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.

Clinical Trial Conditions for Ubrelvy

Condition Name

Condition Name for Ubrelvy
Intervention	Trials
Migraine	3
Migraine Without Aura	1
Episodic Migraine	1
Headache, Migraine	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
Oregon	3
Ohio	3
New York	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
Chicago Headache Center & Research Institute	1

Sponsor Type

Sponsor Type for Ubrelvy
Sponsor	Trials
Industry	6
Other	2

UBRELVY: A Groundbreaking Migraine Treatment - Clinical Trials, Market Analysis, and Projections

Introduction to UBRELVY

UBRELVY (ubrogepant) is a revolutionary oral medication developed by AbbVie for the acute treatment of migraine attacks. It has made significant strides in the medical field, particularly in its ability to treat migraines during the prodrome phase, a period before the actual headache occurs.

Clinical Trials: The PRODROME Study

The PRODROME study, a Phase 3, double-blind, placebo-controlled trial, has been pivotal in demonstrating the efficacy and safety of UBRELVY when administered during the prodrome phase of a migraine attack. Here are the key findings:

• Reduction in Headache Severity: UBRELVY significantly reduced the likelihood of developing moderate or severe headaches within 24 hours after treatment. 46% of patients treated with UBRELVY avoided moderate or severe headaches, compared to 29% in the placebo group[1][4].
• Functional Disability: The study also showed that more patients treated with UBRELVY maintained normal function within 24 hours post-dose compared to those receiving placebo[1][4].
• Absence of Headache: UBRELVY led to the absence of any headache intensity within 24 hours in 24% of qualifying prodrome events, versus 14% in the placebo group[1].

Safety Profile

The PRODROME trial and other clinical studies have reinforced the safety and tolerability of UBRELVY. The most common adverse events reported were nausea, fatigue, dizziness, and somnolence, with no new safety signals of concern[1][4].

Mechanism of Action

UBRELVY works by binding and inhibiting the calcitonin gene-related peptide (CGRP) receptor, which is commonly expressed in primary sensory neurons and is typically elevated during migraine attacks. This mechanism makes it the first oral pill in the U.S. designed to block CGRP receptors for the acute treatment of migraines[4].

Market Analysis

The migraine market is expected to experience significant growth in the coming years. Here are some key market projections and analyses:

• Market Growth: The migraine market across seven major markets (7MM) is projected to grow at a compound annual growth rate (CAGR) of 6.0% from $9.2 billion in 2023 to $16.4 billion in 2033[2].
• Top-Selling Drugs: UBRELVY is expected to be one of the top-selling drugs in the migraine market by 2033, with projected sales of $1.07 billion. However, Pfizer’s Nurtec is expected to peak with the highest sales of $1.96 billion in 2029 before its patent expires[2].
• Current Performance: As of the first quarter of 2024, UBRELVY has shown strong financial performance with global net revenues increasing by 33.8% to $203 million. This growth underscores the drug's increasing acceptance and market penetration[5].

Competitive Landscape

AbbVie has solidified its position in the migraine treatment market with a robust portfolio that includes UBRELVY and Qulipta (atogepant), another oral CGRP receptor antagonist. Here are some key points about the competitive landscape:

• AbbVie’s Migraine Franchise: AbbVie acquired Allergan in 2019, securing rights to UBRELVY. The company has since expanded its migraine franchise with the FDA approval of Qulipta for both episodic and chronic migraine[4].
• Competing Treatments: Pfizer’s Nurtec, approved for both acute and preventive therapy, is a significant competitor. However, its patent is set to expire in the early 2030s, which could impact its market share[2].

Patient Impact

Migraines are a highly debilitating condition affecting nearly 40 million Americans, causing significant disruptions in daily life. UBRELVY offers a unique opportunity for patients who can identify prodromal symptoms to treat their migraines before the headache phase begins.

"For patients who are able to identify prodromal symptoms, the ability to treat a migraine attack before the headache phase creates an opportunity to stop migraine attacks before they become fully debilitating," said Dawn Carlson, vice president, neuroscience development, AbbVie[1].

Financial Performance

UBRELVY has shown impressive financial growth, reflecting its increasing adoption and market acceptance.

• Revenue Growth: In the first quarter of 2024, global net revenues for UBRELVY increased by 33.8% to $203 million. Combined with Qulipta, the total revenues from these two drugs were $334 million[5].

Future Projections

Given the strong clinical data and growing market demand, UBRELVY is poised for continued success:

• Market Share: With its unique position as the first and only acute treatment for migraine that has demonstrated efficacy in the prodrome phase, UBRELVY is expected to maintain a significant market share[1][2].
• Revenue Projections: The drug is projected to achieve sales of $1.07 billion by 2033, making it one of the top-selling migraine treatments in the market[2].

Key Takeaways

• Clinical Efficacy: UBRELVY has demonstrated significant efficacy in reducing the likelihood of moderate or severe headaches when administered during the prodrome phase.
• Safety Profile: The drug has a favorable safety profile with common adverse events being nausea, fatigue, dizziness, and somnolence.
• Market Growth: The migraine market is expected to grow significantly, with UBRELVY projected to be a top-selling drug by 2033.
• Patient Impact: UBRELVY offers patients the opportunity to treat migraines before the headache phase, significantly improving their quality of life.

FAQs

What is UBRELVY and how does it work?

UBRELVY (ubrogepant) is an oral medication that works by binding and inhibiting the calcitonin gene-related peptide (CGRP) receptor, which is elevated during migraine attacks.

What are the key findings of the PRODROME study?

The PRODROME study showed that UBRELVY significantly reduced the likelihood of developing moderate or severe headaches within 24 hours when administered during the prodrome phase, and improved functional disability compared to placebo.

What are the common side effects of UBRELVY?

The most common adverse events reported with UBRELVY are nausea, fatigue, dizziness, and somnolence.

How is the migraine market expected to grow?

The migraine market is projected to grow at a CAGR of 6.0% from $9.2 billion in 2023 to $16.4 billion in 2033.

What is the expected market performance of UBRELVY by 2033?

UBRELVY is expected to achieve sales of $1.07 billion by 2033, making it one of the top-selling migraine treatments.

Sources

1. PR Newswire: Results Published in The Lancet Show UBRELVY® (ubrogepant) Reduces the Headache Phase of a Migraine Attack When Dosed During the Prodrome of Migraine.
2. Clinical Trials Arena: Migraine market expected to reach $16.4bn across 7MM by 2033.
3. AbbVie News: Allergan Receives U.S. FDA Approval for UBRELVY™ for the Acute Treatment of Migraine.
4. BioSpace: AbbVie's Migraine Drug Ubrelvy Scores Victory in Phase III Study.
5. AbbVie Investors: AbbVie Reports First-Quarter 2024 Financial Results.