Last Updated: May 11, 2026

CLINICAL TRIALS PROFILE FOR SANCUSO


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All Clinical Trials for SANCUSO

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00186628 ↗ Phase 2 Trial of Prophylactic Rituximab Therapy for Prevention of CGVHD Completed National Cancer Institute (NCI) Phase 2 2005-06-01 To determine if rituximab administered after allogeneic transplantation decreases the incidence of chronic graft-vs-host disease (cGvHD)
NCT00186628 ↗ Phase 2 Trial of Prophylactic Rituximab Therapy for Prevention of CGVHD Completed The Leukemia and Lymphoma Society Phase 2 2005-06-01 To determine if rituximab administered after allogeneic transplantation decreases the incidence of chronic graft-vs-host disease (cGvHD)
NCT00186628 ↗ Phase 2 Trial of Prophylactic Rituximab Therapy for Prevention of CGVHD Completed Stanford University Phase 2 2005-06-01 To determine if rituximab administered after allogeneic transplantation decreases the incidence of chronic graft-vs-host disease (cGvHD)
NCT00450801 ↗ R-MACLO-IVAM and Thalidomide in Untreated Mantle Cell Lymphoma Completed University of Miami Phase 2 2004-04-01 RATIONALE: To evaluate the efficacy of a new high intensity chemotherapy regimen with thalidomide maintenance in patients with newly diagnosed mantle cell lymphoma PURPOSE: This phase II trial is studying how well giving rituximab together with combination chemotherapy followed by thalidomide works in treating patients with previously untreated mantle cell lymphoma.
NCT00868764 ↗ An Investigation on the Effect of Age and BMI on the Pharmacokinetics of Transdermal Granisetron Completed Prostrakan Pharmaceuticals Phase 1 2009-04-01 This study aims to evaluate the effect of age and BMI on the pharmacokinetics and safety of Sancuso®.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for SANCUSO

Condition Name

Condition Name for SANCUSO
Intervention Trials
Chemotherapy Induced Nausea and Vomiting 3
Healthy 2
Healthy Volunteers 2
Vomiting 2
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Condition MeSH

Condition MeSH for SANCUSO
Intervention Trials
Vomiting 11
Nausea 8
Lymphoma, Mantle-Cell 2
Carcinoma 1
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Clinical Trial Locations for SANCUSO

Trials by Country

Trials by Country for SANCUSO
Location Trials
United States 17
Korea, Republic of 2
United Kingdom 2
Hong Kong 1
China 1
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Trials by US State

Trials by US State for SANCUSO
Location Trials
Pennsylvania 3
Texas 3
California 3
Florida 2
Washington 1
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Clinical Trial Progress for SANCUSO

Clinical Trial Phase

Clinical Trial Phase for SANCUSO
Clinical Trial Phase Trials
Phase 4 3
Phase 3 3
Phase 2 4
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Clinical Trial Status

Clinical Trial Status for SANCUSO
Clinical Trial Phase Trials
Completed 10
Terminated 2
Unknown status 2
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Clinical Trial Sponsors for SANCUSO

Sponsor Name

Sponsor Name for SANCUSO
Sponsor Trials
Prostrakan Pharmaceuticals 6
Kyowa Kirin Pharmaceutical Development Ltd 3
National Cancer Institute (NCI) 3
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Sponsor Type

Sponsor Type for SANCUSO
Sponsor Trials
Industry 14
Other 12
NIH 3
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SANCUSO (granisetron transdermal system): Clinical-trial status, market analysis, and projection

Last updated: May 4, 2026

What is SANCUSO and what indication does it serve?

SANCUSO is a granisetron transdermal system (antiemetic, 5-HT3 receptor antagonist). It is marketed for prevention of nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC) and for prevention of chemotherapy-induced nausea and vomiting (CINV). The product is dosed as a transdermal patch applied prior to chemotherapy. (Drug product labeling; see cited sources.)

Where is SANCUSO in the clinical pipeline today?

No active, late-stage (Phase 3/registrational) SANCUSO trials are identified in public trial registries under the granisetron transdermal system name. The body of clinical evidence is largely historical and supports the current label. (Clinical trial registry coverage; see cited sources.)

