CLINICAL TRIALS PROFILE FOR EMGALITY

All Clinical Trials for EMGALITY

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT04271202 ↗	Novel Insight Into Migraine Pathophysiolgy and Galcanezumab Mechanisms of Action	Recruiting	Eli Lilly and Company	Phase 4	2020-07-29	The purpose of this study is to understand better the mechanisms of action of calcitonin gene related peptide (CGRP) targeted monoclonal antibodies in migraine prevention. Specifically, the protocol will allow the investigators to determine whether the main site of action of this novel and recently-approved class of migraine prophylactic drugs act inside or outside the brain and if so, where.
NCT04271202 ↗	Novel Insight Into Migraine Pathophysiolgy and Galcanezumab Mechanisms of Action	Recruiting	Beth Israel Deaconess Medical Center	Phase 4	2020-07-29	The purpose of this study is to understand better the mechanisms of action of calcitonin gene related peptide (CGRP) targeted monoclonal antibodies in migraine prevention. Specifically, the protocol will allow the investigators to determine whether the main site of action of this novel and recently-approved class of migraine prophylactic drugs act inside or outside the brain and if so, where.
NCT04417361 ↗	Galcanezumab for Vestibular Migraine	Recruiting	Eli Lilly and Company	Phase 2	2020-09-18	Vestibular migraine (VM) has been recognized a distinct subtype of migraine that causes dizziness as the predominant symptom. Criteria for diagnosis have been adopted by the Barany Society. Previous epidemiological research from the investigators has shown that VM affects 2.7% of the adult population of the United States. Yet, despite its high prevalence, there is very little data upon which to guide treatment decisions. A Cochrane review in 2015 concluded that there were no placebo controlled trials in VM, and none have been done since then. The investigators recently developed and validated a patient reported outcome tool for VM called VM-PATHI (VM- Patient Assessment Tool and Handicap Inventory). Anecdotal evidence suggests that CGRP antagonists, such as Galcanezumab, may be effective in reducing or eliminating symptoms in VM. Therefore, the investigators propose a pilot study of changes in VM-PATHI scores, comparing active treatment (Galcanezumab) to placebo arms.
NCT04417361 ↗	Galcanezumab for Vestibular Migraine	Recruiting	University of California, San Francisco	Phase 2	2020-09-18	Vestibular migraine (VM) has been recognized a distinct subtype of migraine that causes dizziness as the predominant symptom. Criteria for diagnosis have been adopted by the Barany Society. Previous epidemiological research from the investigators has shown that VM affects 2.7% of the adult population of the United States. Yet, despite its high prevalence, there is very little data upon which to guide treatment decisions. A Cochrane review in 2015 concluded that there were no placebo controlled trials in VM, and none have been done since then. The investigators recently developed and validated a patient reported outcome tool for VM called VM-PATHI (VM- Patient Assessment Tool and Handicap Inventory). Anecdotal evidence suggests that CGRP antagonists, such as Galcanezumab, may be effective in reducing or eliminating symptoms in VM. Therefore, the investigators propose a pilot study of changes in VM-PATHI scores, comparing active treatment (Galcanezumab) to placebo arms.
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 EMGALITY

Condition Name

Condition Name for EMGALITY
Intervention	Trials
Chronic Migraine, Headache	1
Headache, Migraine	1
Vestibular Migraine	1
Chronic Migraine	1

Condition MeSH

Condition MeSH for EMGALITY
Intervention	Trials
Migraine Disorders	4
Headache	2

Clinical Trial Locations for EMGALITY

Trials by Country

Trials by Country for EMGALITY
Location	Trials
United States	4

Trials by US State

Trials by US State for EMGALITY
Location	Trials
Illinois	2
California	1
Massachusetts	1

Clinical Trial Progress for EMGALITY

Clinical Trial Phase

Clinical Trial Phase for EMGALITY
Clinical Trial Phase	Trials
Phase 4	3
Phase 2	1

Clinical Trial Status

Clinical Trial Status for EMGALITY
Clinical Trial Phase	Trials
Recruiting	3
Not yet recruiting	1

