Drugs / Granisetron
last change Jul 2026 re-read 2 minutes ago

Granisetron

Other / unclassified targets HTR3A via inhibition

Developed for
chemotherapy-induced toxicity · gastroparesis · temporomandibular joint disorder · cyclic vomiting syndrome · infectious disease with sepsis · myofascial pain syndrome · aspiration pneumonia · benign shuddering attacks
+2 more · leukemia · lymphoma
Investigated by
Kyowa Kirin, Inc. · National Cancer Institute (NCI) · Heron Therapeutics · Kyowa Kirin Pharmaceutical Development Ltd · Assiut University · Fudan University
+46 more · LG Life Sciences · Teva Pharmaceuticals USA · Ain Shams University · Alexza Pharmaceuticals, Inc. · Australasian Leukaemia and Lymphoma Group · Bezmialem Vakif University · Clinica Universidad de Navarra, Universidad de Navarra · Duke University · Folktandvården Stockholms län AB · Future University in Egypt · Gary Morrow · GlaxoSmithKline · Gynecologic Oncology Group · Hadassah Medical Organization · Hangzhou Jiuyuan Gene Engineering Co. Ltd. · Hoffmann-La Roche · Indiana University · Jiangsu Simcere Pharmaceutical Co., Ltd. · Jonsson Comprehensive Cancer Center · Joseph Roscoe · Karolinska Institutet · M.D. Anderson Cancer Center · Mansoura University · Mayo Clinic · Memorial Sloan Kettering Cancer Center · Merck Frosst Canada Ltd. · Merck Sharp & Dohme LLC · Milton S. Hershey Medical Center · National Institute of General Medical Sciences (NIGMS) · Proswell Medical Corporation · Rutgers University · Sancuso · Shahid Beheshti University of Medical Sciences · Shin Nippon Biomedical Laboratories, Ltd. · Simbec Research · Solasia Pharma K.K. · Sun Yat-sen University · Sunnybrook Health Sciences Centre · Swiss Cancer Institute · Temple University · Tianjin Medical University Cancer Institute and Hospital · Tigermed Consulting Co., Ltd · Universiti Kebangsaan Malaysia Medical Centre · University of Colorado, Denver · University of Southern California · Zhujiang Hospital

Regulatory milestones approvals, filings & regulatory actions · 7 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved EU (EMA) Sancuso 2012-04-20 europa.eu
Label expansions (5) US (FDA) KYTRIL 1997-01-21 – 2011-04-29 fda.gov
Approved US (FDA) KYTRIL 1993-12-29 fda.gov

