SUSTOL (granisetron)
Sustol is an extended-release 5-HT3 receptor antagonist indicated for use in combination with other antiemetics in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy (MEC) or anthracycline and cyclophosphamide (AC) combination regimens. It is designed to provide therapeutic levels of medication to address symptoms across both the acute (0–24 hours) and delayed (24–120 hours) phases post-chemotherapy.
How SUSTOL Works
Granisetron is a selective 5-hydroxytryptamine 3 (5-HT3) receptor antagonist with minimal affinity for other receptor types. Chemotherapeutic agents trigger the release of serotonin from mucosal enterochromaffin cells in the small intestine, which stimulates 5-HT3 receptors located on vagal nerve terminals (peripheral) and in the chemoreceptor trigger zone of the area postrema (central).
Development Insights
Details
- Status
- Prescription
- First Approved
- 2016-08-09
- Routes
- SUBCUTANEOUS
- Dosage Forms
- INJECTABLE
SUSTOL Approval History
What SUSTOL Treats
2 indicationsSUSTOL is approved for 2 conditions since its original approval in 2016. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Nausea
- Vomiting
SUSTOL 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.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
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.
Drugs Similar to SUSTOL
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
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.
SUSTOL FDA Label Details
Indications & Usage
FDA Label (PDF)SUSTOL 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.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment