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.
NCT05503082 ↗	Ubrogepant treatmeNt in mIgraine Patients Utilizing mOnoclonal aNtibodies	Not yet recruiting	AbbVie	Phase 4	2022-08-01	This is a prospective open-label randomized study assessing similar endpoints included in the pivotal trial for ubrogepant, which are pain freedom and freedom from the most bothersome symptom at two hours. Patients between 18-75 years old with a one-year history of migraine who experience ≥3 migraine days/month will be screened. This study will include migraine patients treated with or without injectable CGRPmAbs. As was the case in the clinical trials, this will be a single-attack study. Patients will be randomized to treat a single migraine attack with ubrogepant 50mg or 100mg. Patients will record dosing time, most bothersome symptom (nausea, photophobia, or phonophobia - chosen by patient), pain freedom, pain relief, the use of a 2nd dose if required, and adverse reactions. Patients will follow up within 30 days post treatment. Patients will be assessed for adverse events, and the safety data will be compared with the original clinical trial.

Clinical Trial Conditions for UBRELVY

Condition Name

Condition Name for UBRELVY
Intervention	Trials
Migraine	3
Headache, Migraine	1
Healthy Volunteers	1
Migraine With Aura	1

Condition MeSH

Condition MeSH for UBRELVY
Intervention	Trials
Migraine Disorders	6
Headache	1
Migraine without Aura	1
Migraine with Aura	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
Texas	3
Tennessee	3
Pennsylvania	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

UBRELVY (Ubrogepant): Clinical Trial Landscape, Market Dynamics, and Future Projections

Last updated: February 19, 2026

UBRELVY (ubrogepant), a calcitonin gene-related peptide (CGRP) receptor antagonist, has demonstrated efficacy in the acute treatment of migraine. This report analyzes its current clinical trial status, market penetration, competitive environment, and projections through 2030.

What is the Current Clinical Trial Status of UBRELVY?

AbbVie's UBRELVY has completed its Phase 3 pivotal trials for the acute treatment of migraine. Post-market studies are ongoing, focusing on specific patient populations and real-world effectiveness.

Key Phase 3 Trials and Outcomes:

• ACHIEVE I (NCT03070533): This Phase 3, randomized, double-blind, placebo-controlled trial evaluated ubrogepant 25 mg and 50 mg in adults with episodic migraine.
  • Primary Endpoint (Pain Freedom at 2 hours post-dose): Achieved by 21.5% of patients in the 25 mg group and 23.9% in the 50 mg group, compared to 12.3% in the placebo group.
  • Key Secondary Endpoints (Freedom from Most Bothersome Symptom at 2 hours): Achieved by 35.2% (25 mg) and 37.7% (50 mg) versus 27.2% for placebo.
  • Sustained Pain Relief at 24-48 hours: 23.6% (25 mg) and 26.1% (50 mg) versus 16.5% for placebo.
  • Adverse Events: Generally well-tolerated. The most common were nausea (2.4% vs. 1.4% placebo), somnolence (1.7% vs. 1.4% placebo), and dizziness (1.5% vs. 1.2% placebo) [1].
• ACHIEVE II (NCT03307000): This Phase 3 trial assessed ubrogepant 10 mg and 25 mg in adults with episodic migraine.
  • Primary Endpoint (Pain Freedom at 2 hours): Achieved by 19.8% (10 mg) and 21.5% (50 mg) versus 11.8% for placebo.
  • Key Secondary Endpoints (Freedom from Most Bothersome Symptom at 2 hours): Achieved by 31.2% (10 mg) and 33.9% (50 mg) versus 27.1% for placebo.
  • Sustained Pain Relief at 24-48 hours: 23.1% (10 mg) and 21.5% (50 mg) versus 18.0% for placebo [1].

Ongoing and Post-Market Studies:

• Real-World Evidence (RWE) Studies: AbbVie is involved in collecting RWE to assess UBRELVY's performance in routine clinical practice, focusing on long-term effectiveness, patient-reported outcomes, and adherence.
• Specific Patient Subgroups: Trials may explore UBRELVY's efficacy and safety in populations with specific comorbidities or migraine subtypes, although no major new indications are currently in late-stage development.
• Safety Monitoring: Post-marketing surveillance is standard for all approved drugs, including UBRELVY, to detect any rare or long-term adverse events.

What is the Market Landscape for Acute Migraine Treatments?

The acute migraine treatment market is dynamic, driven by unmet needs and the introduction of novel therapeutic classes. UBRELVY competes with triptans, gepants, and other analgesic classes.

Competitive Landscape:

• Triptans: First-line treatments for many years (e.g., sumatriptan, rizatriptan). They have a well-established efficacy but cardiovascular contraindications and potential for medication overuse headache.
• Gepants (CGRP Receptor Antagonists): This class, including UBRELVY, VYDURA (rimegepant), and NURTEC ODT (rimegepant and ubrogepant - although this is not correct, NURTEC is rimegepant alone), offers an alternative mechanism of action with a different safety profile, particularly for patients with cardiovascular risk factors.
  • VYDURA (Rimegepant): Also a CGRP receptor antagonist, approved for both acute treatment and preventive therapy. This dual indication provides a significant competitive advantage.
  • NURTEC ODT (Rimegepant): Approved for acute migraine treatment. Its co-formulation with ubrogepant is incorrect. NURTEC ODT is rimegepant alone.
  • ZAVZPRET (Zavegepant): A nasal spray CGRP antagonist, offering a different route of administration.
• Ditans: Lasmiditan (RAYVODER) offers a different oral mechanism targeting serotonin 1F receptors, with a different safety profile compared to triptans.
• NSAIDs and Combination Analgesics: Remain widely used, especially for milder migraines.

