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.

Clinical Trial Conditions for Granisetron

Condition Name

Condition Name for Granisetron
Intervention	Trials
Chemotherapy-induced Nausea and Vomiting	13
Nausea	12
Vomiting	11
Healthy	7

Condition MeSH

Condition MeSH for Granisetron
Intervention	Trials
Vomiting	62
Nausea	51
Postoperative Nausea and Vomiting	19
Breast Neoplasms	5

Clinical Trial Locations for Granisetron

Trials by Country

Trials by Country for Granisetron
Location	Trials
United States	111
China	22
Egypt	12
Canada	7
Korea, Republic of	5

Trials by US State

Trials by US State for Granisetron
Location	Trials
Michigan	7
Illinois	7
California	6
Pennsylvania	5
Massachusetts	5

Clinical Trial Progress for Granisetron

Clinical Trial Phase

Clinical Trial Phase for Granisetron
Clinical Trial Phase	Trials
Phase 4	21
Phase 3	27
Phase 2/Phase 3	2

Clinical Trial Status

Clinical Trial Status for Granisetron
Clinical Trial Phase	Trials
Completed	71
Recruiting	17
Unknown status	13

Clinical Trial Sponsors for Granisetron

Sponsor Name

Sponsor Name for Granisetron
Sponsor	Trials
Prostrakan Pharmaceuticals	9
National Cancer Institute (NCI)	8
Merck Sharp & Dohme Corp.	7

Sponsor Type

Sponsor Type for Granisetron
Sponsor	Trials
Other	119
Industry	57
NIH	9

Granisetron: Clinical Trials, Market Analysis, and Projections

Introduction to Granisetron

Granisetron is a selective serotonin-3 (5-HT3) receptor antagonist widely used to prevent nausea and vomiting associated with chemotherapy, radiotherapy, and postoperative recovery. Its efficacy and safety have been extensively evaluated in various clinical trials, and it remains a crucial component in the management of chemotherapy-induced nausea and vomiting (CINV).

Clinical Trials Update

Extended-Release Granisetron Injection (SUSTOL)

In 2016, the FDA approved extended-release granisetron injection (SUSTOL®) for the prevention of acute and delayed CINV in adults undergoing moderately emetogenic chemotherapy or anthracycline and cyclophosphamide (AC) combination chemotherapy regimens. This approval was based on two large, guideline-based clinical trials involving over 2,000 patients, which demonstrated SUSTOL's efficacy in both the acute and delayed phases of CINV[1].

Granisetron Transdermal Delivery System (GTDS)

A recent open-label, prospective, multi-center phase II trial evaluated the safety and efficacy of the granisetron transdermal delivery system (GTDS) combined with dexamethasone for preventing CINV in patients receiving Capecitabine plus Oxaliplatin (CapeOX) therapy. The trial showed a complete control rate of 72.7% for delayed CINV and 81.8% for the acute phase, with no serious adverse events related to the antiemetic regimen reported[4].

Market Analysis

Market Size and Growth

The granisetron market is projected to experience significant growth over the coming years. As of 2023, the market size was valued at USD 1.4 billion and is expected to reach USD 2 billion by 2031, growing at a CAGR of 5.2% from 2024 to 2031[3].

Another report estimates the market size to be USD 7.01 billion in 2023, expected to reach USD 10.96 billion by 2030 at a CAGR of 6.58%[5].

Key Drivers of Market Growth

• Rise in Chemotherapy and Radiotherapy: The increasing burden of cancer is driving the demand for chemotherapy and radiotherapy, which in turn increases the need for antiemetic drugs like granisetron[2][3][5].
• Prevalence of Gastroparesis: The growing incidence of gastroparesis also contributes to the demand for granisetron[2].
• Advances in Drug Delivery Technologies: Innovations in drug formulations, such as extended-release and transdermal delivery systems, are enhancing the efficacy and patient adherence to granisetron[1][4][5].
• Global Healthcare Infrastructure Expansion: The expansion of healthcare infrastructure and increased access to healthcare services globally are further driving the market growth[3][5].

