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
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| lymphangioleiomyomatosis | — | D018192 | J84.81 |
| perivascular epithelioid cell neoplasms | — | D054973 | — |
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
2903 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 disease | D003324 | — | I25.1 | 7 | 19 | 30 | 62 | 202 | 310 |
| Neoplasms | D009369 | — | C80 | 165 | 68 | 6 | 4 | 17 | 237 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 55 | 84 | 26 | 2 | 12 | 159 |
| Kidney transplantation | D016030 | — | — | 8 | 23 | 33 | 69 | 20 | 146 |
| Myocardial ischemia | D017202 | EFO_1001375 | I20-I25 | 2 | 4 | 9 | 27 | 88 | 128 |
| Renal cell carcinoma | D002292 | EFO_0000376 | — | 44 | 63 | 13 | 5 | 16 | 128 |
| Carcinoma | D002277 | — | C80.0 | 40 | 75 | 9 | 5 | 12 | 123 |
| Coronary disease | D003327 | — | — | 2 | 5 | 11 | 28 | 73 | 117 |
| Lymphoma | D008223 | — | C85.9 | 52 | 52 | 3 | 1 | 2 | 93 |
| Graft vs host disease | D006086 | — | D89.81 | 23 | 46 | 14 | 5 | — | 74 |
Show 139 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Leukemia | D007938 | — | C95 | 43 | 49 | 3 | — | 2 | 81 |
| Multiple myeloma | D009101 | — | C90.0 | 37 | 33 | 1 | — | — | 57 |
| Myelodysplastic syndromes | D009190 | — | D46 | 21 | 42 | 3 | — | — | 56 |
| Precursor cell lymphoblastic leukemia-lymphoma | D054198 | — | C91.0 | 27 | 31 | 5 | — | 1 | 55 |
| Myeloid leukemia acute | D015470 | — | C92.0 | 25 | 33 | 4 | — | 1 | 54 |
| Prostatic neoplasms | D011471 | — | C61 | 25 | 27 | 2 | — | 2 | 44 |
| Kidney neoplasms | D007680 | EFO_0003865 | C64 | 12 | 24 | 4 | — | 2 | 41 |
| Hodgkin disease | D006689 | — | C81 | 19 | 27 | 3 | — | — | 40 |
| Glioblastoma | D005909 | EFO_0000515 | — | 26 | 23 | 1 | — | — | 36 |
| Peripheral arterial disease | D058729 | EFO_0004265 | — | 2 | 4 | 2 | — | 29 | 35 |
Show 108 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Non-small-cell lung carcinoma | D002289 | — | — | 39 | 17 | — | — | 2 | 46 |
| Sickle cell anemia | D000755 | EFO_0000697 | D57 | 13 | 23 | — | — | 1 | 29 |
| Colorectal neoplasms | D015179 | — | — | 16 | 20 | — | — | 1 | 28 |
| Endometrial neoplasms | D016889 | EFO_0004230 | — | 12 | 17 | — | — | — | 28 |
| Plasma cell neoplasms | D054219 | — | — | 17 | 18 | — | — | — | 27 |
| Glioma | D005910 | EFO_0000520 | — | 17 | 13 | — | — | — | 26 |
| Melanoma | D008545 | — | — | 11 | 17 | — | — | — | 24 |
| Head and neck neoplasms | D006258 | — | — | 16 | 12 | — | — | 1 | 22 |
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | 10 | 11 | — | — | — | 20 |
| Central nervous system neoplasms | D016543 | — | — | 17 | 11 | — | — | — | 20 |
Show 343 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Heart failure | D006333 | EFO_0003144 | I50 | 1 | — | — | — | 13 | 14 |
| Sinus floor augmentation | D059546 | — | — | 1 | — | — | — | 5 | 6 |
| Medullary carcinoma | D018276 | — | — | 3 | — | — | — | — | 3 |
| Glycogen storage disease type ii | D006009 | Orphanet_365 | E74.02 | 1 | — | — | — | 2 | 3 |
| Digestive system diseases | D004066 | EFO_0000405 | K92.9 | 1 | — | — | — | 2 | 3 |
| Laryngeal neoplasms | D007822 | EFO_0003817 | C32 | 2 | — | — | — | — | 2 |
| Laryngeal diseases | D007818 | — | J38.7 | 2 | — | — | — | — | 2 |
| Phenylketonurias | D010661 | — | E70.0 | 2 | — | — | — | — | 2 |
| Pelvic neoplasms | D010386 | — | — | 1 | — | — | — | 1 | 2 |
| Pancreatic ductal carcinoma | D021441 | — | — | 2 | — | — | — | — | 2 |
Show 58 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Postoperative pain | D010149 | — | G89.18 | — | — | — | — | 22 | 22 |
| Gingival recession | D005889 | — | K06.0 | — | — | — | — | 15 | 15 |
| Stroke | D020521 | EFO_0000712 | I63.9 | — | — | — | — | 14 | 14 |
| Dental pulp necrosis | D003790 | — | K04.1 | — | — | — | — | 12 | 12 |
| Necrosis | D009336 | — | — | — | — | — | — | 9 | 9 |
| Obstructive lung diseases | D008173 | — | — | — | — | — | — | 7 | 7 |
| Pain | D010146 | EFO_0003843 | R52 | — | — | — | — | 7 | 7 |
| Periapical periodontitis | D010485 | EFO_1001391 | K04.5 | — | — | — | — | 6 | 6 |
| Ischemic stroke | D000083242 | — | — | — | — | — | — | 5 | 5 |
| Lung diseases | D008171 | EFO_0003818 | J98.4 | — | — | — | — | 5 | 5 |
Show 324 more
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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Rapamune – Pfizer
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Rapaflo – Allergan
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Rapaflo – Warner Chilcott
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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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Safety
Black-box Warning
Black-box warning for: Sirolimus
Adverse Events
Top Adverse Reactions
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63,331 adverse events reported
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