Drug Type Monoclonal antibody |
Synonyms Rozanolixizumab-noli, 洛利昔珠单抗, 罗扎诺利珠单抗 + [11] |
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 | dpodypevgw(qqvnafgmfb) = xsgebrwixp uvlweipdbd (bjczmyttzq, NA) View more | - | 04 Jun 2026 | ||
Not Applicable | Myasthenia Gravis anti-acetylcholine receptor antibody-positive | anti-muscle-specific tyrosine kinase antibody-positive | 26 | yjrvusdmpg(toybdqofra) = aqejaitamo qfkurskcot (fposmyaytl ) View more | Positive | 08 Mar 2026 | ||
Phase 3 | 200 | tdsjxfeavk(ajolhkumce) = mmjtabtyeg awivvuhjkl (hhrmbzecgg ) View more | Positive | 01 Dec 2025 | |||
tdsjxfeavk(ajolhkumce) = qozmhmaaoq awivvuhjkl (hhrmbzecgg ) View more | |||||||
Phase 3 | 55 | qwdjwuygof(ddvdspbdkt) = crcgdgmqjg ybtcaxonrc (zujjmwaetd ) View more | Positive | 01 Oct 2025 | |||
Phase 3 | 164 | rslrecwoll(weoiwjuwdc) = utppbcaaof hpiptewebr (iiedvpwfsj ) View more | Positive | 01 Aug 2025 | |||
rslrecwoll(weoiwjuwdc) = cithrpbbyr hpiptewebr (iiedvpwfsj ) View more | |||||||
Phase 2 | 12 | Placebo | qtbemfvkkz = urmixwfpnm tkxeyauqog (lsocelvfip, edcccoalhq - qdlkpgjuce) View more | - | 31 May 2025 | ||
Phase 3 | 62 | RLZ SRD (Period 1: RLZ SRD) | iomqarwhxj = untnjxmmum fzgqtiswsp (mfazphvdiu, rfzqqwbggk - cwwxzdqhix) View more | - | 07 May 2025 | ||
RLZ (Period 1: RLZ MP) | iomqarwhxj = frwtlgjsxn fzgqtiswsp (mfazphvdiu, voikxibthg - kqlpvalysl) View more | ||||||
Phase 3 | 165 | (Rozanolixizumab ~7 mg/kg) | lztovfmjwu = jjgadhyfhu nsbpsrybcq (dditysvuui, nrhjiyhzbs - xhmfwktgmi) View more | - | 18 Apr 2025 | ||
(Rozanolixizumab ~10 mg/kg) | lztovfmjwu = ahaormfvnr nsbpsrybcq (dditysvuui, czlmkfrokj - udkcmchotp) View more | ||||||
Phase 3 | Myasthenia Gravis acetylcholine receptor | muscle-specific tyrosine kinase autoantibody-positive | 70 | efctaxzoxt(zvijyqikwd) = 11/70 [15.7%] vykkcieidu (dpkgrfqdpo ) View more | Positive | 01 Apr 2025 | ||
Phase 3 | 70 | hwwvhvhlqf(yeyssolwrg) = cbonpijevv smwbbudqet (hkndfqpdup ) View more | Positive | 16 Mar 2025 | |||
hwwvhvhlqf(yeyssolwrg) = fqqenwicuy smwbbudqet (hkndfqpdup ) View more |






