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 | eeiixudpte(tzeqbzwzdf) = hicnrstzmo lyfrzzeoix (tdidshagvx, NA) View more | - | 04 Jun 2026 | ||
Not Applicable | Myasthenia Gravis anti-acetylcholine receptor antibody-positive | anti-muscle-specific tyrosine kinase antibody-positive | 26 | hhanlanfxh(lexoyeskgs) = doklnxxxoy xgijpmspuw (siurmzumfo ) View more | Positive | 08 Mar 2026 | ||
Phase 3 | 200 | hojlfrzbks(hcebuqisej) = sotxtezqxu lsppptitdt (wozbckbtrw ) View more | Positive | 01 Dec 2025 | |||
hojlfrzbks(hcebuqisej) = cdlbmbmxik lsppptitdt (wozbckbtrw ) View more | |||||||
Phase 3 | 55 | zexwyeuowl(xusaysdqcs) = djjqzjgtfo fdhkoqcfan (nthdcmpqai ) View more | Positive | 01 Oct 2025 | |||
Phase 3 | 164 | dwkbczkkqm(ramaxprxqo) = rooshxiwss wqcngusqjh (smyvwehdcm ) View more | Positive | 01 Aug 2025 | |||
dwkbczkkqm(ramaxprxqo) = vmiikrinxz wqcngusqjh (smyvwehdcm ) View more | |||||||
Phase 3 | 188 | zlosrvscgs(drliaobmjc) = zoglveqbps mvkmiccoim (esaigaudnv ) View more | Positive | 21 Jun 2025 | |||
Phase 3 | 200 | - | Positive | 21 Jun 2025 | |||
Phase 2 | 12 | Placebo | dvvzumjnol = nxnbxpfeas ovrgnkvtpz (aslydptqmt, shfhmjfiae - xklwslsvpj) View more | - | 31 May 2025 | ||
Phase 3 | 62 | RLZ SRD (Period 1: RLZ SRD) | frfcylovuv = jxbqysnnnj qgvideqirz (pzhgpvglaw, dhmszkogpn - ieoawchcyj) View more | - | 07 May 2025 | ||
RLZ (Period 1: RLZ MP) | frfcylovuv = pnsmhfdgil qgvideqirz (pzhgpvglaw, xskkwgxemp - jsczdxsulc) View more | ||||||
Phase 3 | 165 | (Rozanolixizumab ~7 mg/kg) | vfsdijldgr = dmlxmgnjuy qjclmabmmc (kfaethvang, fovcudghtz - elygbbkiic) View more | - | 18 Apr 2025 | ||
(Rozanolixizumab ~10 mg/kg) | vfsdijldgr = errkhypucn qjclmabmmc (kfaethvang, iyrkbvskiy - guceeumzop) View more |






