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Last Updated: April 4, 2025

CLINICAL TRIALS PROFILE FOR RIZATRIPTAN BENZOATE


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All Clinical Trials for RIZATRIPTAN BENZOATE

Trial IDTitleStatusSponsorPhaseStart DateSummary
NCT00812006 ↗ A Study of Rizatriptan for the Treatment of Acute Migraine in Patients on Topiramate for Migraine Prophylaxis Completed Merck Sharp & Dohme Corp. Phase 3 2009-03-24 This study will provide additional efficacy data for rizatriptan when used for an acute migraine attack in patients already taking topiramate for migraine prophylaxis.
NCT00516737 ↗ Study to Test Rizatriptan in the Early Treatment of Acute Migraine (0462-081) Completed Merck Sharp & Dohme Corp. Phase 3 2007-10-03 The purpose of this study is to test the effectiveness of rizatriptan benzoate in the early treatment of an acute migraine attack.
NCT00898677 ↗ Rizatriptan 5 mg and 10 mg, Sumatriptan 100 mg, and Placebo Comparison Study (0462-030) Completed Merck Sharp & Dohme Corp. Phase 3 1995-09-01 A study to compare rizatriptan 10 mg verse sumatriptan 100 mg in the treatment of migraine attacks and duration of relief provided. This study will also provide additional efficacy data on rizatriptan 5 mg and 10 mg for the treatment of migraine.
>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 3 of 3 entries

Clinical Trial Conditions for RIZATRIPTAN BENZOATE

Condition Name

2210-0.200.20.40.60.811.21.41.61.822.2MigraineMigraine HeadacheAcute Migraine With or Without Aura in Adolescents[disabled in preview]
Condition Name for RIZATRIPTAN BENZOATE
Intervention Trials
Migraine 2
Migraine Headache 2
Acute Migraine With or Without Aura in Adolescents 1
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Condition MeSH

520-0.500.511.522.533.544.555.5Migraine DisordersHeadache[disabled in preview]
Condition MeSH for RIZATRIPTAN BENZOATE
Intervention Trials
Migraine Disorders 5
Headache 2
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Clinical Trial Progress for RIZATRIPTAN BENZOATE

Clinical Trial Phase

100.0%0-0.500.511.522.533.544.555.5Phase 3[disabled in preview]
Clinical Trial Phase for RIZATRIPTAN BENZOATE
Clinical Trial Phase Trials
Phase 3 5
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Clinical Trial Status

100.0%0-0.500.511.522.533.544.555.5Completed[disabled in preview]
Clinical Trial Status for RIZATRIPTAN BENZOATE
Clinical Trial Phase Trials
Completed 5
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Clinical Trial Sponsors for RIZATRIPTAN BENZOATE

Sponsor Name

trials011223344556Merck Sharp & Dohme Corp.[disabled in preview]
Sponsor Name for RIZATRIPTAN BENZOATE
Sponsor Trials
Merck Sharp & Dohme Corp. 5
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Sponsor Type

100.0%0-0.500.511.522.533.544.555.5Industry[disabled in preview]
Sponsor Type for RIZATRIPTAN BENZOATE
Sponsor Trials
Industry 5
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Rizatriptan Benzoate: Clinical Trials, Market Analysis, and Projections

Introduction to Rizatriptan Benzoate

Rizatriptan benzoate is a second-generation triptan, widely recognized for its efficacy in treating acute migraine attacks. It is a selective 5-HT1B/1D agonist that is rapidly absorbed from the gastrointestinal tract, providing quick relief for migraine sufferers.

Clinical Trials and Efficacy

Clinical trials have consistently demonstrated the effectiveness and tolerability of rizatriptan benzoate in the acute treatment of migraines. Here are some key findings:

  • Rapid Absorption and Onset of Action: Rizatriptan achieves maximum plasma concentrations more quickly than other triptans, offering rapid migraine relief. In clinical trials, the onset of effect was seen as early as 30 minutes after dosing with the 10-mg dose[4].
  • Pain Relief and Recurrence: Studies have shown that rizatriptan provides significant pain relief and reduces the recurrence of migraines. At 2 hours post-dose, the percentage of patients with pain relief was significantly higher with rizatriptan (62% for 5 mg and 71% for 10 mg) compared to placebo (35%)[4].
  • Patient Satisfaction: Patients have reported greater satisfaction and a preference for rizatriptan over other agents due to its favorable efficacy and tolerability profiles. Improvements in quality of life reported with rizatriptan are consistent with its clinical benefits[1].

Tolerability and Safety

The tolerability of rizatriptan benzoate has been well established in clinical trials. Here are some key points:

  • Common Adverse Experiences: The most common drug-related adverse experiences include dizziness, somnolence, asthenia/fatigue, and nausea. However, these incidences are low and dose-related[4].
  • Long-term Efficacy: Rizatriptan has shown consistent long-term efficacy across multiple migraine attacks without an increase in adverse experiences even with up to three doses within 24 hours[4].