Regional Market Performance

• North America: This region holds the largest market share due to the high burden of cancer cases and the increased adoption of granisetron among cancer patients. The American Cancer Society estimates a significant increase in cancer cases, which is expected to drive market growth in this region[2].
• Asia-Pacific: This region is expected to be the fastest-growing market for granisetron, driven by emerging healthcare infrastructure and increasing awareness among healthcare professionals about effective nausea management[2][5].

Market Projections

Forecast Period

The granisetron market is expected to grow significantly during the forecast period from 2025 to 2030. Here are some key projections:

• Market Size: The market is projected to grow from USD 7.43 billion in 2024 to USD 10.96 billion by 2030 at a CAGR of 6.58%[5].
• CAGR: The market is expected to register a CAGR of 6.20% to 6.58% during the forecast period[2][5].
• Regional Growth: North America will continue to hold a significant share, while the Asia-Pacific region will experience the highest growth rate[2][5].

Competitive Landscape

The granisetron market is dominated by several key players, including:

• Heron Therapeutics, Inc.
• Kyowa Kirin Co., Ltd.
• Viatris
• Hikma Pharmaceuticals PLC
• Fresenius SE & Co. KGaA[2].

These companies are focusing on product development, innovation in drug delivery systems, and strategic investments to maintain their market position.

Adverse Effects and Safety Considerations

While granisetron is effective in preventing CINV, it is associated with several adverse effects, including:

• Injection Site Reactions: These can include infection, bleeding, pain, tenderness, nodules, swelling, and induration[1].
• Hypersensitivity Reactions: These can occur up to 7 days or longer after administration[1].
• Serotonin Syndrome: This is particularly a risk with concomitant use of serotonergic drugs[1].
• Renal Impairment: Granisetron should be avoided in patients with severe renal impairment and administered cautiously in those with moderate renal impairment[1].

Key Takeaways

• Clinical Efficacy: Granisetron has been proven effective in preventing both acute and delayed phases of CINV through various clinical trials.
• Market Growth: The granisetron market is expected to grow significantly due to the rise in chemotherapy and radiotherapy visits, advances in drug delivery technologies, and the expansion of global healthcare infrastructure.
• Regional Performance: North America holds the largest market share, while the Asia-Pacific region is expected to be the fastest-growing.
• Safety Considerations: While effective, granisetron is associated with several adverse effects that need to be monitored and managed.

FAQs

What is the current market size of the granisetron market?

The granisetron market size was estimated at USD 1.4 billion in 2023 and USD 7.01 billion in another report[3][5].

What is the projected CAGR for the granisetron market?

The market is expected to register a CAGR of 6.20% to 6.58% during the forecast period from 2025 to 2030[2][5].

Which region is expected to grow the fastest in the granisetron market?

The Asia-Pacific region is estimated to grow at the highest CAGR over the forecast period[2][5].

What are the key drivers of the granisetron market growth?

Key drivers include the rise in chemotherapy and radiotherapy visits, the increasing prevalence of gastroparesis, advances in drug delivery technologies, and the expansion of global healthcare infrastructure[2][3][5].

Who are the major players in the granisetron market?

Major players include Heron Therapeutics, Inc., Kyowa Kirin Co., Ltd., Viatris, Hikma Pharmaceuticals PLC, and Fresenius SE & Co. KGaA[2].

Sources

1. FDA Approves Extended-Release Granisetron Injection for the Prevention of CINV. ESMO, August 18, 2016.
2. Granisetron Market Size & Share Analysis - Industry Research Report. Mordor Intelligence.
3. Granisetron Hydrochloride Market Size and Projections. Market Research Intellect.
4. Prolonged administration of the granisetron transdermal delivery system combined with Dexamethasone for preventing chemotherapy-induced nausea and vomiting. PubMed, July 18, 2024.
5. Granisetron Market Size & Share 2025-2030. 360iResearch.

Last updated: 2025-01-01