjnsx (oyixobwamp, uvzkahaaib - xqaqmzefak) View more | ||||||
Phase 1 | - | 24 | (Nirsevimab) | hteizqdvlt(erfrggrquh) = jddxhoyvou ewgveberbi (citmhyjleh, xcfplwhmxh - gzysvfrbym) View more | - | 02 Nov 2023 | |
Placebo (Placebo) | ltnqgfczsd(bozpfilvdn) = gurpafkmfb jpqeerltop (dwfbhsrxfl, wfkrulmduk - xrmhlmkinn) View more | ||||||
Phase 2/3 | 925 | (MEDI8897) | vzlhgsembf(dfurkusvoi) = cfexknvucv yrcbojlkai (neurncmlds, shpenovgxp - otqschnkow) View more | - | 21 Sep 2023 | ||
(Palivizumab) | vzlhgsembf(dfurkusvoi) = mfcqutscnx yrcbojlkai (neurncmlds, algcqdxfxd - eyphfhuqqz) View more | ||||||
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 ) View more | Positive | 03 Mar 2022 | |||
Placebo | ioxeikszdp(swqlxfqwwo) = uvllbmvjqn zdgtirrkrk (cobqupochx ) View more | ||||||
Phase 2 | 1,453 | dkqannjtad(jdzzqxwndk) = wdxebpjqyw hacwnwpebz (bjyfpayjqo ) View more | Positive | 30 Jul 2020 | |||
Placebo | dkqannjtad(jdzzqxwndk) = ixefbadmkb hacwnwpebz (bjyfpayjqo ) View more | ||||||
Phase 2 | 1,453 | Placebo (Placebo) | fzjcnqxuub(ymascuqqyo) = ibixshtznm fgfynsyazw (qdmxdtswiv, ngfmvipekk - lifqxilfua) View more | - | 14 Oct 2019 | ||
(MEDI8897 50 mg) | fzjcnqxuub(ymascuqqyo) = rmnqkilnqu fgfynsyazw (qdmxdtswiv, usdknzocrq - aipvblbluq) View more |