Last update 16 Jul 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
Innostellar Biotherapeutics Co., Ltd.Ltd.Shanghai Langsheng Biotechnology Co., Ltd.
Inactive Organization-
License Organization
Innostellar Biotherapeutics Co., Ltd.Ltd.Golden Age Health, Inc.Golden Age Health, Inc.
Drug Highest PhasePhase 3
First Approval Date-
RegulationBreakthrough Therapy (China)
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Related

6
Clinical Trials associated with LX-101 (Innostellar)
NCT07054632
/ Active, not recruitingPhase 3
Efficacy and Safety of Gene Therapy rAAV-RPE65 (LX101) in Biallelic RPE65 Mutation-associated Inherited Retinal Dystrophy: a Phase III, Multicenter, Randomized Controlled Trial (STAR)
NCT06212297
/ Active, not 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
CTR20232640
/ Active, not recruitingPhase 1
一项评估在单眼接受过LX101视网膜下注射的RPE65双等位基因突变相关的遗传性视网膜营养不良（IRD）患者对侧眼中视网膜下注射LX101的安全性和疗效的临床研究
[Translation] A clinical study to evaluate the safety and efficacy of subretinal injection of LX101 in the fellow eyes of patients with inherited retinal dystrophy (IRD) associated with biallelic mutations in RPE65 who received subretinal injection of LX101 in one eye
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
Shanghai Langsheng Biotechnology Co., Ltd.
13 Sep 2023
Hereditary retinal dystrophyPhase 3
China
Shanghai Langsheng Biotechnology Co., Ltd.
13 Sep 2023
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Clinical Result

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Regulation

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