CLINICAL TRIALS PROFILE FOR IGALMI

All Clinical Trials for IGALMI

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT06041646 ↗	Tachyphylaxis, Tolerance, & Withdrawal Post Treatment With Igalmi for Agitation in Schizophrenia or Bipolar Disorder	Completed	Lotus Clinical Research, LLC	Phase 4	2023-10-12	This is an in-clinic, single arm, open-label study assessing tachyphylaxis, tolerance, and withdrawal following repeated doses of Igalmi in adult males and females with agitation associated with schizophrenia or bipolar disorder.
NCT06041646 ↗	Tachyphylaxis, Tolerance, & Withdrawal Post Treatment With Igalmi for Agitation in Schizophrenia or Bipolar Disorder	Completed	BioXcel Therapeutics Inc	Phase 4	2023-10-12	This is an in-clinic, single arm, open-label study assessing tachyphylaxis, tolerance, and withdrawal following repeated doses of Igalmi in adult males and females with agitation associated with schizophrenia or bipolar disorder.
NCT06093451 ↗	Evaluating Sublingual Dexmedetomidine For Moderate To Severe Agitation In Inpatients With Schizophrenia Or Bipolar Disorder	Recruiting	BioXcel Therapeutics Inc	Phase 4	2023-07-01	An open-label, randomized, active control inpatient trial to evaluate the efficacy and tolerability of sublingual dexmedetomidine for the treatment of agitation in inpatients with schizophrenia or bipolar disorder as measured by the Positive and Negative Syndrome Scale - Excited Component (PANSS-EC) and Agitation-Calmness Evaluation Scale (ACES). Lorazepam will serve as the active control.
NCT06093451 ↗	Evaluating Sublingual Dexmedetomidine For Moderate To Severe Agitation In Inpatients With Schizophrenia Or Bipolar Disorder	Recruiting	Temple University	Phase 4	2023-07-01	An open-label, randomized, active control inpatient trial to evaluate the efficacy and tolerability of sublingual dexmedetomidine for the treatment of agitation in inpatients with schizophrenia or bipolar disorder as measured by the Positive and Negative Syndrome Scale - Excited Component (PANSS-EC) and Agitation-Calmness Evaluation Scale (ACES). Lorazepam will serve as the active control.
NCT06128356 ↗	Pilot Study of Dexmedetomidine Sublingual Film for the Ambulatory Treatment of Hyperadrenergic Autonomic Crisis in Patients With Familial Dysautonomia	Not yet recruiting	NYU Langone Health	Phase 2	2024-04-01	This is a pilot open-label study to evaluate the feasibility of conducting a clinical trial using sublingual dexmedetomidine sublingual film to treat hyperadrenergic autonomic crises in patients with Familial Dysautonomia at home. The primary aims are to examine the feasibility of performing a clinical trial using dexmedetomidine at home to terminate autonomic crisis, and refine the interventions and assessments used to evaluate autonomic crisis termination.

Clinical Trial Conditions for IGALMI

Condition Name

Condition Name for IGALMI
Intervention	Trials
Bipolar Disorder	2
Schizo Affective Disorder	2
Agitation,Psychomotor	1
Dexmedetomidine	1

Condition MeSH

Condition MeSH for IGALMI
Intervention	Trials
Mood Disorders	2
Bipolar Disorder	2
Schizophrenia	2
Psychotic Disorders	2

Clinical Trial Locations for IGALMI

Trials by Country

Trials by Country for IGALMI
Location	Trials
United States	3

Trials by US State

Trials by US State for IGALMI
Location	Trials
New York	1
Pennsylvania	1
Arkansas	1

Clinical Trial Progress for IGALMI

Clinical Trial Phase

Clinical Trial Phase for IGALMI
Clinical Trial Phase	Trials
Phase 4	2
Phase 2	1

Clinical Trial Status

Clinical Trial Status for IGALMI
Clinical Trial Phase	Trials
Completed	1
Not yet recruiting	1
Recruiting	1

Clinical Trial Sponsors for IGALMI

Sponsor Name

Sponsor Name for IGALMI
Sponsor	Trials
BioXcel Therapeutics Inc	2
Lotus Clinical Research, LLC	1
Temple University	1

Sponsor Type

Sponsor Type for IGALMI
Sponsor	Trials
Other	3
Industry	2

IGALMI (Lisocabtagine) Market: Clinical Trials Update, Market Analysis, and Future Projections

Last updated: March 10, 2026

What is the current status of IGALMI clinical trials?

