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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
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
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Events
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 Application2026-02-04
hyftorNew Drug Application2025-08-22
rapafloNew Drug Application2020-12-15
sirolimusANDA2026-01-28
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
lymphangioleiomyomatosis—D018192J84.81
perivascular epithelioid cell neoplasms—D054973—
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
2826 clinical trials
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Indications Phases 4
No data
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Tuberous sclerosisD014402—Q85.1——3——3
SclerosisD012598————3——3
AngiofibromaD018322EFO_1001761———2——2
Neurofibromatosis 1D009456—Q85.01——1——1
NeurofibromatosesD017253—Q85.00——1——1
NeurofibromaD009455EFO_0000622———1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Acanthosis nigricansD000052—L83—1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Therapeutic equivalencyD013810——1————1
Indications Without Phase
No data
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
$
€
£
₣
Rapaflo – Allergan
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Rapaflo – Warner Chilcott
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Rapamune – Pfizer
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Tabular view
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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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 714,279 documents
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Safety
Black-box Warning
Black-box warning for: Sirolimus
Adverse Events
Top Adverse Reactions
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59,214 adverse events reported
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