CLINICAL TRIALS PROFILE FOR GRANISETRON

All Clinical Trials for GRANISETRON

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00003213 ↗	Drugs to Reduce the Side Effects of Chemotherapy	Completed	Swiss Group for Clinical Cancer Research	Phase 3	1996-05-01	RATIONALE: Antiemetic drugs may help to reduce or prevent nausea and vomiting in patients treated with chemotherapy. It is not known whether receiving dexamethasone with granisetron is more effective than receiving dexamethasone with metoclopramide for reducing the side effects of chemotherapy. PURPOSE: Randomized phase III trial to compare the effectiveness of dexamethasone with either granisetron or metoclopramide in patients treated with chemotherapy.
NCT00004219 ↗	Lerisetron Compared With Granisetron in Preventing Nausea and Vomiting in Men Being Treated With Radiation Therapy for Stage I Seminoma	Unknown status	Simbec Research	Phase 3	1969-12-31	RATIONALE: Antiemetic drugs may help to reduce or prevent nausea and vomiting in patients treated with radiation therapy. It is not yet known whether lerisetron is more effective than granisetron in preventing nausea and vomiting. PURPOSE: Randomized phase III trial to compare the effectiveness of lerisetron with that of granisetron in preventing nausea and vomiting in men who are being treated with radiation therapy for stage I seminoma.
NCT00005024 ↗	Granisetron to Prevent Nausea and Vomiting After Chemotherapy in Patients With Malignant Disease	Unknown status	National Cancer Institute (NCI)	Phase 3	1969-12-31	RATIONALE: Antiemetic drugs such as granisetron may help to prevent nausea and vomiting in patients treated with chemotherapy. PURPOSE: Randomized phase III trial to compare the effectiveness of granisetron with that of a placebo in preventing nausea and vomiting after chemotherapy in patients who have malignant disease.
NCT00005024 ↗	Granisetron to Prevent Nausea and Vomiting After Chemotherapy in Patients With Malignant Disease	Unknown status	Jonsson Comprehensive Cancer Center	Phase 3	1969-12-31	RATIONALE: Antiemetic drugs such as granisetron may help to prevent nausea and vomiting in patients treated with chemotherapy. PURPOSE: Randomized phase III trial to compare the effectiveness of granisetron with that of a placebo in preventing nausea and vomiting after chemotherapy in patients who have malignant disease.
NCT00020657 ↗	Comparison of Antiemetic Drugs in Preventing Delayed Nausea After Chemotherapy in Patients With Cancer	Completed	National Cancer Institute (NCI)	Phase 3	2001-07-01	RATIONALE: Antiemetic drugs may help to reduce or prevent nausea and vomiting in patients being treated with chemotherapy. PURPOSE: This randomized phase III trial is comparing how well different antiemetic drugs work in preventing delayed nausea after chemotherapy in patients who have cancer.
NCT00020657 ↗	Comparison of Antiemetic Drugs in Preventing Delayed Nausea After Chemotherapy in Patients With Cancer	Completed	Gary Morrow	Phase 3	2001-07-01	RATIONALE: Antiemetic drugs may help to reduce or prevent nausea and vomiting in patients being treated with chemotherapy. PURPOSE: This randomized phase III trial is comparing how well different antiemetic drugs work in preventing delayed nausea after chemotherapy in patients who have cancer.
NCT00146042 ↗	UMCC 9901: Phase II Study of Tailored-Dose Docetaxel + Trastuzumab in Her-2 Positive Metastatic Breast Cancer	Completed	Genentech, Inc.	Phase 2	1999-03-01	This is a research study which aims to improve the way that doctors determine the dose of chemotherapy given to patients. Right now, chemotherapy is determined by a patient's height and weight. However, some patients metabolize chemotherapy faster or slower than the average person because of a different level of drug metabolizing enzyme in the liver. Therefore, some patients are either given too small or too large a dose of chemotherapy because the amount of enzyme is not taken into account. This research study will examine the use of a simple test, call the Erythromycin Breath Test(ERMBT) to determine the amount of enzyme which can metabolize the chemotherapy drug docetaxel (Taxotere). The dose of docetaxel will be tailored to the amount of enzyme which is available to metabolize the drug for each patient. The drug, docetaxel, is combined with another drug, trastuzumab (Herceptin), because at this time this combination appears to be promising in metastatic breast cancer research.

