Rusalatide acetate
Also known as: Chrysalin, rusalatide, TP508
Source Rusalatide acetate at Peptiology
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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
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.
Frequently Asked Questions
What is Rusalatide acetate?
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.
What is Rusalatide acetate used for?
Rusalatide acetate is educationally associated with: Diabetic foot ulcer healing, Angiogenesis promotion, Re-epithelialization, Fracture repair acceleration. Educational only — not medical advice.
How is Rusalatide acetate administered?
Recorded routes of administration: Intralesional, Subcutaneous, Topical.
What are the potential side effects of Rusalatide acetate?
Reported adverse effects include: Headache, Local injection/application site reactions, Wound infection. This list is not exhaustive — consult a qualified clinician.
Who should avoid Rusalatide acetate?
Recorded contraindications: Active malignancy at or near wound site, Known hypersensitivity to rusalatide or thrombin-derived peptides. Consult a qualified clinician before use.