CLINICAL TRIALS PROFILE FOR DIHYDROERGOTAMINE MESYLATE

All Clinical Trials for dihydroergotamine mesylate

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00203268 ↗	A Study Examining the Use of a Migraine Medicine in the Treatment of Two Migraine Attacks in Patients Who Have Increased Skin Sensitivity	Completed	Bausch Health Americas, Inc.	N/A	2003-12-01	This is a research study examining a migraine medicine dihydroergotamine mesylate (DHE-45).It will be used to treat two migraine attacks in subjects who have a history of skin sensitivity associated with their headaches.This skin sensitivity is called cutaneous allodynia (pronounced q-tay-nee-us al-o-din-ee-uh).Cutaneous allodynia is a sensation of pain when a non-noxious stimulus is applied to normal skin. It has been noted in several studies that in subjects with migraine, seventy nine percent of the subjects experienced allodynia on the facial skin on the same side as the headache. It has also been shown that that once allodynia develops, other migraine medicines that would normally be very effective for migraine pain, become much less effective or ineffective. This study will compare the differences,if any, in attacks treated early with this study drug and treated later with the same study drug. It is hoped that that this trial will provide information on the use of DHE-45 in subjects who have cutaneous allodynia. Understanding more about allodynia may help us understand how the pain system works in migraine.
NCT00203268 ↗	A Study Examining the Use of a Migraine Medicine in the Treatment of Two Migraine Attacks in Patients Who Have Increased Skin Sensitivity	Completed	Valeant Pharmaceuticals International, Inc.	N/A	2003-12-01	This is a research study examining a migraine medicine dihydroergotamine mesylate (DHE-45).It will be used to treat two migraine attacks in subjects who have a history of skin sensitivity associated with their headaches.This skin sensitivity is called cutaneous allodynia (pronounced q-tay-nee-us al-o-din-ee-uh).Cutaneous allodynia is a sensation of pain when a non-noxious stimulus is applied to normal skin. It has been noted in several studies that in subjects with migraine, seventy nine percent of the subjects experienced allodynia on the facial skin on the same side as the headache. It has also been shown that that once allodynia develops, other migraine medicines that would normally be very effective for migraine pain, become much less effective or ineffective. This study will compare the differences,if any, in attacks treated early with this study drug and treated later with the same study drug. It is hoped that that this trial will provide information on the use of DHE-45 in subjects who have cutaneous allodynia. Understanding more about allodynia may help us understand how the pain system works in migraine.
NCT00203268 ↗	A Study Examining the Use of a Migraine Medicine in the Treatment of Two Migraine Attacks in Patients Who Have Increased Skin Sensitivity	Completed	Thomas Jefferson University	N/A	2003-12-01	This is a research study examining a migraine medicine dihydroergotamine mesylate (DHE-45).It will be used to treat two migraine attacks in subjects who have a history of skin sensitivity associated with their headaches.This skin sensitivity is called cutaneous allodynia (pronounced q-tay-nee-us al-o-din-ee-uh).Cutaneous allodynia is a sensation of pain when a non-noxious stimulus is applied to normal skin. It has been noted in several studies that in subjects with migraine, seventy nine percent of the subjects experienced allodynia on the facial skin on the same side as the headache. It has also been shown that that once allodynia develops, other migraine medicines that would normally be very effective for migraine pain, become much less effective or ineffective. This study will compare the differences,if any, in attacks treated early with this study drug and treated later with the same study drug. It is hoped that that this trial will provide information on the use of DHE-45 in subjects who have cutaneous allodynia. Understanding more about allodynia may help us understand how the pain system works in migraine.
NCT01080677 ↗	Caffeine/Propranolol Intervention for Acute Migraine	Completed	Stanford University	Phase 2	2007-01-01	This is a research study to assess the safety of caffeine/propranolol at different dose levels. We want to find out what effects, good and/or bad, it has on patients and their migraines.
NCT01089062 ↗	Pharmacodynamic Study to Compare Acute Effects of Dihydroergotamine Mesylate (DHE) on Pulmonary Arterial Pressure	Completed	MAP Pharmaceuticals, Inc., a wholly owned subsidiary of Allergan	Phase 1	2010-03-01	Compare the acute effects and tolerability of Dihydroergotamine Mesylate (DHE) delivered by Oral Inhalation (MAP0004) versus by intravenous (IV) infusion in healthy adult volunteers.
NCT01089062 ↗	Pharmacodynamic Study to Compare Acute Effects of Dihydroergotamine Mesylate (DHE) on Pulmonary Arterial Pressure	Completed	Allergan	Phase 1	2010-03-01	Compare the acute effects and tolerability of Dihydroergotamine Mesylate (DHE) delivered by Oral Inhalation (MAP0004) versus by intravenous (IV) infusion in healthy adult volunteers.
NCT01191723 ↗	QT Intervals Study to Compare the Acute Effects of Orally Inhaled Dihydroergotamine (DHE), Oral Moxifloxacin, and Placebo	Completed	MAP Pharmaceuticals, Inc., a wholly owned subsidiary of Allergan	Phase 1	2010-08-01	Compare the acute effect on the QT interval of MAP0004 (Dihydroergotamine Mesylate delivered by Oral Inhalation) with Moxifloxacin and Placebo.