Trials 52 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 110 trials
Phase 1 NCT01649258 Sep 2012 → May 2017 breast cancer University of Southern California Terminated No outcome recorded
Phase 1 NCT01596400 May 2012 → Aug 2015 chemotherapy-induced toxicity Kyowa Kirin Pharmaceutical Development Ltd Completed No outcome recorded
Phase 1 NCT00890565 May → Aug 2009 Kyowa Kirin, Inc. Completed No outcome recorded
Phase 1 NCT00873197 Apr → May 2009 Kyowa Kirin, Inc. Completed No outcome recorded
Phase 1 NCT00868764 Apr → Sep 2009 Kyowa Kirin, Inc. Completed No outcome recorded
Phase 1 NCT00511823 Jul → Sep 2007 chemotherapy-induced toxicity GlaxoSmithKline Completed No outcome recorded
Phase 1 NCT00834717 Sep 2005 Teva Pharmaceuticals USA Completed No outcome recorded
Phase 1 NCT00834522 Jul 2005 Teva Pharmaceuticals USA Completed No outcome recorded
Phase 1 NCT01596413 chemotherapy-induced toxicity Kyowa Kirin Pharmaceutical Development Ltd Withdrawn No outcome recorded
Phase 1 NCT01596426 chemotherapy-induced toxicity Kyowa Kirin Pharmaceutical Development Ltd Withdrawn No outcome recorded
Phase 212 trials
Phase 2 NCT05325190 Oct 2021 → Dec 2022 chemotherapy-induced toxicity Tianjin Medical University Cancer Institute and Hospital Unknown No outcome recorded
Phase 2 NCT04645953 Feb 2021 → Jul 2022 cyclic vomiting syndrome Alexza Pharmaceuticals, Inc. Completed No outcome recorded
Phase 2 NCT04472143 Jul 2020 → Sep 2022 chemotherapy-induced toxicity Fudan University Unknown No outcome recorded
Phase 2 NCT03924518 Apr 2019 → Nov 2020 infectious disease with sepsis Zhujiang Hospital Completed No outcome recorded
Phase 2 NCT04501211 Jan 2019 → Dec 2020 gastroparesis Indiana University Withdrawn No outcome recorded
Phase 2 NCT02457195 Feb 2016 → Feb 2018 Milton S. Hershey Medical Center Completed No outcome recorded
Phase 2 NCT01909856 Oct 2011 → Apr 2014 cancer Jiangsu Simcere Pharmaceutical Co., Ltd. Completed No outcome recorded
Phase 2 NCT01183481 Jan 2011 → Mar 2013 Sunnybrook Health Sciences Centre Terminated No outcome recorded
Phase 2 NCT00787566 Oct 2008 → Apr 2009 chemotherapy-induced toxicity Shin Nippon Biomedical Laboratories, Ltd. Completed No outcome recorded
Phase 2 NCT00503386 Apr → Oct 2006 Hangzhou Jiuyuan Gene Engineering Co. Ltd. Completed No outcome recorded
Phase 316 trials
Phase 3 NCT06281418 Feb → Dec 2024 Future University in Egypt Completed No outcome recorded
Phase 3 NCT04912271 Jun 2021 → Jun 2022 chemotherapy-induced toxicity Fudan University Unknown No outcome recorded
Phase 3 NCT05087615 Mar → Aug 2021 Shahid Beheshti University of Medical Sciences Completed No outcome recorded
Phase 3 NCT03817970 Nov 2019 → Sep 2027 expected cisplatin toxicity University of Colorado, Denver Active not recruiting No outcome recorded
Phase 3 NCT03483350 Mar → Aug 2018 Assiut University Unknown No outcome recorded
Phase 3 NCT02106494 Mar 2014 → May 2015 chemotherapy-induced toxicity Heron Therapeutics Completed No outcome recorded
Phase 3 NCT01937156 Aug 2013 → Jan 2014 chemotherapy-induced toxicity Solasia Pharma K.K. Completed No outcome recorded
Phase 3 NCT01989221 Nov 2012 → Dec 2018 gastroparesis Temple University Completed No outcome recorded
Phase 3 NCT01536392 Mar 2012 → Oct 2019 cervical cancer M.D. Anderson Cancer Center Completed No outcome recorded
Phase 3 NCT00475085 Dec 2006 → Dec 2012 Joseph Roscoe Completed No outcome recorded
Phase 410 trials
Phase 4 NCT07360431 Mar 2026 → Oct 2027 expected Assiut University Not yet recruiting No outcome recorded
Phase 4 NCT07401745 Jan → Jul 2026 overdue temporomandibular joint disorder Mansoura University Active not recruiting No outcome recorded
Phase 4 NCT05434663 Jul 2022 → Oct 2025 chemotherapy-induced toxicity Heron Therapeutics Unknown No outcome recorded
Phase 4 NCT06454825 Apr 2020 → Apr 2021 disorder of facial skeleton Bezmialem Vakif University Completed No outcome recorded
Phase 4 NCT06043336 May 2018 → May 2019 Universiti Kebangsaan Malaysia Medical Centre Completed No outcome recorded
Phase 4 NCT03503292 May 2018 → Dec 2019 Mayo Clinic Completed No outcome recorded
Phase 4 NCT01662687 Feb → Oct 2012 chemotherapy-induced toxicity LG Life Sciences Unknown No outcome recorded
