CLINICAL TRIALS PROFILE FOR ZOLMITRIPTAN

All Clinical Trials for Zolmitriptan

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00382993 ↗	A Study of Combination Product (Sumatriptan Succinate and Naproxen Sodium) in Migraine Subjects Who Report Poor Response or Intolerance to Short Acting Triptans (Study 2 of 2)	Completed	GlaxoSmithKline	Phase 3	2006-12-01	This is a randomized, double-blind, placebo-controlled, crossover, two-attack, out-patient, early-intervention evaluation of subjects who have migraine with or without aura and who discontinued use of short acting triptan(s) within the past year due to non-response or intolerance. Subjects will treat 2 separate migraine attacks during the mild phase of each attack; one attack will be treated with one tablet of the Combination Product (sumatriptan succinate and naproxen sodium) and the other attack with one tablet of placebo (crossover design). [Study 2 of 2]
NCT00383162 ↗	A Study of Combination Product (Sumatriptan Succinate and Naproxen Sodium) in Migraine Subjects Who Report Poor Response or Intolerance to Short Acting Triptans (Study 1 of 2)	Completed	GlaxoSmithKline	Phase 3	2006-11-01	This is a randomized, double-blind, placebo-controlled, crossover, two-attack, out-patient, early-intervention evaluation of subjects who have migraine with or without aura and who discontinued use of short acting triptan(s) within the past year due to non-response or intolerance. Subjects will treat 2 separate migraine attacks during the mild phase of each attack; one attack will be treated with one tablet of the Combination Product (sumatriptan succinate and naproxen sodium) and the other attack with one tablet of placebo (crossover design). [Study 1 of 2]
NCT00617695 ↗	Efficacy of Zolmitriptan (Zomig) in the Treatment of Migraines in Adolescents	Completed	AstraZeneca	Phase 3	2003-09-01	The purpose of this study is to evaluate the effectiveness and safety of Zolmitriptan (Zomig) nasal spray, 5.0 mg, compared with placebo (inactive drug) for 2 migraine headaches over a 3-month period in adolescent patients (aged 12 to 17 years) with migraine headaches
NCT00617747 ↗	Efficacy and Tolerability of Zolmitriptan Nasal Spray	Completed	AstraZeneca	Phase 3	2002-09-01	The purpose of this study is to evaluate the effectiveness and tolerability (the ability not to experience ill effects from the study drug) of a zolmitriptan nasal spray, 5.0 mg, compared with placebo (inactive drug) for 2 migraine headaches for up to 12 weeks in adult subjects with migraine headaches
NCT00637286 ↗	ZAP, US. Zomig for Appropriate for Primary Care	Completed	AstraZeneca	Phase 4	2004-07-01	The purpose of this study is to determine how useful and effective the use of ZOMIG-ZMT™ (zolmitriptan) 5.0 mg and ZOMIG® Nasal Spray (zolmitriptan) 5.0 mg is for patients, in treating migraine over a period of 6 months
NCT01085123 ↗	Determine Central 5-HT1B Receptor Occupancy of ZOMIG® Rapimelt (Zolmitriptan) in Healthy Male Volunteers	Completed	AstraZeneca	Phase 1	2010-05-01	The purpose of this study is to determine the central 5-HT1B receptor occupancy of ZOMIG® Rapimelt (zolmitriptan) in healthy male volunteers.
NCT01211145 ↗	Zomig - Treatment of Acute Migraine Headache in Adolescents	Completed	AstraZeneca	Phase 4	2010-09-01	The purpose of this study is to investigate if Zomig® Nasal Spray will help children (age 12-17 years) with migraine headaches feel better. This will be done by comparing 3 different doses of Zomig Nasal Spray with placebo nasal spray (inactive treatment).

