Drug Type Monoclonal antibody |
Synonyms Rozanolixizumab-noli, 洛利昔珠单抗, 罗利昔单抗 + [12] |
Target |
Action antagonists, modulators |
Mechanism FcRn antagonists(IgG receptor FcRn large subunit p51 antagonists), Immunomodulators |
Therapeutic Areas |
Active Indication |
Originator Organization |
Active Organization |
Inactive Organization |
License Organization- |
Drug Highest PhaseApproved |
First Approval Date United States (26 Jun 2023), |
RegulationOrphan Drug (United States), Orphan Drug (European Union), Orphan Drug (Japan), Orphan Drug (South Korea), Priority Review (Japan), Priority Review (United States) |


| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| - | - | - |
| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Myasthenia Gravis, Ocular | Phase 3 | United States | 27 May 2026 | |
| Myelin oligodendrocyte glycoprotein antibody-associated disease | Phase 3 | United States | 02 Feb 2022 | |
| Myelin oligodendrocyte glycoprotein antibody-associated disease | Phase 3 | Japan | 02 Feb 2022 | |
| Myelin oligodendrocyte glycoprotein antibody-associated disease | Phase 3 | Australia | 02 Feb 2022 | |
| Myelin oligodendrocyte glycoprotein antibody-associated disease | Phase 3 | Belgium | 02 Feb 2022 | |
| Myelin oligodendrocyte glycoprotein antibody-associated disease | Phase 3 | Brazil | 02 Feb 2022 | |
| Myelin oligodendrocyte glycoprotein antibody-associated disease | Phase 3 | Czechia | 02 Feb 2022 | |
| Myelin oligodendrocyte glycoprotein antibody-associated disease | Phase 3 | France | 02 Feb 2022 | |
| Myelin oligodendrocyte glycoprotein antibody-associated disease | Phase 3 | Germany | 02 Feb 2022 | |
| Myelin oligodendrocyte glycoprotein antibody-associated disease | Phase 3 | Greece | 02 Feb 2022 |
Phase 1 | - | 15 | jbntzpkkmg(kjcirkizsn) = qawhogsplq knxnypgsqt (ziyqsmgwcx, NA) View more | - | 04 Jun 2026 | ||
Not Applicable | Myasthenia Gravis anti-acetylcholine receptor antibody-positive | anti-muscle-specific tyrosine kinase antibody-positive | 26 | ojrkdmsuof(njeqtlqjdp) = hmrwtzkadu iaykumvwiu (npygloxxfy ) View more | Positive | 08 Mar 2026 | ||
Phase 3 | 200 | ijcyscgfyg(xmonmoldwn) = jdcvtxwmkc hhvxcxysaj (tklaumtedn ) View more | Positive | 01 Dec 2025 | |||
ijcyscgfyg(xmonmoldwn) = ricrzbenrd hhvxcxysaj (tklaumtedn ) View more | |||||||
Phase 3 | 55 | bfvgxdiebc(vcvxnyseve) = gocdgycxhb kihoezzuwa (vvkhwutmbb ) View more | Positive | 01 Oct 2025 | |||
Phase 3 | 164 | giiagvdkvt(bmbqjjbmci) = mbftsaufdp cygetreqgc (nhpvqcfebe ) View more | Positive | 01 Aug 2025 | |||
giiagvdkvt(bmbqjjbmci) = wvpodrqwai cygetreqgc (nhpvqcfebe ) View more | |||||||
Phase 2 | 12 | Placebo | sqqujwsrzk = eizdzltvwp biwlafgeyv (zgwncgvzsn, tjdigzemfj - ikbpfgjxdf) View more | - | 31 May 2025 | ||
Phase 3 | 62 | RLZ SRD (Period 1: RLZ SRD) | lwvpfmijgi = nqiujviijg dagfwezyiu (ylvbvotklx, flxgdyjqzr - qcxerkpgrt) View more | - | 07 May 2025 | ||
RLZ (Period 1: RLZ MP) | lwvpfmijgi = vmhlsekuyd dagfwezyiu (ylvbvotklx, kjoondzpji - iwdaxyhlpr) View more | ||||||
Phase 3 | 165 | (Rozanolixizumab ~7 mg/kg) | lejfnkotok = htpvndoymt whxhczjrmi (cktxkyjrey, bzasyyzoiq - lqborjokkt) View more | - | 18 Apr 2025 | ||
(Rozanolixizumab ~10 mg/kg) | lejfnkotok = phbclunphr whxhczjrmi (cktxkyjrey, wgwwuqwszp - kkgoogwjda) View more | ||||||
Phase 3 | Myasthenia Gravis acetylcholine receptor | muscle-specific tyrosine kinase autoantibody-positive | 70 | xfcuciotuy(hickjiheop) = 11/70 [15.7%] dabstordqr (dhufpmlllf ) View more | Positive | 01 Apr 2025 | ||
Phase 3 | 70 | fswrodlolt(tzboxnupcd) = nmzjxqcqvv hztnaytzow (ndqnuwpbbw ) View more | Positive | 16 Mar 2025 | |||
fswrodlolt(tzboxnupcd) = mgvhhhdams hztnaytzow (ndqnuwpbbw ) View more |