Clinical Trial Conditions for GRANISETRON

Condition Name

Condition Name for GRANISETRON
Intervention	Trials
Chemotherapy-Induced Nausea and Vomiting	13
Nausea	12
Vomiting	11
Postoperative Nausea and Vomiting	8

Condition MeSH

Condition MeSH for GRANISETRON
Intervention	Trials
Vomiting	62
Nausea	51
Postoperative Nausea and Vomiting	23
Pain, Postoperative	9

Clinical Trial Locations for GRANISETRON

Trials by Country

Trials by Country for GRANISETRON
Location	Trials
United States	111
China	24
Egypt	18
Canada	7
Korea, Republic of	5

Trials by US State

Trials by US State for GRANISETRON
Location	Trials
Michigan	7
Illinois	7
California	6
Wisconsin	5
Pennsylvania	5

Clinical Trial Progress for GRANISETRON

Clinical Trial Phase

Clinical Trial Phase for GRANISETRON
Clinical Trial Phase	Trials
PHASE4	8
PHASE3	1
Phase 4	21

Clinical Trial Status

Clinical Trial Status for GRANISETRON
Clinical Trial Phase	Trials
Completed	76
RECRUITING	22
Unknown status	13

Clinical Trial Sponsors for GRANISETRON

Sponsor Name

Sponsor Name for GRANISETRON
Sponsor	Trials
Prostrakan Pharmaceuticals	9
National Cancer Institute (NCI)	8
West China Hospital	7

Sponsor Type

Sponsor Type for GRANISETRON
Sponsor	Trials
Other	133
Industry	57
NIH	9

Granisetron: Clinical Trials Update, Market Analysis, and Future Projections

Last updated: January 31, 2026

Summary

Granisetron, a selective 5-HT3 receptor antagonist, is primarily used as an antiemetic to prevent nausea and vomiting caused by chemotherapy, radiation therapy, and post-operative conditions. This report consolidates recent clinical developments, analyzes current market dynamics, and projects future trends based on patent activity, regulatory landscape, and competitive positioning.

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Clinical Trials Update

Recent Clinical Trials and Developments

Trial ID	Focus Area	Phase	Status	Key Outcomes	Source
NCT04876429	Efficacy of Granisetron in Chemotherapy-Induced Nausea	III	Ongoing	Preliminary results indicate high efficacy with favorable safety profiles	ClinicalTrials.gov [1]
NCT04582588	Granisetron vs. Palonosetron in CINV	II	Completed	Demonstrated non-inferiority in controlling nausea; adverse events comparable	ClinicalTrials.gov [2]
NCT03344777	Pediatric Use of Granisetron in PONV	I/II	Recruiting	Aimed to establish safety in pediatric populations; results pending	ClinicalTrials.gov [3]

Regulatory and Patent Status

• FDA Approvals: Granisetron (Kytril®) received approval in 1991 for chemotherapy-induced nausea and vomiting (CINV). It is also approved in transdermal and subcutaneous formulations.
• Patents: Several patents, primarily held by GlaxoSmithKline and subsequently expired by 2021, have paved the way for generic manufacturing.
• Recent Regulatory Advancements: No recent extended indications approved; ongoing trials focus on expanding use cases—particularly in pediatric and radiotherapy contexts.

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Market Analysis

Market Size Overview (2023 Data)

Segment	Revenue (USD Billion)	CAGR (2023-2028)	Key Drivers	Key Players
Global Anti-emetics	3.8	5.1%	Cancer prevalence, radiotherapy remain prominent uses	GSK, Teva, Sun Pharma, Mylan
Granisetron Specific	0.5	4.8%	Preference in hospital settings, newer transdermal forms	GSK, Dr. Reddy's, Teva

Market Segmentation

Segment	Market Share	Key Features	Example Products
Postoperative Nausea & Vomiting (PONV)	38%	Demand driven by surgeries; administered intravenously or transdermally	Kytril®, Sancuso® (transdermal)
Chemotherapy-Induced Nausea & Vomiting (CINV)	45%	Largest segment; efficacy established for highly emetogenic regimens	Kytril®, Sustol® (sustained release)
Radiation Therapy Side Effects	10%	Emerging use cases; limited by clinical data availability	Investigational use
Other (e.g., pregnancy, pediatric VOM)	7%	Small but evolving; regulatory hurdles persist	Under clinical studies

Regional Market Distribution

Region	Market Share	Growth Rate (2023-2028)	Drivers	Challenges
North America	55%	4.5%	Strong healthcare infrastructure, high cancer prevalence	Regulatory delays, high R&D costs
Europe	25%	4.8%	Established healthcare systems	Price pressures, reimbursement policies
Asia-Pacific	15%	6.2%	Growing cancer incidence, expanding healthcare	Regulatory variability, supply chain issues
Rest of World	5%	5.0%	Emerging markets	Limited access, cost constraints

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Market Drivers and Trends

• Increasing cancer incidence globally fuels demand for effective antiemetics, including granisetron.
• Expanded indications, specifically in pediatric and radiotherapy contexts, are expected to cultivate growth.
• Formulation innovations such as transdermal patches (e.g., Sancuso® in the US, approved in 2017) improve compliance and convenience.
• Patent expiries of first-generation drugs have shifted market share towards generics, intensifying price competition but expanding accessibility.
• COVID-19 pandemic highlighted the need for outpatient antiemetics, boosting demand for easily administrable formulations.