Clinical Trial Conditions for Zolmitriptan

Condition Name

Condition Name for Zolmitriptan
Intervention	Trials
Migraine	12
Migraine Disorders	2
Migraine Headache	2
Acute Migraine	2

Condition MeSH

Condition MeSH for Zolmitriptan
Intervention	Trials
Migraine Disorders	14
Headache	5
Cluster Headache	2
Premature Birth	1

Clinical Trial Locations for Zolmitriptan

Trials by Country

Trials by Country for Zolmitriptan
Location	Trials
United States	136
United Kingdom	1
Estonia	1
Latvia	1
Slovakia	1

Trials by US State

Trials by US State for Zolmitriptan
Location	Trials
Texas	10
California	8
Florida	7
New York	6
Missouri	6

Clinical Trial Progress for Zolmitriptan

Clinical Trial Phase

Clinical Trial Phase for Zolmitriptan
Clinical Trial Phase	Trials
Phase 4	4
Phase 3	6
Phase 2/Phase 3	2

Clinical Trial Status

Clinical Trial Status for Zolmitriptan
Clinical Trial Phase	Trials
Completed	19
Unknown status	3
Recruiting	1

Clinical Trial Sponsors for Zolmitriptan

Sponsor Name

Sponsor Name for Zolmitriptan
Sponsor	Trials
Zosano Pharma Corporation	6
AstraZeneca	6
Acorda Therapeutics	2

Sponsor Type

Sponsor Type for Zolmitriptan
Sponsor	Trials
Industry	21
Other	6
NIH	1

Zolmitriptan: Clinical Trials, Market Analysis, and Projections

Introduction to Zolmitriptan

Zolmitriptan, known by the brand name Zomig, is a synthetic tryptamine derivative used primarily for the acute treatment of migraine and cluster headaches. It is available in various forms, including tablets, capsules, disintegrating tablets, and nasal sprays.

Clinical Trials and Efficacy

Acute Migraine Treatment

Clinical trials have consistently shown zolmitriptan to be effective in treating acute migraine attacks. A study involving 2,750 patients demonstrated that zolmitriptan, particularly at doses of 2.5 mg, is highly effective and well-tolerated. The overall incidence of patients experiencing at least one adverse event was dose-dependent, but the majority of these events were mild or moderate and of short duration[3].

Cluster Headache Treatment

In the treatment of acute cluster headaches, intranasal zolmitriptan has shown significant efficacy. A study involving 69 patients found that 30-minute headache relief rates were 21% for placebo, 40% for 5 mg of zolmitriptan nasal spray, and 62% for 10 mg of zolmitriptan nasal spray. This indicates that both 5 mg and 10 mg doses of intranasal zolmitriptan are effective and well-tolerated for acute cluster headache treatment[1].

Adolescent Migraine Treatment

A multicenter, double-blind, randomized, placebo-controlled study evaluated the efficacy and safety of zolmitriptan nasal spray (5 mg) in adolescents with acute migraine headaches. Although the specific results of this study are not detailed here, it is part of the ongoing research to expand the use of zolmitriptan to younger populations[4].

Tolerability and Safety Profile

Zolmitriptan has a well-defined tolerability profile. In clinical studies, the most frequently reported adverse events included asthenia, heaviness, dry mouth, nausea, dizziness, somnolence, paresthesia, and warm sensations. These events were predominantly mild or moderate and did not significantly differ in severity or type across different patient demographics. Zolmitriptan did not show clinically significant effects on blood pressure, ECGs, or clinical chemistry and hematological measurements[3].

Market Analysis

Global Market Size and Projections

The global zolmitriptan market was valued at USD 143.64 million in 2023 and is projected to reach USD 234.32 million by 2031, growing at a Compound Annual Growth Rate (CAGR) of 6.8% from 2024 to 2031. This growth is driven by increasing demand for effective treatments for migraines and cluster headaches, as well as the expanding use of zolmitriptan in various regions[5].

Regional Market Segmentation

The market is segmented by region, with North America, Europe, Asia-Pacific, South America, and the Middle East and Africa being key areas. Each region is expected to contribute significantly to the overall growth, with the Asia-Pacific region showing promising potential due to its large population and increasing healthcare expenditure[2][5].

