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Timbetasin - RegeneRx Biopharmaceuticals

Drug Profile

Timbetasin - RegeneRx Biopharmaceuticals

Alternative Names: Fx peptide; GBT-201; RGN-137; RGN-259; RGN-352; RGN-457; TB4; TB4 16-38; Thymosin B4; Thymosin beta 4-16-38; Thymosin beta-4; Thymosin-beta-4-RegeneRx-Biopharmaceuticals; Timbetasin-National-Institutes-of-Health-(USA)/RegeneRx-Biopharmaceuticals; Tβ4

Latest Information Update: 14 Feb 2019

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At a glance

  • Originator National Institutes of Health (USA)
  • Developer Chonbuk National University; Defiante Farmaceutica; Lenus Therapeutics; RegeneRx Biopharmaceuticals; sigma-tau SpA; The George Washington University of Washington, D.C.; United States Army Medical Research Institute of Chemical Defense; Wayne State University; Zhejiang University
  • Class Anti-inflammatories; Eye disorder therapies; Heart failure therapies; Neuroprotectants; Peptide hormones; Proteins; Skin disorder therapies; Thymus hormones; Vascular disorder therapies
  • Mechanism of Action Actin modulators; Angiogenesis inducing agents; Apoptosis inhibitors; Cell movement activators; Collagen stimulants; Heat-shock protein modulators; MicroRNA modulators; Nerve growth factor stimulants; Stem cell stimulants
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Keratitis; Epidermolysis bullosa
  • New Molecular Entity No
  • Available For Licensing Yes

Highest Development Phases

  • Phase III Dry eyes; Keratitis
  • Phase II Epidermolysis bullosa
  • Phase I Multiple sclerosis; Myocardial infarction
  • Preclinical Brain injuries; Burns; Diabetic neuropathies; Musculoskeletal disorders; Pulmonary arterial hypertension; Stroke
  • No development reported Eye disorders; Pressure ulcer; Varicose ulcer
  • Discontinued Alopecia; Bronchiectasis; Cystic fibrosis; Diabetic foot ulcer; Diabetic retinopathy; Septic shock

Most Recent Events

  • 12 Feb 2019 RegeneRx announces intention to submit NDA to the US FDA for Dry Eyes
  • 12 Feb 2019 RegeneRx plans to launch Timbetasin for Dry eyes in the US
  • 12 Feb 2019 RegeneRx initiates the phase III ARISE-3 trial for Dry eyes in USA (Ophthalmic)
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