Delving into the Latest Updates on GR-2301 with Synapse

Overview

Basic Info

Drug Type

Monoclonal antibody

Synonyms

GR 2301, GR2301

Target

IL-15

Action

inhibitors

Mechanism

IL-15 inhibitors(Interleukin-15 inhibitors)

Therapeutic Areas

Skin and Musculoskeletal DiseasesOther Diseases

Active Indication

Vitiligo

Inactive Indication-

Originator Organization

Chongqing Genrix Biopharmaceutical Co., Ltd.

Active Organization

Chongqing Genrix Biopharmaceutical Co., Ltd.

Zhixiang (Shanghai) Medical Technology Co., Ltd.

Inactive Organization-

License Organization-

Drug Highest PhasePhase 1/2

First Approval Date-

Regulation-

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This is a randomized, double-blind, placebo-controlled Phase I clinical trial evaluating the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary pharmacodynamic characteristics of GR2301 injection in healthy adult subjects in China.The GR2301 injection dosage will be gradually increased. All healthy subjects will receive a single subcutaneous injection. Following administration, subjects will be followed for at least 16 weeks ± 7 days.

Start Date10 Oct 2025

Sponsor / Collaborator

Zhixiang (Shanghai) Medical Technology Co., Ltd.

CTR20262061

/ Not yet recruitingPhase 1/2

GR2301注射液多次皮下注射给药联合光疗在白癜风试验参与者中的随机、双盲、安慰剂对照的耐受性、安全性、药代动力学和初步疗效的Ib/II期临床试验（GREVIT）

[Translation] A randomized, double-blind, placebo-controlled phase Ib/II clinical trial (GREVIT) of tolerability, safety, pharmacokinetics, and preliminary efficacy of GR2301 injection administered subcutaneously in combination with phototherapy in vitiligo trial participants.

剂量递增阶段（Ib期）主要目的：评价GR2301注射液在白癜风试验参与者中多次给药的安全性、耐受性。次要目的：评价GR2301注射液在白癜风试验参与者中的初步疗效、药代动力学特征、免疫原性特征。探索性目的：探索GR2301注射液在白癜风试验参与者中的药效学指标的变化。病例扩展阶段（II期）主要目的：评价GR2301注射液在白癜风试验参与者中的初步疗效。次要目的：评价GR2301注射液在白癜风试验参与者中的安全耐受性、药代动力学特征、免疫原性特征。探索性目的：探索GR2301注射液在白癜风试验参与者中的药效学指标的变化。

[Translation]

**Dose Escalation Phase (Phase Ib)** Primary Objective: To evaluate the safety and tolerability of GR2301 injection after multiple doses in participants of the vitiligo trial. Secondary Objective: To evaluate the preliminary efficacy, pharmacokinetic characteristics, and immunogenicity of GR2301 injection in participants of the vitiligo trial. Exploratory Objective: To investigate changes in pharmacodynamic parameters of GR2301 injection in participants of the vitiligo trial. **Case Expansion Phase (Phase II)** Primary Objective: To evaluate the preliminary efficacy of GR2301 injection in participants of the vitiligo trial. Secondary Objective: To evaluate the safety, tolerability, pharmacokinetic characteristics, and immunogenicity of GR2301 injection in participants of the vitiligo trial. Exploratory Objective: To investigate changes in pharmacodynamic parameters of GR2301 injection in participants of the vitiligo trial.

Start Date-

Sponsor / Collaborator

Chongqing Genrix Biopharmaceutical Co., Ltd.

[+1]

CTR20262029

/ Not yet recruitingPhase 1

一项评价GR2301注射液多次给药在中国健康成年试验参与者中的安全性、耐受性、药代动力学和免疫原性特征的随机、双盲、安慰剂对照的 Ib期临床试验

[Translation] A randomized, double-blind, placebo-controlled phase Ib clinical trial evaluating the safety, tolerability, pharmacokinetics, and immunogenicity of GR2301 injection in healthy adult Chinese participants with multiple doses.

主要目的评价GR2301注射液多次给药在中国健康成年试验参与者中的安全性、耐受性。次要目的评价GR2301注射液多次给药在中国健康成年试验参与者中的药代动力学特征及免疫原性特征。

[Translation]

Primary Objective: To evaluate the safety and tolerability of GR2301 injection with multiple doses in healthy adult participants in China. Secondary Objective: To evaluate the pharmacokinetic and immunogenic characteristics of GR2301 injection with multiple doses in healthy adult participants in China.

Start Date-

Sponsor / Collaborator

Chongqing Genrix Biopharmaceutical Co., Ltd.

[+1]

100 Clinical Results associated with GR-2301

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100 Translational Medicine associated with GR-2301

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100 Patents (Medical) associated with GR-2301

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100 Deals associated with GR-2301

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Vitiligo	Phase 2	China	Chongqing Genrix Biopharmaceutical Co., Ltd.	25 May 2026

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