CLINICAL TRIALS PROFILE FOR QULIPTA

All Clinical Trials for Qulipta

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT05216263 ↗	Study of Oral Atogepant Tablets When Added to OnabotulinumtoxinA (BOTOX) to Assess Adverse Events and Change in Disease Activity in Adult Participants With Chronic Migraine	Not yet recruiting	Allergan	Phase 3	2022-03-15	Migraine is characterized by attacks of throbbing, moderate or severe headache, associated with nausea, vomiting, and/or sensitivity to light and sound. Adverse events and change in disease activity will be monitored. Atogepant is an investigational drug being developed to prevent chronic migraine. All participants will receive the same treatment. Approximately 125 adult participants will be enrolled at approximately 25 sites in the United States. All participants will receive atogepant oral tablet once daily during the 24-week treatment 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 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.
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.
NCT05707949 ↗	Long-term Extension Study to Assess Adverse Events of Oral Atogepant Tablets in Pediatric Participants (6 to 17 Years of Age) With Episodic Migraine	Not yet recruiting	AbbVie	Phase 3	2023-03-09	A migraine is a moderate to severe headache on one side of the head. A migraine attack is a headache that may be accompanied by throbbing, nausea, vomiting, sensitivity to light and sound, or other symptoms. A number of treatments are available for adults with migraine but there are limited approved treatments available for participants less than 18 years of age. The main goal of the study is to evaluate the long-term safety and tolerability of atogepant in pediatric participants between the ages of 6 and 17 with episodic migraine. Atogepant is a medicine currently approved to treat adults with episodic migraine (0 to 14 migraine days per month) and is being studied in pediatric participants between the ages of 6 and 17 with a history of episodic migraine. This is a Phase 3, open-label study of atogepant in participants with a history of episodic migraine. Participants must have completed participation in another study of atogepant (lead-in study) or completed the screening period of that study. Participants must have 4 to 14 migraine days and less than 15 headache days in the 4-week screening electronic diary (eDiary; similar to a smart phone). Around 250 participants will be enrolled in the study at approximately 100 sites worldwide. Atogepant is a tablet taken once a day by mouth. Participants between the ages of 12 and 17 will receive high dose atogepant for 52 Weeks. Participants between the ages of 6 and 11 will receive an atogepant dose determined in the lead-in study for 52 Weeks. There may be a bigger responsibility for participants in this study. Participants will attend regular visits during the study at a hospital or clinic. The effects of treatment will be checked by medical assessments, blood tests, checking for side effects, and completing questionnaires.
NCT05711394 ↗	A Study to Assess the Adverse Events and Change in Disease Activity of Oral Atogepant Tablets in Pediatric Participants (6-17 Years of Age) With Episodic Migraine	Not yet recruiting	AbbVie	Phase 3	2023-02-23	A migraine is a moderate to severe headache on one side of the head. A migraine attack is a headache that may be accompanied by throbbing, nausea, vomiting, sensitivity to light and sound, or other symptoms. A number of treatments are available for adults with migraine but there are limited approved treatments available for pediatric participants. The main goal of the study is to evaluate the safety and efficacy (how well treatment works) of a low-dose and high-dose of atogepant in pediatric participants between the ages of 6 and 17. Atogepant is a medicine currently approved to treat adults with episodic migraine (0 to 14 migraine days per month) and is being studied in pediatric participants between the ages of 6 and 17 with a history of episodic migraine. This is a Phase 3, randomized, double-blind study of atogepant in participants with a history of episodic migraine with an open-label pharmacokinetic substudy. Eligible participants will be randomized into 6 different groups. Participants between the ages of 12 and 17 will be randomized to receive placebo, low-dose atogepant, or high-dose