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
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
Mock data
Subscribe for the real data
Subscribe for the real data
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 |
|---|---|---|---|
| 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
2853 clinical trials
View more details
Mock data
Subscribe for the real 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 disease | D003324 | — | I25.1 | 9 | 21 | 38 | 87 | 227 | 371 |
| Neoplasms | D009369 | — | C80 | 177 | 79 | 10 | 3 | 17 | 262 |
| Myocardial ischemia | D017202 | EFO_1001375 | I20-I25 | 2 | 5 | 15 | 42 | 122 | 184 |
| Carcinoma | D002277 | — | C80.0 | 52 | 108 | 15 | 6 | 14 | 170 |
| Coronary disease | D003327 | — | — | 2 | 6 | 15 | 45 | 102 | 168 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 55 | 85 | 24 | 3 | 12 | 160 |
| Kidney transplantation | D016030 | — | — | 8 | 22 | 33 | 68 | 21 | 145 |
| Renal cell carcinoma | D002292 | EFO_0000376 | — | 44 | 66 | 13 | 5 | 16 | 131 |
| Lymphoma | D008223 | — | C85.9 | 64 | 67 | 5 | 1 | 2 | 118 |
| Recurrence | D012008 | — | — | 47 | 52 | 2 | 1 | 5 | 96 |
Show 136 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Leukemia | D007938 | — | C95 | 53 | 62 | 4 | — | 2 | 104 |
| Multiple myeloma | D009101 | — | C90.0 | 36 | 33 | 1 | — | — | 56 |
| Myelodysplastic syndromes | D009190 | — | D46 | 19 | 39 | 3 | — | — | 52 |
| Myeloid leukemia | D007951 | — | C92 | 23 | 29 | 3 | — | 2 | 51 |
| Precursor cell lymphoblastic leukemia-lymphoma | D054198 | — | C91.0 | 23 | 24 | 4 | — | 1 | 47 |
| Prostatic neoplasms | D011471 | — | C61 | 25 | 29 | 2 | — | 2 | 46 |
| Myeloid leukemia acute | D015470 | — | C92.0 | 20 | 24 | 3 | — | 2 | 45 |
| Kidney neoplasms | D007680 | EFO_0003865 | C64 | 13 | 25 | 2 | — | 2 | 40 |
| Lymphoid leukemia | D007945 | — | C91 | 21 | 17 | 3 | — | 1 | 37 |
| Peripheral arterial disease | D058729 | EFO_0004265 | — | 2 | 5 | 1 | — | 30 | 37 |
Show 109 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 |
| Plasma cell neoplasms | D054219 | — | — | 24 | 20 | — | — | — | 34 |
| Preleukemia | D011289 | — | — | 10 | 26 | — | — | — | 31 |
| Endometrial neoplasms | D016889 | EFO_0004230 | — | 11 | 19 | — | — | — | 29 |
| Sickle cell anemia | D000755 | EFO_0000697 | D57 | 12 | 21 | — | — | 1 | 27 |
| Melanoma | D008545 | — | — | 11 | 18 | — | — | — | 25 |
| Peripheral vascular diseases | D016491 | EFO_0003875 | I73.9 | 1 | 4 | — | — | 20 | 24 |
| Head and neck neoplasms | D006258 | — | — | 16 | 13 | — | — | 1 | 23 |
| Adenocarcinoma | D000230 | — | — | 12 | 16 | — | — | — | 21 |
| Central nervous system neoplasms | D016543 | — | — | 17 | 11 | — | — | — | 20 |
Show 320 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 5 | — | — | — | 9 | 14 |
| Heart failure | D006333 | EFO_0003144 | I50 | 1 | — | — | — | 11 | 12 |
| Sinus floor augmentation | D059546 | — | — | 1 | — | — | — | 5 | 6 |
| Sarcopenia | D055948 | EFO_1000653 | M62.84 | 1 | — | — | — | 3 | 4 |
| Medullary carcinoma | D018276 | — | — | 3 | — | — | — | — | 3 |
| Glycogen storage disease type ii | D006009 | Orphanet_365 | E74.02 | 1 | — | — | — | 2 | 3 |
| Port-wine stain | D019339 | — | Q82.5 | 2 | — | — | — | 1 | 3 |
| Capillary hemangioma | D018324 | — | Q82.5 | 2 | — | — | — | 1 | 3 |
| Female genital neoplasms | D005833 | — | — | 2 | — | — | — | — | 2 |
| Laryngeal neoplasms | D007822 | EFO_0003817 | C32 | 2 | — | — | — | — | 2 |
Show 61 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Postoperative pain | D010149 | — | G89.18 | — | — | — | — | 19 | 19 |
| Gingival recession | D005889 | — | K06.0 | — | — | — | — | 14 | 14 |
| Stroke | D020521 | EFO_0000712 | I63.9 | — | — | — | — | 11 | 11 |
| Dental pulp necrosis | D003790 | — | K04.1 | — | — | — | — | 10 | 10 |
| Necrosis | D009336 | — | — | — | — | — | — | 9 | 9 |
| Obstructive lung diseases | D008173 | — | — | — | — | — | — | 8 | 8 |
| Lung diseases | D008171 | EFO_0003818 | J98.4 | — | — | — | — | 6 | 6 |
| Periapical periodontitis | D010485 | EFO_1001391 | K04.5 | — | — | — | — | 6 | 6 |
| Dental implants | D015921 | — | — | — | — | — | — | 6 | 6 |
| Ischemic stroke | D000083242 | — | — | — | — | — | — | 5 | 5 |
Show 284 more
Epidemiology
Epidemiological information for investigational and approved indications
View more details
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
No data
Variants
No data
Financial
Revenue by drug
$
€
£
₣
Rapamune – Pfizer
Mock data
Subscribe for the real data
Subscribe for the real data
Mock data
Subscribe for the real data
Subscribe for the real data
Rapaflo – Allergan
Mock data
Subscribe for the real data
Subscribe for the real data
Mock data
Subscribe for the real data
Subscribe for the real data
Rapaflo – Warner Chilcott
Mock data
Subscribe for the real data
Subscribe for the real data
Mock data
Subscribe for the real data
Subscribe for the real data
Tabular view
Estimated US medical usage
Sirolimus
Total medical expenditures per year (USD, in millions)
Mock data
Subscribe for the real data
Subscribe for the real data
Number of persons purchased
Mock data
Subscribe for the real data
Subscribe for the real data
Number of purchases
Mock data
Subscribe for the real data
Subscribe for the real data
Refill frequency
Mock data
Subscribe for the real data
Subscribe for the real data
Price per prescription (USD)
Mock data
Subscribe for the real data
Subscribe for the real data
Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Mock data
Subscribe for the real data
Subscribe for the real data
Additional graphs summarizing 657,059 documents
View more details
Safety
Black-box Warning
Black-box warning for: Rapamune, Sirolimus
Adverse Events
Top Adverse Reactions
Mock data
Subscribe for the real data
Subscribe for the real data
57,722 adverse events reported
View more details
© 2020-2025 Collaborative Drug Discovery Inc. (CDD) | Terms of Use