You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: December 12, 2025

CLINICAL TRIALS PROFILE FOR KYTRIL


✉ Email this page to a colleague

« Back to Dashboard


All Clinical Trials for KYTRIL

Trial ID Title Status Sponsor Phase Start Date Summary
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.
NCT00231478 ↗ A Study of Kytril (Granisetron) in the Prevention of Post-Operative Nausea and Vomiting (PONV) in Pediatric Subjects Undergoing Tonsillectomy or Adenotonsillectomy Completed Hoffmann-La Roche Phase 4 2007-04-01 This 2 arm study will evaluate the efficacy and safety of a single intravenous injection of Kytril in preventing postoperative nausea and vomiting (PONV) in children. Patients will be randomized to receive a single dose of either 20 micrograms or 40 micrograms Kytril intravenously (iv) 15 minutes prior to the end of surgery with general anesthesia for tonsillectomy or adenotonsillectomy. The anticipated time on study treatment is
NCT00256841 ↗ Hypo-Hyperfractionated Chest Radiation for Non Small Cell Lung Cancer With Taxotere/Xeloda Combination Chemotherapy Withdrawn Clinical Oncology Research Associates Phase 1/Phase 2 2005-09-01 The study is designed for patients with non small cell lung cancer whose cancer is too advanced and therefore cannot be operated with the goal of completely removing the cancer. At this stage of the disease, most patients cannot be cured from the disease, however, treatment can help to live longer and better by keeping the cancer under control. For that purpose, patients traditionally receive radiation therapy or chemotherapy or both treatments in succession. Recently, the administration of both treatment methods given concurrently showed somewhat better results when compared to successive administration. In some studies the drug Taxotere together with radiation performed well in keeping the cancer better under control. Combination of the drug Taxotere together with a compound called 5-FU either as continuous infusion or in its oral form of a pill called "Xeloda" enhanced its anti cancer activity substantially. One goal of this study is to investigate how much of the combination can be given in conjunction with chest radiation. Using X-rays, the study will also evaluate how much shrinkage of the cancer is caused by this treatment directly at the tumor site and other areas where the cancer may have also spread. In this study the radiation will be given on only one day per week in two sessions, rather than divided over five days per week (Monday through Friday) as it is more commonly used. However, both schedules have been found to be equally effective. The treatment program will use increasing doses of the 5-FU medication, either as infusion or as pill to find the highest dose that is tolerated. Once the highest tolerated dose is determined, subsequent patients who will be enrolled will continue to be treated at that dose level. The dose of the drug Taxotere will remain the same throughout. Hypothesis: Our previous research suggests that the combination of Taxotere and 5-FU given together with weekly chest radiation will provide a more convenient form of treatment than the conventional approach and also be at least similar in its efficacy.
NCT00360828 ↗ Phase II Study of Irinotecan HCI for Recurrent Anaplastic Astrocytomas, Mixed Malignant Gliomas, and Oligodendrogliomas Terminated H. Lee Moffitt Cancer Center and Research Institute Phase 2 2006-02-01 Phase 2 trial to explore the efficacy and safety of irinotecan (CPT-11). Also administered at each cycle was zofran/Kytril/Anzemet, decadron, and IV atropine. At each cycle, patient exams and interviews as well as lab results were to help the research team to determine the symptomatic side effects of the treatment. Recorded past toxicities were to be compared with current side effects.
NCT00475085 ↗ Prevention of Delayed Nausea A Phase III Double-Blind Placebo-Controlled Clinical Trial Completed National Cancer Institute (NCI) Phase 3 2006-12-01 RATIONALE: Antiemetic drugs, such as granisetron, dexamethasone, prochlorperazine, aprepitant, and palonosetron, may help lessen or prevent nausea. It is not yet known which combination of antiemetic drugs is more effective in preventing nausea caused by chemotherapy. PURPOSE: This randomized phase III trial is comparing different combinations of granisetron, dexamethasone, prochlorperazine, aprepitant, and palonosetron to see how well they work in preventing nausea in patients undergoing chemotherapy for breast cancer.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for KYTRIL

Condition Name

Condition Name for KYTRIL
Intervention Trials
Vomiting 3
Nausea 3
Chemotherapy-induced Nausea and Vomiting 3
Healthy 2
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Condition MeSH

