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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: 06 Nov 2025

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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; Shinshu University; 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 - Fibroma; Lymphangioleiomyomatosis
  • 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; Pure red cell aplasia; 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 Sep 2025 Phase-II clinical trials in Pure-red-cell-aplasia in Japan (unspecified route) (Nobelpharma pipeline, September 2025)
  • 30 Sep 2025 Nobelpharma anticipates filing a marketing authorisation for sirolimus for the treatment of epilepsy with focal cortical dysplasia type II in Japan in September 2026 (Nobelpharma pipeline, September 2025)
  • 30 Sep 2025 Nobelpharma anticipates filing a marketing authorisation for sirolimus for the treatment of primary immunodeficiency syndrome in Japan in September 2026 (Nobelpharma pipeline, September 2025)

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