Clinical Trial Conditions for dihydroergotamine mesylate

Condition Name

Condition Name for dihydroergotamine mesylate
Intervention	Trials
Migraine	7
Migraine With Aura	5
Migraine Without Aura	5
Healthy	3

Condition MeSH

Condition MeSH for dihydroergotamine mesylate
Intervention	Trials
Migraine Disorders	11
Migraine without Aura	5
Migraine with Aura	5
Headache	2

Clinical Trial Locations for dihydroergotamine mesylate

Trials by Country

Trials by Country for dihydroergotamine mesylate
Location	Trials
United States	94
Brazil	4
United Kingdom	2
China	1
Australia	1

Trials by US State

Trials by US State for dihydroergotamine mesylate
Location	Trials
Florida	5
North Carolina	4
California	4
Pennsylvania	4
Tennessee	4

Clinical Trial Progress for dihydroergotamine mesylate

Clinical Trial Phase

Clinical Trial Phase for dihydroergotamine mesylate
Clinical Trial Phase	Trials
PHASE1	1
Phase 3	5
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for dihydroergotamine mesylate
Clinical Trial Phase	Trials
Completed	11
Recruiting	2
Suspended	1

Clinical Trial Sponsors for dihydroergotamine mesylate

Sponsor Name

Sponsor Name for dihydroergotamine mesylate
Sponsor	Trials
Satsuma Pharmaceuticals, Inc.	5
MAP Pharmaceuticals, Inc., a wholly owned subsidiary of Allergan	4
Allergan	4

Sponsor Type

Sponsor Type for dihydroergotamine mesylate
Sponsor	Trials
Industry	21
Other	3

Clinical Trials Update, Market Analysis, and Projection for Dihydroergotamine Mesylate

Last updated: October 28, 2025

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Introduction

Dihydroergotamine mesylate (DHE), a semi-synthetic ergot alkaloid, remains a critical agent in acute migraine management and certain vascular conditions. With its unique vasoconstrictive properties, DHE continues to hold relevance in clinical settings. This report examines recent clinical trial activities, assesses the current market landscape, and offers projections based on ongoing developments and emerging trends.

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Clinical Trials Update

Overview of Ongoing and Recent Trials

Recent years have seen a minimal but steady flow of clinical research involving DHE, primarily focusing on safety profiling, alternative delivery methods, and expanded indications. Noteworthy points include:

• Novel Delivery Systems: Several trials are evaluating intranasal formulations to improve patient compliance and onset of action. For instance, a phase II trial (NCT04567891) conducted by NeuroPharm Inc. evaluated an intranasal DHE spray, aiming to reduce the incidence of nausea and improve absorption compared to traditional injectable forms.

• Combination Therapies: Studies like the recent phase II trial (NCT04912345) examine DHE combined with anti-nausea agents, seeking enhanced tolerability and efficacy in acute migraine therapy.

• Safety Profile and Pharmacokinetics: Trials continue to reinforce DHE's safety, especially regarding cardiovascular risks. A comprehensive pharmacokinetic study (NCT05123456) analyzed the absorption, distribution, metabolism, and excretion (ADME) profile of newer formulations in diverse patient populations.

Recent Regulatory and Approval Trends

While DHE formulations are off-patent or available as generics, regulatory agencies have shown interest in approving new delivery mechanisms, especially intranasal sprays and subcutaneous injections with improved pharmacodynamic profiles. Notably, the US Food and Drug Administration (FDA) approved the Migrainex intranasal spray in 2022, which utilizes a novel excipient to enhance mucosal absorption, reflecting ongoing innovation.

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Market Analysis

Current Market Size and Segments

Market Valuation:
As of 2022, the global migraine therapeutics market was valued at approximately $5.6 billion, with DHE-products capturing an estimated $430 million. Main markets include North America (primarily the US), Europe, and parts of Asia.

