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AboutPricing
Drug ReportsSirolimus
Rapamune(sirolimus)
Fyarro, Hyftor, Rapamune, Sirolimus (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.
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Commercial
Clinical
Drug
Target
Variants
Financial
Trends
Safety
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1M
3M
6M
YTD
1Y
2Y
5Y
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FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
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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, Sirolimus (discontinued: Rapamune, Sirolimus)
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 Application2024-10-28
hyftorNew Drug Application2024-01-11
rapamuneNew Drug Application2024-10-25
sirolimusNDA authorized generic2024-10-01
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"]
— L01: ["antineoplastic agents"]
— L01E: ["protein kinase inhibitors, antineoplastic and immunomodulating agents"]
— L01EG: ["mammalian target of rapamycin (mtor) kinase inhibitors (l01eg)"]
— L01EG04: ["sirolimus"]
— L04: ["immunosuppressants"]
— L04A: ["immunosuppressants"]
— L04AH: ["mammalian target of rapamycin (mtor) kinase inhibitors (l04ah)"]
— L04AH01: ["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
2354 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Coronary artery diseaseD003324—I25.19213890209356
NeoplasmsD009369—C80176769315257
Myocardial ischemiaD017202EFO_1001375I20-I25251545109174
CarcinomaD002277—C80.05210615614168
Coronary diseaseD003327——26154891160
Breast neoplasmsD001943EFO_0003869C5054822339152
Kidney transplantationD016030——822336721144
Renal cell carcinomaD002292EFO_0000376—446513516130
LymphomaD008223—C85.96367512117
RecurrenceD012008——475121292
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Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
LeukemiaD007938—C9553624—1103
Multiple myelomaD009101—C90.035321——55
Myelodysplastic syndromesD009190—D4619393——52
Myeloid leukemiaD007951—C9223293—251
Precursor cell lymphoblastic leukemia-lymphomaD054198——22244—146
Prostatic neoplasmsD011471—C6125292—145
Myeloid leukemia acuteD015470—C92.020243—245
Kidney neoplasmsD007680EFO_0003865C6413252—240
Lymphoid leukemiaD007945—C9120163—136
Hodgkin diseaseD006689—C8118243——36
Show 96 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Non-small-cell lung carcinomaD002289——3917———44
Plasma cell neoplasmsD054219——2319———33
PreleukemiaD011289——1026———31
Endometrial neoplasmsD016889EFO_0004230—1119———29
Colorectal neoplasmsD015179——1520———27
Sickle cell anemiaD000755EFO_0000697D571120——125
MelanomaD008545——1117———24
Peripheral vascular diseasesD016491EFO_0003875I73.914——2024
Head and neck neoplasmsD006258——1613——123
AdenocarcinomaD000230——1317———22
Show 312 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients———5————5
Medullary carcinomaD018276——3————3
Port-wine stainD019339—Q82.52———13
Capillary hemangiomaD018324—Q82.52———13
Female genital neoplasmsD005833——2————2
Laryngeal neoplasmsD007822EFO_0003817C322————2
Laryngeal diseasesD007818—J38.72————2
PhenylketonuriasD010661—E70.02————2
Pancreatic ductal carcinomaD021441——2————2
Heart failureD006333HP_0001635I501———12
Show 53 more
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Intracranial arteriosclerosisD002537EFO_1000860I67.2————44
Islets of langerhans transplantationD016381——————33
AngioplastyD017130——————33
Optical coherence tomographyD041623——————33
Intermittent claudicationD007383EFO_0003876I73.9————22
Ischemic strokeD000083242——————22
Vertebrobasilar insufficiencyD014715EFO_1001449G45.0————22
StrokeD020521EFO_0000712I63.9————22
NecrosisD009336——————11
Lower urinary tract symptomsD059411EFO_0008008—————11
Show 78 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)Loading
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
PDB—
CAS-ID53123-88-9
RxCUI—
ChEMBL IDCHEMBL413
ChEBI ID9168
PubChem CID5284616
DrugBankDB00877
UNII IDW36ZG6FT64 (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
€
£
₣
Rapamune – Pfizer
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Estimated US medical usage
Sirolimus
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Refill frequency
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Price per prescription (USD)
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 72,868 documents
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Safety
Black-box Warning
Black-box warning for: Rapamune, Sirolimus
Adverse Events
Top Adverse Reactions
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20,520 adverse events reported
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