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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.

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
New Jersey	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

Qulipta Market Analysis and Financial Projection

Clinical Trials, Market Analysis, and Projections for QULIPTA

Introduction to QULIPTA

QULIPTA, developed by AbbVie, is a calcitonin gene-related peptide (CGRP) receptor blocker approved by the FDA in September 2021 for the prevention of episodic migraine. Here, we delve into the clinical trials, market analysis, and future projections for this drug.

Clinical Trials Overview

Initial Approval Trials

The FDA approval of QULIPTA was based on evidence from two clinical trials involving 1,562 patients with episodic migraine. These trials, conducted at over 100 sites in the United States, evaluated the efficacy and safety of QULIPTA. The primary outcome was the change in monthly migraine days (MMD), which showed that patients treated with QULIPTA experienced fewer days of migraine headaches per month compared to those receiving placebo treatment[1].

Long-Term Safety and Efficacy

An ongoing Phase III open-label extension (OLE) study has provided interim results on the long-term safety, tolerability, and efficacy of QULIPTA. This study, which includes participants from the previous PROGRESS and ELEVATE trials, has shown consistent reductions in monthly migraine days, monthly headache days, and monthly acute medication use days over 48 weeks. The safety profile remained consistent with previous studies, with no new safety signals identified[3][5].

Additional Safety Data

Further safety data from the Phase IV TANDEM trial, which evaluated QULIPTA monotherapy followed by combination therapy with Ubrelvy (ubrogepant) for acute migraine treatment, confirmed that QULIPTA is well tolerated with no hepatic safety concerns. This is significant, given past concerns about hepatoxicity with other gepants[4].

Efficacy Outcomes

Reduction in Migraine Days

Interim results from the OLE study showed that after 13 to 16 weeks of follow-up, 70% of treated patients experienced at least a 50% drop in the number of monthly migraine days. On average, monthly migraine days improved by 8.5 days, and these benefits were consistent throughout the 48-week follow-up period[5].

Long-Term Benefits

The long-term efficacy of QULIPTA has been a key focus. The drug has demonstrated durable benefits in reducing migraine frequency, with efficacy outcomes consistent over the extended treatment period. This long-term data supports the use of QULIPTA as a reliable preventive treatment for both episodic and chronic migraine[3][5].

Market Analysis

Market Positioning

Despite being second to market after Biohaven’s Nurtec ODT, QULIPTA is gaining ground rapidly. A report by Spherix indicated that three months post-launch, QULIPTA’s share was one-third that of Nurtec ODT, but physicians were optimistic about future use patterns. It is projected that QULIPTA will be close to its competitor in terms of prescribers and market share within six months[2].

Prescriber Adoption

AbbVie’s commercial efforts have been successful, with QULIPTA capturing nearly 20% of the new-to-brand share in the preventive CGRP class just three months post-launch. Two-thirds of physicians expect to be QULIPTA prescribers within the next six months, indicating strong adoption rates[2].

Regulatory Approvals and Access

In addition to FDA approval, QULIPTA has received positive guidance from the UK’s National Institute for Health Care and Excellence (NICE) for use in preventing migraine in adult patients who suffer from at least four migraine days per month. AbbVie has also secured a commercial agreement with the UK’s National Health Service to provide QULIPTA at a discounted rate[5].

Market Projections

Sales and Revenue

AbbVie is guiding $200 million in sales for QULIPTA in the first year, with commercial access increasing rapidly in the first half. Given the strong adoption rates and positive clinical data, QULIPTA is poised to become a significant player in the migraine prevention market[2].

Competitive Landscape

While QULIPTA faces competition from Nurtec ODT, its long-term safety and efficacy data are likely to enhance its market position. However, traditional migraine prevention therapies such as beta-adrenergic receptor blockers, antidepressants, and anti-epileptic drugs may remain first-line treatments due to their availability as generics and lower cost[4].

Future Regulatory Filings

AbbVie is working towards additional regulatory filings for QULIPTA in various international markets, which will further expand its reach and market potential. The company’s efforts to broaden QULIPTA’s label to include chronic migraine prevention are also expected to increase prescribing patterns among physicians[5].

Key Takeaways

• Clinical Efficacy: QULIPTA has demonstrated significant reductions in monthly migraine days and long-term safety in clinical trials.
• Market Adoption: QULIPTA is rapidly gaining ground among prescribers, with strong adoption rates and positive market projections.
• Regulatory Approvals: QULIPTA has received FDA approval and positive guidance from NICE, with ongoing efforts for additional international approvals.
• Competitive Position: While facing competition from Nurtec ODT, QULIPTA’s long-term data and expanding label are expected to enhance its market position.

FAQs

What is QULIPTA and how does it work?

QULIPTA is a small molecule drug that works by blocking the calcitonin gene-related peptide (CGRP) receptor, which plays a role in migraine by dilating cerebral blood vessels and promoting the release of inflammatory mediators.

What were the key findings from the clinical trials of QULIPTA?

Clinical trials showed that QULIPTA significantly reduced monthly migraine days compared to placebo, with long-term safety and efficacy demonstrated in ongoing extension studies.

How is QULIPTA performing in the market?

QULIPTA is gaining ground rapidly, capturing a significant share of the new-to-brand market in the preventive CGRP class, and is projected to be close to its competitor Nurtec ODT in terms of prescribers and market share within six months.

What are the common side effects of QULIPTA?

The most common side effects reported include COVID-19, nasopharyngitis, and constipation, with no new safety signals identified in long-term follow-up.

Is QULIPTA approved for chronic migraine prevention?

While initially approved for episodic migraine, AbbVie is working towards additional regulatory filings to include chronic migraine prevention in QULIPTA’s label.

How does QULIPTA compare to other migraine prevention treatments?

QULIPTA’s long-term safety and efficacy data position it strongly against competitors, though traditional therapies may remain first-line due to cost and availability.

Sources

1. FDA: Drug Trials Snapshots: QULIPTA - FDA
2. FiercePharma: AbbVie's Qulipta gains ground with docs for migraine prevention, as pharma looks to pressure
3. Practical Neurology: Favorable Outcomes Reported from OLE Study of Qulipta Treatment for Migraine Prevention
4. Clinical Trials Arena: AAN 2024: AbbVie highlights long-term safety of atogepant in migraine prevention
5. BioSpace: AbbVie Touts Long-Term Efficacy of Qulipta as Preventive Migraine Treatment