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TB-500

Thymosin Beta-4, TB4, Tβ4

Quick Stats
Studies 6
Trials 21
Terminated PHASE2 INTERVENTIONAL NCT00311766

A Phase 2 Study on Effect of Thymosin Beta 4 on Wound Healing in Patients With Epidermolysis Bullosa

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief Summary

The purpose of this study is to investigate a treatment to enhance the healing of acute and chronic nonhealing cutaneous wounds, such as the erosions experienced by patients with Epidermolysis Bullosa (EB), by the known activity of thymosin beta 4 (Tβ4). Funding Source - FDA Office of Orphan Product Development (OOPD).

Detailed Description

EB is a group of genetic diseases characterized by skin-blistering and lesion-formation after minor trauma to the skin. This family of disorders, most of which are inherited, range in severity from mild to the severely disabling and life-threatening. Tβ4 is a synthetically-produced copy of a naturally-occurring 43 amino acid peptide that has wound healing and anti-inflammatory properties and can up-regulate the expression of laminin-5.

Interventions

Name: Thymosin Beta 4
Type: DRUG
Description: Topical administration, 0.01%, 0.03%, and 0.1% Thymosin Beta 4 gel, qd up to 56 days
Name: Placebo
Type: DRUG
Description: Topical administration, 0.00% Thymosin Beta 4 gel qd up to 56 days

Primary Outcomes

Measure: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
TimeFrame: 70 days
Description:

Trial Information

NCT ID

NCT00311766

Status

Terminated

Study Type

INTERVENTIONAL

Phases

PHASE2

Sponsor

RegeneRx Biopharmaceuticals, Inc.

Last Updated

December 15, 2025