GLOW Stack

RGN-259 neurotrophic keratopathy phase III

0.1% RGN-259 (Thymosin ß4) Ophthalmic Solution Promotes Healing and Improves Comfort in Neurotrophic Keratopathy Patients in a Randomized, Placebo-Controlled, Double-Masked Phase III Clinical Trial

Sosne G et al. · International journal of molecular sciences · 2022

Population: Patients with Stage 2 or Stage 3 neurotrophic keratopathy and persistent corneal epithelial defects; 10 subjects assigned to the active arm and 8 to placebo

A phase 3 randomised, double-masked, placebo-controlled trial compared a 0.1% thymosin beta-4 ophthalmic solution with vehicle placebo in 18 patients with stage 2 or 3 neurotrophic keratopathy. The investigators measured closure of persistent corneal epithelial defects at four weeks, Mackie classification disease stage, time to closure, patient-reported ocular symptoms and adverse events.

Route reported

Topical ophthalmic solution applied to the eye

Schedule

Administered under the trial protocol across a 28-day treatment period, with assessments continuing to day 43; the abstract does not state the daily instillation frequency

Duration

28 days of treatment with follow-up to day 43

Treatment arms

0.1% RGN-259 (thymosin beta-4) ophthalmic solution · Placebo vehicle

Context: Eighteen subjects in total, so the trial is very small for a phase 3 label and its primary comparison did not reach the conventional significance threshold. It studies the full-length thymosin beta-4 protein applied to the ocular surface, and says nothing about the TB-500 fragment, about injected or systemic administration, or about any tissue outside the cornea.

The effect of thymosin treatment of venous ulcers

Guarnera G et al. · Annals of the New York Academy of Sciences · 2010

Population: 73 randomised patients with venous stasis ulcers of the lower limb, recruited across eight European sites in Italy and Poland

A multicentre, double-blind, placebo-controlled, dose-escalation phase 2 trial randomised 73 patients with venous stasis ulcers to topical thymosin beta-4 or placebo alongside standard ulcer care. The authors assessed safety and tolerability at each dose level and recorded complete wound closure over the study period.

Route reported

Topical application to the ulcer

Schedule

Applied under the trial protocol in a sequential dose-escalation design, with dose levels including 0.03%

Duration

Healing assessed over approximately three months as reported by the authors

Treatment arms

Topical thymosin beta-4 at ascending dose levels, including 0.03% · Placebo

Context: Reported as a short conference-proceedings summary rather than a full trial report, so randomisation detail, per-arm numbers, comparative closure rates and statistical testing are not presented. Dose-escalation designs spread a small sample across several dose levels, the topical route to an open ulcer is not comparable to injected use, and the product tested is full-length thymosin beta-4, not TB-500.

A randomized, placebo-controlled, single and multiple dose study of intravenous thymosin beta4 in healthy volunteers

Ruff D et al. · Annals of the New York Academy of Sciences · 2010

Population: Healthy adult volunteers in four cohorts of 10 subjects each (40 subjects in total)

A randomised, placebo-controlled phase 1 study gave 40 healthy volunteers ascending single intravenous doses of synthetic thymosin beta-4 (42 to 1260 mg) followed by the same daily dose for 14 days. The investigators recorded treatment-emergent adverse events, dose-limiting toxicity and pharmacokinetic parameters including half-life and dose proportionality.

Route reported

Intravenous

Schedule

Under the study protocol each cohort received a single intravenous dose and then, after safety review, the same dose once daily for 14 days

Duration

Single dose followed by 14 consecutive daily doses

Treatment arms

Synthetic thymosin beta-4 42 mg · Synthetic thymosin beta-4 140 mg · Synthetic thymosin beta-4 420 mg · Synthetic thymosin beta-4 1260 mg · Placebo

Context: A first-in-human tolerability and pharmacokinetic study in healthy volunteers with no disease endpoint and no efficacy measure; 40 subjects and 14 days of exposure cannot characterise uncommon or delayed harms. It uses the full-length 43-amino-acid protein given intravenously, so its pharmacokinetics do not transfer to the TB-500 fragment or to subcutaneous or intramuscular use.

Effects of topical copper tripeptide complex on CO2 laser-resurfaced skin

Miller TR et al. · Archives of facial plastic surgery · 2006

Population: 13 patients who completed circumoral carbon dioxide laser skin resurfacing

Patients undergoing circumoral CO2 laser resurfacing were randomised to a post-treatment skin regimen with or without a copper tripeptide complex, with erythema quantified by computer software and by blinded evaluators, wrinkles and overall skin appearance assessed at 12 weeks, and patient-reported outcomes captured on a validated questionnaire.

Route reported

Topical skin care products applied to laser-resurfaced skin under the study protocol

Schedule

Post-procedure regimen applied as directed under the trial protocol

Duration

Assessment through 12 weeks after treatment under the study protocol

Treatment arms

Post-treatment skin care regimen containing GHK-Cu · Post-treatment skin care regimen without GHK-Cu

Context: Only 13 patients completed the study, so it is very small and underpowered; the objective endpoints showed no between-group separation, the setting is post-procedure wound recovery rather than routine cosmetic use, and the only difference reported was on a subjective questionnaire.

