Sancuso (granisetron) / Kyowa Kirin, Solasia, Cumberland, Lee's Pharm - LARVOL DELTA

Population pharmacokinetic analysis of transdermal granisetron in healthy Chinese and Caucasian volunteers. (PubMed, Front Pharmacol) - "These findings suggested that no dose adjustment was required when applied to the Chinese population. In conclusion, this Pop PK study comparing the transdermal patch in Chinese and Caucasian healthy subjects provided valuable insights for optimizing dosage across ethnicities."

Journal • PK/PD data • Chemotherapy-Induced Nausea and Vomiting

NCCN Guidelines Insights: Antiemesis, Version 2.2017 (PubMed) - "The NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for Antiemesis address all aspects of management for chemotherapy-induced nausea and vomiting. These NCCN Guidelines Insights focus on recent updates to the NCCN Guidelines for Antiemesis, specifically those regarding carboplatin, granisetron, and olanzapine."

NCCN guideline

Cumberland Pharmaceuticals Announces Key Co-Promotion Agreement with Verity Pharmaceuticals to Expand Support for Sancuso (PRNewswire) - "Specialty pharmaceutical company Cumberland Pharmaceuticals Inc...announced today that it has entered into a national co-promotion agreement with Verity Pharmaceuticals International Ltd. to support Cumberland's new Sancuso® oncology support product....Under the terms of the agreement, Verity Pharmaceuticals, a specialty pharmaceutical company with an established commercial presence in the U.S., will promote Sancuso throughout most of the country through its national oncology sales organization."

Licensing / partnership • Chemotherapy-Induced Nausea and Vomiting • Oncology

Granisetron Transdermal Patch for Prophylaxis of Nausea and Vomiting in Patients Receiving Oral Anticancer Agents (clinicaltrials.gov) - P2 | N=60 | Recruiting | Sponsor: Fudan University | Not yet recruiting ➔ Recruiting | Trial completion date: Dec 2020 ➔ Dec 2022 | Trial primary completion date: Sep 2020 ➔ Sep 2022

Enrollment open • Trial completion date • Trial primary completion date • Chemotherapy-Induced Nausea and Vomiting • Oncology • Oral Cancer • Solid Tumor

Granisetron Transdermal Patch System for Prevention of CINV by CapeOX (clinicaltrials.gov) - P2 | N=57 | Recruiting | Sponsor: Tianjin Medical University Cancer Institute and Hospital

New P2 trial • Chemotherapy-Induced Nausea and Vomiting

Study to Assess Bioequivalence and Adhesion Properties Between Two Granisetron Transdermal Patches. (clinicaltrials.gov) - P1 | N=133 | Completed | Sponsor: Kyowa Kirin, Inc. | Recruiting ➔ Completed | Trial completion date: May 2022 ➔ Dec 2021 | Trial primary completion date: Apr 2022 ➔ Dec 2021

Trial completion • Trial completion date • Trial primary completion date

Bioequivalence Study in Healthy Chinese Subjects Comparing SP-01 (Granisetron Patch) Manufactured at Two Different Sites (clinicaltrials.gov) - P1 | N=66 | Completed | Sponsor: Solasia Pharma K.K. | Active, not recruiting ➔ Completed | Trial completion date: Apr 2022 ➔ Dec 2021

Trial completion • Trial completion date

"#CumberlandPharmaceuticals Acquires #Sancuso From #KyowaKirin North America $CPIX https://t.co/rc2Gp7fK1N" (@1stOncology)

Bioequivalence Study in Healthy Chinese Subjects Comparing SP-01 (Granisetron Patch) Manufactured at Two Different Sites (clinicaltrials.gov) - P1; N=66; Active, not recruiting; Sponsor: Solasia Pharma K.K.; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed

Bioequivalence Study in Healthy Chinese Subjects Comparing SP-01 (Granisetron Patch) Manufactured at Two Different Sites (clinicaltrials.gov) - P1; N=66; Recruiting; Sponsor: Solasia Pharma K.K.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open

Bioequivalence Study in Healthy Chinese Subjects Comparing SP-01 (Granisetron Patch) Manufactured at Two Different Sites (clinicaltrials.gov) - P1; N=66; Not yet recruiting; Sponsor: Solasia Pharma K.K.

Clinical • New P1 trial

Effect of Granisetron on Morphine Induced Pruritus in Cesarean Section (clinicaltrials.gov) - P2; N=80; Completed; Sponsor: Assiut University; Not yet recruiting ➔ Completed; N=40 ➔ 80; Trial completion date: Jul 2019 ➔ Oct 2020; Trial primary completion date: May 2019 ➔ Oct 2020

Enrollment change • Trial completion • Trial completion date • Trial primary completion date • Dermatology • Pruritus

Study to Assess Bioequivalence and Adhesion Properties Between Two Granisetron Transdermal Patches. (clinicaltrials.gov) - P1; N=132; Recruiting; Sponsor: Kyowa Kirin, Inc.