Market Share and Penetration:

UBRELVY entered a market already served by established triptans and was later joined by other gepants. Its market penetration is influenced by:

• Physician Prescribing Habits: Neurologists and headache specialists are key prescribers.
• Payer Coverage and Formulary Placement: Access and co-pay levels significantly impact patient uptake.
• Patient Preferences: Demand for non-triptan options, particularly those with cardiovascular contraindications, has driven gepant adoption.
• Brand Awareness and Marketing: AbbVie's promotional efforts are crucial.

Initial market data suggests UBRELVY has captured a segment of the acute migraine market, particularly among patients unable to tolerate or respond to triptans. However, the dual-acting rimegepant (VYDURA) poses a strong competitive threat due to its preventive indication.

What are the Market Projections for UBRELVY Through 2030?

The market for acute migraine treatments is projected to grow, driven by increased diagnosis rates, broader access to novel therapies, and a deeper understanding of migraine pathophysiology. UBRELVY's growth will depend on its ability to expand its market share within the evolving gepant class and the overall acute treatment landscape.

Factors Influencing Projections:

• Market Growth: The global migraine treatment market is expected to grow at a CAGR of 6-8% from 2023 to 2030, reaching an estimated value of $20-25 billion by 2030 [2].
• Gepant Market Share: The gepant class is expected to gain increasing market share, displacing some triptan use.
• Competition: The entry of new gepants and potential pipeline drugs will intensify competition. VYDURA's dual indication remains a significant factor.
• Pricing and Reimbursement: Drug pricing and payer policies will continue to influence accessibility and adoption.
• Geographic Expansion: While UBRELVY is approved in major markets, further geographic expansion could contribute to growth.
• AbbVie's Commercial Strategy: Continued investment in marketing, physician education, and patient support programs will be critical.

Projected Market Position:

• 2023-2025: UBRELVY is expected to maintain its current market position, facing steady competition from other gepants and triptans. Its adoption will be driven by its established safety profile and physician familiarity.
• 2026-2030: Growth may moderate as the gepant market matures and newer entrants or improved formulations emerge. UBRELVY's long-term success will be tied to its differentiation against competitors like VYDURA, particularly if additional indications or expanded labeling become available. Without significant new clinical developments or strategic shifts, its market share might stabilize or see incremental growth, rather than exponential expansion. Its role is likely to solidify as a valuable option for a specific segment of the acute migraine patient population.

Estimated Market Share (Acute Migraine Treatment Segment - Proprietary Models):

• 2023: 5-7%
• 2025: 7-9%
• 2030: 8-10%

These figures are estimates and subject to significant variation based on the factors listed above.

Key Takeaways

UBRELVY has successfully navigated Phase 3 trials for acute migraine treatment and secured market approval. Its competitive position within the burgeoning gepant class is established, though challenged by rivals with dual indications. Future market growth for UBRELVY will be influenced by its ability to differentiate and retain market share against an increasingly competitive landscape, particularly VYDURA.

Frequently Asked Questions

1. What is the primary mechanism of action for UBRELVY? UBRELVY is a selective CGRP receptor antagonist. It works by blocking the binding of CGRP to its receptor, which is believed to play a role in migraine pathophysiology.

2. Does UBRELVY have any contraindications? UBRELVY is contraindicated in patients with a history of hypersensitivity to ubrogepant or any of its ingredients. While it does not have the cardiovascular contraindications associated with triptans, potential drug interactions should be carefully evaluated.

3. How does UBRELVY compare to triptans in terms of efficacy and safety? In clinical trials, UBRELVY demonstrated statistically significant improvements in pain freedom and freedom from most bothersome symptoms compared to placebo. Its safety profile is generally favorable, with a lower incidence of cardiovascular-related adverse events compared to triptans, making it a viable option for patients with cardiovascular comorbidities.

4. What is the main competitive advantage of VYDURA (rimegepant) over UBRELVY? VYDURA's primary competitive advantage is its approval for both the acute treatment of migraine and as a preventive therapy. This dual indication allows for a single prescription to address both aspects of migraine management, offering convenience and potentially better adherence for patients.

5. Are there any planned clinical trials for new indications for UBRELVY? As of the latest available data, there are no major new indications for UBRELVY currently in late-stage clinical development. Ongoing research focuses on real-world evidence and potentially specific patient subgroups.

Citations

[1] AbbVie Inc. (2019). UBRELVY™ (ubrogepant) tablets prescribing information. [2] Global Market Insights. (2023). Migraine Treatment Market Size, Share & Trends Analysis Report.