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Sirolimus - Pfizer

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Drug Profile

Sirolimus - Pfizer

Alternative Names: AY 22989; CYPHER; CYPHER SELECT PLus; HYFTOR; NEVO; NPC-12; NPC-12G; NPC-12T; NPC-12Y; NSC 226080; NSC 606698; Rapalimus; Rapamune; Rapamycin

Latest Information Update: 05 Nov 2023

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At a glance

  • Originator Wyeth
  • Developer Boston Childrens Hospital; Cordis Corporation; Food and Drug Administration; Gifu Pharmaceutical University; Keio University; Kyoto University; Le Bonheur Children's Hospital; Nagasaki University School of Medicine; National Center for Advancing Translational Sciences; Nobelpharma; Osaka University; Pfizer; Showa University; Tokyo Medical and Dental University; Wakayama Medical University; Wyeth
  • 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 - Lymphangioleiomyomatosis; Fibroma
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Coronary artery restenosis; Fibroma; Lymphangioleiomyomatosis; Renal transplant rejection
  • Preregistration Haematological disorders
  • Phase III Epilepsy; Neurofibromatosis 1; Tuberous sclerosis
  • Phase II/III Fibrodysplasia ossificans progressiva; Sturge-Weber syndrome
  • Phase II Giant lymph node hyperplasia; Immunodeficiency disorders; Kasabach-Merritt syndrome; Sensorineural hearing loss; Skin disorders
  • Phase I/II Systemic scleroderma
  • No development reported Osteosarcoma; Solid tumours
  • Discontinued Autosomal dominant polycystic kidney disease; Mycoses; Systemic lupus erythematosus

Most Recent Events

  • 30 Oct 2023 Launched for Fibroma (In adolescents, In children, In the elderly, In adults) in United Kingdom (Topical)
  • 30 Oct 2023 Launched for Fibroma (In children, In adolescents, In adults, In the elderly) in Germany (Topical)
  • 20 Sep 2023 NobelPharma plans to file an IND application with the Minisry of Health, Labour and Welfare in Japan for vascular abnormality- associated skin leasions
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