Last update 10 Apr 2025

LX-101 (Innostellar)

Overview

Basic Info

Drug Type
AAV based gene therapy
Synonyms
LX 101, LX101
Target
RPE65
Action-
Mechanism
RPE65 gene transference
Therapeutic Areas
Congenital DisordersEye DiseasesOther Diseases
Active Indication
Biallelic RPE65 mutation associated retinal dystrophyHereditary retinal dystrophy
Inactive Indication-
Originator Organization
Shanghai Langsheng Biotechnology Co., Ltd.
Active Organization
Shanghai Langsheng Biotechnology Co., Ltd.Innostellar Biotherapeutics Co., Ltd.Ltd.
Inactive Organization-
Drug Highest PhasePhase 3
First Approval Date-
RegulationBreakthrough Therapy (China)
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Related

5
Clinical Trials associated with LX-101 (Innostellar)
NCT06212297
/ RecruitingPhase 1/2
A Clinical Trial to Evaluate the Safety and Efficacy of Subretinal Re-Administration of LX101 to the Contralateral Eye in Subjects With Biallelic RPE65 Mutation-associated Inherited Retinal Dystrophy
NCT06196827
/ Active, not recruitingPhase 1/2
A Multi-center Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of rAAV2-RPE65 Gene Therapy (LX101) in Subjects With Biallelic RPE65 Mutation-associated Inherited Retinal Dystrophy
CTR20221608
/ Active, not recruitingPhase 1
在RPE65双等位基因突变相关的遗传性视网膜变性（ IRD）患者中评价 rAAV2-RPE65 基因治疗制剂（LX101）安全性和有效性的多中心、多阶段临床研究
[Translation] A multi-center, multi-phase clinical study to evaluate the safety and efficacy of the rAAV2-RPE65 gene therapy agent (LX101) in patients with inherited retinal degeneration (IRD) associated with biallelic mutations in RPE65
100 Clinical Results associated with LX-101 (Innostellar)
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100 Translational Medicine associated with LX-101 (Innostellar)
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100 Patents (Medical) associated with LX-101 (Innostellar)
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100 Deals associated with LX-101 (Innostellar)
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R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Biallelic RPE65 mutation associated retinal dystrophyPhase 3
China
Innostellar Biotherapeutics Co., Ltd.Ltd.
30 Jul 2024
Hereditary retinal dystrophyPhase 2
China
Shanghai Langsheng Biotechnology Co., Ltd.
02 Jul 2022
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Clinical Result

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