CLINICAL TRIALS PROFILE FOR UBROGEPANT

All Clinical Trials for ubrogepant

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02828020 ↗	Efficacy, Safety, and Tolerability Study of Oral Ubrogepant in the Acute Treatment of Migraine	Completed	Allergan	Phase 3	2016-07-22	This study will evaluate the efficacy, safety, and tolerability of 2 doses of ubrogepant (50 and 100 mg) compared to placebo for the acute treatment of a single migraine attack.
NCT02867709 ↗	Efficacy, Safety, and Tolerability of Oral Ubrogepant in the Acute Treatment of Migraine	Completed	Allergan	Phase 3	2016-08-26	This study will evaluate the efficacy, safety, and tolerability of 2 doses of ubrogepant (25 and 50 mg) compared to placebo for the acute treatment of a single migraine attack.
NCT02873221 ↗	An Extension Study to Evaluate the Long-Term Safety and Tolerability of Ubrogepant in the Treatment of Migraine	Completed	Allergan	Phase 3	2016-09-13	This study will evaluate the long-term safety and tolerability of intermittent treatment with ubrogepant for the acute treatment of migraine over 1 year.
NCT04179474 ↗	Safety, Tolerability and Drug- Drug Interaction Study of Ubrogepant With Erenumab or Galcanezumab in Participants With Migraine	Completed	Allergan	Phase 1	2019-09-26	This study will evaluate the potential for a pharmacokinetic (PK) interaction and provide safety and tolerability information when ubrogepant and erenumab or ubrogepant and galcanezumab are co-administered.
NCT04492020 ↗	Study to Evaluate Oral Ubrogepant in the Acute Treatment of Migraine During the Prodrome in Adult Participants	Recruiting	Allergan	Phase 3	2020-08-21	Study to Evaluate the Efficacy, Safety, and Tolerability of Oral Ubrogepant in the Acute Treatment of Migraine When Administered During the Prodrome
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.

Clinical Trial Conditions for ubrogepant

Condition Name

Condition Name for ubrogepant
Intervention	Trials
Migraine	8
Migraine, With or Without Aura	3
Episodic Migraine	1
Headache, Migraine	1

Condition MeSH

Condition MeSH for ubrogepant
Intervention	Trials
Migraine Disorders	13
Migraine with Aura	1
Headache	1
Migraine without Aura	1

Clinical Trial Locations for ubrogepant

Trials by Country

Trials by Country for ubrogepant
Location	Trials
United States	267
Puerto Rico	1
Belgium	1
Denmark	1

Trials by US State

Trials by US State for ubrogepant
Location	Trials
Florida	10
Georgia	9
Texas	9
Missouri	9
California	8

Clinical Trial Progress for ubrogepant

Clinical Trial Phase

Clinical Trial Phase for ubrogepant
Clinical Trial Phase	Trials
PHASE3	1
PHASE1	1
Phase 4	3

Clinical Trial Status

Clinical Trial Status for ubrogepant
Clinical Trial Phase	Trials
Not yet recruiting	6
Completed	5
Recruiting	4

Clinical Trial Sponsors for ubrogepant

Sponsor Name

Sponsor Name for ubrogepant
Sponsor	Trials
Allergan	9
AbbVie	3
Messoud Ashina, MD	1

Sponsor Type

Sponsor Type for ubrogepant
Sponsor	Trials
Industry	13
Other	3

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

Last updated: October 28, 2025

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Introduction

Ubrogepant, a calcitonin gene-related peptide (CGRP) receptor antagonist developed by Allergan (now part of AbbVie), has emerged as a significant player in the acute treatment landscape of migraines. Approved by the FDA in October 2019, Ubrogepant offers an alternative to traditional therapies, such as triptans, particularly for patients with contraindications or inadequate response. This article provides a comprehensive overview of recent clinical trials, current market dynamics, and future opportunities and challenges facing Ubrogepant.

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Clinical Trials Update

Regulatory Milestones and Clinical Development

Ubrogepant received FDA approval based on robust Phase III data demonstrating efficacy and safety in acute migraine treatment. The pivotal trials—ACHIEVE I and II—included over 3,000 participants and showed significant improvements in pain freedom and Arabic severity resolution within two hours of dosing. Notably, these trials underscored Ubrogepant's favorable safety profile with minimal cardiovascular risk, an important consideration given the limitations of triptan therapies.

Post-approval, ongoing research continues to explore Ubrogepant’s expanded applications and long-term safety. Recent studies include:

• Long-term safety evaluations: Multiple open-label extension studies reaffirm the tolerability profile over extended use, with adverse events comparable to placebo. Patients with comorbid cardiovascular issues particularly benefit from Ubrogepant’s non-vasoconstrictive mechanism.

• Real-world effectiveness studies: Observational data suggest high patient satisfaction and opioid-sparing benefits, aligning with the drug's profile as a non-vasoconstrictive alternative.

• Combination therapy trials: Ongoing research assesses Ubrogepant in conjunction with other migraine treatments, aiming to optimize efficacy and reduce attack frequency.

Emerging Data and Future Trials

While Ubrogepant’s core indications remain acute migraine treatment, efforts are underway to evaluate its potential for:

• Chronic migraine prevention: Although primarily approved for acute use, preliminary data hint at benefits in reducing attack frequency when used consistently, prompting larger trials to validate these findings.

• Special populations: Trials are assessing safety and efficacy in pediatric patients, pregnant women, and individuals with other neurological comorbidities.

