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Sirolimus - Emtora Biosciences

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Drug Profile

Sirolimus - Emtora Biosciences

Alternative Names: Encapsulated rapamycin; Encapsulated rapamycin - Emtora Biosciences; eRapa™

Latest Information Update: 02 Dec 2025

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At a glance

  • Originator University of Texas Health Science Center at San Antonio
  • Developer Biodexa Pharmaceuticals; Emtora Biosciences
  • Class Anti-infectives; Anti-inflammatories; Antiepileptic drugs; Antifungals; Antineoplastics; Cardiovascular therapies; Eye disorder therapies; Lactones; Macrolides; Nootropics; Polyenes; Pyridines; Skin disorder therapies
  • Mechanism of Action Immunosuppressants; Methylmalonyl CoA mutase stimulants; MTOR protein inhibitors; T lymphocyte inhibitors
  • Orphan Drug Status

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

    Yes - Familial adenomatous polyposis
  • New Molecular Entity No

Highest Development Phases

  • Phase III Familial adenomatous polyposis
  • Phase II Bladder cancer
  • Phase I Prostate cancer
  • No development reported Autoimmune disorders; Breast cancer; Cognition disorders; Lung cancer

Most Recent Events

  • 24 Nov 2025 Phase-III clinical trials in Familial adenomatous polyposis in Germany (PO)
  • 03 Nov 2025 European Medicines Agency approves a Clinical Trial Application (CTA) for pivotal phase III Serenta trial in Familial adenomatous polyposis in Europe
  • 14 Jul 2025 Biodexa Pharmaceuticals files CTA to expand phase III SERENTA trial in Familial adenomatous polyposis in Europe

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