PharmaKB logo
Company Reports
Company Reports
Drug Reports
Drug Reports
Disease Reports
Disease Reports
Sets
Sets
Favorites
Favorites
Log in
Log in
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.
Download report
Favorite
COVID-19
Events Timeline
Commercial
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
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
Plot placeholder
Mock data
Subscribe for the real data
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
No data
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
2324 clinical trials
View more details
Plot placeholder
Mock data
Subscribe for the real data
Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Coronary artery diseaseD003324—I25.19213472175300
NeoplasmsD009369—C80137413312182
Breast neoplasmsD001943EFO_0003869C5049701628127
Renal cell carcinomaD002292EFO_0000376—385211515109
Kidney transplantationD016030——51428441299
Coronary diseaseD003327———16223059
Graft vs host diseaseD006086—D89.81153484—52
Neuroendocrine tumorsD018358EFO_1001901D3A.8131773440
Myocardial ischemiaD017202EFO_1001375I20-I25——242935
Type 1 diabetes mellitusD003922EFO_0001359E10102141633
Show 69 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Myelodysplastic syndromesD009190—D4618383——50
Multiple myelomaD009101—C90.028251——43
Prostatic neoplasmsD011471—C6125262—142
Precursor cell lymphoblastic leukemia-lymphomaD054198—C91.021214—142
LymphomaD008223—C85.924191——40
Myeloid leukemia acuteD015470—C92.016213—137
Hodgkin diseaseD006689—C8118233——35
SarcomaD012509——16251——35
Pancreatic neoplasmsD010190EFO_0003860C2516192——29
GlioblastomaD005909EFO_0000515—20171——29
Show 56 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Non-small-cell lung carcinomaD002289——3313———37
LeukemiaD007938—C951624———34
Endometrial neoplasmsD016889EFO_0004230—1115———25
MelanomaD008545——1015———22
Sickle cell anemiaD000755EFO_0000697D57917——122
Head and neck neoplasmsD006258——1412——120
Colorectal neoplasmsD015179——1312———19
GliomaD005910EFO_0000520—128———18
Central nervous system neoplasmsD016543——148———16
Hematologic neoplasmsD019337——812———15
Show 238 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients———5————5
MesotheliomaD008654—C453————3
Medullary carcinomaD018276——3————3
Port-wine stainD019339—Q82.52———13
PhenylketonuriasD010661—E70.02————2
Pancreatic ductal carcinomaD021441——2————2
Heart failureD006333HP_0001635I501———12
Glycogen storage disease type iiD006009Orphanet_365E74.021———12
Idiopathic pulmonary fibrosisD054990—J84.1121———12
PharmacokineticsD010599——2————2
Show 41 more
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Heart diseasesD006331EFO_0003777I51.9————55
Pathologic constrictionD003251——————44
Intracranial arteriosclerosisD002537EFO_1000860I67.2————44
Islets of langerhans transplantationD016381——————33
AngioplastyD017130——————33
Optical coherence tomographyD041623——————33
Erectile dysfunctionD007172EFO_0004234F52.21————33
Ischemic strokeD000083242——————22
StrokeD020521EFO_0000712I63.9————22
InfarctionD007238EFO_0009463—————11
Show 30 more
Epidemiology
Epidemiological information for investigational and approved indications
View more details
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
Plot placeholder
Mock data
Subscribe for the real data
Plot placeholder
Mock data
Subscribe for the real data
Tabular view
Estimated US medical usage
Sirolimus
Total medical expenditures per year (USD, in millions)
Plot placeholder
Mock data
Subscribe for the real data
Number of persons purchased
Plot placeholder
Mock data
Subscribe for the real data
Number of purchases
Plot placeholder
Mock data
Subscribe for the real data
Refill frequency
Plot placeholder
Mock data
Subscribe for the real data
Price per prescription (USD)
Plot placeholder
Mock data
Subscribe for the real data
Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Plot placeholder
Mock data
Subscribe for the real data
Additional graphs summarizing 164,077 documents
View more details
Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
Plot placeholder
Mock data
Subscribe for the real data
17,023 adverse events reported
View more details
© 2020-2023 Collaborative Drug Discovery Inc. (CDD) | Terms of Use