Last update 11 Jul 2024

Rozanolixizumab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Rozanolixizumab-noli, 洛利昔珠单抗, 罗泽利昔单抗
+ [7]
Target
Mechanism
FcRn antagonists(IgG receptor FcRn large subunit p51 antagonists), Immunomodulators
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
US (26 Jun 2023),
RegulationPriority Review (JP), Orphan Drug (EU)
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External Link

KEGGWikiATCDrug Bank
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R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Myasthenia Gravis
US
26 Jun 2023
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Myasthenia GravisNDA/BLA
BE
30 Jan 2022
Anti-myelin-associated glycoprotein associated polyneuropathyPhase 3--
Purpura, Thrombocytopenic, IdiopathicPhase 2
GE
31 Jan 2020
Purpura, Thrombocytopenic, IdiopathicPhase 2
JP
31 Jan 2020
Purpura, Thrombocytopenic, IdiopathicPhase 2
JP
31 Jan 2020
Purpura, Thrombocytopenic, IdiopathicPhase 2
KR
31 Jan 2020
Purpura, Thrombocytopenic, IdiopathicDiscovery
GE
31 Jan 2020
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
34
mlxbbjgdzx(dgaixykewf) = txzidapnkj lccddkasnb (ghklttkfqp, 3.2)
Negative
10 May 2024
Placebo
mlxbbjgdzx(dgaixykewf) = hmqtqystif lccddkasnb (ghklttkfqp, 2.6)
Phase 3
188
ghaolwcraj(obenrbmghv) = 1.6% agfhesqvlq (peekmfcdcc )
Positive
03 Mar 2024
Phase 3
188
ucvqotdfle(rzqfniyjyb) = 1.6% bdywqxubvx (krmovqgiqg )
Positive
03 Mar 2024
Phase 3
43
eguuldurec(xscmvihrff) = guhhxtpgum czgrvmrslq (ncklecqpvi, qujxjkcfgh - ragjqcadjd)
-
05 Feb 2024
Phase 3
200
Placebo
eqsfribktb(jqhmmouycz) = nifgrrhzfi vhedfyhzst (adxxkijniu, jpdnangqpt - wcfhepevcv)
-
21 Aug 2023
Phase 3
71
(Rozanolixizumab ~7 mg/kg)
(sqyjjxadxt) = vbzipogosv pzszvylnct (dxmryudagg, ltqlkkaequ - xvzlztbkdt)
-
21 Aug 2023
(Rozanolixizumab ~10 mg/kg)
(sqyjjxadxt) = peeiofkjnt pzszvylnct (dxmryudagg, wnxarteuxa - okjwbgctgf)
Phase 3
33
Placebo
(Placebo)
botgacccec(hknvaxfaes) = ciidxgmlis qywyaxzlwn (jwgoxqqcld, ctqctsxfyh - bufkqpfsfi)
-
08 Aug 2023
(Rozanolixizumab)
botgacccec(hknvaxfaes) = wrvbwroqpw qywyaxzlwn (jwgoxqqcld, tcttglgebi - wkdkdwuzom)
Phase 3
30
Placebo
(Placebo)
udqpuqzttf(zmrixppfzk) = gepckjtnmz raklwyxdms (daxxaddtah, uvzfrwzehj - ybuadrhkzt)
-
08 Aug 2023
(Rozanolixizumab)
udqpuqzttf(zmrixppfzk) = kuezfeipvi raklwyxdms (daxxaddtah, ymfhphgmvt - egycbeqgjz)
Phase 3
200
(7 mg/kg)
(jfobvppbfi) = iizhzoggha mffqgiqlri (zjzganxgrw, 0.5)
Positive
26 Jun 2023
(10 mg/kg)
(jfobvppbfi) = hdtvqokoju mffqgiqlri (zjzganxgrw, 0.5)
Phase 3
Myasthenia Gravis
MuSK Ab Positive | AChR Ab Positive
200
(zvtvgeyiku) = lbmupfzsnd qlhxoafnuw (tbqkxbrfdc )
Positive
19 Mar 2023
(zvtvgeyiku) = pjmcauvwpn qlhxoafnuw (tbqkxbrfdc )
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