Clinical-trial footprint (public record, historical)

Publicly disclosed studies for granisetron transdermal and CINV prevention are primarily:

  • Phase 2/3 support studies for efficacy and safety in CINV prevention with MEC and/or similar chemotherapy settings.
  • Comparative and supportive pharmacology/safety analyses tied to transdermal delivery.

A current pipeline “read-through” is limited because the question asks for an update and projection for the marketed product, and the observable public record centers on label-supporting trials rather than new registrational programs. (Clinical trial registry coverage; see cited sources.)

What does the commercial market look like for SANCUSO-like therapy?

SANCUSO sits in the antiemetic segment of CINV supportive care, where usage is driven by chemotherapy administration patterns and guideline-based antiemetic regimens. The competitive set includes:

  • Other serotonin receptor antagonists (e.g., oral granisetron, ondansetron products, other 5-HT3 agents)
  • NK1 receptor antagonists (aprepitant, fosaprepitant)
  • Corticosteroids (dexamethasone)
  • Dopamine antagonists (e.g., metoclopramide in specific settings)
  • Combination regimen products and regimen protocols across MEC and HEC (highly emetogenic chemotherapy)

Key structural demand drivers

Demand for transdermal granisetron style therapy is influenced by:

  • Outpatient infusion workflows and the need for dosing convenience and adherence
  • Formulary selection within oncology support care pathways
  • Steroid-sparing or regimen simplification practices, where applicable
  • Patient-level considerations (e.g., nausea/vomiting risk plus inability to tolerate oral dosing)

Pricing, reimbursement, and channel dynamics (high-level)

For a U.S.-market assessment, SANCUSO’s commercial outcome is typically determined by:

  • Specialty pharmacy distribution and oncology-support formulary inclusion
  • Contracting and buy-and-bill patterns across oncology centers
  • Generic availability for comparators (primarily 5-HT3 products), which can compress pricing
  • Brand competition from more broadly entrenched CINV regimens and fixed protocols

What is the evidentiary base supporting SANCUSO’s differentiation?

SANCUSO’s primary differentiators in clinical practice and payer decisioning are tied to:

  • Transdermal delivery for granisetron (reducing reliance on oral intake at the moment of chemotherapy)
  • Convenient dosing workflow aligned with outpatient chemotherapy schedules
  • 5-HT3 mechanism with documented efficacy in CINV prevention within its labeled chemotherapy context

The label is the anchor for payer coverage and prescriber utilization; the clinical differentiation is typically not “new outcomes,” but operational fit (patch use vs. tablets/injection regimens). (Drug product labeling; see cited sources.)

What revenue and market projection is supportable from public data?

A precise, quarter-by-quarter revenue projection for SANCUSO requires company-specific sales disclosure or third-party forecasting datasets that are not included in the available public sources cited here. Under strict sourcing rules, only projections anchored in publicly citable metrics can be produced.

Market projection framework (transparency on what can be projected)

A supportable projection for SANCUSO can be framed around:

  • Chemotherapy-treated patient population trends
  • CINV supportive care utilization patterns within MEC cohorts
  • Share pressures from generic 5-HT3 agents and regimen standardization
  • Potential label stability (no new registrational pipeline signal changes in the public record)

Given the lack of citable product-level revenue metrics in the cited sources, this section focuses on scenario-based market sizing logic rather than numeric revenue forecasts.

Scenario-based commercialization outlook (2026-2030): how SANCUSO is likely to perform

The most decision-useful view is directional, driven by competitive structure and label position:

Base case: stable but modest share pressure

Assumptions implied by the competitive landscape:

  • Generic oral 5-HT3 agents remain widely available.
  • Guideline antiemetic regimens continue to favor combination approaches in many chemotherapy settings, limiting the addressable incremental value of single-mechanism options.
  • Transdermal convenience preserves a niche use case, supporting retention of existing demand.

Outcome: SANCUSO demand is likely to track broad chemotherapy supportive care stability with gradual share loss to lower-cost alternatives, absent new clinical or operational differentiators.

Downside case: greater substitution into oral/generic regimens

Assumptions:

  • Continued payer and provider preference for generics.
  • Broader adoption of standardized CINV pathways reduces “patch-first” decisions.

Outcome: declining unit demand over time, with potential erosion in formulary position and distribution share.

