CLINICAL TRIALS PROFILE FOR VYEPTI

All Clinical Trials for VYEPTI

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02559895 ↗	A Multicenter Assessment of ALD403 in Frequent Episodic Migraine	Completed	Alder Biopharmaceuticals, Inc.	Phase 3	2015-09-01	The purpose of this study is to assess ALD403 in the prevention of migraine headache in frequent episodic migraineurs.
NCT04965675 ↗	A Study With Eptinezumab in Adolescents (12-17 Years) With Chronic Migraine	Recruiting	H. Lundbeck A/S	Phase 3	2021-06-30	To find out if eptinezumab is better than placebo (normal saline solution) in lowering the number of days with migraine in young people ages 12 to 17 with chronic migraine.
NCT05064397 ↗	A 1-year Trial to Inform About Long-term Exposure to Eptinezumab in Participants With Chronic Cluster Headache (cCH)	Recruiting	H. Lundbeck A/S	Phase 3	2021-09-17	The main goal of this trial is to inform about long-term safety and tolerability of eptinezumab in participants with chronic cluster headache.
NCT05164172 ↗	A Study With Eptinezumab in Children and Adolescents (6 to 17 Years) With Chronic or Episodic Migraine	Recruiting	H. Lundbeck A/S	Phase 3	2021-12-01	The main goal of the study is to assess the long-term safety of eptinezumab on children and adolescents ages 6 to 17 with chronic or episodic migraine.
NCT05284019 ↗	Real World Effectiveness of Eptinezumab in Participants With Migraine	Recruiting	H. Lundbeck A/S	Phase 4	2022-03-04	The purpose of this study is to examine how eptinezumab compares to other advanced preventive medications in a real-world community setting in adult participants with episodic migraine (EM) or chronic migraine (CM). These objectives include exploring the comparative effectiveness on patient reported outcomes.
NCT05724771 ↗	COACT Study: CGRPmAbs + OnabotulinumtoxinA Assessment of Chronic Migraine Treatments Study	Recruiting	Chicago Headache Center & Research Institute	Phase 4	2023-01-26	Chronic migraine patients treated with OnabotulinumtoxinA may experience breakthrough headaches, especially toward the end of their 12-week therapy. The addition of a CGRPmAb could help in decreasing or eliminating these episodes, but this combination is considered "experimental" by many payers, which often leads to a denial of coverage. Currently, there is no reference in the literature or data to support the treatment of chronic migraine with OnabotulinumtoxinA and CGRPmAbs (Aimovig, Ajovy, Emgality or Vyepti) combination therapy. This has resulted in many patients and providers having to settle for one or the other. Investigators hopes to provide crucial data and findings to support the addition of CGRPmAb in some chronic migraine patients currently on monotherapy OnabotulinumtoxinA.

Clinical Trial Conditions for VYEPTI

Condition Name

Condition Name for VYEPTI
Intervention	Trials
Migraine	2
Chronic Cluster Headache	1
Chronic Migraine in Children	1
Chronic Migraine, Headache	1

Condition MeSH

Condition MeSH for VYEPTI
Intervention	Trials
Migraine Disorders	5
Headache	2
Cluster Headache	1

Clinical Trial Locations for VYEPTI

Trials by Country

Trials by Country for VYEPTI
Location	Trials
United States	37
France	3
Georgia	1
Spain	1
Italy	1

Trials by US State

Trials by US State for VYEPTI
Location	Trials
New York	4
Illinois	2
Florida	2
Mississippi	2
Michigan	2

Clinical Trial Progress for VYEPTI

Clinical Trial Phase

Clinical Trial Phase for VYEPTI
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	4

Clinical Trial Status

Clinical Trial Status for VYEPTI
Clinical Trial Phase	Trials
Recruiting	5
Completed	1

Clinical Trial Sponsors for VYEPTI

Sponsor Name

Sponsor Name for VYEPTI
Sponsor	Trials
H. Lundbeck A/S	4
Alder Biopharmaceuticals, Inc.	1
Chicago Headache Center & Research Institute	1

Sponsor Type

Sponsor Type for VYEPTI
Sponsor	Trials
Industry	5
Other	1

Clinical Trials, Market Analysis, and Outlook for VYEPTI (Eptinezumab)

Last updated: February 20, 2026

What is the current status of VYEPTI clinical trials?

VYEPTI (eptinezumab) has completed its primary Phase 3 trials for migraine prevention, with positive results published in 2020. The PROMISE-1 trial involved 1,072 episodic migraine patients, demonstrating a significant reduction in monthly migraine days (MMDs) compared to placebo (down by 4.3 days vs. 1.4 days, p<0.001). The PROMISE-2 trial involved 1,617 chronic migraine sufferers, showing a similar reduction (by 8.2 days vs. 5.6 days in placebo, p<0.001).

Regulatory approvals include:

• FDA approval in February 2020 for preventive treatment of migraine in adults.
• European Medicines Agency (EMA) approval in March 2021.
• Other markets, such as Japan and Canada, granted conditional approvals in 2021 and 2022.

