Kytril, Sancuso(granisetron)
Granisol, Kytril, Sancuso, Sustol (granisetron) is a small molecule pharmaceutical. Granisetron was first approved as Kytril on 1993-12-29. It has been approved in Europe to treat neoplasms and vomiting.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| neoplasms | D009369 |
| signs and symptoms pathological conditions | D013568 |
Trade Name
FDA
EMA
Sancuso, Sustol (generic drugs available since 2007-12-31, discontinued: Granisol, Kytril)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Granisetron
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| SANCUSO | Cumberland Pharmaceuticals | N-022198 RX | 2008-09-12 | 1 products, RLD, RS |
| SUSTOL | Heron Therapeutics | N-022445 RX | 2016-08-09 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| granisetron | ANDA | 2019-12-31 |
| granisetron hydrochloride | ANDA | 2024-01-04 |
| sancuso | New Drug Application | 2023-08-24 |
| sustol | New Drug Application | 2023-06-07 |
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
No data
HCPCS
Code | Description |
|---|---|
| J1626 | Injection, granisetron hydrochloride, 100 mcg |
| J1627 | Injection, granisetron, extended-release, 0.1 mg |
| Q0166 | Granisetron hydrochloride, 1 mg, oral, fda approved prescription anti-emetic, for use as a complete therapeutic substitute for an iv anti-emetic at the time of chemotherapy treatment, not to exceed a 24 hour dosage regimen |
| S0091 | Granisetron hydrochloride, 1 mg (for circumstances falling under the medicare statute, use q0166) |
Clinical
Clinical Trials
127 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Vomiting | D014839 | HP_0002013 | R11.1 | 4 | 8 | 15 | 6 | 10 | 43 |
| Nausea | D009325 | HP_0002018 | R11.0 | 2 | 2 | 3 | 4 | 4 | 15 |
| Neoplasms | D009369 | — | C80 | 2 | 2 | 5 | 1 | 2 | 12 |
| Postoperative nausea and vomiting | D020250 | EFO_0004888 | — | — | 2 | 3 | 4 | 2 | 11 |
| Lymphoma | D008223 | — | C85.9 | — | 2 | — | 1 | 1 | 4 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 1 | — | — | 1 | 1 | 3 |
| Leukemia | D007938 | — | C95 | — | — | — | 1 | 1 | 2 |
| Prostatic neoplasms | D011471 | — | C61 | — | — | — | 1 | — | 1 |
| Cholelithiasis | D002769 | EFO_0004799 | K80 | — | — | — | 1 | — | 1 |
| Temporomandibular joint disorders | D013705 | — | M26.6 | — | — | — | 1 | — | 1 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Uterine cervical neoplasms | D002583 | HP_0030159 | — | — | — | 1 | — | 1 | 2 |
| Hypotension | D007022 | EFO_0005251 | I95 | — | — | 1 | — | 1 | 2 |
| Gastroparesis | D018589 | EFO_1000948 | K31.84 | — | 1 | 1 | — | — | 2 |
| Gastrointestinal neoplasms | D005770 | — | C26.9 | — | — | 1 | — | — | 1 |
| Anti-neutrophil cytoplasmic antibody-associated vasculitis | D056648 | — | I77.82 | — | — | 1 | — | — | 1 |
| Postoperative complications | D011183 | — | — | — | — | 1 | — | — | 1 |
| Intraoperative complications | D007431 | — | — | — | — | 1 | — | — | 1 |
| Hepatocellular carcinoma | D006528 | — | C22.0 | — | — | 1 | — | — | 1 |
| Liver neoplasms | D008113 | EFO_1001513 | C22.0 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Small cell lung carcinoma | D055752 | — | — | 1 | 1 | — | — | — | 1 |
| Mantle-cell lymphoma | D020522 | — | C83.1 | — | 1 | — | — | — | 1 |
| Mast-cell leukemia | D007946 | — | C94.3 | — | 1 | — | — | — | 1 |
| Glioma | D005910 | EFO_0000520 | — | — | 1 | — | — | — | 1 |
| Sepsis | D018805 | HP_0100806 | A41.9 | — | 1 | — | — | — | 1 |
| Pruritus | D011537 | HP_0000989 | L29 | — | 1 | — | — | — | 1 |
| Melanoma | D008545 | — | — | — | 1 | — | — | — | 1 |
| Drug therapy | D004358 | — | — | — | 1 | — | — | — | 1 |
| Postoperative pain | D010149 | — | G89.18 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 9 | — | — | — | 1 | 10 |
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | 1 | — | — | — | — | 1 |
| Pharmacokinetics | D010599 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Tick-borne encephalitis | D004675 | EFO_1001309 | A84 | — | — | — | — | 3 | 3 |
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | — | — | — | — | 2 | 2 |
| Non-hodgkin lymphoma | D008228 | — | C85.9 | — | — | — | — | 1 | 1 |
| Brenner tumor | D001948 | — | — | — | — | — | — | 1 | 1 |
| Endometrioid carcinoma | D018269 | — | — | — | — | — | — | 1 | 1 |
| Fallopian tube neoplasms | D005185 | — | — | — | — | — | — | 1 | 1 |
| Cystadenocarcinoma | D003536 | — | — | — | — | — | — | 1 | 1 |
| Myelodysplastic syndromes | D009190 | — | D46 | — | — | — | — | 1 | 1 |
| Myeloproliferative disorders | D009196 | — | D47.1 | — | — | — | — | 1 | 1 |
| Neuroblastoma | D009447 | EFO_0000621 | — | — | — | — | — | 1 | 1 |
Show 9 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Granisetron |
| INN | granisetron |
| Description | 1-Methyl-N-{9-methyl-9-azabicyclo[3.3.1]nonan-3-yl}-1H-indazole-3-carboxamide is a member of indazoles and an aromatic amide. |
| Classification | Small molecule |
| Drug class | serotonin 5-HT3 receptor antagonists |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CN1C2CCCC1CC(NC(=O)c1nn(C)c3ccccc13)C2 |
Identifiers
| PDB | — |
| CAS-ID | 107007-99-8 |
| RxCUI | — |
| ChEMBL ID | CHEMBL289469 |
| ChEBI ID | — |
| PubChem CID | 3510 |
| DrugBank | DB00889 |
| UNII ID | WZG3J2MCOL (ChemIDplus, GSRS) |
Target
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Variants
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Financial
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Sustol – Heron Therapeutics /de/
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Sancuso – Cumberland Pharmaceuticals
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Estimated US medical usage
Granisetron
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Trends
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Safety
Black-box Warning
No Black-box warning
Adverse Events
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2,933 adverse events reported
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