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 |
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Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| 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
2862 clinical trials
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Indications Phases 4
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Indications Phases 3
No data
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasms | D009369 | — | C80 | 2 | 3 | — | — | — | 5 |
| Recurrence | D012008 | — | — | — | 2 | — | — | — | 2 |
| Perivascular epithelioid cell neoplasms | D054973 | — | — | — | 1 | — | — | 1 | 2 |
| Neuroendocrine tumors | D018358 | EFO_1001901 | D3A.8 | — | 2 | — | — | — | 2 |
| Glioblastoma | D005909 | EFO_0000515 | — | — | 1 | — | — | — | 1 |
| Glioma | D005910 | EFO_0000520 | — | — | 1 | — | — | — | 1 |
| Colorectal neoplasms | D015179 | — | — | 1 | 1 | — | — | — | 1 |
| Syndrome | D013577 | — | — | — | 1 | — | — | — | 1 |
| Leigh disease | D007888 | Orphanet_506 | G31.82 | — | 1 | — | — | — | 1 |
| Urinary bladder neoplasms | D001749 | — | C67 | 1 | 1 | — | — | — | 1 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hypertension | D006973 | EFO_0000537 | I10 | 1 | — | — | — | — | 1 |
| Pulmonary hypertension | D006976 | EFO_0001361 | I27.20 | 1 | — | — | — | — | 1 |
| Pulmonary arterial hypertension | D000081029 | — | — | 1 | — | — | — | — | 1 |
| Non-small-cell lung carcinoma | D002289 | — | — | 1 | — | — | — | — | 1 |
| Epilepsy | D004827 | EFO_0000474 | G40.9 | 1 | — | — | — | — | 1 |
| Drug resistant epilepsy | D000069279 | — | — | 1 | — | — | — | — | 1 |
| Multiple myeloma | D009101 | — | C90.0 | 1 | — | — | — | — | 1 |
| Plasma cell neoplasms | D054219 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
No data
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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Rapaflo – Warner Chilcott
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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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Number of persons purchased
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 663,298 documents
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Safety
Black-box Warning
Black-box warning for: Rapamune, Sirolimus
Adverse Events
Top Adverse Reactions
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57,722 adverse events reported
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