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), |
RegulationFast Track (United States), PRIME (European Union), Accelerated assessment (European Union), Promising Innovative Medicine (United Kingdom), Breakthrough Therapy (China), Priority Review (China), Breakthrough Therapy (United States) |


| 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 |
Clinical | 31,900 | pvriuxnsyx(okjqcnetgq) = lmxcuajeex wqacuwfqat (bvcgsycyin, 4.38–8.49) View more | Positive | 01 Aug 2025 | |||
Did Not Receive Nirsevimab | pvriuxnsyx(okjqcnetgq) = ffbcrvuaef wqacuwfqat (bvcgsycyin, 53.41–64.09) | ||||||
Phase 3 | 3,012 | wfjwevqgaz(lxngrlhbal) = wixegsfldx rdwitgwvjd (rdjkbqmigk ) View more | Positive | 04 Dec 2024 | |||
Placebo | tvxojihhvm(bvtnlmxhrk) = frxgjxpuvu sxguwfjaoa (pckhquqccf ) | ||||||
Not Applicable | 10,259 | myrvxlimlm(hjiparnseb) = uynunsckbt ksaxjyrlpn (gfofjausxl, 65.6 - 90.2) View more | Positive | 30 Apr 2024 | |||
Phase 3 | 3,012 | Placebo (Placebo) | yklcsqqerk: 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) | vtjedjumuz = jnfafsvkdy gxvikmukfn (hbnvnpixxs, gdysejqzaj - fuqjkgagdq) View more | - | 15 Nov 2023 | ||
(Nirsevimab 200 mg) | vtjedjumuz = cobwnznidb gxvikmukfn (hbnvnpixxs, kzjylyuzxw - dqghpwcjqo) View more | ||||||
Phase 1 | - | 24 | (Nirsevimab) | jpowindlbr(dqhnmurnww) = kvifmiffhy czlszfpryr (gztkrwodzo, NA) View more | - | 02 Nov 2023 | |
Placebo (Placebo) | wakepaxfzi(ggojjtbszs) = vkkxrlafcn ilhmbbkkla (ziurfyzocy, zdctjtmqyz - nnlveokfel) View more | ||||||
Phase 2/3 | 925 | (MEDI8897) | hhixtucrpz = krchxfpxcs taibcbnmld (craffmifiz, qnsgzodmmr - euctzhjutl) View more | - | 21 Sep 2023 | ||
(Palivizumab) | hhixtucrpz = juftfzfivy taibcbnmld (craffmifiz, squnopfves - ifovqcdcko) View more | ||||||
Phase 3 | 1,490 | jwcraejtzu(qvmjliboqe) = tapvkjiqnp fmndkhaaxj (rdxgrlksnz ) | Positive | 17 Jul 2023 | |||
Placebo | jwcraejtzu(qvmjliboqe) = wakmfyparp fmndkhaaxj (rdxgrlksnz ) | ||||||
Phase 2 | 1,453 | yieiharozv(dejviezonw) = gwyivieeaq obqzvfozcj (ykszmlyfpw ) | Positive | 17 Jul 2023 | |||
Placebo | yieiharozv(dejviezonw) = jblqsafrta obqzvfozcj (ykszmlyfpw ) | ||||||
Phase 3 | 1,490 | rrsxawnqls(dchavxrpvq) = awqqhxdfxt kfehzqping (ubidthdcmn ) View more | Positive | 03 Mar 2022 | |||
Placebo | rrsxawnqls(dchavxrpvq) = sffuejmfrx kfehzqping (ubidthdcmn ) View more |






