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 | rmiwftmzfy(dtgwqnoigr) = bmjcltptiy mmhprhgqmk (qysntvvnod, NA) View more | - | 04 Jun 2026 | ||
Not Applicable | Myasthenia Gravis anti-acetylcholine receptor antibody-positive | anti-muscle-specific tyrosine kinase antibody-positive | 26 | anvbyczusq(theiwnxsav) = uypcsazljk cmimvkxxry (neoclwepwj ) View more | Positive | 08 Mar 2026 | ||
Phase 3 | 200 | lmdopiiaxr(xpweigioyw) = rzejaxqoko vzzfpvbdqg (pmdmrecnkp ) View more | Positive | 01 Dec 2025 | |||
lmdopiiaxr(xpweigioyw) = fonadbdqpy vzzfpvbdqg (pmdmrecnkp ) View more | |||||||
Phase 3 | 55 | domyzdlvhw(ypxubkonzp) = ywpmlywmwa nhditxguyy (flfatsqolc ) View more | Positive | 01 Oct 2025 | |||
Phase 3 | 164 | fbtbvqsoqn(mnihyykyrf) = wpwvsvjcnl moyadddgnn (tgaghxfekc ) View more | Positive | 01 Aug 2025 | |||
fbtbvqsoqn(mnihyykyrf) = eaggktfjwg moyadddgnn (tgaghxfekc ) View more | |||||||
Phase 2 | 12 | Placebo | exbjamyjhu = biiyrvtsut ownidzyhnk (gurffcaejk, iaavpdxtun - mwlvmlicnh) View more | - | 31 May 2025 | ||
Phase 3 | 62 | RLZ SRD (Period 1: RLZ SRD) | ivjveehvwy = kwrqvpwuid dvyaehfmxr (cywwaswiaz, kqgwcrjbpz - onkpslosuv) View more | - | 07 May 2025 | ||
RLZ (Period 1: RLZ MP) | ivjveehvwy = btykjxifjh dvyaehfmxr (cywwaswiaz, fksmetntbb - xudumhcgeo) View more | ||||||
Phase 3 | 165 | (Rozanolixizumab ~7 mg/kg) | ymmpffquws = cspayatcvo mftwlpmakk (foeguekwpi, uxbkmqtgoi - fzpfgndeig) View more | - | 18 Apr 2025 | ||
(Rozanolixizumab ~10 mg/kg) | ymmpffquws = hislnjykoq mftwlpmakk (foeguekwpi, clocbaohtd - qszshowudp) View more | ||||||
Phase 3 | Myasthenia Gravis acetylcholine receptor | muscle-specific tyrosine kinase autoantibody-positive | 70 | xvodqetvps(dderohugjt) = 11/70 [15.7%] bhuhieatlc (qfvtjjwuxv ) View more | Positive | 01 Apr 2025 | ||
Phase 3 | 70 | whantixozx(plcdbxbifk) = svxcxsdxgw cnhpugqmdx (ipowwyzolw ) View more | Positive | 16 Mar 2025 | |||
whantixozx(plcdbxbifk) = vwmfvvftxs cnhpugqmdx (ipowwyzolw ) View more |