Phase 4 NCT01659775 Aug 2011 → Nov 2012 chemotherapy-induced toxicity LG Life Sciences Completed No outcome recorded
Phase 4 NCT00231478 Apr → Dec 2007 Hoffmann-La Roche Completed No outcome recorded
Phase 4 NCT02230371 Mar 2007 → Oct 2014 myofascial pain syndrome, temporomandibular joint disorder Karolinska Institutet Completed No outcome recorded
Phase not applicable4 trials
NCT06175806 Sep → Nov 2023 Ain Shams University Completed No outcome recorded
NCT01843868 Jan 2012 → Jun 2015 non-Hodgkin lymphoma Australasian Leukaemia and Lymphoma Group Withdrawn No outcome recorded
NCT01275664 Jun 2011 → May 2014 fallopian tube cancer, ovarian Brenner tumor, ovarian clear cell cystadenocarcinoma, ovarian endometrioid adenocarcinoma +5 Gynecologic Oncology Group Terminated No outcome recorded
NCT00502437 Hadassah Medical Organization Unknown No outcome recorded
Also used as a comparator or background therapy in 53 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 01 trial
Phase 0 NCT04290026 Comparator Apr 2021 → Jan 2022 aspiration pneumonia Assiut University Unknown No outcome recorded
Phase 14 trials
Phase 1 NCT04200092 Comparator Nov 2019 → Jan 2020 Nova Pneuma Inc. Completed No outcome recorded
Phase 1 NCT03333824 Background Dec 2017 → Jan 2019 cancer AstraZeneca Completed No outcome recorded
Phase 1 NCT02563951 Comparator Sep → Dec 2015 cancer Maxinase Life Sciences Ltd. Completed No outcome recorded
Phase 1 NCT01073696 Comparator Mar → Apr 2010 Kyowa Kirin, Inc. Completed No outcome recorded
Phase 1/21 trial
Phase 1/2 NCT02858310 Background Jan 2017 → Jul 2025 cervical intraepithelial neoplasia, human papilloma virus infection, in situ carcinoma, vulvar neoplasm National Cancer Institute (NCI) Completed No outcome recorded
Phase 29 trials
Phase 2 NCT06031090 Comparator Mar → Oct 2023 benign shuddering attacks Zagazig University Unknown No outcome recorded
Phase 2 NCT04570592 Comparator Oct 2020 → Apr 2021 Universiti Sains Malaysia Unknown No outcome recorded
Phase 2 NCT04085393 Comparator Aug 2020 chemotherapy-induced toxicity University of Alabama at Birmingham Withdrawn No outcome recorded
Phase 2 NCT03483870 Comparator Jun 2018 → Oct 2020 Assiut University Completed No outcome recorded
Phase 2 NCT02588547 Comparator Nov 2015 → May 2017 benign shuddering attacks Assiut University Completed No outcome recorded
Phase 2/31 trial
Phase 2/3 NCT05314257 Comparator Apr → Nov 2022 Assiut University Unknown No outcome recorded
Phase 311 trials
Phase 3 NCT05711823 Comparator Jul → Dec 2024 hepatocellular carcinoma Guangxi Medical University Unknown No outcome recorded
Phase 3 NCT04918862 Comparator Jan → May 2021 Cairo University Completed No outcome recorded
Phase 3 NCT04437017 Comparator Feb 2020 → May 2022 chemotherapy-induced toxicity Fifth Affiliated Hospital, Sun Yat-Sen University Completed No outcome recorded
Phase 3 NCT04613726 Comparator Dec 2018 → Dec 2019 hypotensive disorder Ataturk University Completed No outcome recorded
Phase 3 NCT02116530 Background Aug 2014 → Apr 2015 cancer of unknown primary site, hematopoietic and lymphoid cell neoplasm Alliance for Clinical Trials in Oncology Completed No outcome recorded
Phase 413 trials
Phase 4 NCT06540885 Comparator Jan 2025 → Jul 2026 overdue idiopathic scoliosis University of Malaya Recruiting No outcome recorded
Phase 4 NCT06513806 Comparator Aug → Sep 2024 Ain Shams University Completed No outcome recorded
Phase 4 NCT05632224 Comparator Nov 2022 → Jan 2023 Baskent University Unknown No outcome recorded
Phase 4 NCT04899817 Comparator May 2021 → Mar 2022 Assiut University Unknown No outcome recorded
Phase 4 NCT04817189 Comparator Feb 2021 → Jul 2024 chemotherapy-induced toxicity Helsinn Healthcare SA Completed No outcome recorded
Phase not applicable13 trials
NCT06502067 Background Jul 2024 → Jun 2025 overdue breast cancer Ain Shams University Not yet recruiting No outcome recorded
NCT06437236 Comparator Apr → Dec 2024 Sohag University Unknown No outcome recorded
NCT06762860 Comparator Jan 2024 → Jan 2025 benign shuddering attacks Minia University Unknown No outcome recorded
NCT06778460 Background May 2023 → Mar 2027 expected chronic pain syndrome West China Hospital Recruiting No outcome recorded
NCT05474001 Comparator Jun 2022 → Aug 2023 Mohamed Youssef Mohamed Unknown No outcome recorded

