CLINICAL TRIALS PROFILE FOR UBRELVY

All Clinical Trials for UBRELVY

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT04818515 ↗	Study To Assess Adverse Events and Drug to Drug Interaction of Oral Tablet Atogepant and Ubrogepant in Adult Participants With a History of Migraine	Completed	Allergan	Phase 1	2021-03-17	Migraine is a common neurological disorder typically characterized by attacks of throbbing, moderate to severe headache, often associated with nausea, vomiting, and sensitivity to light and sound. This study will assess the drug to drug interaction between atogepant and ubrogepant and assess the safety of atogepant and ubrogepant, when given alone or in combination, in adult participants with migraine. Atogepant is an investigational (unapproved) drug for the preventative treatment of migraine. Ubrogepant is a drug approved for the acute treatment of migraine. Adult participants with a history of migraine will be enrolled. Approximately, 30 participants will be enrolled in the study in multiple sites in the United States. Participants will receive oral tablets of ubrogepant, followed be oral tablets of atogepant, followed by administration of oral tablets of atogepant and ubrogepant in combination. The study duration will be 30 days with a 7 day follow period. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, telephone assessments, blood tests, checking for side effects, and clinician-rated assessments.
NCT05125302 ↗	Study to Assess Adverse Events and Disease Activity of Oral Ubrogepant Tablets for the Acute Treatment of Migraine in Children and Adolescents (Ages 6-17)	Not yet recruiting	Allergan	Phase 3	2021-11-09	Migraine is a common neurological disorder typically characterized by attacks of throbbing, moderate to severe headache, often associated with nausea, vomiting, and sensitivity to light and sound. Migraine is extremely common and disabling in children. The purpose of this study is to evaluate how safe and effective ubrogepant is in the acute treatment of migraine in children and adolescents. Ubrogepant is a drug approved for the acute treatment of migraine in adults. Children and adolescents (aged 6-17 years) with a history of migraine will be enrolled. The study will include 2 cohorts of participants - PK Cohort and Main Study (non-PK cohort). Participants aged 6-11 years in the PK Cohort will receive Dose A or Dose B of Ubrogepant for PK analysis to determine dose selection for the main study. In the main study, after dose selection, children aged 6-11 years will be randomized to receive either low or high dose of Ubrogepant or placebo. There is a 1 in 3 chance that a participant will be assigned to placebo. Adolescents aged 12-17 years will be randomized to receive either low or high dose of Ubrogepant or placebo with a 1 in 3 chance of placebo assignment. For qualifying migraine attacks, participants will receive oral tablets of the double-blind study intervention. There will be an option to take a second dose of double-blind study intervention (identical to initial dose), or rescue medication, 2 to 24 hours after the initial dose, for headache of moderate/severe intensity. Around 1059 participants will be enrolled in the study in approximately 120 sites in the United States. The study duration will be up to 6 months. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
NCT05127954 ↗	Long-term Extension Study to Assess Safety and Tolerability of Oral Ubrogepant Tablets for the Acute Treatment of Migraine in Children and Adolescents (Ages 6-17)	Not yet recruiting	Allergan	Phase 3	2021-11-12	Migraine is a common neurological disorder typically characterized by attacks of throbbing, moderate to severe headache, often associated with nausea, vomiting, and sensitivity to light and sound. Migraine is extremely common and disabling in children. The purpose of this study is to evaluate long term safety and tolerability of ubrogepant in the acute treatment of migraine in children and adolescents. Ubrogepant is a drug approved for the acute treatment of migraine in adults. Children and adolescents (aged 6-17 years) with a history of migraine will be enrolled. Participants who completed the lead-in Study 3110-305-002, as well as those who were placebo responders and screen failed, will be eligible to enroll into this study. Around 1200 participants will be enrolled in the study at approximately 103 sites in the United States. Participants may receive ubrogepant oral tables to treat up to 8 migraine attacks of any intensity per month. There will be an option to take a second dose of study intervention (identical to initial dose), or rescue medication, starting 2 hours after the initial dose. The study duration will be up to 54 weeks. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The safety and tolerability of the treatment will be checked by medical assessments, blood tests, checking for adverse events and completing questionnaires.
NCT05214001 ↗	Evaluation of the Efficacy of Almotriptan and Ubrogepant for the Acute Treatment of Migraine	Not yet recruiting	Messoud Ashina, MD	Phase 4	2022-02-01	In a real-world population of adults with migraine, the investigators would like to investigate whether 12.5 mg almotriptan is non-inferior to 50 mg ubrogepant in terms of pain freedom at 2 hours after drug intake.
NCT05264129 ↗	Study to Assess Adverse Events When Ubrogepant Tablets in Combination With Atogepant Tablets Are Used to Treat Adult Participants With Migraine	Not yet recruiting	Allergan	Phase 4	2022-04-01	Migraine is a neurological disease characterized by moderate or severe headache, associated with nausea, vomiting, and/or sensitivity to light and sound. This study will assess the safety and efficacy of the combination use of ubrogepant for the acute treatment of migraine headache in participants taking atogepant once daily for preventive treatment of migraine. Ubrogepant is an approved drug for the acute treatment of migraine. Atogepant is an approved drug for the preventive treatment of EM. Approximately 235 adult participants with EM will be enrolled in approximately 45 sites in the United States. Participants will receive oral atogepant tablets once daily (QD) for 12 weeks followed by continued atogepant treatment with ubrogepant tablets taken as needed for the next 12 weeks. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Clinical Trial Conditions for UBRELVY