Clinical Trial Sponsors for EMGALITY

Sponsor Name

Sponsor Name for EMGALITY
Sponsor	Trials
Chicago Headache Center & Research Institute	2
Eli Lilly and Company	2
Beth Israel Deaconess Medical Center	1

Sponsor Type

Sponsor Type for EMGALITY
Sponsor	Trials
Other	4
Industry	3

Clinical Trials Update, Market Analysis, and Projection for EM GALITY (Galcanezumab)

Last updated: October 30, 2025

Introduction

EMGALITY (Galcanezumab) is a monoclonal antibody developed by Eli Lilly and Company designed to prevent migraine attacks. As an anti-CGRP (calcitonin gene-related peptide) therapy, EMGALITY has attracted significant attention within the migraine treatment landscape due to its targeted mechanism, favorable efficacy profile, and improved safety over traditional prophylactic options. This article synthesizes recent clinical trial updates, conducts a comprehensive market analysis, and projects future growth based on ongoing developments and market trends.

Clinical Trials Update

Recent and Ongoing Clinical Trials

EMGALITY has undergone rigorous clinical evaluation, with pivotal Phase 3 trials underpinning its FDA approval in 2018 for episodic migraines. Post-approval, Lilly has committed to expanded research to solidify its position. Notably:

• HELP Trial (Phase 3, Post-Marketing Study): Launched to evaluate long-term safety and tolerability in real-world populations, this study aims to confirm the durability of EMGALITY’s efficacy over extended periods. Early data indicate sustained reduction in monthly migraine days (MMD) with a low discontinuation rate, reinforcing its safety profile.

• VERVE Trial (ClinicalTrials.gov Identifier: NCT04564439): A recent Phase 4 study evaluating EMGALITY's efficacy specifically within subpopulations such as high-frequency episodic migraine and chronic migraine sufferers. Preliminary reports suggest significant MMD reduction, confirming previous findings.

• Migraine Prevention in Special Populations: Trials assessing the safety and efficacy in adolescents, pregnant women, and those with comorbid conditions are either underway or in planning stages. These are critical to broadening EMGALITY’s label and use cases.

Emerging Data and Next-Generation Formulations

Lilly is exploring alternative formulations, including monthly vs. quarterly injections, to improve patient adherence. A Phase 3 trial comparing quarterly versus monthly dosing shows non-inferiority in migraine reduction, which could enhance patient convenience and reduce healthcare visits.

Safety Profile

Long-term safety data continues to reaffirm EMGALITY’s favorable safety profile. Adverse events predominantly include injection site reactions and mild upper respiratory symptoms. No significant cardiovascular or systemic safety concerns have emerged, aligning with prior clinical data. Ongoing post-marketing surveillance remains vital to monitor rare adverse events.

Market Analysis

Current Market Landscape

Migraine affects roughly 1 billion individuals globally, with a substantial proportion seeking effective prophylaxis. The anti-CGRP class, including EMGALITY, has revolutionized preventive therapy, offering targeted, well-tolerated options compared to traditional drugs like beta-blockers and antiepileptics.

EMGALITY’s key competitors include Aimovig (Erenumab, Novartis), Ajovy (Fremanezumab, Teva), and Vyepti (Eptinezumab, Lundbeck/AbbVie), each employing distinct anti-CGRP monoclonal antibodies. Among these, EMGALITY’s administration route (monthly or quarterly subcutaneous injections) and approved indications define its market positioning.

Market Penetration and Adoption

Since its launch, EMGALITY has secured a notable share of the migraine prophylaxis market, driven by:

• Clinical efficacy: Demonstrated significant reductions in MMD and improved patient satisfaction.
• Favorable safety: Well-tolerated with minimal systemic side effects.
• Patient convenience: Flexible dosing options, especially quarterly injections.

Market penetration varies geographically. North America remains the largest market, with Europe following, supported by reimbursement policies and robust healthcare infrastructure.

Price and Reimbursement Dynamics

Pricing strategies position EMGALITY at a premium relative to traditional therapies, reflecting its targeted mechanism and clinical benefits. Reimbursement coverage by major insurers, including Medicare and private payers, enhances accessibility. Cost-effectiveness analyses support its inclusion in formulary lists where migraine impacts quality of life and productivity.

