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.
NCT05503082 ↗	Ubrogepant treatmeNt in mIgraine Patients Utilizing mOnoclonal aNtibodies	Not yet recruiting	Chicago Headache Center & Research Institute	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.
NCT05724771 ↗	COACT Study: CGRPmAbs + OnabotulinumtoxinA Assessment of Chronic Migraine Treatments Study	Recruiting	Chicago Headache Center & Research Institute	Phase 4	2023-01-26	Chronic migraine patients treated with OnabotulinumtoxinA may experience breakthrough headaches, especially toward the end of their 12-week therapy. The addition of a CGRPmAb could help in decreasing or eliminating these episodes, but this combination is considered "experimental" by many payers, which often leads to a denial of coverage. Currently, there is no reference in the literature or data to support the treatment of chronic migraine with OnabotulinumtoxinA and CGRPmAbs (Aimovig, Ajovy, Emgality or Vyepti) combination therapy. This has resulted in many patients and providers having to settle for one or the other. Investigators hopes to provide crucial data and findings to support the addition of CGRPmAb in some chronic migraine patients currently on monotherapy OnabotulinumtoxinA.

Clinical Trial Conditions for EMGALITY

Condition Name

Condition Name for EMGALITY
Intervention	Trials
Chronic Migraine	1
Chronic Migraine, Headache	1
Headache, Migraine	1
Vestibular 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
Eli Lilly and Company	2
Chicago Headache Center & Research Institute	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 Forecast for EMGALITY (Galcanezumab)

Last updated: February 1, 2026

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Summary

EMGALITY (galcanezumab) is a monoclonal antibody developed by Lilly designed to prevent migraine attacks. Approved by the FDA in September 2018, it is marketed for episodic and chronic migraine prophylaxis, as well as cluster headache prevention. This report consolidates the latest clinical trial data, analyzes current market dynamics, and provides future market projections, underlining factors influencing growth such as regulatory developments, competition, and evolving treatment guidelines.

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1. Clinical Trials Update for EMGALITY

Aspect	Details & Data	Latest Developments
Regulatory Approvals	Approved in the US (2018), EU (2020), and other regions	Lilly expanded indications from migraine prevention to include cluster headaches (FDA approval 2022)
Phase of Trials	Ongoing and completed trials span phases 2-3	Notable ongoing studies evaluating long-term safety and broader patient populations
Key Clinical Studies	- REGAIN (Phase 3): Randomized trial confirmed efficacy for chronic migraine - Galcanezumab for Cluster Headache (Phase 3): Showed significant reduction in cluster headache attacks	REGAIN demonstrated a >50% reduction in monthly migraine days in 45% of patients versus 17% with placebo (p<0.001). Cluster headache trials showed 70% of patients experienced reductions in attack frequency
Post-Approval Surveillance	Active pharmacovigilance trials	Focus on long-term safety, rare adverse events, and comparative effectiveness against other CGRPs

2. Market Analysis of EMGALITY

Parameter	Details	Implication/Notes
Market Size (2023)	- Global migraine market: ~$4.3 billion (2022) - Cluster headache segment: Estimated at ~$250 million	EMGALITY holds a significant share, especially in US migraine prophylaxis (estimated at 30%)
Key Competitors	Aimovig (erenumab), Ajovy (fremanezumab), Nurtec ODT (rimegepant), and static oral therapies	Aimovig leads with ~35% market share; EMGALITY's share is growing due to expanded indication and patient preference for subcutaneous injections vs oral medications
Pricing & Reimbursement	- Listed Price (US): ~$675 per dose, administered monthly - Reimbursement varies by payer	High cost influences patient access; insurance coverage improves with stronger clinical evidence
Market Penetration	- Prescription growth rate (2019-2023): ~15% CAGR	Driven by increased neurologist prescribing and patient demand
Regional Distribution	- US (~80% of sales), EU (~15%), others (~5%)	US remains dominant, with expansion potential in Europe and Asia-Pacific

3. Future Market Projections

Forecast Metric	2023	2028	CAGR (2023-2028)	Comments
Global migraine prophylaxis market	~$4.8 billion	~$7.0 billion	8%	Driven by increasing prevalence and acceptance of CGRP therapies
EMGALITY's market share	30%	40%	10%	Achieved through expanded indications, improved wallet share, and competitive positioning
Cluster headache segment	$250 million	$400 million	10%	New indication with high unmet need fosters growth

4. Key Drivers & Restraints

Drivers	Details	Impact
Expanding indications	Approval for cluster headache	Opens new patient segment
Increased awareness & diagnosis	Better recognition of migraines and cluster headaches	Expands eligible patient pool
Improved access & reimbursement	Generous insurance coverage	Enhances affordability and prescriptions

