Kytril

(Granisetron)

ApprovedSmall molecule

Granisetron is used to prevent nausea and vomiting caused by cancer chemotherapy treatments and surgery. It works by blocking signals in the brain that trigger nausea.[2] Kytril is currently approved and in use across 14 indications[4].[1]

Kytril is one of 355 small molecule programs targeting Gastroparesis. It is currently in Approved.

Indications

Total Trials

Active Trials

354

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

GastroparesisApproved

Post Operative Nausea and VomitingApproved

Kidney InjuryActive, not recruiting

Malignant GliomaActive, not recruiting

Chemotherapy-Induced Nausea and VomitingActive, not recruiting

Nausea and VomitingActive, not recruiting

Hepatocellular CarcinomaApproved

Mantle Cell LymphomaActive, not recruiting

Cervical CancerApproved

Cesarean SectionActive, not recruiting

GastroparesisApproved

Approved

Post Operative Nausea and VomitingApproved

Approved

Kidney InjuryPhase 3

Active, not recruiting

Malignant GliomaPhase 2

Active, not recruiting

Chemotherapy-Induced Nausea and VomitingPhase 3

Active, not recruiting

Nausea and VomitingApproved

Active, not recruiting

Hepatocellular CarcinomaApproved

Approved

Mantle Cell LymphomaPhase 2

Active, not recruiting

Cervical CancerApproved

Approved

Cesarean SectionPhase 3

Active, not recruiting

Showing 10 of 11 indications

Competition

Competitive Landscape

797 competitors in Hepatocellular Carcinoma

#DrugCompanyPhaseTrials

Kytril

CConrado Roberto Hoffmann Filho

Approved

54 2

Viread

Gilead

Preclinical

1 3

Sovaldi

Gilead

Preclinical

1 4

Cysteine Hydrochloride

Novartis

Preclinical

1 5

Apatinib

LLaNova Medicines Zhejiang Co., Ltd.

Preclinical

16 6

Vermox

WWim Janssens

Preclinical

1 7

Opdivo

Bristol-Myers Squibb

Preclinical

2 8

Lyrica

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Preclinical

—9

Anlotinib

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Preclinical

5 10

QL1706

Qilu Pharmaceutical Co., Ltd.

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2026

Post-ApprovalRecruiting

Spine Surgery

NCT06540885

Q4 2027

Post-ApprovalNot yet recruiting

Laparoscopic Cholecystectomy

NCT07360431

Phase 3Active, not recruiting

Kidney Injury

NCT03817970

Clinical

Trials by Indication[1]

Nausea and vomiting12 trials

Real-time Decision Support for Postoperative Nausea and Vomiting (PONV) Prophylaxis

Completed·VVanderbilt University·N/A·NCT02625181·27,034 enrolled

A Study of Kytril (Granisetron) in the Prevention of Post-Operative Nausea and Vomiting (PONV) in Pediatric Subjects Undergoing Tonsillectomy or Adenotonsillectomy

Completed· Roche logo

Roche·Phase 4·NCT00231478·171 enrolled

A COMPARATIVE STUDY BETWEEN 1MG AND 3 MG OF GRANISETRON IN THE PREVENTION OF POSTOPERATIVE NAUSEA AND VOMITING IN STRABISMUS OPHTHALMIC SURGERIES DURING GENERAL ANESTHESIA

Completed·—·Phase 3·NCT04918862·210 enrolled

Show 9 more trials

Granisetron Transdermal Patch for Prevention of Postoperative Nausea and Vomiting

Completed·MMilton S. Hershey Medical Center·Phase 2·NCT02457195·50 enrolled

Pharmacogenomics and Post-Operative Nausea and Vomiting

Completed·MMayo Clinic·Phase 4·NCT03503292·92 enrolled

Treatment Algorithm for Nausea and Vomiting in the Palliative Phase

Unknown status·RRadboud University Medical Center·Phase 4·NCT03017391·20 enrolled

Aprepitant/MK0869 for Prevention of Chemotherapy Induced Nausea and Vomiting Associated With Cisplatin (0869-169)(COMPLETED)

