Avotermin

Transforming Growth Factor Beta 3 (TGF Β3) Recombinant Human ProteinRx: ResearchCompound: Withdrawn

Also known as: Juvista, recombinant human TGF-beta3, rhTGF-β3

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

Summary

Avotermin (juvista) is a recombinant human TGF-β3 developed by Renovo Group for the prevention and reduction of scar formation following skin incisions. It was administered intradermally at wound margins. Phase III clinical trials (JUVISTA studies) failed to meet primary endpoints, leading to discontinuation of development.

Mechanism of Action

Recombinant human TGF-β3 that modulates wound healing by shifting the cytokine balance toward a regenerative, scar-free phenotype; promotes re-epithelialization and reduces fibroblast-mediated collagen deposition, thereby minimizing hypertrophic scarring.

Routes of Administration

Intradermal

Goals & Uses

  • Scar preventionDermatology / Wound HealingModerate
  • Reduction of hypertrophic scarringDermatologyLow
  • Improved cosmetic wound outcomesAesthetic MedicineLow

Contraindications

  • Active infection at wound siteInfectionHigh
  • History of keloid or abnormal scarring disordersDermatologyModerate
  • Known hypersensitivity to TGF-β3 or excipientsAllergyHigh

Adverse Effects

  • Injection site painLocalCommonPain at the injection site
  • PruritusDermatologicUncommonItching
  • Injection site edemaLocal ReactionCommon
  • Hypersensitivity reactionImmunologicRare
  • Injection site erythemaLocalCommonRedness at the injection site

Drug Interactions

  • NSAIDsLowMay increase renal risk in susceptible patients
  • CorticosteroidsModerate

Population Constraints

  • Patients with active malignancyOncologyRelative
  • Pediatric patientsAgeRelative
  • Immunocompromised patientsImmunologicRelative
  • Pregnant womenReproductiveRelative

Regulatory Status

  • European UnionUnapprovedDevelopment discontinued after Phase III failure; no MAA approved.
  • United StatesUnapprovedPhase III trials failed; no NDA filed or approved.
  • United KingdomUnapprovedRenovo was a UK company; product never reached UK marketing authorization.

Avotermin never received marketing authorization in any jurisdiction. Phase III trials failed, and Renovo halted development circa 2011. No approved indication exists in the US, EU, or UK.

Evidence & Sources

No sources recorded yet.

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