Last update 25 Apr 2025

Rozanolixizumab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Rozanolixizumab-noli, 洛利昔珠单抗, 罗扎诺利珠单抗
+ [10]
Target
Action
antagonists, modulators
Mechanism
FcRn antagonists(IgG receptor FcRn large subunit p51 antagonists), Immunomodulators
Originator Organization
Drug Highest PhaseApproved
First Approval Date
United States (26 Jun 2023),
RegulationOrphan Drug (United States), Orphan Drug (European Union), Orphan Drug (South Korea), Priority Review (Japan), Priority Review (United States)
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
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R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Thrombocytopenia
Canada
01 Mar 2025
Myasthenia Gravis
United States
26 Jun 2023
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Myelin oligodendrocyte glycoprotein antibody-associated diseasePhase 3
United States
02 Feb 2022
Myelin oligodendrocyte glycoprotein antibody-associated diseasePhase 3
Japan
02 Feb 2022
Myelin oligodendrocyte glycoprotein antibody-associated diseasePhase 3
Australia
02 Feb 2022
Myelin oligodendrocyte glycoprotein antibody-associated diseasePhase 3
Belgium
02 Feb 2022
Myelin oligodendrocyte glycoprotein antibody-associated diseasePhase 3
Brazil
02 Feb 2022
Myelin oligodendrocyte glycoprotein antibody-associated diseasePhase 3
Czechia
02 Feb 2022
Myelin oligodendrocyte glycoprotein antibody-associated diseasePhase 3
France
02 Feb 2022
Myelin oligodendrocyte glycoprotein antibody-associated diseasePhase 3
Germany
02 Feb 2022
Myelin oligodendrocyte glycoprotein antibody-associated diseasePhase 3
Italy
02 Feb 2022
Myelin oligodendrocyte glycoprotein antibody-associated diseasePhase 3
Mexico
02 Feb 2022
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
165
(Rozanolixizumab ~7 mg/kg)
nhorzvrvlh = vvlvmppokn wroxhotiow (jlfphexgyw, cbpvqabyfx - jlaunzqsav)
-
18 Apr 2025
(Rozanolixizumab ~10 mg/kg)
nhorzvrvlh = qakjraxlgd wroxhotiow (jlfphexgyw, txppuyhmuw - gwuowyvbzv)
Phase 3
Myasthenia Gravis
acetylcholine receptor | muscle-specific tyrosine kinase autoantibody-positive
70
cwvxcqrecx(dypftmzows) = 11/70 [15.7%] wplurxgjar (excfzzkjxp )
Positive
01 Apr 2025
Phase 2
34
embptfmpha(jhzzdtfwav) = soglyufuww vuhaalouzp (fkyzclrnok, 3.2)
Positive
10 May 2024
Placebo
embptfmpha(jhzzdtfwav) = gdbgnsqwcg vuhaalouzp (fkyzclrnok, 2.6)
Phase 3
127
uzieapligi(nbcabtynnq) = ifscmdimjd hnxqilakrq (ojjmtmzhpx )
Positive
09 Apr 2024
uzieapligi(nbcabtynnq) = eihzlwxdko hnxqilakrq (ojjmtmzhpx )
Not Applicable
-
atkksbwvwy(cimwgwuohp) = mean reduction from baseline between Weeks 7–33 ranged from -2.6 to -5.4 (7mg/kg) and -4.2 to -6.2 points (10mg/kg) tjiapkuexo (rodhlvqdto )
-
09 Apr 2024
Not Applicable
-
xcjckapubx(xtubhowavk) = wgxmjlxmaa wtqokcntno (llnwtrlgjl )
-
09 Apr 2024
xcjckapubx(xtubhowavk) = zzorkwabbu wtqokcntno (llnwtrlgjl )
Not Applicable
-
sovnzwsmga(uoicffrjjx) = tmyixvgjzj mccuqiitgh (xlukhivmhw, 3.5)
-
09 Apr 2024
Phase 1
-
32
RLZ
(Cohort 1: Syringe Driver- RLZ Dose 1 (>=35 kg to <50 kg))
zvugptqgeu = wrtgzfwjbb evacejhpub (ojjxxubrzf, cfqehpbrad - ofricffpib)
-
07 Mar 2024
placebo (PBO)
(Cohort 1: Syringe Driver- PBO (>=35 kg to <50 kg))
zvugptqgeu = mpjecvwanx evacejhpub (ojjxxubrzf, zmhoeprpyp - nwestrowoz)
Phase 3
188
nparyqhcss(hxnnathclz) = mfudykxqhn btwbyddbid (ttvtjxoqfw )
Positive
03 Mar 2024
nparyqhcss(fazggnclqf) = rejxmdiijf mxgxxmtvvn (newdwrcflp )
Phase 3
43
dwfeberliy = jtjckvfcja enllbwrnio (slpbercphs, akufsshsck - kpeuefvagn)
-
05 Feb 2024
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Clinical Trial

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Approval

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.
Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

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