SANCUSO (granisetron)
Sancuso is indicated for the prevention of nausea and vomiting in adults receiving moderately or highly emetogenic chemotherapy regimens for up to five consecutive days. This transdermal system provides a prophylactic option for patients undergoing multi-day chemotherapy cycles.
How SANCUSO Works
Granisetron is a selective 5-HT3 receptor antagonist. During chemotherapy, mucosal enterochromaffin cells release serotonin, which stimulates 5-HT3 receptors located on peripheral vagal nerve terminals and centrally in the chemoreceptor trigger zone. By blocking these receptors, granisetron prevents the vagal afferent discharge and subsequent signaling that induces the vomiting reflex.
Details
- Status
- Prescription
- First Approved
- 2008-09-12
- Routes
- TRANSDERMAL
- Dosage Forms
- FILM, EXTENDED RELEASE
SANCUSO Approval History
What SANCUSO Treats
2 indicationsSANCUSO is approved for 2 conditions since its original approval in 2008. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Nausea
- Vomiting
SANCUSO Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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Clinical Trial Registry
22 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT02858310 results posted | 160154 16-C-0154 | Ph 1, Ph 2 | completed | E7 TCR T Cells for Human Papillomavirus-Associated Cancers |
| NCT07401745 TMD | R.25.10.27 | Ph 4 | active not recruiting | Occlusal Splint Combined With Granisetron Injection for Management of Myofascial Pain Related to Temporomandibular Disorders |
| NCT07360431 | GRAN-PONV-LC | Ph 4 | not yet recruiting | Granisetron Combined With Dexamethasone or Metoclopramide for PONV Prevention After Laparoscopic Cholecystectomy |
| NCT03817970 | 18-1752.cc R01GM123330 | Ph 3 | active not recruiting | Cisplatin Disposition and Kidney Injury |
| NCT00868764 | 392MD/40/C | Ph 1 | completed | An Investigation on the Effect of Age and BMI on the Pharmacokinetics of Transdermal Granisetron |
| NCT00873197 | 392MD/41/C | Ph 1 | completed | PK, Tolerability and Safety of the Co-administration of Sancuso® (Transdermal Granisetron) and IV Granisetron |
| NCT00890565 | 392MD/39/C | Ph 1 | completed | Safety Study of Electrocardiogram (ECG) Effects of Sancuso® (Granisetron TDS) |
| NCT04501211 | 1706966663 | Ph 2 | withdrawn | Open Label Transdermal Granisetron to Relieve Chronic Nausea and Emesis |
| NCT05087615 PONV | ManoochehrEbrahimian | Ph 3 | completed | Effects of Ondansetron, Metoclopramide and Granisetron on Perioperative Nausea and Vomiting in Patients Undergone Bariatric Surgery |
| NCT03483870 | Granisetron in C.S | Ph 2 | completed | Effect of Granisetron on Morphine Induced Pruritus in Cesarean Section |
| NCT04918862 | MS-380-2020 | Ph 3 | completed | 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 |
| NCT01536392 results posted | 2011-1107 NCI-2012-00221 | Ph 3 | completed | Oral Ondansetron Versus Transdermal Granisetron (Sancuso) for Women With Cervical, Endometrial or Vaginal Cancer Receiving Pelvic Chemoradiation |
| NCT04613726 | B.30.2.ATA.0.01.00/166 | Ph 3 | completed | The Effect of Intravenous Granisetron and Ondansetron in Patients Undergoing Cesarean Section |
| NCT03503292 results posted | 17-011283 | Ph 4 | completed | Pharmacogenomics and Post-Operative Nausea and Vomiting |
| NCT02457195 GTPPONV results posted | HRP-592 | Ph 2 | completed | Granisetron Transdermal Patch for Prevention of Postoperative Nausea and Vomiting |
| NCT01183481 results posted | RINV Prophylaxis | Ph 2 | terminated | Aprepitant and Granisetron for the Prophylaxis of Radiation Induced Nausea and Vomiting - A Pilot Study |
| NCT02588547 | SM102015 | Ph 2 | completed | Prevention of Spinal Induced Shivering During CS |
| NCT00952341 results posted | 0869-169 2009_626 | Ph 3 | completed | Aprepitant/MK0869 for Prevention of Chemotherapy Induced Nausea and Vomiting Associated With Cisplatin (0869-169)(COMPLETED) |
| NCT01499849 results posted | TS-P04832 | Ph 3 | completed | Ph3 Safety/Efficacy Study of Rolapitant for the Prevention of CINV in Subjects Receiving Highly Emetogenic Chemotherapy |
| NCT01500226 results posted | TS-P04834 | Ph 3 | completed | Ph 3 Safety/Efficacy Study of Rolapitant for Prevention of CINV in Subjects Receiving Moderately Emetogenic Chemotherapy |
| NCT01500213 HEC results posted | TS-P04833 | Ph 3 | completed | Ph3 Safety/Efficacy Study of Rolapitant for the Prevention of CINV in Subjects Receiving Highly Emetogenic Chemotherapy |
| NCT01909856 | sim-palonosetron | Ph 2 | completed | The Efficacy and Safety of Palonosetron in Preventing the Gastrointestinal Reactions Induced by 3-day Highly Emetogenic Chemotherapy |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
SANCUSO FDA Label Details
Indications & Usage
FDA Label (PDF)SANCUSO is indicated for the treatment of Nausea; Vomiting.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.