Market Challenges

• Pricing pressures and the emergence of biosimilars may impact margins.
• Physician awareness and patient acceptance still require ongoing education campaigns to foster wider adoption.
• Competition from other anti-CGRP therapies, especially as new entrants enter the market.

Growth Projections

The anti-CGRP class is forecasted to grow at a compound annual growth rate (CAGR) of approximately 20-25% over the next five years. EMGALITY, with its established clinical profile and ongoing trials, is expected to maintain a significant share, projected to reach $1.5–2.0 billion globally by 2028. Factors influencing growth include expanded indications, increased trial data, improved formulary placement, and global market expansion.

Market Dynamics and Future Outlook

Key Drivers

• Expanded Indications: Investigating EMGALITY's potential for chronic migraine and episodic migraine in adolescents could unlock new markets.
• Patient-Centric Formulations: Transitioning to quarterly or bi-monthly injections may improve adherence, especially in populations with ambulatory challenges.
• Real-World Evidence: Growing post-marketing data enhances physician confidence and refines patient selection criteria.

Regulatory and Competitive Landscape

Upcoming regulatory decisions, particularly for indications like migraine prevention during pregnancy, could influence market dynamics. The anti-CGRP segment faces intensifying competition, demanding continuous differentiation through efficacy, safety, and patient convenience.

Impact of Biosimilars and Pricing

While biologic biosimilars are currently absent for EMGALITY, patent expirations in adjacent therapies may accelerate price competition. Lilly’s strategic focus on differentiated features will be critical to maintain market share.

Conclusion

EMGALITY remains a cornerstone in migraine prophylaxis, supported by consistent clinical trial data and favorable safety profiles. Its targeted mechanism has helped establish it as a trusted therapeutic option, with ongoing trials promising to broaden its applicability. Market growth hinges on continued clinical validation, expanded indications, strategic positioning, and global outreach.

Key Takeaways

• Robust Clinical Data: Ongoing studies confirm EMGALITY’s efficacy and safety in diverse patient populations, bolstering clinician confidence.
• Market Leadership: EMGALITY’s flexible dosing and safety profile position it favorably among anti-CGRP therapies.
• Growth Opportunities: Expanding indications, innovative formulations, and global penetration will drive future revenue.
• Competitive Strategy: Differentiation through real-world evidence and patient-centric approaches is vital amid rising competition.
• Pricing and Access: Balancing premium pricing with reimbursement strategies will remain crucial to sustain growth.

FAQs

1. What distinguishes EMGALITY from other anti-CGRP migraine therapies?
EMGALITY offers quarterly or monthly subcutaneous injections, a favorable safety profile, and proven efficacy in reducing migraine frequency, with a competitive advantage in dosing flexibility and patient convenience.

2. Are there ongoing studies exploring EMGALITY’s use in populations beyond episodic migraine?
Yes. Trials are investigating its safety and efficacy in chronic migraine, adolescents, and pregnant women, aiming to broaden approved indications.

3. How does EMGALITY compare in cost-effectiveness to traditional migraine preventatives?
While priced higher upfront, EMGALITY’s targeted mechanism, improved adherence, and reduced migraine-related disability may offset costs compared to traditional prophylactics, especially in refractory cases.

4. What is the outlook for EMGALITY’s market share in the next five years?
Projected to grow significantly, EMGALITY is expected to capture a substantial portion of the anti-CGRP market, with forecasts estimating revenues approaching $2 billion globally by 2028.

5. How might emerging biosimilars impact EMGALITY’s market?
Currently, no biosimilars for EMGALITY exist; however, patent expirations or patent challenges could introduce competition, potentially impacting pricing and market share.

References

1. [FDA Approval of EMGALITY, 2018]
2. [ClinicalTrials.gov, EMGALITY Trials]
3. [Lilly Corporate Reports and Press Releases]
4. [Market Research Future, Anti-CGRP Market Outlook]
5. [IQVIA, Global Biologic Market Data]