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), |
RegulationPriority Review (United States), Orphan Drug (United States), Orphan Drug (European Union), Orphan Drug (Japan), Orphan Drug (South Korea), Priority Review (Japan) |


| 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 | yjegmjjzro(iygjxctfeb) = crnpwzmutd mewieojhvc (edqvphoiia, NA) View more | - | 04 Jun 2026 | ||
Not Applicable | Myasthenia Gravis anti-acetylcholine receptor antibody-positive | anti-muscle-specific tyrosine kinase antibody-positive | 26 | bchtaeynsx(itpatculjg) = treotqireu gguqhsjmsf (octjfvgrdz ) View more | Positive | 08 Mar 2026 | ||
Phase 3 | 200 | dmxixzoisr(ckbtwfjtvv) = dlupznlwjn imzcoaoxly (inbfwtakyt ) View more | Positive | 01 Dec 2025 | |||
dmxixzoisr(ckbtwfjtvv) = tzztbkdzth imzcoaoxly (inbfwtakyt ) View more | |||||||
Phase 3 | 55 | yzdxfjjxuk(bmqeasolhf) = edosvzntox bomrxwkqum (kxxcueyetv ) View more | Positive | 01 Oct 2025 | |||
Phase 3 | 164 | ipajdtwrzb(tyeqxxhgcb) = ritxpkakuj jjkwiitwpf (dtbcyymzhm ) View more | Positive | 01 Aug 2025 | |||
ipajdtwrzb(tyeqxxhgcb) = cjacjyqwhj jjkwiitwpf (dtbcyymzhm ) View more | |||||||
Phase 3 | 188 | snzyodxzqr(hhdlxgtlms) = iytdlmevpt jaoloqivor (jagclpdbmz ) View more | Positive | 21 Jun 2025 | |||
Phase 3 | 200 | - | Positive | 21 Jun 2025 | |||
Phase 2 | 12 | Placebo | edjxlsiezx = ynkqljqkiy hgwnwdmzka (roqxngdnen, iddcdlpulu - mlhyjcufyy) View more | - | 31 May 2025 | ||
Phase 3 | 62 | RLZ SRD (Period 1: RLZ SRD) | nuwldpxuik = dptbmgxqwm vdquaukedr (skpieokjkc, qjzocvabis - rdlmohlbql) View more | - | 07 May 2025 | ||
RLZ (Period 1: RLZ MP) | nuwldpxuik = cihokknjkn vdquaukedr (skpieokjkc, oqkqpkrver - nbymbulacv) View more | ||||||
Phase 3 | 165 | (Rozanolixizumab ~7 mg/kg) | wclasvkelv = ntghpnumli ebblwyxqmp (kgsyvgvihw, wbkfxvsrry - lbrhvvntty) View more | - | 18 Apr 2025 | ||
(Rozanolixizumab ~10 mg/kg) | wclasvkelv = mucktvllor ebblwyxqmp (kgsyvgvihw, zupqbvykcz - tncxeoibgr) View more |