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT00952341·421 enrolled

Effects of Ondansetron, Metoclopramide and Granisetron on Perioperative Nausea and Vomiting in Patients Undergone Bariatric Surgery

Completed·SShahid Beheshti University of Medical Sciences·Phase 3·NCT05087615·130 enrolled

Postoperative Nausea and Vomiting in Laparoscopic Abdominal Surgery

Unknown status·—·Phase 4·NCT05632224·60 enrolled

Aromatherapy for Prevention of Intrathecal Morphine Induced Nausea and Vomiting

Completed·UUniversiti Kebangsaan Malaysia Medical Centre·N/A·NCT03434340·155 enrolled

Aprepitant and Granisetron for the Prophylaxis of Radiation Induced Nausea and Vomiting - A Pilot Study

Terminated·SSunnybrook Health Sciences Centre·Phase 2·NCT01183481·19 enrolled

Granisetron, Aprepitant, and Dexamethasone in Preventing Nausea and Vomiting in Patients Receiving Chemotherapy for Stage II, III, or IV Ovarian Cancer

Terminated·GGynecologic Oncology Group·N/A·NCT01275664·4 enrolled

Chemotherapy-induced nausea and vomiting4 trials

Safety and Efficacy of Palonosetron in Preventing Chemotherapy-induced Nausea and Vomiting

Completed·HHangzhou Jiuyuan Gene Engineering Co. Ltd.,·Phase 2·NCT00503386·144 enrolled

To Study the Safety and Effectiveness of a Granisetron Patch to Treat Chemotherapy-Induced Nausea and Vomiting (CINV)

Completed· Kyowa Kirin Co., Ltd. logo

Kyowa Kirin Co., Ltd.·Phase 3·NCT00273468·630 enrolled

An Efficacy and Safety Study of Palonosetron in Preventing Chemotherapy-Induced Nausea and Vomiting (CINV) in the Chinese Cancer Patients

Completed·XXijing Hospital·Phase 2·NCT00666783·208 enrolled

Show 1 more trial

Granisetron Extended Release Injection (GERSC) for the Prevention of Chemotherapy-induced Nausea and Vomiting

Withdrawn·UUniversity of Alabama at Birmingham·Phase 2·NCT04085393

Cesarean Section3 trials

Effect of Granisetron on Morphine Induced Pruritus in Cesarean Section

Completed·—·Phase 2·NCT03483870·80 enrolled

The Effect of Intravenous Granisetron and Ondansetron in Patients Undergoing Cesarean Section

Completed·—·Phase 3·NCT04613726·120 enrolled

Intravenous Granisetron Vs Dexmedetomidine on Postspinal in the Cesarean Section.

Unknown status·MMinia University·N/A·NCT06762860·99 enrolled

Chemotherapy3 trials

Ph 3 Safety/Efficacy Study of Rolapitant for Prevention of CINV in Subjects Receiving Moderately Emetogenic Chemotherapy

Completed·TTesaro, Inc.·Phase 3·NCT01500226·1,369 enrolled

Ph3 Safety/Efficacy Study of Rolapitant for the Prevention of CINV in Subjects Receiving Highly Emetogenic Chemotherapy

Completed·TTesaro, Inc.·Phase 3·NCT01500213·555 enrolled

Ph3 Safety/Efficacy Study of Rolapitant for the Prevention of CINV in Subjects Receiving Highly Emetogenic Chemotherapy

Completed·TTesaro, Inc.·Phase 3·NCT01499849·532 enrolled

Laparoscopic Cholecystectomy2 trials

Granisteron Versus Metoclopramide in Laparoscopic Cholecystectomy

Unknown status·—·Phase 4·NCT04899817·60 enrolled

Granisetron Combined With Dexamethasone or Metoclopramide for PONV Prevention After Laparoscopic Cholecystectomy

Not yet recruiting·—·Phase 4·NCT07360431·102 enrolled

27 more indications

Nausea2 trials

Open Label Transdermal Granisetron to Relieve Chronic Nausea and Emesis

Withdrawn·IIndiana University·Phase 2·NCT04501211

AMENO-2: Aprepitant Plus Palonosetron Versus Granisetron in the Prevention of Nausea and the Emesis Induced by Chemotherapy in Patients Treated With Haematopoietic Progenitors