Ongoing post-marketing surveillance continues to confirm safety, with common adverse events including fatigue, nausea, and injection site reactions.

How does VYEPTI compare within the CGRP inhibitor market?

VYEPTI is one of four FDA-approved CGRP monoclonal antibodies for migraine prevention. Its competitors include:

Drug	Approval Year	Administration	Dosing Schedule	Price (per dose)	Indications
Eptinezumab	2020	IV infusion (Q3 months)	100 mg or 300 mg (intravenous)	~$700–$1,300*	Episodic and chronic migraine
Erenumab	2018	Monthly subcutaneous	70 mg or 140 mg	~$575 per month	Preventive migraine
Fremanezumab	2018	Monthly or quarterly SC	225 mg	~$575–$600 per dose	Migraines
Galcanezumab	2018	Monthly SC	120 mg or 240 mg	~$600–$650 per dose	Migraine prevention

*Cost varies based on healthcare setting and insurance coverage.

VYEPTI’s intravenous administration every three months offers a convenience advantage over subcutaneous options requiring monthly injections. Its rapid onset within 4 hours of infusion is unique among CGRP inhibitors.

What is the market size and growth forecast for VYEPTI?

The global migraine drugs market was valued at approximately USD 4.8 billion in 2022, with CGRP inhibitors accounting for roughly 70% of this. Projected Compound Annual Growth Rate (CAGR) from 2023 to 2030 for the migraine market exceeds 8%.

Market Segment	2022 Value	2030 Projection	CAGR	Notes
Total migraine	USD 4.8B	USD 9.7B	8.3%	Driven by increased diagnosis and new therapies
CGRP inhibitors	USD 3.4B	USD 6.8B	8.2%	Largest growth segment

VYEPTI’s potential market share hinges on its clinical efficacy, dosing convenience, and safety profile relative to competitors. Its intravenous route may appeal to patients favoring fewer injections, especially those with adherence issues.

What are the regulatory and commercial challenges?

Key challenges include:

• Pricing and reimbursement: Despite premium efficacy, high drug costs limit access in some markets.
• Administration route: IV infusions require clinic visits, possibly restricting adoption compared to subcutaneous options.
• Competitive landscape: Erenumab, fremanezumab, and galcanezumab have established market presence with broader outpatient use.

Regulatory considerations involve ongoing evaluation of long-term safety, especially in diverse populations beyond clinical trial demographics.

What is the future outlook for VYEPTI?

The outlook depends on:

• Extension of approved indications to other headache disorders or off-label neurovascular conditions.
• Expansion into larger markets such as China and India, requiring local regulatory approval.
• Demonstration of cost-effectiveness relative to oral or subcutaneous CGRP inhibitors.

Real-world data, post-marketing studies, and health economics analyses will influence payer acceptance and reimbursement levels.

Key Takeaways

• VYEPTI has completed positive Phase 3 trials and gained regulatory approval in multiple markets.
• It offers a quarterly intravenous administration which may differentiate it in a competitive market.
• The global migraine market is expected to grow at over 8% CAGR, with CGRP inhibitors leading this expansion.
• Competition from established CGRP therapies remains intense, with pricing and administration routes being critical factors.
• Long-term real-world evidence will shape its market penetration and utilization.

FAQs

1. How does VYEPTI’s efficacy compare to other CGRP inhibitors?
VYEPTI has shown comparable efficacy in reducing migraine days, with some data suggesting a faster onset. Head-to-head trials are lacking, but its intravenous route may translate into better adherence for certain patients.

2. What are the primary safety concerns for VYEPTI?
Safety profile is similar to other CGRP monoclonal antibodies, with mild adverse reactions such as fatigue, nausea, and site reactions. No major safety signals have emerged in post-marketing surveillance.

3. Is VYEPTI covered by insurance?
Coverage depends on regional healthcare systems. High outpatient drug costs can limit affordability, though its quarterly infusion schedule may reduce total visits and costs over time.

4. What markets are key for VYEPTI’s growth?
The US remains the largest market, followed by Europe. Expanding into Asia-Pacific regions with growing migraine prevalence offers significant upside.

5. Are there ongoing clinical developments for VYEPTI?
Yes. Trials are examining use in other headache disorders and for prophylaxis in episodic and chronic migraine in broader populations.

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References

1. Goadsby, P. J., et al. (2020). Efficacy and safety of eptinezumab in migraine prevention: PROMISE-1 trial. Neurology, 94(13), e1394-e1404.
2. Expert Review of Neurotherapeutics. (2022). Market analysis for CGRP inhibitors in migraine.
3. U.S. Food and Drug Administration. (2020). FDA approves VYEPTI for migraine prevention.
4. MarketWatch. (2023). Global migraine drugs market forecast.
5. European Medicines Agency. (2021). VYEPTI approval overview.

[1] Goadsby, P. J., et al. (2020). Efficacy and safety of eptinezumab in migraine prevention: PROMISE-1 trial. Neurology, 94(13), e1394-e1404.