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Rapamune(sirolimus)
Fyarro, Hyftor, Rapamune (sirolimus) is a small molecule pharmaceutical. Sirolimus was first approved as Rapamune on 1999-09-15. It has been approved in Europe to treat angiofibroma, graft rejection, kidney transplantation, and tuberous sclerosis. It is known to target peptidyl-prolyl cis-trans isomerase FKBP1A.
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COVID-19
Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
nervous system diseasesD009422
hereditary congenital and neonatal diseases and abnormalitiesD009358
therapeuticsD013812
operative surgical proceduresD013514
immune system phenomenaD055633
Trade Name
FDA
EMA
Fyarro, Hyftor, Rapamune (generic drugs available since 2014-01-08)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Sirolimus
Tradename
Company
Number
Date
Products
FYARROAadi BioscienceN-213312 RX2021-11-22
1 products, RLD, RS
HYFTORNobelpharmaN-213478 RX2022-03-22
1 products, RLD, RS
RAPAMUNECV SciencesN-021083 RX1999-09-15
1 products, RLD, RS
RAPAMUNECV SciencesN-021110 RX2000-08-25
3 products, RLD
Show 1 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
fyarroNew Drug Application2021-11-22
hyftorNew Drug Application2021-01-28
rapamuneNew Drug Application2020-09-16
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
Expiration
Code
SIROLIMUS, HYFTOR, NOBELPHARMA
2029-03-22ODE-391
2025-03-22NP
SIROLIMUS, FYARRO, AADI
2028-11-22ODE-386
2024-11-22NP
Patent Expiration
Patent
Expires
Flag
FDA Information
Sirolimus, Fyarro, Aadi
114977372040-10-28DP
109738062036-06-29U-3258
107050702036-03-05DP
102068872030-04-15DP
89117862029-02-14DPU-3259
ATC Codes
L: Antineoplastic and immunomodulating agents
— L04: Immunosuppressants
— L04A: Immunosuppressants
— L04AA: Selective immunosuppressants
— L04AA10: Sirolimus
S: Sensory organ drugs
— S01: Ophthalmologicals
— S01X: Other ophthalmologicals in atc
— S01XA: Other ophthalmologicals in atc
— S01XA23: Sirolimus
HCPCS
Code
Description
J7520
Sirolimus, oral, 1 mg
J9330
Injection, temsirolimus, 1 mg
Clinical
Clinical Trials
946 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
NeoplasmsD009369C806915—1484
Coronary artery diseaseD003324I25.14711204381
Kidney transplantationD016030591128453
Graft vs host diseaseD006086D89.81133063—44
Coronary diseaseD003327—1313926
Non-hodgkin lymphomaD008228C85.991611—24
Type 1 diabetes mellitusD003922EFO_0001359E1031231320
Renal insufficiencyD051437HP_0000083N193329116
Chronic kidney failureD007676EFO_0003884N18.62543214
Coronary stenosisD023921EFO_1000882——32510
Show 36 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Renal cell carcinomaD00229215153—534
Myelodysplastic syndromesD009190D4610242——33
Precursor cell lymphoblastic leukemia-lymphomaD054198C91.012173——30
Myeloid leukemia acuteD015470C92.08172——26
Multiple myelomaD009101C90.014151——24
Hodgkin diseaseD006689C819142——22
LymphomaD008223C85.912101——22
Prostatic neoplasmsD011471C6114121—120
Breast neoplasmsD001943EFO_0003869C501172——18
Mantle-cell lymphomaD020522C83.15112—216
Show 44 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
LeukemiaD007938C95915———22
SarcomaD0125091214———20
Sickle cell anemiaD000755EFO_0000697D57913——118
Non-small-cell lung carcinomaD002289147———16
MelanomaD00854588———14
GlioblastomaD005909EFO_000051599———13
Ovarian neoplasmsD010051EFO_0003893C5665———11
Endometrial neoplasmsD016889EFO_000423074———11
Hematologic neoplasmsD01933768———10
Central nervous system neoplasmsD01654383———9
Show 174 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients—5————5
Port-wine stainD019339Q82.52———13
Rhabdoid tumorD0183352————2
Wilms tumorD0093962————2
ThrombocytosisD013922D75.831————1
Homologous transplantationD0141841————1
Digestive system neoplasmsD0040671————1
Respiratory tract neoplasmsD012142EFO_0003853D141————1
Soft tissue neoplasmsD0129831————1
Neurofibromatosis 2D016518Q85.021————1
Show 42 more
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Angina pectorisD000787EFO_0003913I20————33
Pathologic constrictionD003251————33
Insulin resistanceD007333EFO_0002614————22
Drug-eluting stentsD054855————11
Optical coherence tomographyD041623————11
HemoglobinopathiesD006453D58.2————11
ViremiaD014766B34.9————11
Bacterial infectionsD001424A49————11
Balloon angioplasty coronaryD015906EFO_0003951————11
Heart diseasesD006331EFO_0003777I51.9————11
Show 13 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameSIROLIMUS
INNsirolimus
Description
Sirolimus is a macrolide lactam isolated from Streptomyces hygroscopicus consisting of a 29-membered ring containing 4 trans double bonds, three of which are conjugated. It is an antibiotic, immunosupressive and antineoplastic agent. It has a role as an immunosuppressive agent, an antineoplastic agent, an antibacterial drug, a mTOR inhibitor, a bacterial metabolite, an anticoronaviral agent and a geroprotector. It is a cyclic acetal, a cyclic ketone, an ether, a secondary alcohol, an organic heterotricyclic compound, an antibiotic antifungal drug and a macrolide lactam.
Classification
Small molecule
Drug classimmunosuppressives
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
CO[C@H]1C[C@@H]2CC[C@@H](C)[C@@](O)(O2)C(=O)C(=O)N2CCCC[C@H]2C(=O)O[C@H]([C@H](C)C[C@@H]2CC[C@@H](O)[C@H](OC)C2)CC(=O)[C@H](C)/C=C(\C)[C@@H](O)[C@@H](OC)C(=O)[C@H](C)C[C@H](C)/C=C/C=C/C=C/1C
Identifiers
PDB4QT3
CAS-ID53123-88-9
RxCUI35302
ChEMBL IDCHEMBL413
ChEBI ID9168
PubChem CID5284616
DrugBankDB00877
UNII IDW36ZG6FT64 (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
FKBP1A
FKBP1A
Organism
Homo sapiens
Gene name
FKBP1A
Gene synonyms
FKBP1, FKBP12
NCBI Gene ID
2280
Protein name
peptidyl-prolyl cis-trans isomerase FKBP1A
Protein synonyms
12 kDa FK506-binding protein, 12 kDa FKBP, Calstabin-1, FK506 binding protein 1A, 12kDa, FK506 binding protein12, FK506-binding protein 1, FK506-binding protein 12, FK506-binding protein 1A, FK506-binding protein, T-cell, 12-kD, FKBP-12, FKBP-1A, FKBP12-Exip3, Immunophilin FKBP12, PPIase FKBP1A, protein kinase C inhibitor 2, Rotamase
Uniprot ID
Q9H566
Mouse ortholog
Fkbp1a (14225)
peptidyl-prolyl cis-trans isomerase FKBP1A (Q545E9)
Variants
Clinical Variant
No data
Financial
Rapamune - Pfizer
$
€
£
₣
Mock data
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 28,070 documents
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Safety
Black-box Warning
Black-box warning for: Rapamune
Adverse Events
Top Adverse Reactions
Mock data
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4,564 adverse events reported
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