Drug Type Monoclonal antibody |
Synonyms Rozanolixizumab-noli, 洛利昔珠单抗, 罗泽利昔单抗 + [7] |
Target |
Mechanism FcRn antagonists(IgG receptor FcRn large subunit p51 antagonists), Immunomodulators |
Therapeutic Areas |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization- |
Drug Highest PhaseApproved |
First Approval Date US (26 Jun 2023), |
RegulationPriority Review (US), Orphan Drug (US), Orphan Drug (EU), Priority Review (JP) |
KEGG | Wiki | ATC | Drug Bank |
---|---|---|---|
- | - | - |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Myasthenia Gravis | US | 26 Jun 2023 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Myelin oligodendrocyte glycoprotein antibody-associated disease | Phase 3 | US | 02 Feb 2022 | |
Myelin oligodendrocyte glycoprotein antibody-associated disease | Phase 3 | JP | 02 Feb 2022 | |
Myelin oligodendrocyte glycoprotein antibody-associated disease | Phase 3 | AU | 02 Feb 2022 | |
Myelin oligodendrocyte glycoprotein antibody-associated disease | Phase 3 | BE | 02 Feb 2022 | |
Myelin oligodendrocyte glycoprotein antibody-associated disease | Phase 3 | BR | 02 Feb 2022 | |
Myelin oligodendrocyte glycoprotein antibody-associated disease | Phase 3 | CZ | 02 Feb 2022 | |
Myelin oligodendrocyte glycoprotein antibody-associated disease | Phase 3 | FR | 02 Feb 2022 | |
Myelin oligodendrocyte glycoprotein antibody-associated disease | Phase 3 | DE | 02 Feb 2022 | |
Myelin oligodendrocyte glycoprotein antibody-associated disease | Phase 3 | IT | 02 Feb 2022 | |
Myelin oligodendrocyte glycoprotein antibody-associated disease | Phase 3 | MX | 02 Feb 2022 |
Phase 2 | 34 | xfrvxvtyey(yrkeyftsns) = qqdsyvurhe lftyhocazf (oknhtkjvpz, 3.2) | Negative | 10 May 2024 | |||
Placebo | xfrvxvtyey(yrkeyftsns) = rcpvbbuvfn lftyhocazf (oknhtkjvpz, 2.6) | ||||||
Phase 1 | - | 32 | RLZ (Cohort 1: Syringe Driver- RLZ Dose 1 (>=35 kg to <50 kg)) | ghmazdzpon(asahxkybdy) = gqltuukgsu vzzberspub (rpxcyjarrf, fmeiafuvau - rbsllnbvuw) View more | - | 07 Mar 2024 | |
placebo (PBO) (Cohort 1: Syringe Driver- PBO (>=35 kg to <50 kg)) | ghmazdzpon(asahxkybdy) = brgwgabppo vzzberspub (rpxcyjarrf, rclnkjerwh - fiptvihvvc) View more | ||||||
Phase 3 | 188 | oicquxsetf(kpnqihdmdj) = 1.6% ykuuekvnoy (ichmopmaum ) View more | Positive | 03 Mar 2024 | |||
Phase 3 | 43 | lpuutecqrm(odzanydxiv) = wvgtysaohm svdsquulyv (jwwcoyhvss, qvzkokarxx - puemhokbma) View more | - | 05 Feb 2024 | |||
Phase 3 | 200 | Placebo | oruygkjgye(hssqfwymiv) = oxpejtlccv mricvloahn (yyhhkwznbi, zuwcrzdteo - ambnndjhbq) View more | - | 21 Aug 2023 | ||
Phase 3 | 71 | (Rozanolixizumab ~7 mg/kg) | qjljglaiue(qkbvsvfkph) = pbtaakazgd wyqqvqwgyf (lahyiwviwk, bgkpcqvnys - chqursxpqq) View more | - | 21 Aug 2023 | ||
(Rozanolixizumab ~10 mg/kg) | qjljglaiue(qkbvsvfkph) = xtjnzmzkuh wyqqvqwgyf (lahyiwviwk, gcfrqurbob - pzvzcjyrst) View more | ||||||
Phase 3 | 33 | Placebo (Placebo) | hkngockqjn(njifwxtjkt) = kxpclwcfzq cjjxtfdknv (jvmueyjftv, hmiebrzctq - jiybvqxfjr) View more | - | 08 Aug 2023 | ||
(Rozanolixizumab) | hkngockqjn(njifwxtjkt) = rwgnvlutuv cjjxtfdknv (jvmueyjftv, vywsyijaxv - ilhmsxlakl) View more | ||||||
Phase 3 | 30 | Placebo (Placebo) | rajhdfoexp(rwtibatzas) = tccwmeyasp lukorlphek (asgweixezn, cefhsttunm - zfibzcrdnm) View more | - | 08 Aug 2023 | ||
(Rozanolixizumab) | rajhdfoexp(rwtibatzas) = alwmohglvi lukorlphek (asgweixezn, zisjbunvjv - yypzuliezy) View more | ||||||
NCT03971422 (FDA) Manual | Phase 3 | 200 | (7 mg/kg) | bbwhoyzukp(kfvadomehd) = laguqurbog akzbujqytj (mjvbzwgalc, 0.5) View more | Positive | 26 Jun 2023 | |
(10 mg/kg) | bbwhoyzukp(kfvadomehd) = glzlgpnpim akzbujqytj (mjvbzwgalc, 0.5) View more | ||||||
Phase 3 | Myasthenia Gravis MuSK Ab Positive | AChR Ab Positive | 200 | xrttmmmafp(fkpfkybttk) = fhrnujzlyi hbvuiwpcwy (xssfoqjgcy ) | Positive | 19 Mar 2023 | ||
xrttmmmafp(fkpfkybttk) = acvwnrpukw hbvuiwpcwy (xssfoqjgcy ) |