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Evidence: MediumPeptideIn Clinical TrialsAngiotensin (1-7) analogueInvestigational · phase 3 terminatedDiabetic foot ulcers

Aclerastide

A topical angiotensin peptide for diabetic foot ulcers that failed in phase 3

Aclerastide, NorLeu3-angiotensin (1-7), is an investigational topical peptide derived from angiotensin (1-7), developed to heal diabetic foot ulcers. In animals and a phase 2 trial it sped healing markedly, but its phase 3 trials were terminated, and mouse work suggests it may raise an enzyme that harms diabetic wounds.

Overview

What is it?

Angiotensin peptides influence cell growth, blood vessel formation and skin repair. In rats and diabetic mice, NorLeu3-angiotensin (1-7) healed full-thickness wounds faster than natural angiotensin (1-7) and faster than Regranex, a growth-factor gel used for diabetic ulcers; 60% of treated diabetic mice were fully healed by day 18. In rats it also reduced scar formation after incisions.

A phase 2 trial in diabetic foot ulcers randomised patients to four weeks of once-daily 0.03% or 0.01% gel or placebo, then 20 weeks of standard care. Ulcer area fell by 80% with the higher dose against 40% with placebo at week 12, and by 95% against 23% at week 24, in a dose-dependent pattern. Two phase 3 trials and an open-label safety study followed.

All three are recorded on ClinicalTrials.gov as terminated, and a 2018 study refers to the drug's failure in phase 3. That study found that in diabetic mouse wounds, aclerastide raised reactive oxygen species and active MMP-9, an enzyme that keeps diabetic wounds from healing, which the authors proposed as a likely contributor to the failure. It is not approved.

Structured data

At a Glance

Every value in this table is printed from the Grey Peptides dataset, the same record the compound explorer and comparison tool read, so the three can never disagree.

ClassAn investigational topical analogue of angiotensin (1-7), NorLeu3-angiotensin (1-7), developed to heal diabetic foot ulcers; it promoted healing in a phase 2 trial but its phase 3 trials were terminated.
US statusIn Clinical Trials
Evidence levelMedium
Last reviewed2026-10-03
Evidence

Published Research

Studies of aclerastide, from their PubMed abstracts.

Human2012

Phase 2 in diabetic foot ulcers

With four weeks of topical 0.03% NorLeu3-A(1-7), ulcer area fell 80% against 40% with placebo at week 12 and 95% against 23% at week 24, with dose-dependent effects and comparable safety.

PMID: 22672145
Animal2018

Why phase 3 may have failed

Aclerastide, which failed in phase 3 trials for diabetic foot ulcers, raised reactive oxygen species and active MMP-9 in diabetic mouse wounds, which the authors proposed as a likely contributor to its clinical failure.

PMID: 30012502
Animal2003

Faster healing than Regranex in animals

NorLeu3-A(1-7) healed full-thickness wounds faster than angiotensin (1-7) and Regranex in rats and diabetic mice; 60% of treated diabetic mice were fully healed by day 18, when no placebo or Regranex wounds were.

PMID: 12621191
Animal2005

Less scarring in rats

Building on evidence that NorLeu3-A(1-7) accelerates dermal healing and reduces scarring, this study characterised its effect on scar formation over time after full-thickness incisions in rats.

PMID: 15953051
Review2015

The case going into phase 3

A review described DSC127 (aclerastide) as a topical analogue of angiotensin 1-7 that induces progenitor proliferation, vascularisation, collagen deposition and re-epithelialisation, then recruiting in two phase 3 trials.

PMID: 26029484
Safety

Side Effects & Contraindications

Reported Side Effects

From the studies above.

● Safety comparable to placebo in phase 2

Contraindications & Cautions

No label; it is investigational.

● Not approved for any use
Questions

Frequently Asked Questions

?What is aclerastide?

An investigational topical peptide, NorLeu3-angiotensin (1-7), developed to heal diabetic foot ulcers.

?Did aclerastide work?

It looked strong in a phase 2 trial, but its phase 3 trials were terminated and it is described as having failed in phase 3.

?Why might it have failed?

A 2018 mouse study found it raised reactive oxygen species and active MMP-9, an enzyme that impairs diabetic wound healing, which the authors proposed as a likely contributor.

?Is it related to BPC-157 or GHK-Cu?

No. All three are peptides discussed for wound healing, but aclerastide comes from the angiotensin system and was the only one taken through phase 3 trials for diabetic ulcers.

Bibliography

References

  1. [registry] ClinicalTrials.gov API v2, read October 3, 2026: NCT01849965 (phase 3, 396, terminated), NCT01830348 (phase 3, 266, terminated), NCT01840085 (phase 3 open-label safety, 261, terminated), NCT00796744 (phase 2, 78, completed).
  2. [clinical-trial] Balingit PP, et al. "NorLeu3-A(1-7) stimulation of diabetic foot ulcer healing: results of a randomized, parallel-group, double-blind, placebo-controlled phase 2 clinical trial." Wound Repair Regen, 2012;20(4):482-90. PMID: 22672145.
  3. [pubmed] Nguyen TT, et al. "Expression of active matrix metalloproteinase-9 as a likely contributor to the clinical failure of aclerastide in treatment of diabetic foot ulcers." Eur J Pharmacol, 2018;834:77-83. PMID: 30012502.
  4. [pubmed] Rodgers KE, et al. "Acceleration of healing, reduction of fibrotic scar, and normalization of tissue architecture by an angiotensin analogue, NorLeu3-A(1-7)." Plast Reconstr Surg, 2003;111(3):1195-206. PMID: 12621191.
  5. [pubmed] Rodgers KE, et al. "Effect of NorLeu3-A(1-7) on scar formation over time after full-thickness incision injury in the rat." Wound Repair Regen, 2005;13(3):309-17. PMID: 15953051.
  6. [pubmed] Rodgers KE, et al. "NorLeu(3)-Angiotensin (1-7) [DSC127] as a Therapy for the Healing of Diabetic Foot Ulcers." Adv Wound Care (New Rochelle), 2015;4(6):339-345. PMID: 26029484.

Sources & Citations

Studies were read from their PubMed records; trial registrations from ClinicalTrials.gov, read October 3, 2026.

Medical Disclaimer: This content is for educational and informational purposes only. It is not medical advice, and nothing here is an instruction to obtain or use any compound. Consult a licensed healthcare provider before making health decisions.

Last reviewed: 2026-10-03