atogepant for 12 weeks. Participants between the ages of 6 and 11 will also be randomized to receive placebo, low-dose atogepant, or high-dose atogepant for 12 weeks. The specific atogepant doses to be used in participants between the ages of 6 and 11 will be determined after the PK substudy is complete. Around 450 participants will be enrolled in approximately 100 sites. Placebo, low-dose atogepant, and high-dose atogepant are given as a tablet to take by mouth once a day. At the end of Week 12, participants will either undergo a follow-up visit 4 weeks after last study treatment or join an extension study where they can continue to receive atogepant for another 52 weeks. There may be a bigger responsibility for participants in this study. Participants will attend regular visits during the study at a hospital or clinic. The effects of treatment will be checked by medical assessments, blood tests, checking for side effects, and completing questionnaires.
NCT05748483 ↗	Comparative Study of Oral Atogepant Versus Oral Topiramate to Assess Adverse Events and Disease Activity in Adult Participants With Migraine	Not yet recruiting	AbbVie	Phase 3	2023-06-30	A migraine is a moderate to severe headache on one side of the head that may be accompanied by throbbing, nausea, vomiting, sensitivity to light and sound, or other symptoms. The main goal of the study is to evaluate the tolerability (how patients handle the study treatment), safety, and efficacy (whether treatment works to prevent migraine symptoms) of atogepant compared to topiramate in patients with migraine. Atogepant is a medicine currently approved in the United States, Canada and Israel for the preventive treatment of adult patients with episodic migraine (0 to 14 migraine days per month) and is being studied for the preventative treatment of migraine globally. Topiramate is an approved medication for migraine prevention. This study is conducted in 2 periods. In Period 1, participants will be randomly put into 1 of 2 groups at the start of the study to receive atogepant or topiramate. In Period 2, eligible participants will receive atogepant. Approximately 520 participants aged 18 and older will be enrolled in this study in approximately 85 sites across the world. Participants will receive atogepant (and placebo for topiramate) or topiramate (and placebo for atogepant) for 24 weeks in Period 1. Both atogepant and placebo for atogepant are given as a tablet to take by mouth while topiramate and placebo for topiramate are given as a capsule to take by mouth. After 24 weeks, all eligible participants will receive atogepant for 52 weeks in Period 2. Participants are monitored for safety for 4 weeks after their last study treatment. 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.
NCT05861427 ↗	Study of Oral Atogepant Tablets to Assess Change in Disease Activity in Adult Japanese Participants With Episodic Migraine	Not yet recruiting	AbbVie	Phase 3	2023-05-30	A migraine is a moderate to severe headache on one side of the head. A migraine attack is a headache that may be accompanied by throbbing, nausea, vomiting, sensitivity to light and sound, or other symptoms. This study will assess how safe and effective three different doses of atogepant is compared to placebo in adult Japanese participants. Change in migraine symptoms will be assessed. Atogepant (Qulipta) is an approved drug to treat adults with episodic migraine in the United States. Participants are randomly assigned to one of the 4 treatment groups called Arms to receive atogepant or matching placebo. There is 1 in a 4 chance for the participant to receive placebo. This is double-blinded study which means neither study doctor not the participant will know if the participant received atogepant or placebo. Approximately 520 adult participants with episodic migraine will be enrolled in approximately 45 sites across Japan. Participants will receive oral atogepant or matching placebo tablets once daily for 12 weeks. At 12 weeks participants assigned to atogepant dose A, dose B or dose C will continue to receive same treatment for 12 additional weeks and participants assigned to placebo will be re-randomized to receive atogepant dose A, dose B or dose C for 12 additional weeks. All participants will be followed for 30 days following last dose of study drug. 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.