Condition MeSH for KYTRIL
Intervention Trials
Vomiting 11
Nausea 10
Postoperative Nausea and Vomiting 3
Glioma 2
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Locations for KYTRIL

Trials by Country

Trials by Country for KYTRIL
Location Trials
United States 35
Canada 2
France 1
Korea, Republic of 1
Jamaica 1
This preview shows a limited data set
Subscribe for full access, or try a Trial

Trials by US State

Trials by US State for KYTRIL
Location Trials
Massachusetts 4
Pennsylvania 2
Florida 2
Nebraska 2
North Carolina 2
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Progress for KYTRIL

Clinical Trial Phase

Clinical Trial Phase for KYTRIL
Clinical Trial Phase Trials
Phase 4 3
Phase 3 6
Phase 2 3
[disabled in preview] 7
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Status

Clinical Trial Status for KYTRIL
Clinical Trial Phase Trials
Completed 11
Unknown status 3
Withdrawn 2
[disabled in preview] 4
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Sponsors for KYTRIL

Sponsor Name

Sponsor Name for KYTRIL
Sponsor Trials
Tesaro, Inc. 3
Teva Pharmaceuticals USA 2
National Cancer Institute (NCI) 2
[disabled in preview] 4
This preview shows a limited data set
Subscribe for full access, or try a Trial

Sponsor Type

Sponsor Type for KYTRIL
Sponsor Trials
Other 14
Industry 10
NIH 3
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trials Update, Market Analysis, and Projection for Kytril (Granisetron)

Last updated: October 28, 2025

Introduction

Kytril (granisetron) is a serotonin 5-HT3 receptor antagonist primarily indicated for the prevention of nausea and vomiting associated with chemotherapy, radiotherapy, and postoperative care. Since its initial approval by the FDA in 1993, Kytril has established itself as a prominent antiemetic in oncology supportive care. This analysis provides a comprehensive update on ongoing clinical trials, evaluates market dynamics, and offers future projections for Kytril.

Clinical Trials Update

Ongoing and Recent Clinical Investigations

Recent clinical trials focusing on granisetron have centered around optimizing its efficacy, safety profile, and expanding its application scope. Notable among these are:

  • Extended-release formulations: Multiple phase II and III trials are evaluating long-acting formulations designed to improve patient compliance. For instance, a phase III trial (NCT04151430) conducted in 2022 assessed the efficacy of a sustained-release transdermal patch delivering granisetron, showing promising results in reducing breakthrough nausea during multi-day chemotherapy regimens.

  • Combination therapy studies: Several trials are assessing granisetron in conjunction with NK1 receptor antagonists such as aprepitant to enhance antiemetic control. A recent study published in Supportive Care in Cancer highlighted that combining granisetron with aprepitant significantly reduces nausea severity compared to monotherapy.

  • Expanded indications: Trials exploring off-label application, such as management of nausea induced by novel immunotherapies, are underway. A phase II study (NCT04576655) initiated in 2021 is investigating granisetron's efficacy in controlling immune checkpoint inhibitor–related nausea.

Regulatory and Safety Updates

The European Medicines Agency (EMA) approved a new transdermal patch formulation of granisetron in 2022, emphasizing improved adherence and convenience. Regulatory agencies have also endorsed guidelines for dose adjustments in special populations, particularly those with hepatic impairment.

No recent safety concerns have emerged beyond well-known side effects such as headaches, constipation, and transient ECG changes, which are predominantly manageable.

Market Analysis

Current Market Landscape

Kytril, as a branded formulation of granisetron, remains a significant player within the antiemetic market segment, which is estimated to be valued at approximately USD 600 million globally in 2022 (Grand View Research).

Market share and competitive positioning:
Kytril’s market share has gradually declined due to the rise of generic formulations and alternative agents such as ondansetron and palonosetron. However, Kytril maintains a competitive position thanks to its validated efficacy, established dosing protocols, and newer delivery systems such as transdermal patches.

Pricing and reimbursement factors:
Pricing strategies vary geographically, with brand-name Kytril commanding premium pricing in developed regions. Reimbursement policies generally favor newer formulations that demonstrate improved patient compliance and reduced hospitalization costs.

Emerging Competitors and Market Dynamics

  • Generics: The surging availability of generic granisetron has eroded Kytril’s revenue share. Generic versions accounted for approximately 70% of antiemetic prescriptions in the U.S. in 2022.

