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Drug

Sirolimus

Approved · EMA
ClassFK506-binding protein 1A inhibitorActively researchedLate-stage developmentRising momentum
Also known as Felycin, Fyarro, Hyftor, Rapamune+4 more

Felycin, Fyarro, Hyftor, Rapamune, (-)-Rapamycin, Rapamycin, Sirolimusum, Sirolimús.

33
Research papers
43
Active clinical trials
FKBP1A
Primary target
3
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Targeting PI3K/AKT/mTOR and MAPK Signaling Pathways in Gastric Cancer.

Research2024-02-03International journal of molecular sciences

PI3K-AKT/mTOR Signaling in Psychiatric Disorders: A Valuable Target to Stimulate or Suppress?

Research2024-02-01The international journal of neuropsychopharmacology

Rapamycin extenuates experimental colitis by modulating the gut microbiota.

Research2023-11-02Journal of gastroenterology and hepatology

Approval: Hyftor (EMA)

Regulatory2023-05-15EMA

Approval: Rapamune (EMA)

Regulatory2001-03-13EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Sirolimus
Aliases & brands
FelycinFyarroHyftorRapamune(-)-RapamycinRapamycinSirolimusumSirolimús
RxNorm CUI
35302
ChEMBL ID
CHEMBL413
ATC codes
S01XA23L04AH01L01EG04
UNII
W36ZG6FT64
Primary mechanism
FK506-binding protein 1A inhibitor
Regulatory jurisdictions
emamhra

Pharmacology & targets

1 target

Known molecular targets and mechanisms supported by curated pharmacology databases.

INHIBITORFK506-binding protein 1A inhibitor

Regulatory timeline

3 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2001-03-13
Latest approval
2023-05-15
Authorities
EMA · MHRA
Total events
3
emaEuropean Medicines Agency· 2 events
2023-05-15Approval
Approval: Hyftor (EMA)

Indication: Hyftor is indicated for the treatment of facial angiofibroma associated with tuberous sclerosis complex in adults and paediatric patients aged 6 years and older.

Evidence ↗
2001-03-13Approval
Approval: Rapamune (EMA)
Indication: Rapamune is indicated for the prophylaxis of organ rejection in adult patients at low to moderate immunological risk receiving a renal transplant. It is recommended that RapamuneShow full indication

Rapamune is indicated for the prophylaxis of organ rejection in adult patients at low to moderate immunological risk receiving a renal transplant. It is recommended that Rapamune be used initially in combination with ciclosporin microemulsion and corticosteroids for 2 to 3 months. Rapamune may be continued as maintenance therapy with corticosteroids only if ciclosporin microemulsion can be progressively discontinued. Rapamune is indicated for the treatment of patients with sporadic lymphangioleiomyomatosis with moderate lung disease or declining lung function.

Evidence ↗
mhraMedicines and Healthcare products Regulatory Agency· 1 event
2014-12-11Safety communicationSafety
Drug Safety Update: Sirolimus: different immunoassays for therapeutic drug monitoring—risk of incorrect dose adjustment
Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Contains public sector information from the Medicines and Healthcare products Regulatory Agency (MHRA) licensed under the Open Government Licence (OGL v3).

Clinical trials

192 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
192
registered trials across all phases
LATEST COMPLETION 2025
43
Active studies
27
Recruiting
52
Late-stage (III+)
102
Completed
47
Discontinued
PHASE DISTRIBUTIONn = 192
Early Phase 18Phase 134Phase 1 / 231Phase 267Phase 2 / 37Phase 318Phase 421Phase N / A6

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Recent completions

Trials that read out recently, adding to the completed evidence base.

Research activity

33 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time
20022024
Most influential

Intratumor heterogeneity and branched evolution revealed by multiregion sequencing.

The New England journal of medicine · 2012 · 5,974 cites

Nivolumab versus Everolimus in Advanced Renal-Cell Carcinoma.

The New England journal of medicine · 2015 · 4,442 cites

Cabozantinib versus Everolimus in Advanced Renal-Cell Carcinoma.

The New England journal of medicine · 2015 · 890 cites

Efficacy and safety of sirolimus in lymphangioleiomyomatosis.

The New England journal of medicine · 2011 · 796 cites
Recent papers
Major research themes8
Proto-Oncogene Proteins c-akt2Sirolimus2Aging1Angiofibroma1Antioxidants1Autoimmune Diseases1Biological Products1Caloric Restriction1
Journals, researchers & institutions
Top journals
  • The New England journal of medicine5
  • GeroScience2
  • Investigative ophthalmology & visual science2
  • American journal of ophthalmology1
  • Annals of clinical psychiatry : official journal of the American Academy of Clinical Psychiatrists1
  • Annals of the American Thoracic Society1
Leading researchers
  • Lee HS4
  • McCormack FX4
  • Strange C4
  • Barker AF3
  • Brantly ML3
  • Brown KK3
  • Chapman JT3
  • Chew EY3
Leading institutions
free-text, unnormalised
  • National Eye Institute4
  • University of Cincinnati3
  • Cincinnati Children's Hospital Medical Center2
  • College of Medicine2
  • Medical University of South Carolina2
  • University of California2

Related diseases

3 conditions

Regulator-approved indications and conditions co-mentioned with this drug across the research literature. Number shows shared papers.

Related drugs

8 matches

Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).

Acts on the same molecular target as Sirolimus, with 6 overlapping disease areas.

Shared target6 shared diseases4 shared papers

Studied across 6 of the same disease areas as Sirolimus in the shared literature.

6 shared diseases1 shared paper

Studied across 4 of the same disease areas as Sirolimus in the shared literature.

4 shared diseases1 shared paper

Studied across 4 of the same disease areas as Sirolimus in the shared literature.

4 shared diseases1 shared paper

Studied across 4 of the same disease areas as Sirolimus in the shared literature.

4 shared diseases1 shared paper

Studied across 4 of the same disease areas as Sirolimus in the shared literature.

4 shared diseases1 shared paper

Studied across 4 of the same disease areas as Sirolimus in the shared literature.

4 shared diseases1 shared paper

Studied across 3 of the same disease areas as Sirolimus in the shared literature.

3 shared diseases1 shared paper
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.