Press releases naming this drug 2 releases

DateIssuerRelease
2008-01-03 Teva Branded Pharmaceutical Products R&D, Inc. Teva Announces Approval Of Generic Kytril® Injection And Tablets tevapharm.com
2005-08-18 Teva Branded Pharmaceutical Products R&D, Inc. Teva Announces Tentative Approval of Granisetron Hydrochloride Injection tevapharm.com

Evidence & citations 36 cited values

Every value below carries the sentence it was read from. 108 sources stand behind the page.

FieldValueCited text
Known as Granisetrón “5HT3 (5-Hydroxytryptamine 3) antagonists (ondansetron, granisetron or tropisetron) used as the local institutional standard of care will be permitted, although the preferential...” NCT01843868
100

“The granisetron transdermal system (GTS) showed non-inferior efficacy to oral granisetron to control chemotherapy-induced nausea and vomiting (CINV) during multiday chemotherapy.” PMID 25465680 Dec 2014

“APF530, extended-release granisetron, provides sustained release for ≥5 days for acute- and delayed-phase chemotherapy-induced nausea and vomiting (CINV).” PMID 26997579 Mar 2016

“Patients will receive symptomatic therapy (paracetamol, Lekadol®, granisetron, Kytril®, metamizol, Analgin®, parenteral hydration with saline).” NCT02463942

“Granisetron+dexamethasone: granisetron:40mcg/kg, IV ; dexamethasone : S\<0.6m2, 2 mg/dose, q12h IV/PO; S\>0.6m2, 4 mg/dose, q12h , IV/PO.” NCT05230654

“SUSTOL® (granisetron) extended-release injection, for subcutaneous use for prevention of chemotherapy induced nausea and vomiting (CINV)” NCT05434663

“Another PCIA device contained sufentanil 2 ug/kg, granisetron 12 mg diluted to 200 mL in 0.9 % normal saline.” NCT06778460

“as compared to Granisetron IV Injection and Granisetron Tablet in healthy Volunteers.” NCT02563951

Granisetrón : 3 mg iv day, all days the patient will be treated with chemotherapy” NCT00415103

“Sancuso Patch (Granisetron) in Chemotherapy-induced Nausea and Vomiting (CINV)” NCT01659775

“Staccato Granisetron® (AZ 010) for the Treatment of Cyclic Vomiting Syndrome” NCT04645953

“Patients in Group G received 3 mg granisetron (Neoset, Deva, Istanbul)” NCT06454825

“Granisetron (Granitryl 1 mg/ml, ampules, EGYPHARMA, Egypt)” NCT07401745

“Sancuso® (granisetron transdermal system) 3.1 mg/24 hours” NCT01989221

“Granisetron: 1 mg d1 intravenously, or 2 mg d1 orally” NCT04437017

“1 mg (1 mL) IV granisetron after spinal placement.” NCT05474001

“granisetron transdermal system” NCT01596413

“IV Granisetron 1mg” NCT04200092

“IV granisetron” NCT01596426

NCT00272285

NCT01649258

NCT01636947

NCT05325190

NCT01275664

NCT00450853

NCT04873284

NCT05087615

NCT06000137

NCT01500213

NCT06281418

NCT04501211

NCT01073696

NCT00834522

NCT04912271

NCT05632224

NCT00890565

NCT06437236

NCT04570592

NCT07401745

NCT01536392

NCT06513806

NCT02625181

NCT02116530

NCT06043336

NCT00273468

NCT00503386

NCT03180229

NCT00952341

NCT00450801

NCT06175806

NCT04817189

NCT00003817

NCT01352130

NCT00475085

NCT00873197

NCT00834717

NCT03091881

NCT06031090

NCT00787566

NCT04918862

NCT01183481

NCT02588547

NCT02230371

NCT01952886

NCT04613726

NCT04085393

NCT00005024

NCT01909856

NCT01499849

NCT01596400

NCT01500226

NCT03333824

NCT05314257

NCT07360431

NCT06762860

NCT04150614

NCT00511823

NCT00020657

NCT00868764

NCT02858310

NCT03483350

NCT02441894

NCT03956446

NCT01937156

NCT02457195

NCT00231478

NCT03817970

NCT00003213

NCT06540885

NCT05711823

NCT00186628

NCT00415103

NCT00666783

NCT04472143

NCT03017391

NCT00502437

NCT03434340

NCT04290026

NCT03483870

NCT04899817

NCT03503292

Known as APF530 “AIM: APF530, extended-release granisetron, provides sustained release for ≥5 days for acute- and delayed-phase chemotherapy-induced nausea and vomiting (CINV).” PMID 26997579 Mar 2016
1