Completed·PPETHEMA Foundation·Phase 4·NCT00415103·196 enrolled

Prevention2 trials

Prevention of Spinal Induced Shivering During CS

Completed·—·Phase 2·NCT02588547·212 enrolled

Phase 2 Trial of Prophylactic Rituximab Therapy for Prevention of CGVHD

Completed·SStanford University·Phase 2·NCT00186628·36 enrolled

Tics2 trials

An Investigation on the Effect of Age and BMI on the Pharmacokinetics of Transdermal Granisetron

Completed· Kyowa Kirin Co., Ltd. logo

Kyowa Kirin Co., Ltd.·Phase 1·NCT00868764·60 enrolled

Effect of External Heat on a Transdermal Granisetron Patch in Pharmacokinetics (PK) of Healthy Subjects

Completed· Kyowa Kirin Co., Ltd. logo

Kyowa Kirin Co., Ltd.·Phase 1·NCT01073696·16 enrolled

Efficacy and Safety1 trial

The Efficacy and Safety of Palonosetron in Preventing the Gastrointestinal Reactions Induced by 3-day Highly Emetogenic Chemotherapy

Completed· Jiangsu Simcere Pharmaceutical Co., Ltd. logo

Jiangsu Simcere Pharmaceutical Co., Ltd.·Phase 2·NCT01909856·92 enrolled

CAR1 trial

Safety Study of Electrocardiogram (ECG) Effects of Sancuso® (Granisetron TDS)

Completed· Kyowa Kirin Co., Ltd. logo

Kyowa Kirin Co., Ltd.·Phase 1·NCT00890565·240 enrolled

Midazolam1 trial

Comp Granisetron Midazolam Comb in Lap Children

Unknown status·—·Phase 3·NCT03483350·90 enrolled

Mantle Cell Lymphoma1 trial

R-MACLO-IVAM and Thalidomide in Untreated Mantle Cell Lymphoma

Completed·UUniversity of Miami·Phase 2·NCT00450801·22 enrolled

Cesarean Delivery1 trial

Comparative Study Between Intravenous Granisetron and Ondansetron on Their Effect on Hemodynamics and Shivering After Spinal Anesthesia in Elective Cesarean Delivery

Recruiting·SSohag University·N/A·NCT06437236·100 enrolled

Fasting Conditions1 trial

A Single Dose, 4-Period, 2-Treatment Replicate Design Bioequivalency Study of Granisetron Hydrochloride 1 mg Tablets Under Fasting Conditions

Completed·RRoxane Laboratories·N/A·NCT00618254·32 enrolled

Vomiting1 trial

A Study of Ramosetron Plus DX, Dexamethasone, Compared to Granisetron Plus DX for the Prevention of Vomiting and Nausea

Completed· Astellas logo

Astellas·Phase 3·NCT00272285·287 enrolled

Single Dose1 trial

A Single Dose, 4-Period, 2-Treatment Replicate Design Bioequivalency Study of Granisetron Hydrochloride 1 mg Tablets Under Fed Conditions

Completed·RRoxane Laboratories·N/A·NCT00618111·32 enrolled

Intravenous1 trial

Randomized Crossover Pharmacokinetic Evaluation of Subcutaneous Versus Intravenous Granisetron in Cancer Patients

Completed·—·Phase 2·NCT00450853·31 enrolled

Vaginal Cancer1 trial

Oral Ondansetron Versus Transdermal Granisetron (Sancuso) for Women With Cervical, Endometrial or Vaginal Cancer Receiving Pelvic Chemoradiation

Completed·MM.D. Anderson Cancer Center·Phase 3·NCT01536392·76 enrolled

Ondansetron1 trial

Granisetron Versus Ondansetron: Comparative Effects on ECG, QTc

Completed·TTata Memorial Hospital·Phase 4·NCT01352130·70 enrolled

Papilloma1 trial

E7 TCR T Cells for Human Papillomavirus-Associated Cancers

Completed·NNational Cancer Institute (NCI)·Phase 1/2·NCT02858310·224 enrolled

Drug1 trial

The Antigagging Effect of Granisetron (Kytril), an Antiemetic Drug, in Dental Situations

