Delving into the Latest Updates on GBI268 with Synapse

Overview

Basic Info

Drug Type

Chemical drugs

Synonyms

GBI268

Target-

Action-

Mechanism-

Therapeutic Areas

Nervous System DiseasesOther Diseases

Active Indication

Acute PainPain, PostoperativeAnesthesia

Inactive Indication-

Originator Organization

Guangzhou Zhiyao Biotechnology Co., Ltd.

Active Organization

Guangzhou Zhiyao Biotechnology Co., Ltd.

Inactive Organization-

License Organization-

Drug Highest PhasePhase 3

First Approval Date-

Regulation-

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主要目的：评价GBI268注射液单次局部注射用于痔疮切除患者术后镇痛或术中麻醉的有效性。次要目的：1)评价GBI268注射液单次局部注射用于痔疮切除患者术后镇痛或术中麻醉的安全性。 2)评价GBI268注射液单次局部注射用于痔疮切除患者术后镇痛的药代动力学特征。

[Translation]

Primary objective: To evaluate the efficacy of a single local injection of GBI268 injection for postoperative analgesia or intraoperative anesthesia in patients undergoing hemorrhoidectomy. Secondary objectives: 1) To evaluate the safety of a single local injection of GBI268 injection for postoperative analgesia or intraoperative anesthesia in patients undergoing hemorrhoidectomy. 2) To evaluate the pharmacokinetic characteristics of a single local injection of GBI268 injection for postoperative analgesia in patients undergoing hemorrhoidectomy.

Start Date07 Aug 2025

Sponsor / Collaborator

Suzhou Zhiyao Biotechnology Co., Ltd.

[+1]

CTR20244972

/ CompletedPhase 2

一项多中心、随机、双盲、阳性药和安慰剂平行对照评价GBI268注射液单次给药用于开放式单侧拇外翻矫形手术受试者的有效性、安全性和药代动力学特征研究

[Translation] A multicenter, randomized, double-blind, active drug and placebo parallel controlled study to evaluate the efficacy, safety and pharmacokinetic characteristics of a single dose of GBI268 injection in subjects undergoing open unilateral hallux valgus correction surgery

1.评估GBI268单次给药用于开放式单侧拇外翻矫形手术术后镇痛的有效性。 2.探索GBI268单次给药用于开放式单侧拇外翻矫形手术术后镇痛的合理剂量。 3.评价GBI268单次给药用于开放式单侧拇外翻矫形手术术后镇痛的安全性。 4.评价GBI268单次给药用于开放式单侧拇外翻矫形手术术后镇痛的药代动力学（PK）特征。

[Translation]

1. To evaluate the effectiveness of a single administration of GBI268 for postoperative analgesia in open unilateral hallux valgus surgery. 2. To explore the reasonable dose of GBI268 for postoperative analgesia in open unilateral hallux valgus surgery. 3. To evaluate the safety of a single administration of GBI268 for postoperative analgesia in open unilateral hallux valgus surgery. 4. To evaluate the pharmacokinetic (PK) characteristics of a single administration of GBI268 for postoperative analgesia in open unilateral hallux valgus surgery.

Start Date10 Feb 2025

Sponsor / Collaborator

Suzhou Zhiyao Biotechnology Co., Ltd.

[+1]

100 Clinical Results associated with GBI268

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100 Translational Medicine associated with GBI268

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100 Patents (Medical) associated with GBI268

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100 Deals associated with GBI268

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Acute Pain	Phase 3	China	Guangzhou Zhiyao Biotechnology Co., Ltd.	20 May 2026
Pain, Postoperative	Phase 2	China	Guangzhou Zhiyao Biotechnology Co., Ltd.	10 Feb 2025
Anesthesia	IND Approval	China	Guangzhou Zhiyao Biotechnology Co., Ltd.	18 Jul 2025