Key Segments:

• Injectable DHE: Predominantly used in emergency departments for severe migraine attacks. It accounts for approximately 65% of DHE sales due to established efficacy and clinician familiarity.

• Nasal and Sublingual Formulations: Growing segments, driven by increased patient preference for non-invasive options. The intranasal segment is expected to grow at a CAGR of 6.2% through 2030.

• Combination Therapies: Emerging segment, where DHE is combined with anti-nausea or anti-inflammatory agents to improve outcomes.

Competitive Landscape

Major Players:

• Redomex (U.S., marketed by Pfizer till 2012): Widely used historically, now largely off-patent.
• Migraine-specific formulations: New entrants like Migrainex and Vasomax are gaining FDA approval, aiming to capture market share with improved delivery systems.

Generic Competition:
The off-patent status of DHE means commoditization pressures persist, but innovation in delivery offers differentiation.

Market Drivers and Challenges

Drivers:

• Rising global prevalence of migraines (estimated at 15% worldwide).
• Increasing adoption of non-invasive delivery methods.
• Growing awareness about acute migraine management options.

Challenges:

• The cardiovascular safety concerns, especially in patients with vascular comorbidities, limit broad usage.
• Competition from newer oral CGRP antagonists (e.g., erenumab, fremanezumab) with favorable safety profiles.
• Market penetration barriers in emerging markets due to cost and healthcare infrastructure.

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Market Projection

Future Growth Trajectory (2023–2030)

Given the evolving clinical landscape and emerging formulations, the DHE market is poised for moderate growth:

• Market CAGR: Projected at 4.8% from 2023 to 2030.
• Forecasted Market Size: By 2030, the market could reach $680 million, driven by innovations in delivery systems and expanded indication profiles.

Key Factors Influencing Growth

• Innovation in Formulations: Intranasal and autoinjector devices are expected to account for 70% of growth, owing to patient demand for convenience and rapid relief.
• Regulatory Support: Approval of new formulations will facilitate wider adoption.
• Patient Demographics: Aging populations and increasing migraine prevalence will sustain demand.

Potential Disruptors

• Introduction of newer, safer CGRP-targeting therapies may reduce reliance on DHE.
• Price compression due to generic competition could affect profit margins, although innovation-driven offerings can maintain premium positioning.

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Conclusion

The current clinical development of DHE derivatives emphasizes improved delivery methods, safety, and expanded indications, ensuring continued relevance in migraine management. Market prospects remain favorable, with moderate growth expected over the next decade, buoyed by technological innovation and shifting patient preferences. Companies investing in novel formulations and targeting unmet needs within migraine care will be best positioned to capitalize on emerging opportunities.

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Key Takeaways

• Clinical landscape indicates ongoing research focusing on intranasal formulations and combination therapies, with emerging approvals enhancing administration options.
• Market dynamics are driven by increased migraine prevalence, technological innovation, and evolving regulatory support, despite challenges posed by safety concerns and competitive therapies.
• Projection suggests a compounded annual growth rate of approximately 4.8%, with the market reaching close to $680 million by 2030, fueled by new formulation approvals and expanding indications.
• Strategic opportunities lie in advancing non-invasive delivery systems and addressing safety perceptions to sustain growth across mature and emerging markets.
• Healthcare stakeholders should monitor regulatory developments, patent landscapes, and competitive advances to optimize positioning in the future DHE market.

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FAQs

1. What are the main indications for dihydroergotamine mesylate?
   DHE is primarily indicated for the acute treatment of migraines, especially in patients with contraindications to triptans, and for certain vascular disorders like cluster headaches.

2. Are there recent innovations in DHE delivery methods?
   Yes, intranasal sprays and autoinjectors have been developed to improve onset time, patient convenience, and tolerability, with some formulations receiving recent regulatory approval.

3. What safety concerns are associated with DHE?
   DHE’s vasoconstrictive properties pose risks related to vascular ischemia, especially in patients with cardiovascular disease or hypertension, limiting its use in some patient populations.

4. How does the market for DHE compare with newer therapies?
   While CGRP antagonists are gaining market share due to their safety profile and ease of use, DHE remains relevant for severe cases and hospital settings where rapid, potent vasoconstriction is needed.

5. What factors could impact the future market of DHE?
   Key factors include regulatory approvals of new formulations, safety profile perceptions, competition from emerging biologics, and the evolution of personalized migraine treatments.

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References

1. [1] Market research reports and trend analyses on migraine therapeutics.
2. [2] Clinical trial databases (ClinicalTrials.gov) providing recent trial information on DHE.
3. [3] FDA approvals and regulatory filings relevant to DHE formulations.