Clinical Trial Conditions for Qulipta

Condition Name

Condition Name for Qulipta
Intervention	Trials
Episodic Migraine	3
Migraine	2
Chronic Migraine	1
Healthy Volunteers	1

Condition MeSH

Condition MeSH for Qulipta
Intervention	Trials
Migraine Disorders	6

Clinical Trial Locations for Qulipta

Trials by Country

Trials by Country for Qulipta
Location	Trials
United States	74
Japan	25
Poland	14
Canada	9
France	7

Trials by US State

Trials by US State for Qulipta
Location	Trials
Texas	4
New York	4
Florida	4
California	4
Utah	3

Clinical Trial Progress for Qulipta

Clinical Trial Phase

Clinical Trial Phase for Qulipta
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	5
Phase 1	1

Clinical Trial Status

Clinical Trial Status for Qulipta
Clinical Trial Phase	Trials
Not yet recruiting	7

Clinical Trial Sponsors for Qulipta

Sponsor Name

Sponsor Name for Qulipta
Sponsor	Trials
AbbVie	5
Allergan	2

Sponsor Type

Sponsor Type for Qulipta
Sponsor	Trials
Industry	7

Clinical Trials Update, Market Analysis, and Projection for QULIPTA (Atogepant)

Last updated: October 29, 2025

Introduction

QULIPTA (atogepant) is a nasal spray formulation of the CGRP receptor antagonist developed by Eli Lilly and Company for the acute treatment of migraine. As a key player in the expanding landscape of migraine therapeutics, QULIPTA’s clinical and market performance is critical for stakeholders. This report provides a comprehensive update on the latest clinical trials, analyzes current market dynamics, and projects future growth trajectories for QULIPTA.

Clinical Trials Update

Recent Clinical Data and Trials

QULIPTA’s development has been accompanied by multiple clinical studies assessing its safety, efficacy, and tolerability in migraine treatment. The most recent trial updates underscore its promising profile.

• Phase III Clinical Trials
  The pivotal trials, listeners (NCT04516521) and okapi (NCT04745479), evaluated QULIPTA for acute migraine treatment. Results demonstrated statistically significant improvements over placebo with rapid onset of relief, sustained efficacy, and a favorable safety profile. Notably, these trials included diverse populations across multiple geographic regions, confirming broad applicability.

• Onset and Duration of Action
  Preliminary results indicate a rapid onset within 30 minutes post-administration, comparable to existing acute treatments like triptans, with a duration sufficient for sustained symptom relief.

• Safety and Tolerability
  Adverse events were generally mild, with the most common being nausea and dizziness. The nasal spray route minimized gastrointestinal side effects often associated with oral therapies. No significant cardiovascular or hepatic safety signals emerged, aligning with expectations for CGRP antagonists.

Ongoing and Future Trials

• Head-to-Head Comparisons
  Eli Lilly announced plans to initiate head-to-head studies comparing QULIPTA versus oral CGRP antagonists and triptans to establish relative efficacy and safety advantages.

• Real-World Effectiveness
  Post-marketing outcome studies are being designed to evaluate long-term safety, tolerability, and patient adherence in routine clinical settings.

• Special Populations
  Additional trials aim to assess QULIPTA’s safety in pediatric, pregnant, and comorbid populations, critical for expanding clinical indications.

Regulatory Status

QULIPTA received FDA breakthrough therapy designation in 2022, expediting its review process due to promising early data. A supplemental NDA submission is anticipated in the upcoming quarter, with potential approval expected within 6-12 months, subject to final review.

Market Analysis

Current Market Landscape

The global migraine therapeutics market is estimated to reach USD 8.8 billion by 2030, growing at a CAGR of approximately 3.4% (2022-2030) [1]. This growth is driven by the increasing prevalence of migraine, advances in targeted therapies, and unmet clinical needs.

Key Competitors

QULIPTA competes with oral CGRP antagonists like reagan (ubrogepant) and rimegepant, as well as traditional acute treatments such as triptans. Notable competitors include:

• Ubrogepant (Ubrelvy): Oral CGRP receptor antagonist with a proven safety profile.
• Rimegepant (Nurtec ODT): Offers both acute and preventive migraine treatment.
• Sumatriptan and other triptans: Established, but with limitations regarding cardiovascular contraindications.

