Delving into the Latest Updates on Alpha-0261 with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

AM 001, AM-001, AM001

+ [1]

Target

MRGPRX2

Action

modulators

Mechanism

MRGPRX2 modulators(MAS related GPR family member X2 modulators)

Therapeutic Areas

Immune System DiseasesCongenital DisordersSkin and Musculoskeletal Diseases

Active Indication

Dermatitis, AtopicUrticaria

Inactive Indication-

Originator Organization

Shenzhen Alpha Molecular Technology Co., Ltd.

Active Organization

Shenzhen Alpha Molecular Technology Co., Ltd.

Inactive Organization-

License Organization-

Drug Highest PhasePhase 1

First Approval Date-

Regulation-

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主要目的：评价中国健康研究参与者单次口服Alpha-0261片后的安全性和耐受性。次要目的：1. 评价中国健康研究参与者单次口服Alpha-0261片后的药代动力学特征。2. 评价中国健康研究参与者单次口服Alpha-0261片后的排泄特征。探索性（或其他）目的：探索中国健康研究参与者单次口服Alpha-0261片后血浆，尿液，粪便中的代谢物鉴定。

[Translation]

Primary Objective: To evaluate the safety and tolerability of Alpha-0261 following a single oral dose in Chinese health study participants. Secondary Objectives: 1. To evaluate the pharmacokinetic profile of Alpha-0261 following a single oral dose in Chinese health study participants. 2. To evaluate the excretion profile of Alpha-0261 following a single oral dose in Chinese health study participants. Exploratory (or Other) Objectives: To investigate the identification of metabolites in plasma, urine, and feces of Alpha-0261 following a single oral dose in Chinese health study participants.

Start Date-

Sponsor / Collaborator

Shenzhen Alpha Molecular Technology Co., Ltd.

100 Clinical Results associated with Alpha-0261

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100 Translational Medicine associated with Alpha-0261

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100 Patents (Medical) associated with Alpha-0261

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100 Deals associated with Alpha-0261

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Dermatitis, Atopic	Phase 1	-	Shenzhen Alpha Molecular Technology Co., Ltd.	21 Aug 2025
Urticaria	Preclinical	United States	Shenzhen Alpha Molecular Technology Co., Ltd.	03 Jun 2025