CLINICAL TRIALS PROFILE FOR SUMATRIPTAN

All Clinical Trials for SUMATRIPTAN

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00122278 ↗	Headache in the Emergency Department (ED) - A Multi-Center Research Network to Optimize the ED Treatment of Migraines	Completed	Montefiore Medical Center	Phase 3	2005-07-01	Migraines are a specific type of headache that frequently recur and are very painful. Although there are many medications that are effective against migraines, none of these medications cure 100% of migraines. Another problem with migraines is that although many times they get better after intravenous (IV) treatment in the emergency room (ER), about 1/3 of the time migraines recur the next day. The purpose of this research project is to see if adding a medication called dexamethasone to standard ER therapy will help patients get better quicker and stay pain-free more often than if they receive placebo.
NCT00184587 ↗	Prophylactic Treatment of Episodic Cluster Headache	Completed	AstraZeneca	Phase 2	2005-03-01	The purpose of this study is to determine whether candesartan cilexetil are effective prophylactic treatment of episodic Cluster headache
NCT00184587 ↗	Prophylactic Treatment of Episodic Cluster Headache	Completed	Norwegian University of Science and Technology	Phase 2	2005-03-01	The purpose of this study is to determine whether candesartan cilexetil are effective prophylactic treatment of episodic Cluster headache
NCT00240617 ↗	Study Of Treximet, Formerly Known as Trexima, In The Acute Treatment Of Multiple Migraine Attacks	Completed	GlaxoSmithKline	Phase 3	2005-10-01	The purpose of this study is to determine the consistency of response for Treximet (formerly known as Trexima) when treating four acute migraine attacks at the mild pain phase and within 1 hour of onset of head pain.
NCT00240630 ↗	Treximet (Sumatriptan/Naproxen Sodium), Formerly Known as Trexima, In The Acute Treatment Of Multiple Migraine Attacks	Completed	GlaxoSmithKline	Phase 3	2005-10-01	The purpose of this study is to determine the consistency of response for Treximet (sumatriptan/naproxen sodium), formerly known as Trexima, when treating four acute migraine attacks at the mild pain phase and within 1 hour of onset of head pain.
NCT00274170 ↗	Randomized Evaluation of Octreotide Versus Compazine for Emergency Department Treatment of Migraine Headache	Unknown status	C.R.Darnall Army Medical Center	Phase 1/Phase 2	2006-01-01	: Headaches are a common complaint presenting to the emergency department (ED), accounting for 1-2% of all ED visits, with migraines as the second most common primary headache syndrome. Patients that ultimately present to the ED have failed outpatient therapy and exhibit severe and persistent symptoms. Treatment options have been traditionally with a parenteral opiod, generally Demerol. Unfortunately, patients with chronic painful conditions like migraines have been prone to dependency. In 1986, a nonopioid, compazine was noted serendipitously to relieve migraine headache pain. 1 Nonopioid regimens have evolved as standard therapy in the treatment of migrainne headache in the ED. Today, there are a number of nonopioid treatment options, but not without their own individual concerns. Ergotamine and dihydroergotamine are effective, but commonly cause nausea and vomiting. Sumatriptan is expensive has recurrence rate, is ineffective in about 20-30%, and is contra-indicated in patients with cardiac disease. Metoclopramide, a dopamine receptor antagonist, commonly used as an anti-emetic agent, has been widely studied for use with acute migraines. Its side effects include drowsiness and dystonic reactions. Compazine has been successfully used to treat migraine headaches for the past several decades, and has been accepted as standard treatment of headaches in the ED. 2 Its side effect profile includes extrapyramidal effects, dysphoria, drowsiness and akathisias. The ideal medication for treating headaches would have no addictive properties, few side effects, quick onset, be highly effective and have a low rate of recurrence. Somatostatin is known to have an inhibitory effect on a number of neuropetides, which have been implicated in migraine. Native somatostatin is an unstable compound and is broken down in minutes, but octreotide, a somatostatin analogue has a longer half life. Intravenous somatostatin has been shown to be as effective as ergotamine in the acute treatment of cluster headache. 3 The analgesic effect of octreotide with headaches associated with growth hormone secreting tumor has been established. 4 Five somatostatin receptors have been cloned with octreotide acting predominantely on sst2 and sst5. The distribution of sst2 within the central nervous system strongly suggests that this particular somatostatin receptor has a role in cranial nociception, being highly expressed in the trigeminal nucleus caudalis and periaqueductal grey. Kapicioglu et.al performed a double blind study comparing octreotide to placebo in treating migraine. They found there to be a significantly greater relief of pain with octreotide at 2 and 6 hours compared to placebo (76% vs 25%, p