Clinical • New P1 trial

BMT-08: A Comparative Effectiveness Study of Transdermal Granisetron to Ondansetron (clinicaltrials.gov) - P4; N=90; Recruiting; Sponsor: University of Illinois at Chicago; Trial completion date: Oct 2021 ➔ May 2022; Trial primary completion date: Oct 2021 ➔ May 2022

Trial completion date • Trial primary completion date • Bone Marrow Transplantation • Chemotherapy-Induced Nausea and Vomiting • Transplantation

Granisetron Transdermal Patch for Prophylaxis of Delayed CINV (clinicaltrials.gov) - P3; N=140; Not yet recruiting; Sponsor: Fudan University

Clinical • Head-to-Head • New P3 trial • Chemotherapy-Induced Nausea and Vomiting

Sancuso® for Gastroparesis: An Open Label Study. (clinicaltrials.gov) - P3; N=14; Completed; Sponsor: Temple University; Recruiting ➔ Completed; N=40 ➔ 14

Clinical • Enrollment change • Trial completion • Gastrointestinal Disorder

Safety and Pharmacokinetics of Sancuso and IV Granisetron in Patients Aged 2 to 5 Years (clinicaltrials.gov) - P1; N=0; Withdrawn; Sponsor: Kyowa Kirin Pharmaceutical Development Ltd; N=16 ➔ 0; Not yet recruiting ➔ Withdrawn

Clinical • Enrollment change • Trial withdrawal • Chemotherapy-Induced Nausea and Vomiting • Oncology • Pediatrics

Pharmacokinetics and Safety of Sancuso and IV Granisetron in Pediatrics Aged 6 to 12 Years (clinicaltrials.gov) - P1; N=0; Withdrawn; Sponsor: Kyowa Kirin Pharmaceutical Development Ltd; N=16 ➔ 0; Not yet recruiting ➔ Withdrawn

Clinical • Enrollment change • Trial withdrawal • Chemotherapy-Induced Nausea and Vomiting • Oncology • Pediatrics

GRANISETRON TRANSDERMAL SYSTEM (GTDS) IN PREVENTING NAUSEA AND VOMITING INDUCED BY CISPLATIN-BASED CHEMOTHERAPY AND CONCURRENT RADIOTHERAPY FOR HEAD AND NECK CANCER GRANISTERON CEROTTO TRANSDERMICO (GTDS) NELLA PREVENZIONE DI NAUSEA E VOMITO INDOTTI DA RADIO-CHEMOTERAPIA A BASE DI CISPLATINO PER IL TRATTAMENTO DEI TUMORI DELLA TESTA E COLLO (clinicaltrialsregister.eu) - P2; N=88; Ongoing; Sponsor: G.O.N.O. - GRUPPO ONCOLOGICO DEL NORD OVEST

New P2 trial • Head and Neck Cancer • Oncology • Solid Tumor

[VIRTUAL] Effect of transdermal granisetron on prevention of nausea and vomiting during chemotherapy of lung cancer (ESMO Asia 2020) - "The granisetron transdermal delivery system (GTDS) has been developed to deliver granisetron continuously over 7 days to prevent CINV. Some previous cases receiving multiday highly emetogenic chemotherapy (HEC) regimens showed that the GTDS plus dexamethasone was not inferior to the GTDS plus dexamethasone and aprepitant...Legal entity responsible for the study: The authors. Funding: Has not received any funding."

Chemotherapy-Induced Nausea and Vomiting • Lung Cancer • Oncology • Solid Tumor

[VIRTUAL] Effect of transdermal granisetron on prevention of nausea and vomiting during chemotherapy of lung cancer (ESMO Asia 2020) - "The granisetron transdermal delivery system (GTDS) has been developed to deliver granisetron continuously over 7 days to prevent CINV. Some previous cases receiving multiday highly emetogenic chemotherapy (HEC) regimens showed that the GTDS plus dexamethasone was not inferior to the GTDS plus dexamethasone and aprepitant...Our study indicate that the two regimens therapy provides effective, well-tolerated control of multiday HEC. It offers a alternative route for delivering two regimens for up to 7 days that is as effective as three regimens."

Chemotherapy-Induced Nausea and Vomiting • Lung Cancer • Oncology • Solid Tumor

[VIRTUAL] Effect of transdermal granisetron on prevention of nausea and vomiting during chemotherapy of lung cancer (ESMO Asia 2020) - "The granisetron transdermal delivery system (GTDS) has been developed to deliver granisetron continuously over 7 days to prevent CINV. Some previous cases receiving multiday highly emetogenic chemotherapy (HEC) regimens showed that the GTDS plus dexamethasone was not inferior to the GTDS plus dexamethasone and aprepitant...Our study indicate that the two regimens therapy provides effective, well-tolerated control of multiday HEC. It offers a alternative route for delivering two regimens for up to 7 days that is as effective as three regimens."

Chemotherapy-Induced Nausea and Vomiting • Lung Cancer • Oncology • Solid Tumor

Oral Ondansetron Versus Transdermal Granisetron (Sancuso) for Women With Cervical, Endometrial or Vaginal Cancer Receiving Pelvic Chemoradiation (clinicaltrials.gov) - P3; N=76; Completed; Sponsor: M.D. Anderson Cancer Center; N=150 ➔ 76

Clinical • Enrollment change • Cervical Cancer • Endometrial Cancer • Oncology • Solid Tumor • Vaginal Cancer

Granisetron transdermal system and dexamethasone for the prevention of nausea and vomiting in multiple myeloma patients receiving chemo-mobilization: An observational real-world study of effectiveness and safety. (PubMed, Transfus Apher Sci) - "In real world, GTDS provided an innovative, effective, and well-tolerated control of CINV in MM patients after chemo-mobilization with CY. The study found out effectiveness of a non-invasive delivery system of antiemetic."

Clinical • Journal • Real-World Evidence • Chemotherapy-Induced Nausea and Vomiting • Hematological Malignancies • Multiple Myeloma • Oncology • CSF3

Transdermal versus oral granisetron in controlling chemotherapy-induced nausea and vomiting: a meta-analysis. (PubMed, Support Care Cancer) - "Oral granisetron is better in achieving complete control of CINV in patients receiving chemotherapy. As for the risk of constipation and QTc prolongation as adverse effects, there was no statistically significant difference between the two routes."

CINV • Journal • Retrospective data • Review • Chemotherapy-Induced Nausea and Vomiting • Constipation • Gastrointestinal Disorder • Oncology