Delving into the Latest Updates on RF-16001 with Synapse

Overview

Basic Info

Drug Type

Chemical drugs

Synonyms

罗哌卡因（宜昌人福药业）, RF 16001, RF-16001

+ [1]

Target

SCNA

Action

modulators

Mechanism

SCNA modulators(Sodium voltage-gated channel alpha subunits modulators)

Therapeutic Areas

Nervous System DiseasesOther Diseases

Active Indication

Pain, Postoperative

Inactive Indication-

Originator Organization

Yichang Humanwell Pharmaceuticals Co., Ltd.

Active Organization

Beijing Huili Technology Co., Ltd.

Yichang Humanwell Pharmaceuticals Co., Ltd.

Inactive Organization-

License Organization-

Drug Highest PhasePhase 3

First Approval Date-

Regulation-

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主要目的：评价注射用RF16001在健康受试者中神经阻滞给药后的安全性。次要目的：评价注射用RF16001在健康受试者中神经阻滞给药后的药代动力学特征。探索性目的：评价注射用RF16001在健康受试者中神经阻滞给药后的药效学特征。

[Translation]

Primary objective: To evaluate the safety of RF16001 for injection following nerve block administration in healthy subjects. Secondary objective: To evaluate the pharmacokinetic profile of RF16001 for injection following nerve block administration in healthy subjects. Exploratory objective: To evaluate the pharmacodynamic profile of RF16001 for injection following nerve block administration in healthy subjects.

Start Date16 Oct 2025

Sponsor / Collaborator

Huili Pharmaceutical (Suzhou) Co., Ltd.

[+1]

CTR20253476

/ RecruitingPhase 2

评价注射用RF16001局部浸润用于全髋关节置换术后镇痛的疗效、安全性、药代动力学的多中心、随机、双盲、平行、阳性及安慰剂对照、剂量探索Ⅱ期临床试验

[Translation] A multicenter, randomized, double-blind, parallel, positive- and placebo-controlled, dose-finding phase II clinical trial to evaluate the efficacy, safety, and pharmacokinetics of local infiltration of RF16001 for injection for analgesia after total hip replacement surgery

主要目的： 1)评估注射用RF16001局部浸润用于全髋关节置换术后镇痛的疗效；次要目的： 1)评估注射用RF16001局部浸润用于全髋关节置换术后镇痛的安全耐受性； 2)评估注射用RF16001局部浸润在全髋关节置换患者中的药代动力学特征； 3)探索注射用RF16001局部浸润用于全髋关节置换术后镇痛的合适剂量。

[Translation]

Primary Objectives: 1) Evaluate the efficacy of local infiltration of RF16001 for injection for postoperative analgesia after total hip replacement. Secondary Objectives: 1) Evaluate the safety and tolerability of local infiltration of RF16001 for injection for postoperative analgesia after total hip replacement. 2) Evaluate the pharmacokinetic characteristics of local infiltration of RF16001 for injection in patients undergoing total hip replacement. 3) Develop an appropriate dose of local infiltration of RF16001 for postoperative analgesia after total hip replacement.

Start Date14 Oct 2025

Sponsor / Collaborator

Beijing Huili Technology Co., Ltd.

[+2]

ChiCTR2500107498

/ Not yet recruitingPhase 2IIT

To evaluate the efficacy, safety and pharmacokinetics of local infiltration of RF16001 for injection for analgesia after total hip arthroplasty (THA) in a multicenter, randomized, double-blind, parallel, positive and placebo-controlled, dose-finding phase Ⅱ clinical trial

Start Date15 Aug 2025

Sponsor / Collaborator

The Third Xiangya Hospital of Central South University

100 Clinical Results associated with RF-16001

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100 Translational Medicine associated with RF-16001

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100 Patents (Medical) associated with RF-16001

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100 Deals associated with RF-16001

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Pain, Postoperative	Phase 3	China	Beijing Huili Technology Co., Ltd.	15 Jul 2025
Pain, Postoperative	Phase 3	China	Yichang Humanwell Pharmaceuticals Co., Ltd.	15 Jul 2025