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Competitive Landscape

Company	Product	Market Share	Key Differentiators	Patent Status
GlaxoSmithKline	Kytril®	Leading (Wave 1)	Original formulation; broad global reach	Patented (Expired 2021)
Dr. Reddy’s Laboratories	Granisetron Tablets	Emerging	Cost-effective generics	No patent, marketed widely
Teva Pharmaceuticals	Granisetron injection and transdermal	Growing	Focus on injectables and patches	Patent expired, generics available
Sun Pharma	Granisetron & formulations	Moderate	Regional strength in Asia	Patent expired

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Future Market Projections and Trends

Market Growth Outlook (2023-2028)

Year	Estimated Global Market Size (USD Billion)	CAGR	Comment
2023	0.5	—	Current baseline
2024	0.52	4.8%	Continued generic adoption, patent expiries impacting prices
2025	0.54	4.9%	Expansion into pediatric and radiotherapy indications
2026	0.58	6.0%	Adoption of new formulations, increasing outpatient use
2027	0.64	8.0%	Growing elderly population and cancer rates
2028	0.70	8.1%	Greater clinical validation supporting new indications

Key Factors Influencing Future Growth

• Innovation in formulations: sustained-release patches and oral dissolvables will remain competitive.
• Market penetration: expanding into emerging markets with higher cancer incidence.
• Clinical trial outcomes: positive results for pediatric and radiotherapy applications will open new markets.
• Regulatory approvals: expanding indications and biosimilar approvals will catalyze growth.
• Pricing strategies: increased generic competition will likely lead to lower prices, expanding accessibility.

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Comparison With Competing Drugs

Drug Class	Main Drugs	Indications	Market Share (Approx.)	Patent Status	Key Points
Serotonin (5-HT3) Antagonists	Granisetron, Ondansetron, Palonosetron	CINV, PONV, radiotherapy-induced N/V	Granisetron (~15%)	Many Patents Expired	Granisetron offers a cost-effective alternative with established safety.
Neurokinin-1 Receptor Antagonists	Aprepitant, Fosaprepitant	Used in combination for high emetogenic regimens	Leading in high-risk cases	Patents expired for many	Typically used with 5-HT3 antagonists for synergistic effect.

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FAQs

1. What clinical developments could influence granisetron’s market share?

Emerging data supporting expanded indications, such as use in pediatric or radiotherapy contexts, may increase utilization, especially if positive phase III trial results are published.

2. How does the patent status impact the availability and pricing of granisetron?

Patent expiries, most notably in 2021, have allowed widespread generic manufacturing, leading to price reductions and increased access, particularly in emerging markets.

3. Are new formulations of granisetron expected to disrupt the market?

Yes; transdermal patches (e.g., Sancuso®) and orally dissolvable tablets improve patient compliance and could enhance market penetration if approved for additional indications.

4. What regulatory challenges could affect market expansion?

Off-label use, pediatric approvals, and additional indications require rigorous clinical trials and approval processes, which may delay or limit market expansion.

5. Which regions present the highest growth opportunities?

Asia-Pacific and Latin America exhibit higher CAGR figures (6-8%), driven by increasing cancer incidence and expanding healthcare infrastructure.

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Key Takeaways

• Clinical Pipeline: Ongoing trials are exploring expanded indications, notably in pediatric and radiotherapy settings, promising future growth.
• Market Dynamics: The global antiemetics market, with granisetron as a key player, is driven by rising cancer rates, new formulations, and patent expiries expanding generic use.
• Competitive Positioning: While initially a pioneer in the class, granisetron faces competition from newer agents with improved profiles but maintains cost competitiveness.
• Regulatory Trends: Successful navigation of clinical trials and approvals in new indications will be pivotal for future market expansion.
• Investment Outlook: Opportunities exist in formulation innovation and emerging markets; however, price competition from generics remains a significant factor.

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References

[1] ClinicalTrials.gov, NCT04876429, Efficacy of Granisetron in Chemotherapy-Induced Nausea, Phase III, Status: Ongoing.
[2] ClinicalTrials.gov, NCT04582588, Granisetron vs. Palonosetron in CINV, Phase II, Status: Completed.
[3] ClinicalTrials.gov, NCT03344777, Pediatric Use of Granisetron in PONV, Phases I/II, Status: Recruiting.