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
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 |
|---|---|---|---|---|
| FYARRO | Aadi Bioscience | N-213312 RX | 2021-11-22 | 1 products, RLD, RS |
| HYFTOR | Nobelpharma | N-213478 RX | 2022-03-22 | 1 products, RLD, RS |
| RAPAMUNE | CV Sciences | N-021083 RX | 1999-09-15 | 1 products, RLD, RS |
| RAPAMUNE | CV Sciences | N-021110 RX | 2000-08-25 | 3 products, RLD |
Show 1 discontinued
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
SIROLIMUS, HYFTOR, NOBELPHARMA | |||
| 2029-03-22 | ODE-391 | ||
| 2025-03-22 | NP | ||
SIROLIMUS, FYARRO, AADI | |||
| 2028-11-22 | ODE-386 | ||
| 2024-11-22 | NP | ||
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"]
Clinical
Clinical Trials
2360 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Kidney transplantation | D016030 | — | — | 1 | 1 | 2 | 3 | 5 | 11 |
| Lymphoma | D008223 | — | C85.9 | 2 | 2 | 1 | 1 | 2 | 8 |
| Non-hodgkin lymphoma | D008228 | — | C85.9 | 1 | 3 | — | 1 | — | 5 |
| Mantle-cell lymphoma | D020522 | — | — | — | — | 1 | 1 | 2 | 4 |
| Graft rejection | D006084 | — | — | 1 | — | — | 1 | — | 2 |
| Inflammation | D007249 | MP_0001845 | — | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Renal cell carcinoma | D002292 | EFO_0000376 | — | 2 | 3 | 3 | — | 7 | 15 |
| Carcinoma | D002277 | — | C80.0 | 1 | 4 | 3 | — | 7 | 15 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 2 | 3 | 1 | — | — | 5 |
| Syndrome | D013577 | — | — | — | 2 | 1 | — | — | 2 |
| Kidney neoplasms | D007680 | EFO_0003865 | C64 | 1 | — | 1 | — | — | 2 |
| Renal insufficiency | D051437 | HP_0000083 | N19 | — | — | 1 | — | — | 1 |
| Carotid artery diseases | D002340 | EFO_0003781 | — | — | — | 1 | — | — | 1 |
| Atherosclerosis | D050197 | EFO_0003914 | I25.1 | — | — | 1 | — | — | 1 |
| Brain stem infarctions | D020526 | EFO_1000847 | G46.3 | — | 1 | 1 | — | — | 1 |
| Sturge-weber syndrome | D013341 | Orphanet_3205 | Q85.89 | — | 1 | 1 | — | — | 1 |
Show 2 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasms | D009369 | — | C80 | 14 | 5 | — | — | — | 18 |
| Head and neck neoplasms | D006258 | — | — | 2 | 1 | — | — | 1 | 3 |
| Recurrence | D012008 | — | — | 2 | 1 | — | — | — | 3 |
| Multiple myeloma | D009101 | — | C90.0 | — | 2 | — | — | — | 2 |
| Colorectal neoplasms | D015179 | — | — | 1 | 2 | — | — | — | 2 |
| Squamous cell neoplasms | D018307 | — | — | 2 | 1 | — | — | — | 2 |
| Non-small-cell lung carcinoma | D002289 | — | — | 2 | 1 | — | — | — | 2 |
| Glioblastoma | D005909 | EFO_0000515 | — | 1 | 1 | — | — | — | 2 |
| Squamous cell carcinoma | D002294 | — | — | 1 | 1 | — | — | — | 1 |
| Nasopharyngeal neoplasms | D009303 | — | — | — | 1 | — | — | — | 1 |
Show 20 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Port-wine stain | D019339 | — | Q82.5 | 2 | — | — | — | — | 2 |
| Capillary hemangioma | D018324 | — | Q82.5 | 2 | — | — | — | — | 2 |
| Triple negative breast neoplasms | D064726 | — | — | 1 | — | — | — | — | 1 |
| Leukemia | D007938 | — | C95 | 1 | — | — | — | — | 1 |
| Precursor cell lymphoblastic leukemia-lymphoma | D054198 | — | — | 1 | — | — | — | — | 1 |
| T-cell lymphoma peripheral | D016411 | — | — | 1 | — | — | — | — | 1 |
| Lymphoid leukemia | D007945 | — | C91 | 1 | — | — | — | — | 1 |
| Sarcoma | D012509 | — | — | 1 | — | — | — | — | 1 |
| Osteosarcoma | D012516 | — | — | 1 | — | — | — | — | 1 |
| Neoplasm metastasis | D009362 | EFO_0009708 | — | 1 | — | — | — | — | 1 |
Show 9 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Gastrointestinal stromal tumors | D046152 | EFO_0000505 | C49.A | — | — | — | — | 1 | 1 |
| Neuroendocrine tumors | D018358 | EFO_1001901 | D3A.8 | — | — | — | — | 1 | 1 |
| Islet cell adenoma | D007516 | EFO_0007331 | D13.7 | — | — | — | — | 1 | 1 |
| Kidney diseases | D007674 | EFO_0003086 | N08 | — | — | — | — | 1 | 1 |
| Viremia | D014766 | — | B34.9 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Sirolimus |
| INN | sirolimus |
| 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 class | immunosuppressives |
| 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
| PDB | — |
| CAS-ID | 53123-88-9 |
| RxCUI | — |
| ChEMBL ID | CHEMBL413 |
| ChEBI ID | 9168 |
| PubChem CID | 5284616 |
| DrugBank | DB00877 |
| UNII ID | W36ZG6FT64 (ChemIDplus, GSRS) |
Target
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Variants
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Rapamune – Pfizer
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Estimated US medical usage
Sirolimus
Total medical expenditures per year (USD, in millions)
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Trends
PubMed Central
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Additional graphs summarizing 73,950 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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