Sancuso

(granisetron hydrochloride)

PreclinicalSmall molecule

CConrado Roberto Hoffmann Filho

Indications

Total Trials

Active Trials

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Clinical

Trials by Indication[1]

Nausea and vomiting3 trials

Lerisetron Compared With Granisetron in Preventing Nausea and Vomiting in Men Being Treated With Radiation Therapy for Stage I Seminoma

Unknown status·SSimbec Research·Phase 3·NCT00004219·150 enrolled

Acupressure and Acustimulation Wrist Bands for the Prevention of Nausea and Vomiting Caused by Chemotherapy

Completed·GGary Morrow·Phase 2·NCT00003817·700 enrolled

Granisetron to Prevent Nausea and Vomiting After Chemotherapy in Patients With Malignant Disease

Unknown status·JJonsson Comprehensive Cancer Center·Phase 3·NCT00005024

Nausea2 trials

Comparison of Antiemetic Drugs in Preventing Delayed Nausea After Chemotherapy in Patients With Cancer

Completed·GGary Morrow·Phase 3·NCT00020657

Prevention of Delayed Nausea A Phase III Double-Blind Placebo-Controlled Clinical Trial

Completed·JJoseph Roscoe·Phase 3·NCT00475085·1,021 enrolled

Caesarean Section1 trial

Effect of Granisetron on Usage of Sympathomimetics During Caesarean Section

Completed·JJohann Wolfgang Goethe University Hospital··NCT03318536·240 enrolled

Cesarean Section1 trial

Role of Granisetron in Preventing Hypotension After Spinal Anesthesia With Levobupivacaine in Rheumatic Patients Undergoing Elective Cesarean Section

Unknown status·—·Phase 2/3·NCT05314257·102 enrolled

Chemotherapy1 trial

Comparative Study of Palonosetron With Granisetron as a Control in Patients Receiving Highly Emetogenic Chemotherapy

Completed· Taiho Pharmaceutical Co., Ltd. logo

Taiho Pharmaceutical Co., Ltd.·Phase 3·NCT00359567·1,140 enrolled

6 more indications

Fasting Conditions1 trial

Granisetron 1 mg Tablets Under Fasting Conditions

Completed· Teva logo

Teva·Phase 1·NCT00834717·40 enrolled

Chemotherapy-induced nausea and vomiting1 trial

A Randomized Controlled Trial of SP-01 (Granisetron Transdermal Delivery System) in Chemotherapy-induced Nausea and Vomiting

Completed·SSolasia Pharma K.K.·Phase 3·NCT01937156·313 enrolled

Effects of Chemotherapy1 trial

Drugs to Reduce the Side Effects of Chemotherapy

Completed·SSwiss Cancer Institute·Phase 3·NCT00003213·267 enrolled

Vomiting1 trial

Aprepitant, Granisetron, & Dexamethasone in Preventing Nausea & Vomiting in Pts. Receiving Cyclophosphamide Before a Stem Cell Transplant

Completed·BBarbara Ann Karmanos Cancer Institute·N/A·NCT00293384·40 enrolled

Septic Shock1 trial

Adjunctive Granisetron Therapy in Patients With Sepsis or Septic Shock

Completed·ZZhujiang Hospital·Phase 2·NCT03924518·154 enrolled

Unspecified1 trial

Granisetron 1 mg Tablets, Non-fasting

Completed· Teva logo

Teva·Phase 1·NCT00834522·80 enrolled

Regulatory

FDA Approval Timeline[4]

Mar 16, 1995

KYTRIL

NDA NDA020305

Jun 27, 2001

KYTRIL

NDA NDA021238

Sep 17, 2004

KYTRIL

NDA NDA020239

Sep 12, 2008

SANCUSO

NDA NDA022198

Aug 9, 2016

SUSTOL

NDA NDA022445

Sources

References

[1]
ClinicalTrials.gov — 14 trial records for granisetron hydrochloride. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — granisetron hydrochloride compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for granisetron hydrochloride. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA022445). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Conrado Roberto Hoffmann Filho company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Preclinical[1]
Company: CConrado Roberto Hoffmann Filho

Sancuso

Trials by Indication[1]

Nausea and vomiting3 trials

Nausea2 trials

Caesarean Section1 trial

Cesarean Section1 trial

Chemotherapy1 trial

Fasting Conditions1 trial

Chemotherapy-induced nausea and vomiting1 trial

Effects of Chemotherapy1 trial

Vomiting1 trial

Septic Shock1 trial

Unspecified1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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