Drugs / Granisetron
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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 · 8 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Filed chemotherapy-induced toxicity 1 milestone
Filed US (FDA) SUSTOL chemotherapy-induced toxicity 2015-07-20

“resubmitted its New Drug Application (NDA) for SUSTOL® (granisetron) Injection, extended release, for the prevention of acute and delayed chemotherapy-induced nausea and vomiting (CINV)” herontx.com ↗

“In July 2015, Heron resubmitted its New Drug Application (NDA) for SUSTOL®” herontx.com ↗

Approved Indication not stated 3 milestones
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

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 110 trials · 2 met primary
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 Met primary
Phase 1 NCT00834522 Jul 2005 — Teva Pharmaceuticals USA Completed Met primary
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 · 1 missed
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 Missed primary
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 Stop: Enrollment
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 · 4 met primary · 1 missed
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 Met primary
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 Met primary
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 Mixed
Phase 410 trials · 2 met primary
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 Met primary
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 Met primary
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 Stop: Enrollment
— 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
Comparator or background therapy52 trials
Phase 0 NCT04290026 Comparator Apr 2021 → Jan 2022 aspiration pneumonia Assiut University Unknown No outcome recorded
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

News releases announcing trial results or a regulatory action · 16

DateIssuerRelease
2016-08-10 Heron Therapeutics Regulatory Heron Therapeutics Announces U.S. FDA Approval of SUSTOL® (granisetron) Extended-Release Injection for the Prevention of Chemotherapy-Induced Nausea and Vomiting herontx.com ↗
Heron Therapeutics, Inc. (NASDAQ:HRTX), today announced that the U.S. Food and Drug Administration (FDA) has approved SUSTOL® (granisetron) extended-release injection.
2015-09-28 Heron Therapeutics Results Heron Therapeutics Announces Oral Presentation of Data from Completed Phase 3 MAGIC Study for SUSTOL® at the ASCO Breast Cancer Symposium herontx.com ↗
These data were presented in an oral presentation and poster titled “Phase III Study of APF530 versus Ondansetron with a Neurokinin 1 Antagonist + Corticosteroid in Preventing Highly Emetogenic Chemotherapy-Induced Nausea and Vomiting: MAGIC Trial.”
2015-09-18 Heron Therapeutics Regulatory Heron Therapeutics Announces FDA Acceptance of New Drug Application for SUSTOL® herontx.com ↗
The FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of January 17, 2016.
2015-07-20 Heron Therapeutics Regulatory Heron Therapeutics Resubmits SUSTOL® New Drug Application to FDA herontx.com ↗
2012-10-16 Heron Therapeutics Regulatory A.P. Pharma Announces PDUFA Action Date for APF530 New Drug Application Resubmission herontx.com ↗
A.P. Pharma, Inc. (OTCBB: APPA), a specialty pharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has accepted the Company’s resubmission of its New Drug Application (NDA) for APF530.
2012-09-28 Heron Therapeutics Regulatory A.P. Pharma Resubmits New Drug Application for APF530, a Product Candidate for the Prevention of Chemotherapy-Induced Nausea and Vomiting herontx.com ↗
A.P. Pharma, Inc. (OTCBB: APPA), a specialty pharmaceutical company, today announced that it has resubmitted its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its lead product candidate, APF530, for the prevention of acute- and delayed-onset chemotherapy-induced nausea and vomiting (CINV).
2011-04-25 Heron Therapeutics Regulatory A.P. Pharma Provides Regulatory Update on APF530 NDA herontx.com ↗
The FDA acknowledged that the single-syringe design would be an improvement, suggested certain labeling enhancements, and requested additional, non-clinical, human factors studies be conducted prior to resubmission.
2010-03-19 Heron Therapeutics Regulatory A.P. Pharma Receives FDA Complete Response Letter for APF530 herontx.com ↗
A.P. Pharma, Inc. (Nasdaq:APPA), a specialty pharmaceutical company, today announced that it received a Complete Response Letter from the U.S. Food and Drug Administration (FDA or Agency) regarding its New Drug Application (NDA) for APF530 in the prevention of both acute and delayed onset chemotherapy-induced nausea and vomiting (CINV).
2009-07-20 Heron Therapeutics Regulatory A.P. Pharma Announces FDA Acceptance of APF530 New Drug Application for Chemotherapy-Induced Nausea and Vomiting herontx.com ↗
A.P. Pharma, Inc. (Nasdaq:APPA), a specialty pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for APF530 for the potential treatment of chemotherapy-induced nausea and vomiting (CINV).
2008-11-05 Heron Therapeutics Results A.P. Pharma Reports Results for the Third Quarter 2008 herontx.com ↗
The additional data from the Phase 3 study provided herein includes predetermined secondary efficacy endpoints and safety data that were not available at the time the top-line data were released.
2008-09-30 Heron Therapeutics Results A.P. Pharma Announces Positive Phase 3 Results with APF530 in the Prevention of CINV herontx.com ↗
A.P. Pharma, Inc. (NASDAQ:APPA), a specialty pharmaceutical company, announced today positive results from its pivotal Phase 3 study comparing the efficacy of APF530 (the Company's proprietary, sustained release formulation of granisetron) with Aloxi(R) for the prevention of chemotherapy induced nausea and vomiting (CINV).
2008-01-03 Teva Branded Pharmaceutical Products R&D, Inc. Regulatory Teva Announces Approval Of Generic Kytril® Injection And Tablets tevapharm.com ↗
the U.S. Food and Drug Administration (FDA) has granted final approval for the Company's Abbreviated New Drug Applications (ANDA)

All press releases naming this drug 33 releases

DateIssuerRelease

Evidence & citations 36 cited values

Every value below carries the sentence it was read from. 107 sources stand behind the page.

FieldValueCited text
Known as Granisetron “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 ↗

Show 90 more sources

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

NCT00293384 ↗

NCT00004219 ↗

NCT03924518 ↗

NCT00359567 ↗

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 “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 graniseton” NCT05474001 ↗
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 ↗