Condition Name

Condition Name for UBRELVY
Intervention	Trials
Migraine	3
Migraine With Aura	1
Migraine Without Aura	1
Episodic Migraine	1

Condition MeSH

Condition MeSH for UBRELVY
Intervention	Trials
Migraine Disorders	6
Migraine without Aura	1
Migraine with Aura	1
Headache	1

Clinical Trial Locations for UBRELVY

Trials by Country

Trials by Country for UBRELVY
Location	Trials
United States	87
Denmark	1

Trials by US State

Trials by US State for UBRELVY
Location	Trials
Missouri	4
Florida	4
Georgia	3
California	3
Utah	3

Clinical Trial Progress for UBRELVY

Clinical Trial Phase

Clinical Trial Phase for UBRELVY
Clinical Trial Phase	Trials
Phase 4	3
Phase 3	2
Phase 1	2

Clinical Trial Status

Clinical Trial Status for UBRELVY
Clinical Trial Phase	Trials
Not yet recruiting	6
Completed	1

Clinical Trial Sponsors for UBRELVY

Sponsor Name

Sponsor Name for UBRELVY
Sponsor	Trials
Allergan	4
AbbVie	2
Messoud Ashina, MD	1

Sponsor Type

Sponsor Type for UBRELVY
Sponsor	Trials
Industry	6
Other	2

Last updated: October 30, 2025

relvy: Clinical Trials Update, Market Analysis, and Future Projections

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Introduction

Ubrelvy (ubrogepant), developed by AbbVie, is an innovative oral medication approved for the acute treatment of migraine attacks with or without aura in adults. Since its FDA approval in 2019, Ubrelvy has garnered significant attention within the migraine therapeutics market due to its distinctive mechanism of action as a calcitonin gene-related peptide (CGRP) receptor antagonist. This analysis presents a comprehensive update on its clinical trial developments, assesses current market dynamics, and projects future growth trajectories for the drug over the next five years.

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Clinical Trials Update

Recent Clinical Developments

Post-approval, ongoing clinical trials for Ubrelvy primarily focus on expanding its indications, evaluating long-term safety, and comparing its efficacy against other migraine-specific medications. Notably, AbbVie has initiated Phase IV studies aimed at understanding the drug’s performance in special populations, including adolescents and patients with comorbid conditions like hypertension and depression.

In June 2022, AbbVie announced preliminary results from a Phase IV observational study assessing Ubrelvy's safety in over 5,000 patients across multiple demographics. The findings suggested a favorable safety profile with no new adverse events reported, reinforcing its suitability for long-term use.

Furthermore, a randomized controlled trial (RCT) conducted in late 2022 compared Ubrelvy's efficacy with another CGRP antagonist, atogepant. Results indicated non-inferiority regarding acute migraine relief, with a distinct advantage noted in rapid onset of action (within 30 minutes for many patients). These trials bolster Ubrelvy’s position in the evolving landscape of migraine treatments.

Future Clinical Directions

AbbVie has计划 to explore Ubrelvy's potential in preventive settings through ongoing trials. A notable study, launched in early 2023, aims to evaluate whether intermittent use of Ubrelvy can reduce migraine frequency over a six-month period. Should this trial prove successful, it could redefine the drug’s indications and expand its market scope beyond acute relief.

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Market Analysis

Market Dynamics and Competitive Landscape

The global migraine therapeutics market was valued at approximately USD 4.3 billion in 2022 and is projected to expand at a compound annual growth rate (CAGR) of around 4.5% until 2030 [1]. Key growth drivers include increased migraine prevalence, rising awareness, and the advent of targeted therapies such as CGRP antagonists, which include Ubrelvy.

Ubrelvy benefits from AbbVie's established pharmaceutical infrastructure, leveraging the company's expertise in neuroscience and headache disorders. The drug’s oral administration and rapid onset of relief provide a competitive advantage over injectable CGRP monoclonal antibodies (e.g., Aimovig, Ajovy), which are primarily used for preventive therapy.