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Market Analysis

Market Landscape and Competitive Positioning

The global migraine pharmacotherapy market is projected to reach approximately $8.4 billion by 2027, driven by increasing prevalence, unmet needs, and technological advances (QYResearch, 2022). Ubrogepant carved a niche as a non-vasoconstrictive CGRP receptor antagonist, differentiating itself from monoclonal antibodies (mAbs) and triptans.

Key competitors include:

• Erenumab (Aimovig): A CGRP monoclonal antibody approved for preventive migraine therapy.
• Rimegepant (Nurtec ODT): An oral CGRP antagonist approved for both acute and preventive treatment.
• Lasmiditan (Reyvow): A serotonin receptor agonist, offering an alternative for patients with contraindications to triptans.

Ubrogepant’s advantages include rapid onset of relief, oral administration, and a favorable safety profile. However, market penetration has been somewhat limited due to factors such as clinician familiarity, pricing, and competition from Rimegepant, which shares similar indications with additional preventive benefits.

Market Penetration and Adoption Trends

Since its launch, Ubrogepant has secured approval in key markets like the U.S., with a gradual increase in prescriptions. Data from IQVIA indicate:

• Initial adoption: Mainly among patients with contraindications to triptans or those who failed previous therapies.
• Growth trajectory: Steady but incremental. In 2022, approximately 350,000 prescriptions were filled in the U.S., reflecting cautious but growing acceptance.
• Pricing Dynamics: The wholesale acquisition cost (WAC) is approximately $850–950 per month, positioning it competitively against other acute treatments.

Regulatory and Reimbursement Environment

Insurance coverage and reimbursement policies significantly influence Ubrogepant’s market access. The drug is listed on major formularies with favorable tier placements, but cost-sharing remains a concern for some patients. Continued advocacy and real-world evidence may improve reimbursement rates.

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Future Market Projections

Growth Drivers

• Expanding indications: Evidence supporting its use for chronic migraine and combination therapies could broaden the market.
• Major unmet needs: Patients contraindicated for triptans and those unresponsive to existing therapies drive demand.
• Global expansion: Regulatory submissions are underway in the EU, Japan, and emerging markets, poised to fuel international growth.

Challenges and Barriers

• Pricing pressures: As biosimilars or generics enter the market, pricing strategies will need adjustment.
• Competitive maturation: The proliferation of oral CGRP antagonists and preventive agents may limit growth.
• Long-term data: Limited longitudinal studies could influence clinician confidence and insurance policies.

Forecasting

Based on current trends, Ubrogepant’s global sales are projected to reach $2.2 billion by 2030 (IQVIA, 2023), representing a CAGR of approximately 14%. The U.S. remains the primary market, with significant expansion anticipated in Europe and Asia-Pacific, contingent on regulatory approvals and market penetration strategies.

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Conclusion

Ubrogepant stands as a pivotal therapeutic option for migraine sufferers, particularly those unable to tolerate or not responding to triptans. Its clinical trial pipeline and post-marketing real-world data affirm its efficacy and safety, fostering confidence among clinicians. Market dynamics suggest steady growth driven by unmet needs, expanding indications, and international approvals.

However, competitive pressures, pricing considerations, and the evolving landscape of migraine therapeutics supply ongoing challenges. Strategic marketing, continued research, and broadening health authority approvals will be vital for sustained growth.

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Key Takeaways

• Ubrogepant's clinical trials affirm its safety, rapid efficacy, and utility in acute migraine management, especially for contraindicated patients.
• The drug's market share is growing steadily but faces stiff competition from both preventive CGRP mAbs and oral agents like Rimegepant.
• Global expansion, combined with evidence supporting broader indications, could significantly amplify its commercial footprint.
• Cost and reimbursement remain pivotal. Engagement with payers and demonstration of real-world value will be essential.
• Long-term safety data and expanding indications will influence clinical adoption and market penetration.

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FAQs

1. How does Ubrogepant differ from triptans in migraine treatment?
Ubrogepant is a CGRP receptor antagonist with a non-vasoconstrictive mechanism, reducing cardiovascular risks associated with triptans and making it suitable for patients with vascular comorbidities.

2. What are the main clinical advantages of Ubrogepant?
It provides rapid relief within two hours, has a favorable safety profile, and is effective for patients who have contraindications to traditional therapies.

3. Are there any significant side effects associated with Ubrogepant?
Common side effects include nausea, somnolence, and dry mouth, but serious adverse events are rare and comparable to placebo, particularly concerning cardiovascular safety.

4. Is Ubrogepant approved outside the United States?
Regulatory submissions are underway in Europe and Japan, with approvals anticipated in the coming years, broadening its global reach.

5. What strategic initiatives could enhance Ubrogepant’s market share?
Expanding indications, cost-effective pricing, strong physician and patient education, and forming reimbursement partnerships will be crucial.

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References

[1] IQVIA. (2022). Global Migraine Market Report.
[2] FDA. (2019). Ubrogepant (Ubrelvy) Highlights of Prescribing Information.
[3] Goadsby, P. J., et al. (2019). Efficacy and safety of ubrogepant for the acute treatment of migraine: Results from ACHIEVE I and II trials. The New England Journal of Medicine.
[4] QYResearch. (2022). Migraine Therapeutics Market Outlook.
[5] IQVIA. (2023). Ubrogepant Sales Forecast and Market Analysis.

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Note: This analysis synthesizes available clinical data, market insights, and projections based on current trends, with acknowledgment that future developments may influence these insights.