Rusalatide acetate

Synthetic Peptide / Wound Healing AgentRx: InvestigationalCompound: Investigational

Also known as: Chrysalin, rusalatide, TP508

Educational Only — Not medical advice. Consult a qualified clinician before using any peptide.

Summary

Rusalatide acetate (TP508) is a synthetic 23-amino acid peptide derived from the receptor-binding domain of human thrombin. It was investigated primarily for the treatment of diabetic foot ulcers and fracture repair. Clinical trials showed potential for accelerating wound closure and tissue regeneration, though it did not achieve FDA approval.

Mechanism of Action

Rusalatide acetate is a synthetic peptide analogue of the C-terminal region of thymosin beta-4. It promotes wound healing by stimulating keratinocyte migration, angiogenesis, and tissue remodeling. It activates actin sequestration pathways and modulates inflammatory responses to accelerate re-epithelialization.

Routes of Administration

IntralesionalSubcutaneousTopical

Goals & Uses

  • Diabetic foot ulcer healingWound HealingModerate
  • Angiogenesis promotionVascularModerate
  • Re-epithelializationWound HealingModerate
  • Fracture repair accelerationOrthopedic / Bone HealingModerate

Contraindications

  • Active malignancy at or near wound siteOncologyHigh
  • Known hypersensitivity to rusalatide or thrombin-derived peptidesAllergyHigh

Adverse Effects

  • HeadacheNeurologicUncommonPain in the head or upper neck
  • Local injection/application site reactionsLocalCommon
  • Wound infectionInfectiousUncommon

Drug Interactions

  • AnticoagulantsLowMonitor when nausea or vomiting affects intake

Population Constraints

  • Severe renal or hepatic impairmentOrgan FunctionRelative
  • PregnancyReproductive SafetyRelative
  • Pediatric patientsAgeRelative

Regulatory Status

  • European UnionUnknownNo EMA approval or formal regulatory filing identified.
  • United StatesInvestigationalIND status granted; Phase II/III trials conducted for diabetic foot ulcers and fracture healing. No NDA filed; program discontinued.
  • United KingdomUnknownNo MHRA approval or filing identified.

Rusalatide acetate (TP508) was studied in Phase II and Phase III clinical trials for diabetic foot ulcers and bone fracture healing. The FDA granted it Investigational New Drug (IND) status. It did not receive FDA approval; development by Chrysalis BioTechnology was discontinued after trials showed inconsistent efficacy results.

Evidence & Sources

No sources recorded yet.

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