  • Newer agents: Palonosetron, with its longer half-life and proven sustained efficacy, continues to gain favor, especially for single-day chemotherapy protocols.

  • Innovative formulations: Transdermal patches and subcutaneous depots are gaining traction for their convenience, prompting established players to innovate further.

Regulatory and Market Trends

There’s increasing regulatory emphasis on drug delivery optimization and patient-centric formulations. Payers are incentivizing dosing convenience and reduced adverse events, which could influence the market share dynamics for Kytril and its competitors.

Market Projection and Future Outlook

Forecast Period (2023-2030)

The antiemetic market is projected to grow at a CAGR of approximately 4% over the next decade, driven by:

  • Growing cancer incidence: The global prevalence of cancer is expected to reach 28.4 million cases by 2040 (WHO), intensifying demand for effective supportive care medications.

  • Advances in oncology treatment: Novel chemotherapies and immunotherapies increasing the need for reliable antiemetics.

  • Expansion into new indications: Trials exploring use in immunotherapy-related nausea could open additional revenue streams.

Implications for Kytril

  • Potential resurgence: The development of long-acting, patient-friendly formulations could revitalize Kytril’s market share amid increased competition.

  • Generic erosion: Patents for branded formulations are nearing expiration or have expired in significant markets, leading to increased generic penetration.

  • Regulatory landscape: Approval of innovative delivery methods and expanded indications can provide competitive advantage, but patent challenges may constrain pricing strategies.

Strategic Outlook

Manufacturers and stakeholders should consider investing in:

  • Formulation innovation: Emphasize transdermal patches or depot formulations tailored to specific patient populations.

  • Combination therapies: Optimize combinations with NK1 antagonists for superior control, appealing to oncologists seeking comprehensive antiemetic regimens.

  • Market expansion: Explore off-label indications such as immunotherapy-induced nausea to diversify revenue sources.

Key Takeaways

  • Clinical innovation: Ongoing trials focus on sustained-release formulations and expanded indications, aiming to improve patient compliance and control of breakthrough nausea.

  • Market challenges: While brand Kytril faces threats from generics and newer agents like palonosetron, formulation innovations offer a pathway to differentiation.

  • Growth prospects: The antiemetic market is set for steady expansion, driven by rising cancer rates and novel treatments, providing opportunities for Kytril and similar drugs if supported by continuous innovation.

  • Regulatory environment: Emphasis on patient-centric formulations and combination therapies can shape competitive strategies, with regulatory approvals potentially opening new markets.

  • Strategic imperative: Stakeholders should prioritize R&D efforts towards long-acting, convenient delivery systems and broadened indications to sustain competitiveness.

FAQs

  1. What are the latest clinical developments involving Kytril (granisetron)?
    Recent trials have emphasized extended-release formulations, combination therapy efficacy with NK1 antagonists, and off-label applications such as immunotherapy-induced nausea, with some promising results supporting further development.

  2. How is the market for Kytril expected to evolve?
    While generics and newer agents have increased market competition, innovations in delivery systems and expanded indications could stabilize or even grow Kytril’s market share over the next decade.

  3. What factors are influencing the decline in Kytril’s market share?
    The proliferation of generic formulations, the advent of longer-acting alternatives like palonosetron, and changing prescribing habits focused on convenience and cost are key factors.

  4. Are there potential regulatory hurdles for Kytril’s future formulations?
    Yes, obtaining approvals for novel delivery systems and expanded indications requires rigorous clinical evidence, but successful regulatory filings can enhance competitiveness.

  5. What strategic moves can manufacturers consider to capitalize on market opportunities?
    Investment in long-acting formulations, combination therapy development, and exploring new indications offer pathways to improve market positioning and revenue streams.


Sources

  1. Grand View Research. "Antiemetics Market Size, Share & Trends Analysis." 2022.
  2. U.S. Food and Drug Administration (FDA). "Kytril (granisetron) Drug Approval Details," 1993.
  3. Supportive Care in Cancer. "Combination antiemetic therapy trials," 2022.
  4. WHO. "Global Cancer Statistics," 2020.
  5. European Medicines Agency (EMA). "Approval of transdermal granisetron patch," 2022.

More… ↓

⤷  Get Started Free

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.