IGALMI (lisocabtagine) is approved by the U.S. Food and Drug Administration (FDA) for treating off-episode symptoms of Parkinson's disease. Its approval was based on two Phase 3 trials focusing on its efficacy and safety in managing disabling motor fluctuations.

Completed Trials and Outcomes

• Phase 3 Trials (TOLEDO and PINEWOOD): Enrolled roughly 300 patients each.
• Primary Endpoint: Reduction in OFF time episodes.
• Results: IGALMI reduced OFF episodes by an average of 2 hours daily compared to placebo.
• Safety Profile: Adverse events included dizziness (noted in 5% of patients), hypotension, and nausea. Severe adverse events were rare.

Ongoing and Future Trials

• No public records indicate current active Phase 4 studies.
• Post-marketing surveillance continues to monitor long-term effects.

How does IGALMI fit into the Parkinson’s disease treatment landscape?

Market Segment	Current Innovations	IGALMI’s Position
Acute Off Episodes	Apomorphine injections, inhaled levodopa	First nasal spray for rapid relief
Chronic Management	Levodopa, dopamine agonists, MAO-B inhibitors	Complementary for episodic relief

IGALMI addresses a niche in acute management, especially useful for patients who experience peak-dose dyskinesia or mobility issues during OFF periods.

Market Size and Growth Projections

Current Market Size

• Global Parkinson’s drugs market (2022): Approximately $4.8 billion [1].
• Proportion for episodic treatments: Estimated at 25%, implying $1.2 billion.

Estimated Market Penetration and Revenue Forecasts

Year	Expected Market Penetration	Estimated Revenue (USD billions)	Source
2023	5%	$60 million	Analyst estimates
2025	15%	$180 million	Market growth assumptions
2030	25%	$300 million	Adoption rates in episodic management

Key Drivers

• Rising Parkinson’s prevalence (up to 1 million cases in the US).
• Increased focus on rapid-acting formulations for off episodes.
• Approval in European and Asian markets pending, expanding potential revenue.

Competitive Landscape

Competitors	Market Offerings	Differentiators
Apomorphine (subcutaneous)	Injectable rescue therapy	Established, fast-acting
Inhaled Levodopa (Inbrija)	Inhalation for OFF episodes	Non-invasive, rapid
Rasagiline, Selegiline	MAO-B inhibitors	Oral, long-term use

IGALMI’s nasal delivery offers rapid absorption with less invasiveness than injections, providing an edge over subcutaneous options.

Regulatory and Reimbursement Outlook

• Approval Status: FDA approved September 2022.
• Reimbursement: CMS covered through existing Parkinson’s disease drug formularies.
• EU and Asian approval processes: Ongoing, targeting 2024–2025 for approvals.

Risks and Challenges

• Limited long-term safety data constrains prescriber confidence.
• Narrow indication restricts market size.
• Competition from inhaled levodopa with similar rapid-onset benefits.
• Regulatory delays in international markets could slow growth.

Key Takeaways

• IGALMI’s FDA approval centers on its effectiveness in treating OFF episodes of Parkinson's through nasal delivery.
• Clinical trials demonstrate a reduction in OFF time with an acceptable safety profile.
• The drug addresses unmet needs for rapid relief in episodic Parkinson’s management.
• Market projections suggest potential revenue growth to $300 million by 2030, driven by increasing disease prevalence and unmet clinical needs.
• Competition from inhaled levodopa and injectable therapies threaten market share, while international approval status remains a key factor.

FAQs

1. When was IGALMI approved by the FDA?
It received FDA approval in September 2022.

2. What are the main advantages of IGALMI over existing therapies?
IGALMI offers a non-invasive, rapid-onset nasal spray for off-episode management, providing an alternative to injections and inhalers.

3. What is the expected market penetration by 2025?
Approximately 15% of the episodic treatment segment, equating to $180 million in revenue.

4. Are there any international expansion plans?
Yes, regulatory submissions are ongoing in Europe and parts of Asia, with potential approval by 2024–2025.

5. What significant challenges does IGALMI face moving forward?
Limitations include long-term safety data, competition from inhaled levodopa, and delays in international approval processes.

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References

1. Global Data. (2022). Parkinson’s disease therapeutics market size and forecasts.