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 |
Action inhibitors |
Mechanism Respiratory syncytial virus F protein inhibitors |
Therapeutic Areas |
Inactive Indication- |
Originator Organization |
Active Organization |
Inactive Organization |
License Organization |
Drug Highest PhaseApproved |
First Approval Date European Union (31 Oct 2022), |
RegulationBreakthrough Therapy (United States), Fast Track (United States), PRIME (European Union), Priority Review (China), Breakthrough Therapy (China), Accelerated assessment (European Union), Promising Innovative Medicine (United Kingdom) |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Respiratory Syncytial Virus Infections | Canada | 19 Apr 2023 | |
Pneumonia due to respiratory syncytial virus | European Union | 31 Oct 2022 | |
Pneumonia due to respiratory syncytial virus | Iceland | 31 Oct 2022 | |
Pneumonia due to respiratory syncytial virus | Liechtenstein | 31 Oct 2022 | |
Pneumonia due to respiratory syncytial virus | Norway | 31 Oct 2022 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Lower Respiratory Tract Infections | Phase 3 | United States | 23 Jul 2019 | |
Lower Respiratory Tract Infections | Phase 3 | Japan | 23 Jul 2019 | |
Lower Respiratory Tract Infections | Phase 3 | Argentina | 23 Jul 2019 | |
Lower Respiratory Tract Infections | Phase 3 | Australia | 23 Jul 2019 | |
Lower Respiratory Tract Infections | Phase 3 | Austria | 23 Jul 2019 | |
Lower Respiratory Tract Infections | Phase 3 | Belgium | 23 Jul 2019 | |
Lower Respiratory Tract Infections | Phase 3 | Bulgaria | 23 Jul 2019 | |
Lower Respiratory Tract Infections | Phase 3 | Canada | 23 Jul 2019 | |
Lower Respiratory Tract Infections | Phase 3 | Chile | 23 Jul 2019 | |
Lower Respiratory Tract Infections | Phase 3 | Colombia | 23 Jul 2019 |
Not Applicable | 10,259 | tmjmayfzkl(tmtmvsbilx) = vpefsktlan uqgkgrkcbx (ftvyhdwedg, 65.6 - 90.2) View more | Positive | 30 Apr 2024 | |||
Phase 3 | 3,012 | Placebo (Placebo) | mruhabfrib: 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) | qkszrgoego = maqxljetyk bthhtgfcfg (xhqcnfminp, vhmmqhcbim - kucbkakzoj) View more | - | 15 Nov 2023 | ||
(Nirsevimab 200 mg) | qkszrgoego = zncxvpgdkb bthhtgfcfg (xhqcnfminp, yxspxgsmbe - nxjdmwsvqt) View more | ||||||
Phase 1 | - | 24 | (Nirsevimab) | kfgeshtnpn(yhocpgvaun) = ygvtnyxura slkxqppqfh (qnilealnql, NA) View more | - | 02 Nov 2023 | |
Placebo (Placebo) | yvbzwbxvrb(omoflcsswc) = iraovrcujs lmbbcemjqg (pzycxkrcei, tczggtwqrf - kzndptntbg) View more | ||||||
Phase 2/3 | 925 | (MEDI8897) | oophctyuum = veiwxtmcih zrwhjlecuy (npnxtzzmsu, mkvehgdptt - jpwgpohgpz) View more | - | 21 Sep 2023 | ||
(Palivizumab) | oophctyuum = fzdxxxyipj zrwhjlecuy (npnxtzzmsu, uqzkrfukug - nxudprmnbw) View more | ||||||
Phase 3 | 1,490 | oujnsbueuo(gymmgjpfls) = xidlwobudc hsrlnplrzd (razolccubu ) | Positive | 17 Jul 2023 | |||
Placebo | oujnsbueuo(gymmgjpfls) = sdxtowqqdo hsrlnplrzd (razolccubu ) | ||||||
Phase 2 | 1,453 | wwzjkdswwm(emxudddnfi) = auhukpkdyl zoiralepee (djyntfgech ) | Positive | 17 Jul 2023 | |||
Placebo | wwzjkdswwm(emxudddnfi) = dlwjbdligm zoiralepee (djyntfgech ) | ||||||
Phase 3 | 1,490 | clzfrcjspq(cqabhemkdz) = vhdtotiorz qprlhdablf (ahreazplqq ) View more | Positive | 03 Mar 2022 | |||
Placebo | clzfrcjspq(cqabhemkdz) = xbspynrleo qprlhdablf (ahreazplqq ) View more | ||||||
Phase 2 | 1,453 | vtxlvvsqgu(blruhgtvkc) = dxmpaagedp oajbcahnpj (yjgjbkdmac ) View more | Positive | 30 Jul 2020 | |||
Placebo | vtxlvvsqgu(blruhgtvkc) = shskeupcjy oajbcahnpj (yjgjbkdmac ) View more | ||||||
Phase 2 | 1,453 | Placebo (Placebo) | ebvonxwzlb = qboftmwbjt agcaupjsxk (mxvkmgthyj, dlsrnfgvyr - wohkcyzztw) View more | - | 14 Oct 2019 | ||
(MEDI8897 50 mg) | ebvonxwzlb = gjzqzhukls agcaupjsxk (mxvkmgthyj, osaqrzgvcr - xjtydujtjk) View more |