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Drug ReportsGranisetron
Kytril, Sancuso(granisetron)
Granisetron, 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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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
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
Granisetron, Sancuso, Sustol (discontinued: Granisetron, Kytril)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
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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Granisetron
Tradename
Company
Number
Date
Products
SANCUSOCumberland PharmaceuticalsN-022198 RX2008-09-12
1 products, RLD, RS
SUSTOLHeron TherapeuticsN-022445 RX2016-08-09
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
granisetronANDA2022-11-15
granisetron hydrochlorideANDA2025-04-24
granisolANDA2025-03-21
sancusoNew Drug Application2024-11-04
sustolNew Drug Application2024-09-30
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Granisetron, Sancuso, Cumberland
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
135 clinical trials
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Indications Phases 4
No data
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
VomitingD014839—R11.13—1——4
NauseaD009325—R11.0——1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
GliomaD005910EFO_0000520——1———1
GastroparesisD018589EFO_1000948K31.84—1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients———4————4
PharmacokineticsD010599——1————1
Tissue adhesionsD000267——1————1
Indications Without Phase
No data
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)Loading
Structure (InChI/SMILES or Protein Sequence)
CN1C2CCCC1CC(NC(=O)c1nn(C)c3ccccc13)C2
Identifiers
PDB—
CAS-ID107007-99-8
RxCUI—
ChEMBL IDCHEMBL289469
ChEBI ID—
PubChem CID3510
DrugBankDB00889
UNII IDWZG3J2MCOL (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
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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Refill frequency
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 3,677 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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3,476 adverse events reported
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