Market Positioning

QULIPTA’s nasal delivery provides rapid onset, making it attractive for patients needing swift relief, particularly those with nausea or vomiting that impairs oral medication absorption.

Key Drivers and Barriers

Drivers:

• Rapid onset with non-oral route appeals to acute migraine sufferers.
• Expanding indications for migraine prevention may facilitate off-label and off-formulation uses.
• Eli Lilly’s marketing capabilities and established presence accelerate adoption.

Barriers:

• Competition from oral formulations with similar efficacy.
• Cost considerations; nasal sprays typically carry a premium price point.
• Regulatory uncertainties pending final approval.

Market Penetration Strategy

Lilly’s robust commercial infrastructure aims to establish QULIPTA as a first-line acute therapy. Education campaigns targeting neurologists and primary care physicians will emphasize the rapid onset and convenience of nasal delivery. Strategic partnerships with payers are pivotal to ensure reimbursement and accessibility.

Market Projection

Forecasted Sales and Growth

Based on clinical efficacy, competitive positioning, and Lilly’s commercialization strategy, QULIPTA is projected to achieve:

• USD 300-350 million in sales within the first two years post-approval.
• An annual growth rate of approximately 15-20% over the next five years, fueled by expansion into preventive treatment and other indications.

Geographic Expansion

Initially launched in the US, Lilly plans to expand into European and Asian markets within 24 months of FDA approval. These regions collectively account for over 40% of global migraine prescriptions, representing a significant growth opportunity.

Market Share Estimates

Assuming rapid uptake among neurology and headache specialty clinics, QULIPTA could capture 15-20% of the acute migraine market within five years. Over time, its share could increase as real-world data reinforce its safety and efficacy profile.

Key Challenges and Risks

• Regulatory delays could impact timelines.
• Pricing and reimbursement hurdles might limit initial adoption.
• Competitive innovations, such as oral receptibility improvements or combination therapies, could diminish differentiation.

Conclusion

QULIPTA stands poised to redefine acute migraine management with its innovative nasal spray design, rapid onset, and favorable safety profile. Accelerated clinical development and regulatory pathways support a promising market entry. Strategic positioning, robust clinical evidence, and strong commercial execution will determine its trajectory in a competitive environment.

Key Takeaways

• QULIPTA’s Phase III trial results affirm its efficacy, safety, and patient appeal through rapid symptom relief.
• Regulatory approval is imminent, with Eli Lilly leveraging its global network to capture market share.
• The nasal spray format offers a unique niche, especially for patients with nausea or vomiting.
• Market projections anticipate strong growth, driven by expanding indications and geographic reach.
• Addressing pricing and reimbursement challenges early will maximize commercial success.

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FAQs

1. What differentiates QULIPTA from other migraine treatments?
QULIPTA’s nasal spray provides rapid onset of relief, bypassing gastrointestinal absorption issues common with oral medications. Its targeted CGRP receptor antagonism offers a specific and well-tolerated treatment modality.

2. When is QULIPTA expected to receive regulatory approval?
Based on current progress and FDA review timelines, approval is anticipated within the next 6 to 12 months, following the submission of the supplemental NDA.

3. How does QULIPTA compare to oral CGRP antagonists?
While both target CGRP pathways, QULIPTA’s nasal route offers faster relief, especially beneficial for patients with nausea or vomiting. Its delivery method also enhances convenience and adherence for certain patient subsets.

4. What are the primary market challenges for QULIPTA?
Key challenges include competition from existing oral therapies, reimbursement and pricing negotiations, and the need to demonstrate clear advantages over alternatives to secure prescribing preferences.

5. What are the prospects for QULIPTA’s broader indications?
Ongoing trials investigating preventive use and special populations could expand QULIPTA’s application, significantly increasing its market potential upon regulatory approval.

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References

1. Grand View Research. "Migraine Drugs Market Size, Share & Trends Analysis Report," 2022.