Market Analysis

The market for rizatriptan benzoate is robust and growing, driven by several factors:

Market Size and Growth

  • The rizatriptan benzoate market was valued at USD 120 million in 2023 and is expected to reach USD 200 million by 2031, growing at a CAGR of 6.7% from 2024 to 2031[2].
  • This growth is attributed to the rising incidence of migraine disorders and the increasing need for efficient therapies.

Market Segmentation

  • The market is segmented based on application (tablets, oral dissolvable tablets, powder for solution), product (migraine relief, cluster headache treatment, acute headache management), and geographical regions (North America, Europe, Asia-Pacific, South America, and Middle-East and Africa)[2].

Driving Factors

  • Increasing Incidence of Migraines: The significant frequency of migraine diseases worldwide drives the demand for effective treatments like rizatriptan benzoate[2].
  • Improvements in Formulation and Delivery: Advances in medication delivery and formulation technologies enhance patient outcomes and adherence, contributing to market growth[2].
  • Generic Versions and Awareness: The advent of generic substitutes and growing awareness of migraine management also fuel market expansion[2].

Competitive Landscape

The rizatriptan benzoate market includes both established and emerging players. Here are some key points:

  • Prominent Players: The market report includes extensive lists of prominent companies categorized by the types of products they offer and various market-related factors. This includes information on the year of market entry for each player, providing valuable insights for research analysis[2][5].
  • Competitive Analysis: The competitive landscape analysis provides insights into the market share and regional proliferation of these businesses, along with SWOT analysis and profitability graphs[5].

Future Projections

Overall Migraine Market

  • The broader migraine market is expected to grow significantly, reaching $16.4 billion across seven major markets by 2033, driven primarily by the increased prescription of CGRP antagonists and oral gepants[3].

Rizatriptan Benzoate Specifics

  • Despite the rise of newer therapies like CGRP antagonists, rizatriptan benzoate is expected to maintain its market presence due to its established efficacy, tolerability, and the ongoing research aimed at optimizing dose regimes and extending indications[2][3].

Regulatory Approvals

Recent regulatory approvals have further solidified the position of rizatriptan benzoate in the market:

  • FDA Approval: The FDA has approved a new drug application for Rizafilm, an oral thin film formulation of rizatriptan benzoate, marking the first oral thin film for the treatment of acute migraines available in the US[1].

Conclusion

Rizatriptan benzoate remains a cornerstone in the treatment of acute migraines due to its rapid absorption, effective pain relief, and favorable tolerability profile. The market for this drug is expected to continue growing, driven by increasing demand for efficient migraine therapies and advancements in formulation and delivery technologies.

Key Takeaways

  • Clinical Efficacy: Rizatriptan benzoate is highly effective in treating acute migraines with rapid onset and consistent long-term efficacy.
  • Market Growth: The market is projected to grow at a CAGR of 6.7% from 2024 to 2031, reaching USD 200 million by 2031.
  • Driving Factors: Increasing incidence of migraines, improvements in formulation and delivery, and the advent of generic versions are key drivers.
  • Regulatory Approvals: Recent FDA approval for an oral thin film formulation enhances its market presence.
  • Competitive Landscape: The market includes established and emerging players, with ongoing research to optimize treatment approaches.

FAQs

Q: What is rizatriptan benzoate used for?

Rizatriptan benzoate is used for the acute treatment of migraine attacks. It is a selective 5-HT1B/1D agonist that provides rapid relief from migraine symptoms.

Q: How effective is rizatriptan benzoate in clinical trials?

Clinical trials have shown that rizatriptan benzoate is highly effective, with significant pain relief observed as early as 30 minutes after dosing. It also reduces the recurrence of migraines and is well tolerated by patients[4].

Q: What are the common adverse experiences associated with rizatriptan benzoate?

The most common drug-related adverse experiences include dizziness, somnolence, asthenia/fatigue, and nausea, which are low and dose-related[4].

Q: How is the market for rizatriptan benzoate expected to grow?

The market for rizatriptan benzoate is expected to grow at a CAGR of 6.7% from 2024 to 2031, reaching USD 200 million by 2031, driven by increasing demand for efficient migraine therapies and advancements in formulation and delivery technologies[2].

Q: What recent regulatory approvals have been granted for rizatriptan benzoate?

The FDA has recently approved Rizafilm, an oral thin film formulation of rizatriptan benzoate, marking the first oral thin film for the treatment of acute migraines available in the US[1].

Sources

  1. FDA Approves Rizatriptan Benzoate Oral Film to Treat Acute Migraine - Pharmacy Times
  2. Rizatriptan Benzoate Market Size, Share and Forecast to 2031 - Market Research Intellect
  3. Migraine market expected to reach $16.4bn across 7MM by 2033 - Clinical Trials Arena
  4. Rizatriptan (MAXALT) for the acute treatment of migraine ... - PubMed
  5. Rizatriptan Benzoate Market Overview - FutureWise Research

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