Unknown status·HHadassah Medical Organization·N/A·NCT00502437

Kidney Injury1 trial

Cisplatin Disposition and Kidney Injury

Active, not recruiting·UUniversity of Colorado, Denver·Phase 3·NCT03817970·72 enrolled

Interaction1 trial

The Pharmacokinetic Interaction Between Oral Casopitant and Oral Dolasetron, Granisetron or Rosiglitazone in Subjects

Completed· GSK logo

GSK·Phase 1·NCT00511823·16 enrolled

Malignant Glioma1 trial

Patient Satisfaction, Efficacy and Compliance of Antiemetic Patch vs Pill in Malignant Glioma Patients

Withdrawn·—·Phase 2·NCT01952886

Pain1 trial

Study on the Effect of Granisetron on Myofascial Pain in the Orofacial Muscles

Completed·KKarolinska Institutet·Phase 4·NCT02230371·40 enrolled

Temporomandibular Disorders1 trial

Occlusal Splint Combined With Granisetron Injection for Management of Myofascial Pain Related to Temporomandibular Disorders

Active, not recruiting·MMansoura University·Phase 4·NCT07401745·48 enrolled

Spine Surgery1 trial

A Comparison Between Palonosetron Versus Granisetron as PONV Prophylaxis in Scoliotic Patients Undergoing Spine Surgery

Recruiting·UUniversity of Malaya·Phase 4·NCT06540885·74 enrolled

Effectiveness1 trial

BMT-08: A Comparative Effectiveness Study of Transdermal Granisetron to Ondansetron

Recruiting·UUniversity of Illinois at Chicago·Phase 4·NCT04150614·90 enrolled

Prophylaxis1 trial

Granisetron Transdermal Patch for Prophylaxis of Delayed CINV

Unknown status·FFudan University·Phase 3·NCT04912271·140 enrolled

Patient-Controlled Analgesia1 trial

The Comparison of the Analgesic Effects of Dezocine and Sufentanil in Patient-controlled Analgesia After Laryngectomy

Completed·EEye & ENT Hospital of Fudan University·N/A·NCT06000137·129 enrolled

Shivering1 trial

Clonidine Versus Granisetron for Shivering Prevension

Unknown status·ZZagazig University·Phase 2·NCT06031090·186 enrolled

Unspecified1 trial

PK, Tolerability and Safety of the Co-administration of Sancuso® (Transdermal Granisetron) and IV Granisetron

Completed· Kyowa Kirin Co., Ltd. logo

Kyowa Kirin Co., Ltd.·Phase 1·NCT00873197·12 enrolled

Regulatory

FDA Approval Timeline[5]

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 — 54 trial records for Granisetron. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Kytril drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Granisetron compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Granisetron. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA022445). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Conrado Roberto Hoffmann Filho company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Serotonin 3a (5-Ht3a) Receptor Antagonist[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: CConrado Roberto Hoffmann Filho

Kytril

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q3 2026

Q4 2027

Trials by Indication[1]

Nausea and vomiting12 trials

Chemotherapy-induced nausea and vomiting4 trials

Cesarean Section3 trials

Chemotherapy3 trials

Laparoscopic Cholecystectomy2 trials

Nausea2 trials

Prevention2 trials

Tics2 trials

Efficacy and Safety1 trial

CAR1 trial

Midazolam1 trial

Mantle Cell Lymphoma1 trial

Cesarean Delivery1 trial

Fasting Conditions1 trial

Vomiting1 trial

Single Dose1 trial

Intravenous1 trial

Vaginal Cancer1 trial

Ondansetron1 trial

Papilloma1 trial

Drug1 trial

Kidney Injury1 trial

Interaction1 trial

Malignant Glioma1 trial

Pain1 trial

Temporomandibular Disorders1 trial

Spine Surgery1 trial

Effectiveness1 trial

Prophylaxis1 trial

Patient-Controlled Analgesia1 trial

Shivering1 trial

Unspecified1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

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