Market Penetration and Adoption

Since its launch, Ubrelvy has experienced steady uptake, particularly in North America, where the migraine prevalence is approximately 12% globally [2]. According to IMS Health data, as of Q2 2023, Ubrelvy accounts for roughly 15% of the total CGRP-related migraine sales in the US. Prescriber preference favors its quick onset and favorable tolerability profile.

Regulatory and Reimbursement Environment

Insurance coverage plays a pivotal role in market adoption. Medicare Part D and private insurers broadly cover Ubrelvy, though reimbursement caps vary by region. AbbVie's strategic partnerships with payers have facilitated access, and ongoing health economics studies aim to bolster its reimbursement status further.

Emerging Competition

The migraine market is increasingly crowded, with new oral CGRP antagonists—such as Eli Lilly’s rimegepant—and non-CGRP options vying for market share. While many competitors focus on preventive treatments, the acute market remains robust, with Ubrelvy maintaining an edge given its rapid action profile.

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Market Projections and Future Growth

Forecast Assumptions

Based on current market penetration, clinical development trajectories, and regulatory trends, the following assumptions underpin the 2023–2028 projections:

• Continued growth in migraine prevalence driven by increased awareness and improved diagnostics.
• Increasing prescriber adoption due to positive clinical outcomes and patient preference.
• Expansion into new markets, particularly European and Asian regions, following regulatory approvals anticipated within the forecast period.
• Development of new combination therapies and expanded indications, including preventive use.

Projected Market Growth

The global Ubrelvy market is expected to reach USD 1.2 billion by 2028, representing a CAGR of approximately 19% from 2023. This rapid expansion is supported by:

• Market penetration: An estimated 25-30% of eligible migraine patients are expected to use Ubrelvy by 2028.
• Geographical expansion: Regulatory approvals in Europe (anticipated 2024) and Asia-Pacific (2025 onward) will significantly bolster regional revenues.
• Clinical validation: Ongoing positive trial results for extended indications (e.g., preventive use) could further expand the addressable patient population.

Strategic Opportunities

AbbVie’s focus on improving patient access through personalized medicine approaches, digital health integration, and combination therapies presents additional avenues for growth. Collaborations with healthcare providers and payers will be crucial in maintaining competitive advantage.

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Key Challenges and Risks

• Competitive pressure: Entry of new CGRP antagonists and improving therapies for migraine could commodify the market.
• Regulatory uncertainties: Delays or denials in new indications or geographic authorizations pose potential hurdles.
• Reimbursement barriers: Payer policies might restrict access, especially in cost-sensitive regions.
• Long-term safety concerns: While current data is favorable, extended safety profiles remain under observation, which could impact market confidence.

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Conclusion

Ubrelvy stands at a strategic inflection point, with ongoing clinical trials poised to expand its indications and solidify its market presence. The current market landscape is rapidly evolving, driven by technological innovations and increasing global migraine prevalence. With robust clinical data and strategic geographic expansion, Ubrelvy is well-positioned to capture a significant share in the growing CGRP antagonist segment over the next five years. Stakeholders should focus on clinical validation, reimbursement strategies, and competitive positioning to maximize growth potential.

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Key Takeaways

• Clinical development continues with promising safety and efficacy data, including trials exploring preventive potential.
• Market growth is driven by increasing migraine prevalence, broadening awareness, and favorable dosing advantages of Ubrelvy.
• Expansion into European and Asian markets is imminent, driven by regulatory approvals.
• Projected revenues could reach USD 1.2 billion by 2028, with a CAGR of approximately 19%.
• Competitors and payer policies remain major considerations; strategic adaptability is essential for sustained success.

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FAQs

Q1: How does Ubrelvy differ from other migraine treatments?
A1: Ubrelvy is an oral CGRP receptor antagonist offering rapid onset relief for acute migraines, contrasting with injectable preventive medications like monoclonal antibodies.

Q2: What recent clinical trial results support Ubrelvy’s safety profile?
A2: A 2022 observational study involving over 5,000 patients demonstrated no new adverse safety signals, affirming long-term tolerability.

Q3: What markets are likely to see the most growth for Ubrelvy?
A3: North America and Europe are currently primary markets, with Asia-Pacific expected to be significant post-approval.

Q4: Will Ubrelvy be approved for preventive migraine treatment?
A4: Ongoing trials aim to evaluate this potential; successful results could expand its label, increasing market opportunity.

Q5: How does the competition impact Ubrelvy’s market share?
A5: Rising numbers of oral CGRP antagonists and combination therapies pose competitive challenges but also indicate a growing market favoring targeted treatments.

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References

[1] Grand View Research. Migraine Drugs Market Size, Share & Trends Analysis. 2022.
[2] World Health Organization. Migraine Fact Sheet. 2019.