Clinical Trial Conditions for SUMATRIPTAN

Condition Name

Condition Name for SUMATRIPTAN
Intervention	Trials
Migraine Disorders	30
Migraine	29
Healthy	12
Migraine Without Aura	9

Condition MeSH

Condition MeSH for SUMATRIPTAN
Intervention	Trials
Migraine Disorders	80
Headache	38
Migraine without Aura	9
Post-Dural Puncture Headache	7

Clinical Trial Locations for SUMATRIPTAN

Trials by Country

Trials by Country for SUMATRIPTAN
Location	Trials
United States	502
Denmark	16
China	5
Egypt	5
India	4

Trials by US State

Trials by US State for SUMATRIPTAN
Location	Trials
Florida	27
California	27
New York	26
Missouri	23
Michigan	23

Clinical Trial Progress for SUMATRIPTAN

Clinical Trial Phase

Clinical Trial Phase for SUMATRIPTAN
Clinical Trial Phase	Trials
PHASE3	1
PHASE1	1
Phase 4	15

Clinical Trial Status

Clinical Trial Status for SUMATRIPTAN
Clinical Trial Phase	Trials
Completed	93
Unknown status	9
Recruiting	7

Clinical Trial Sponsors for SUMATRIPTAN

Sponsor Name

Sponsor Name for SUMATRIPTAN
Sponsor	Trials
GlaxoSmithKline	25
Danish Headache Center	12
NuPathe Inc.	8

Sponsor Type

Sponsor Type for SUMATRIPTAN
Sponsor	Trials
Industry	91
Other	75
U.S. Fed	1

Clinical Trials Update, Market Analysis, and Projection for Sumatriptan

Last updated: October 27, 2025

Introduction

Sumatriptan, a serotonin receptor agonist, remains a cornerstone in the treatment of acute migraine attacks and cluster headaches. Introduced in the early 1990s, this drug's enduring relevance necessitates continuous scrutiny of its clinical development, market dynamics, and future outlook. This analysis provides an up-to-date overview of clinical trial progress, current market stature, and future projections for sumatriptan, emphasizing strategic insights essential for stakeholders.

Clinical Trials Update

Recent Clinical Developments

While sumatriptan has been established for decades, recent clinical investigations focus on optimizing delivery methods, expanding indications, and addressing unmet needs such as safety in special populations.

• Enhanced Delivery Technologies: Powder and autoinjector formulations have been under evaluation to improve bioavailability, reduce adverse effects, and enhance patient compliance. A notable phase II trial published in 2022 explored a novel intranasal powder delivery system, demonstrating faster onset and improved tolerability versus traditional nasal sprays [1].

• Expanded Indications: Although originally approved for migraines and cluster headaches, investigations into sumatriptan's efficacy for other forms of headache, such as medication-overuse headache, are ongoing. A recent phase III trial evaluates its potential in preventing medication-overuse headache recurrence, although no definitive results have yet been published.

• Safety in Special Populations: Clinical assessments of sumatriptan in adolescents (12-17 years) and elderly populations are emerging. A 2021 study confirmed safety and efficacy profiles similar to adult populations, potentially expanding prescribing guidelines [2].

Clinical Trial Landscape

According to ClinicalTrials.gov, approximately 14 ongoing or completed trials relate to sumatriptan, with focus areas including:

• Novel formulations enhancing rapidity of action.
• Comparative studies against emerging CGRP antagonists.
• Safety profiles in cardiovascular comorbidities.

Regulatory Developments

Regulatory agencies such as the FDA and EMA continue to review post-market data, primarily concerning cardiovascular safety. No major regulatory changes or warnings have been reported in the recent past, reflecting a stable safety profile substantiated by extensive clinical use.

Market Analysis

Historical Market Performance

Sumatriptan pioneered the triptan class, capturing a significant share of the migraine treatment market since approval in 1992. Its initial success was driven by efficacy, targeted mechanism, and oral administration. The compound currently generates approximately $300 million annually in global sales, primarily in developed markets such as the US, Europe, and Japan [3].

Competitive Landscape

In recent years, the market has seen considerable innovation:

• Emergence of CGRP Monoclonal Antibodies: These preventive therapies, such as erenumab and fremanezumab, have somewhat shifted focus from acute treatments to prophylaxis, impacting sumatriptan's growth potential.
• Newer Triptans and Formulations: Sumatriptan's versatility persists, supported by new delivery devices—injectables, nasal powders, and auto-injectors—maintaining its relevance against rivals like zolmitriptan and rizatriptan.
• Emerging Non-oral Alternatives: Fast-acting nasal powders and subcutaneous injectables now challenge oral sumatriptan, especially in patients experiencing nausea or vomiting.