Market Segmentation by Type and Application

The zolmitriptan market is also segmented by type (tablets, nasal sprays, disintegrating tablets, branded, and generic) and application (migraine, cluster headaches, acute migraine attacks, headache relief, and pain management). The nasal spray form, particularly, is gaining traction due to its rapid onset of action and ease of use[5].

Key Players and Market Share

The global zolmitriptan market is dominated by several key players, including Sun Pharmaceutical Industries, Tapi Teva, Venturepharm Group, Tiantaishan Pharmaceutical, SMS Pharmaceuticals, Midas Pharma, and Sinopharm Chuankang Pharmaceutical. These companies hold a significant share of the market revenue and are driving innovation and expansion in the sector[2].

Market Trends and Growth Factors

Increasing Prevalence of Migraines and Cluster Headaches

The rising prevalence of migraines and cluster headaches is a major driver of the zolmitriptan market. As more people seek effective treatments, the demand for zolmitriptan is expected to increase.

Advancements in Delivery Mechanisms

The development of new delivery mechanisms, such as nasal sprays, has improved the efficacy and patient compliance of zolmitriptan, contributing to its market growth.

Expanding Use in Different Populations

Research into the use of zolmitriptan in adolescents and other specific populations is expanding its potential market, further driving growth.

Challenges and Risks

Adverse Events and Tolerability

While zolmitriptan is generally well-tolerated, adverse events such as asthenia, nausea, and dizziness can occur. Monitoring and managing these side effects are crucial for maintaining patient safety.

Regulatory Environment

Changes in regulatory policies and approval processes can impact the market dynamics and the availability of zolmitriptan in different regions.

Conclusion

Zolmitriptan is a highly effective and well-tolerated medication for the acute treatment of migraines and cluster headaches. Clinical trials have consistently demonstrated its efficacy, and market projections indicate significant growth driven by increasing demand and advancements in delivery mechanisms. However, it is important to monitor and manage adverse events to ensure patient safety.

Key Takeaways

• Efficacy in Migraines and Cluster Headaches: Zolmitriptan is effective in treating acute migraine and cluster headache attacks.
• Tolerability Profile: Zolmitriptan is generally well-tolerated with mild to moderate adverse events.
• Market Growth: The global zolmitriptan market is projected to grow at a CAGR of 6.8% from 2024 to 2031.
• Regional Segmentation: The market is segmented by region, with Asia-Pacific showing significant growth potential.
• Key Players: Major pharmaceutical companies dominate the market, driving innovation and expansion.

FAQs

What is zolmitriptan used for?

Zolmitriptan is used for the acute treatment of migraines and cluster headaches.

What are the common adverse events associated with zolmitriptan?

Common adverse events include asthenia, heaviness, dry mouth, nausea, dizziness, somnolence, paresthesia, and warm sensations.

How effective is intranasal zolmitriptan in treating cluster headaches?

Intranasal zolmitriptan has shown significant efficacy in treating cluster headaches, with 30-minute headache relief rates of 40% for 5 mg and 62% for 10 mg doses compared to 21% for placebo[1].

What is the projected market size of zolmitriptan by 2031?

The global zolmitriptan market is projected to reach USD 234.32 million by 2031, growing at a CAGR of 6.8% from 2024 to 2031[5].

Which regions are expected to drive the growth of the zolmitriptan market?

The Asia-Pacific region, along with North America and Europe, is expected to drive the growth of the zolmitriptan market due to increasing healthcare expenditure and a large patient population[2][5].

Sources

1. Effectiveness of Intranasal Zolmitriptan in Acute Cluster Headache - JAMA Network[1]
2. Zolmitriptan - Global Market Share and Ranking, Overall Sales and Demand Forecast 2024-2030 - QY Research[2]
3. Tolerability profile of zolmitriptan (Zomig; 311C90), a novel dual ... - PubMed[3]
4. Efficacy of Zolmitriptan (Zomig) in the treatment of migraines in ... - AstraZeneca Clinical Trials[4]
5. Zolmitriptan Market Size and Projections - Market Research Intellect - Market Research Intellect[5]

Last updated: 2024-12-31