NCT00343460

Known as AZ 010 “A single oral dose of 0.5 mg AZ-010 (Staccato Granisetron) administered to 8 subjects” NCT04200092
1

“Staccato Granisetron® (AZ 010) for the Treatment of Cyclic Vomiting Syndrome” NCT04645953

Known as Bema granisetron ChEMBL registry synonym — accepted as the source's own label CHEMBL289469
Known as BRL 43694 ChEMBL registry synonym — accepted as the source's own label CHEMBL289469
Known as BRL 43694A ChEMBL registry synonym — accepted as the source's own label CHEMBL289469
Known as G Setron “the effect of the antiemetic drug Granisetron (G Setron 1 mg in 1 ml ampule) in reducing the incidence of hypotension” NCT03091881
Known as GERSC GERSC is a new, subcutaneously (SC) administered polymeric formulation of Granisetron that was developed to provide slow, controlled, and sustained release of granisetron to...” NCT04085393
Known as GNS “Study of Granisetron Hydrochloride Nasal Spray (GNS) in Healthy Volunteers” NCT02563951
Known as Granisetron (as hydrochloride) ChEMBL registry synonym — accepted as the source's own label CHEMBL289469
Known as GRANISETRON EXTENDED RELEASE INJECTION GRANISETRON EXTENDED RELEASE INJECTION (GERSC)” NCT04085393
Known as Granisetron hcl ChEMBL registry synonym — accepted as the source's own label CHEMBL289469
Known as granisetron hydrochloride “Kytril® (granisetron hydrochloride)” NCT00873197
4

NCT00359567

NCT00293384

NCT03924518

NCT00004219

Known as Granisetron Hydrochloride Nasal Spray “Study of Granisetron Hydrochloride Nasal Spray (GNS) in Healthy Volunteers” NCT02563951
Known as Granisetron hydrochloride preservative free ChEMBL registry synonym — accepted as the source's own label CHEMBL289469
Known as Granisetron TDS “Safety Study of Electrocardiogram (ECG) Effects of Sancuso® (Granisetron TDS)” NCT00890565
Known as Granisetron Transdermal Delivery System “The study is to demonstrate non-inferiority of the Granisetron Transdermal Delivery System (GTDS) compared with the intravenous and oral Granisetron in the prevention of CINV...” NCT01662687
Known as Granisetron Transdermal System “The granisetron transdermal system (GTS) showed non-inferior efficacy to oral granisetron to control chemotherapy-induced nausea and vomiting (CINV) during multiday chemotherapy.” PMID 25465680 Dec 2014
Known as Granisol ChEMBL registry synonym — accepted as the source's own label CHEMBL289469
Known as Granisteron hydrochloride ChEMBL registry synonym — accepted as the source's own label CHEMBL289469
Known as Granitryl “1gm of paracetamol, 30mg of ketorolac and 1mg Granitryl will be given twenty minutes before the end of the operation .” NCT06502067
1

“Granisetron (Granitryl 1 mg/ml, ampules, EGYPHARMA, Egypt)” NCT07401745

Known as GTDS “The study is to demonstrate non-inferiority of the Granisetron Transdermal Delivery System (GTDS) compared with the intravenous and oral Granisetron in the prevention of CINV...” NCT01662687
1

“OBJECTIVE: To evaluate the safety and efficacy of the granisetron transdermal delivery system (GTDS) combined with Dexamethasone for preventing” PMID 39026165 Jul 2024

Known as GTS “The granisetron transdermal system (GTS) showed non-inferior efficacy to oral granisetron to control chemotherapy-induced nausea and vomiting (CINV) during multiday chemotherapy.” PMID 25465680 Dec 2014
Known as intravenous graniseton “Drug: intravenous granisetonNCT05474001
Known as Kytril “Patients should be administered Kytril (granisetron) 1 mg orally, under fasted conditions (-2 to 2 hours away from meals), 30 minutes prior to administration of the AZD1775...” NCT03333824
1

“The Antigagging Effect of Granisetron (Kytril), an Antiemetic Drug, in Dental Situations” NCT00502437