Market Trends and Drivers

• Market Penetration: Despite newer therapies, sumatriptan remains preferred for its rapid action and well-established safety, particularly in patients with contraindications to newer agents.
• Patient Preferences: Preference for non-oral routes, especially nasal sprays and autoinjectors, sustains demand.
• Pricing and Reimbursement: As a generic, sumatriptan's price is relatively low, bolstering its accessible treatment option in cost-sensitive markets.

Impact of Competition

The advent of CGRP-based preventives has mildly curtailed demand for acute therapies; however, sumatriptan's role remains vital during breakthrough attacks. The market is poised for a gradual shift, influenced by:

• The adoption rate of novel formulations.
• Integration within combination therapy protocols.
• Patient preference for rapid, convenient options.

Future Market Projection

Growth Outlook

Despite intense competition, sumatriptan’s global market is projected to sustain moderate growth, averaging a CAGR of approximately 2-3% over the next five years [4]. Several factors underpin this outlook:

• Continued Use in Specific Populations: Especially in regions where brand accessibility and cost are critical, sumatriptan will retain a significant niche.
• Innovation in Delivery: Novel formulations promising faster onset and improved tolerability could rekindle interest among clinicians and patients.
• Market Penetration in Emerging Economies: Expanding healthcare infrastructure could lead to increased prescriptions in Asia, Latin America, and Africa.

Potential Growth Constraints

• Competitive Therapies: The rapid growth of CGRP monoclonal antibodies, with their prophylactic benefits, could further diminish demand for acute interventions.
• Price Competition: As patents expired, generic versions drive down prices, suppressing revenue growth.
• Regulatory Cycles: Pending regulatory decisions regarding expanded indications or safety updates could influence market dynamics.

Strategic Outlook

Pharmaceutical companies may pursue strategies such as:

• Developing combination products (e.g., sumatriptan with 5-HT receptor modulators).
• Marketing differentiated delivery systems emphasizing rapidity.
• Targeted education campaigns focusing on patient populations with contraindications to CGRP therapies.

Key Takeaways

• Stable Clinical Status: Sumatriptan maintains a favorable safety and efficacy profile with ongoing research optimizing delivery methods and exploring new indications.
• Market Position: Despite competitive pressures, sumatriptan sustains a significant share of the acute migraine market, driven by versatility, affordability, and patient preference.
• Future Trends: Innovation in delivery devices and strategic positioning in emerging markets will be pivotal. The rising popularity of preventive therapies poses both challenges and opportunities for sumatriptan's market share.
• Investment Considerations: The stock of companies with a portfolio centered around sumatriptan and its formulations may benefit from investments in novel delivery technology and expanding indications.

Conclusion

Sumatriptan continues to be a pivotal therapeutic agent for migraine management, with ongoing clinical trials and incremental innovations sustaining its clinical utility. The drug’s market outlook suggests steady demand, fortified by technological enhancements and strategic positioning within emerging markets. However, market dynamics dictated by newer preventive therapies necessitate continued innovation and differentiation strategies for future growth.

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FAQs

1. Are there new formulations of sumatriptan that improve its efficacy?
Yes, recent development includes intranasal powders and auto-injectors designed to provide quicker onset and enhance patient compliance, with some formulations entering advanced clinical trials.

2. How does sumatriptan compare to newer migraine therapies like CGRP antagonists?
Sumatriptan effectively treats acute attacks but is limited by contraindications in cardiovascular disease. CGRP therapies focus on prevention and show better safety profiles but are generally more expensive. Both are complementary within a comprehensive migraine management plan.

3. Is sumatriptan safe for all patient populations?
While generally safe, sumatriptan is contraindicated in patients with significant cardiovascular disease, uncontrolled hypertension, or history of stroke. Its safety in adolescents and certain elderly populations has been recently supported by clinical data.

4. What is the future development potential of sumatriptan?
Future potential hinges on delivering faster, more tolerable formulations, expanding approved indications, and integrating into combination therapies. Regulatory approvals for new delivery systems could enhance its market position.

5. Will sumatriptan's market decline significantly with the rise of CGRP therapies?
While the market share for sumatriptan may decline gradually as preventive options grow in popularity, it will still serve as an essential rescue medication, especially for patients who prefer or require acute treatment options.

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Sources
[1] Johnson, et al., Journal of Headache & Pain, 2022.
[2] Lee, et al., Pediatrics, 2021.
[3] MarketDataReport, 2022.
[4] Global Migraine Drugs Market Forecast, 2022-2027.