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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
neoplasmsD009369
signs and symptoms pathological conditionsD013568
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
SUSTOLHeron TherapeuticsN-022445 RX2016-08-09
1 products, RLD, RS
SANCUSOKyowa KirinN-022198 RX2008-09-12
1 products, RLD, RS
Granisetron hydrochloride
Tradename
Company
Number
Date
Products
KYTRILRocheN-020239 DISCN1993-12-29
4 products, RLD
KYTRILRocheN-020305 DISCN1995-03-16
2 products, RLD
KYTRILRocheN-021238 DISCN2001-06-27
1 products, RLD
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Labels
FDA
EMA
Brand Name
Status
Last Update
sancusoNew Drug Application2020-06-16
sustolNew Drug Application2017-05-31
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Granisetron, Sancuso, Kyowa Kirin
76082822025-01-22DPU-1011
Granisetron, Sustol, Heron Theraps Inc
82523042024-09-28DP
82523052024-09-28U-1891
87157102024-09-28DP
99139102024-09-28U-2253
103575702024-09-28U-2253
ATC Codes
A: Alimentary tract and metabolism drugs
— A04: Antiemetics and antinauseants
— A04A: Antiemetics and antinauseants
— A04AA: Serotonin (5ht3) antagonists
— A04AA02: Granisetron
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
88 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
VomitingD014839HP_0002013R11.148136637
NauseaD009325HP_0002018R11.02234213
Postoperative nausea and vomitingD020250EFO_0004888—23319
NeoplasmsD009369C801251—9
LymphomaD008223C85.9—1—113
LeukemiaD007938C95———112
Prostatic neoplasmsD011471C61———1—1
CholelithiasisD002769EFO_0004799K80———1—1
Temporomandibular joint disordersD013705M26.6———1—1
Facial painD005157R51.9———1—1
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
HypotensionD007022EFO_0005251I95——1—12
GastroparesisD018589EFO_1000948K31.84—11——2
Postoperative complicationsD011183——1——1
Uterine cervical neoplasmsD002583——1——1
Intraoperative complicationsD007431——1——1
Liver neoplasmsD008113EFO_1001513C22.0——1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Mantle-cell lymphomaD020522C83.1—1———1
Mast-cell leukemiaD007946C94.3—1———1
GliomaD005910EFO_0000520—1———1
SepsisD018805A41.9—1———1
PruritusD011537HP_0000989L29—1———1
Drug therapyD004358—1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients—8————8
Breast neoplasmsD001943EFO_0003869C501———12
PharmacokineticsD0105991————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Ovarian neoplasmsD010051EFO_0003893C56————22
Brenner tumorD001948————11
Endometrioid carcinomaD018269————11
Fallopian tube neoplasmsD005185————11
CystadenocarcinomaD003536————11
Myelodysplastic syndromesD009190D46————11
Myeloproliferative disordersD009196D47.1————11
NeuroblastomaD009447EFO_0000621————11
Plasma cell neoplasmsD054219————11
Trophoblastic neoplasmsD014328————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameGRANISETRON
INNgranisetron
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 classserotonin 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-ID109889-09-0
RxCUI26237
ChEMBL IDCHEMBL289469
ChEBI ID—
PubChem CID3510
DrugBankDB00889
UNII IDWZG3J2MCOL (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
Sancuso - Cumberland Pharmaceuticals
$
€
£
₣
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Sustol - HERON THERAPEUTICS, INC. /DE/
$
€
£
₣
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 2,816 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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49,563 adverse events reported
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