Restraints	Details	Impact
Pricing & reimbursement hurdles	High costs limit patient access in some regions	Dampens market penetration
Competition from oral agents	Emerging oral CGRP antagonists (e.g., rimegepant)	May erode injectable market share
Patient adherence issues	Injection frequency and side effects	Impact long-term market adoption

5. Comparison of Key CGRP Therapies

Agent	Type	Indications	Dosage & Regimen	Market Share (2023)	Notable Features
EMGALITY (galcanezumab)	Monoclonal antibody	Migraine, cluster headache	120 mg SC monthly	30%	First approved for both migraine and cluster headaches
Aimovig (erenumab)	Monoclonal antibody	Migraine	70-140 mg SC monthly	35%	First marketed CGRP antibody
Ajovy (fremanezumab)	Monoclonal antibody	Migraine	225 mg SC quarterly or monthly	20%	Flexible dosing options
Nurtec ODT (rimegepant)	Oral CGRP antagonist	Acute and preventive migraine	75 mg orally as needed or weekly	10%	Oral route enhances adherence

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6. Regulatory & Policy Trends

• FDA & EMA: Expanded indications for CGRP inhibitors, including EMGALITY's use in cluster headache (2022), improving market potential.
• Pricing & Reimbursement: Payers increasingly scrutinize high-cost biologics; Value-based pricing models are emerging.
• Patent & Biosimilar Outlook: Patents for EMGALITY expire around 2030, with biosimilar competition anticipated thereafter.

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7. Strategic Implications & Business Opportunities

Opportunity	Action Points	Rationale
Market expansion in Europe & Asia	Tailor clinical trials for diverse populations, engage regulators	Untapped demand for migraine therapies
Combination therapy approaches	Research synergistic effects with other preventive agents	Address refractory cases and improve adherence
Pursue additional indications	Investigate efficacy in other neurovascular disorders	Broaden revenue streams
Pricing innovation	Explore outcome-based reimbursement strategies	Enhance market access

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8. Key Challenges & Risks

Challenge	Description	Mitigation Strategies
Competitive landscape	Rise of oral CGRP antagonists	Differentiate through efficacy, safety, and convenience
Regulatory delays or restrictions	Potential hurdles for new indications	Maintain robust clinical pipelines and early engagement
Market saturation	Slowing growth in mature markets	Focus on emerging markets and patient education
Patent expiry	Biosimilar entry around 2030	Invest in pipeline diversification

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Key Takeaways

• Clinical efficacy and expanded indications position EMGALITY as a leading prophylactic treatment in migraine and cluster headache segments.
• Market penetration remains steady, with US dominance but growing international interest, especially in Europe and Asia-Pacific.
• Pricing strategies influence overall access; evolving reimbursement policies could enhance coverage.
• Competition from oral CGRP antagonists and biosimilars pose near-to-mid-term threats but can be countered through clinical advantages and differentiated positioning.
• Long-term growth depends on innovative clinical trials, market diversification, and regulatory navigation.

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FAQs

Q1: What are the primary clinical advantages of EMGALITY over other CGRP inhibitors?
A: EMGALITY offers validated efficacy for both episodic and chronic migraine, and uniquely gained approval for cluster headache prevention, expanding its clinical utility compared to some peers.

Q2: How does the pricing of EMGALITY compare with other CGRP therapies?
A: Listed at approximately $675 per dose in the US, EMGALITY’s pricing is aligned with other monoclonal antibody treatments, though negotiations and patient assistance programs influence actual costs.

Q3: What are the key challenges for EMGALITY’s market growth?
A: Challenges include high drug costs, competition from oral therapies, potential biosimilar entry post-patent expiry, and regional regulatory hurdles.

Q4: Which regions offer the highest growth potential for EMGALITY?
A: Europe and Asia-Pacific are key growth regions, where regulatory approvals and awareness are expanding, with significant unmet needs in migraine and cluster headache care.

Q5: How does EMGALITY’s clinical profile influence future research directions?
A: Its safety profile and indications encourage trials in broader neurovascular disorders, pain syndromes, and potential combination therapies to expand indications.

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References

1. Lilly. (2022). "EMGALITY (galcanezumab) prescribing information."
2. FDA. (2018). "Approval of galcanezumab for migraine prevention."
3. European Medicines Agency. (2020). "EMA approval of galcanezumab."
4. MarketWatch. (2023). "Migraine treatments – Market size & forecasts."
5. GlobalData. (2023). "CGRP inhibitor market analysis."

Note: All market figures are estimates based on recent industry reports and clinical data as of Q1 2023.

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