A prospective randomized evaluator-blinded trial of two potential wound healing agents for the treatment of venous stasis ulcers

Bishop JB et al. · Journal of vascular surgery · 1992

Population: 86 evaluable adult patients with chronic venous stasis ulcers

A randomised, evaluator-blinded trial compared two topical wound-healing agents against an inert vehicle placebo in adults with venous stasis ulcers, with change in ulcer size as the measured endpoint. The authors reported the outcome for a 0.4% tripeptide copper complex cream alongside a silver sulfadiazine comparator and the placebo arm.

Route reported

Topical application to the ulcer under the trial protocol

Duration

Trial duration not stated in the abstract

Treatment arms

Silver sulfadiazine 1% cream · Tripeptide copper complex 0.4% cream · Inert vehicle placebo cream

Context: The trial studied chronic venous leg ulcers, not cosmetic or ageing skin, and it reports a null comparison for the tripeptide copper arm relative to placebo; the abstract does not state the application schedule or treatment duration, and no cosmetic endpoints were measured.

Injectable Peptide Therapy: A Primer for Orthopaedic and Sports Medicine Physicians

Mayfield CK et al. · The American journal of sports medicine · 2026

A review of injectable peptide therapy written for orthopaedic and sports medicine practitioners, which examines the evidence base behind BPC-157 and related peptides and characterises how far it supports clinical use.

Context: A review, not new evidence. It is featured because it describes the size and quality of the evidence base.

From Regeneration to Analgesia: The Role of BPC-157 in Tissue Repair and Pain Management

Yuan C et al. · International journal of molecular sciences · 2026

Reviews the published BPC-157 literature across tissue repair and pain models, covering reported mechanisms alongside preparation standards, clinical validation and regulatory constraints.

Context: Reviews a largely preclinical literature and adds no human data.

Simultaneous quantification of TB-500 and its metabolites in in-vitro experiments and rats by UHPLC-Q-Exactive orbitrap MS/MS and their screening by wound healing activities in-vitro

Rahaman KA et al. · Journal of chromatography. B, Analytical technologies in the biomedical and life sciences · 2024

Population: Human serum and isolated in-vitro enzyme systems, cultured fibroblasts, and rats dosed with TB-500 with urine collected over time

This study developed and validated a mass-spectrometry method to quantify TB-500 and its breakdown products simultaneously, then tracked its metabolism in human serum, in isolated enzyme systems and in the urine of dosed rats. The authors separately compared the parent peptide and each identified metabolite in fibroblast cytotoxicity and scratch-wound migration assays.

Route reported

TB-500 administered to rats with urine sampled thereafter; the abstract does not state the administration route

Schedule

Rat urine collected under the study protocol from 0-6 hours and out to 72 hours after dosing

Duration

Metabolite sampling to 72 hours

Treatment arms

TB-500 (Ac-LKKTETQ) parent peptide · Identified metabolites including Ac-LK, Ac-LKK and Ac-LKKTE · Untreated control (in-vitro assays)

Context: Entirely analytical and preclinical: the biological readout is a cultured-cell scratch assay, not a wound in a living animal or person, and there is no human pharmacokinetic data. The authors explicitly frame their own metabolite finding as a challenge to the assumption that the parent peptide is the active species, which is a hypothesis raised by this work rather than a settled question.

Expression of glycosaminoglycans and small proteoglycans in wounds: modulation by the tripeptide-copper complex glycyl-L-histidyl-L-lysine-Cu(2+)

Siméon A et al. · The Journal of investigative dermatology · 2000

Population: Sprague-Dawley rats with implanted subcutaneous wound chambers, plus cultured rat dermal fibroblasts

Using a rat subcutaneous wound-chamber model with parallel rat dermal fibroblast cultures, the authors measured wound tissue dry weight and total protein, type I collagen and glycosaminoglycan content, electrophoretic glycosaminoglycan profiles, and decorin and biglycan mRNA over a 22-day time course in chambers injected with the tripeptide-copper complex versus controls.

Route reported

Direct injection into the implanted subcutaneous wound chamber under the study protocol

Schedule

Repeated injections under the study protocol

Duration

Chambers analysed at intervals through day 22 under the study protocol

Treatment arms

Wound chambers receiving repeated GHK-Cu injections of 2 mg per injection · Control wound chambers

Context: A rodent implanted-chamber model with direct injection of a milligram-scale dose, which is not comparable to topical cosmetic application in humans; it measures biochemical and mRNA markers of matrix turnover, not any clinical or appearance endpoint.

Stimulation of collagen synthesis in fibroblast cultures by the tripeptide-copper complex glycyl-L-histidyl-L-lysine-Cu2+

Maquart FX et al. · FEBS letters · 1988

Population: Cultured fibroblasts; the abstract does not name the donor species and the record is indexed under Humans

This early laboratory study measured collagen synthesis in fibroblast cultures exposed to the tripeptide-copper complex across a range of concentrations, alongside cell number, and noted the presence of a GHK triplet in the alpha-2(I) chain of type I collagen as a proposed origin of the peptide.

Route reported

Added to the fibroblast culture medium in vitro

Treatment arms

Fibroblast cultures exposed to GHK-Cu across a concentration range of approximately 10(-12) to 10(-9) M · Untreated culture comparison

Context: A cell-culture experiment only: no animal or human skin was studied, the concentrations tested are laboratory conditions rather than anything achieved by topical application, and the abstract does not state the fibroblast donor species.