Upside case: formulary rescue via patient-specific workflow

Assumptions:

  • Transdermal use expands in outpatient centers seeking reduced adherence failures or simplified dosing workflows for MEC schedules.
  • Contracting outcomes sustain access.

Outcome: unit stabilization and potentially slower erosion versus base case.

Regulatory and lifecycle considerations that matter commercially

Patent and exclusivity posture

A projection for 2026-2030 depends on whether SANCUSO’s exclusivity or patent protections remain relevant in key markets. Patent calendars are usually decisive for generic entry risk. Under strict sourcing, no patent-expiration date can be asserted without cited patent documents.

Label continuity

Clinical development signals in the public record appear limited to historical trials supporting the current label. That typically implies:

  • Low probability of new indication-driven demand shocks in the near term.
  • Performance tied to uptake within existing label-constrained prescribing.

(Drug product labeling; see cited sources.)

Competitive positioning: where SANCUSO wins

SANCUSO is most likely to win when:

  • The oncology center’s antiemetic workflow has high adherence sensitivity.
  • Patients face oral intake barriers at key times.
  • Pharmacy teams prioritize simple administration aligned to clinic operations.

SANCUSO is less likely to win when:

  • Generic oral 5-HT3 is preferred by payers and used routinely.
  • Regimen standardization pushes clinicians toward combination schedules where transdermal 5-HT3 is not the marginal choice.

(Drug product labeling and the mechanism class evidence base; see cited sources.)

Competitive pressures: what constrains growth

Key constraints:

  • Class commoditization of 5-HT3 agents due to generic availability.
  • Protocol standardization and the dominance of multi-agent antiemetic regimens in many settings.
  • Limited “new-to-market” expansion if no new trial endpoints broaden the label or differentiate outcomes beyond operational fit.

What to watch in the next 12-24 months

Trial activity signals (public registry monitoring)

The highest-value signals for investors and partners would be:

  • Any new registrational trial registration for granisetron transdermal (new protocol number, new phase, new sponsor).
  • Any label expansion filing tied to a new chemotherapy emetogenicity category or expanded prophylaxis window.

Commercial signals

Commercial traction signals would be:

  • Formulary additions and contract wins at large payers and major oncology networks.
  • Evidence of sustained specialty pharmacy pull-through in outpatient chemotherapy settings.

(No forward-looking trial announcements are evidenced in the cited sources.)


Key Takeaways

  • SANCUSO is a granisetron transdermal system used for prevention of CINV in chemotherapy contexts covered by its label.
  • Public clinical-trial evidence is largely historical; the public record shows no clear active registrational pipeline signal for new SANCUSO indication expansion.
  • Commercial performance is likely driven by operational convenience and formulary access, while facing structural share pressure from generic oral 5-HT3 agents and protocol standardization.
  • A strict-data projection cannot produce defensible numeric revenue forecasts from the cited public sources; the decision-useful view is directional scenarios for 2026-2030: base case stable demand with modest share erosion, downside risk if substitution accelerates, upside only if transdermal workflow adoption strengthens.

FAQs

1) Is SANCUSO a 5-HT3 antagonist?

Yes. SANCUSO contains granisetron, a 5-HT3 receptor antagonist, formulated as a transdermal patch. (Drug product labeling; see cited sources.)

2) Does SANCUSO have active Phase 3 trials publicly listed right now?

No active registrational (Phase 3/label-expansion) trials for SANCUSO are evidenced in the cited public trial registry coverage. (Clinical trial registry coverage; see cited sources.)

3) What differentiates SANCUSO from oral granisetron in practice?

The main differentiator is transdermal delivery, which aligns with outpatient chemotherapy workflows and reduces dependence on oral dosing at critical times. (Drug product labeling; see cited sources.)

4) What is the biggest commercial headwind?

Substitution pressure from generic 5-HT3 products and standardized multi-agent CINV protocols that limit the incremental value of a single-agent transdermal option. (Mechanism class and label-based use; see cited sources.)

5) How should investors project demand without product revenue data?

Use scenario-based outlook tied to chemotherapy volumes, formulary access, and substitution dynamics, rather than attempting a numeric revenue forecast without citable sales inputs.


References

[1] U.S. Food and Drug Administration. Sancuso (granisetron transdermal system) prescribing information.
[2] ClinicalTrials.gov. Granisetron transdermal system search results and associated study records.

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