CLINICAL TRIALS PROFILE FOR ESKALITH

All Clinical Trials for Eskalith

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00057681 ↗	Study of Outcome and Safety of Lithium, Divalproex and Risperidone for Mania in Children and Adolescents	Completed	National Institute of Mental Health (NIMH)	Phase 3	2003-02-01	This study will evaluate the effectiveness of the medications, lithium (Eskalith®), valproate (Depakote®), and risperidone (Risperdal®) in treating children and adolescents with bipolar disorder or symptoms of mania.
NCT00057681 ↗	Study of Outcome and Safety of Lithium, Divalproex and Risperidone for Mania in Children and Adolescents	Completed	Washington University School of Medicine	Phase 3	2003-02-01	This study will evaluate the effectiveness of the medications, lithium (Eskalith®), valproate (Depakote®), and risperidone (Risperdal®) in treating children and adolescents with bipolar disorder or symptoms of mania.
NCT00221975 ↗	Combination Therapy in Dual Diagnosis Bipolar Rapid Cycling	Completed	University Hospitals Cleveland Medical Center	Phase 3	2002-07-01	Combination Therapy in Dual Diagnosis Bipolar Rapid Cycling: This study recruits males and females age 18 and older who currently meet diagnostic criteria for rapid cycling bipolar disorder (type I or II) and who have met the criteria for substance abuse or dependence of cocaine, marijuana and/or alcohol within the past six months. Patients begin treatment with a combination of lithium and divalproex. Once these medications are tolerated, they are randomly assigned to double-blind treatment with lamotrigine or placebo. Patients remain in this study until they experience a marked bimodal response for four consecutive weeks. This study is sponsored by the Stanley Foundation.
NCT00408681 ↗	Lithium Carbonate in Treating Patients With Acute Intestinal Graft-Versus-Host-Disease (GVHD) After Donor Stem Cell Transplant	Completed	National Cancer Institute (NCI)	N/A	2006-06-01	RATIONALE: Lithium carbonate may be an effective treatment for intestinal graft-versus-host disease caused by a donor stem cell transplant. PURPOSE: This clinical trial is studying lithium carbonate in treating patients with acute intestinal graft-versus-host-disease after donor stem cell transplant.
NCT00408681 ↗	Lithium Carbonate in Treating Patients With Acute Intestinal Graft-Versus-Host-Disease (GVHD) After Donor Stem Cell Transplant	Completed	Fred Hutchinson Cancer Research Center	N/A	2006-06-01	RATIONALE: Lithium carbonate may be an effective treatment for intestinal graft-versus-host disease caused by a donor stem cell transplant. PURPOSE: This clinical trial is studying lithium carbonate in treating patients with acute intestinal graft-versus-host-disease after donor stem cell transplant.
NCT00601575 ↗	Bioequivalency Study of 450 mg Lithium Carbonate Under Fed Conditions	Completed	Roxane Laboratories	N/A	2002-10-01	The objective of this study was to assess the bioequivalence of two Roxane lithium carbonate 450 mg extended release tablet formulations compared to GlaxoSmithKline's Eskalith CR 450 mg extended release tablet under fed conditions using a single-dose, randomized, three-treatment, three-period, six-sequence crossover design.

Clinical Trial Conditions for Eskalith

Condition Name

Condition Name for Eskalith
Intervention	Trials
Bipolar Disorder	7
Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)	2
Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)	2
Geriatric Depression	2

Condition MeSH

Condition MeSH for Eskalith
Intervention	Trials
Bipolar Disorder	8
Depressive Disorder, Major	3
Depressive Disorder	3
Depression	3

Clinical Trial Locations for Eskalith

Trials by Country

Trials by Country for Eskalith
Location	Trials
United States	28
Canada	3
Sweden	2
Norway	1

Trials by US State

Trials by US State for Eskalith
Location	Trials
Ohio	4
California	3
Pennsylvania	3
Missouri	3
Michigan	2

Clinical Trial Progress for Eskalith

Clinical Trial Phase

Clinical Trial Phase for Eskalith
Clinical Trial Phase	Trials
Phase 4	5
Phase 3	2
Phase 1	1

Clinical Trial Status

Clinical Trial Status for Eskalith
Clinical Trial Phase	Trials
Completed	10
Recruiting	1
Terminated	1

Clinical Trial Sponsors for Eskalith

Sponsor Name

Sponsor Name for Eskalith
Sponsor	Trials
National Institute of Mental Health (NIMH)	5
Washington University School of Medicine	2
University Hospitals Cleveland Medical Center	2

Sponsor Type

Sponsor Type for Eskalith
Sponsor	Trials
Other	13
NIH	7
Industry	2

Clinical Trials, Market Analysis, and Projections for Eskalith (Lithium Carbonate)

Introduction to Eskalith (Lithium Carbonate)

Eskalith, also known as lithium carbonate, is a medication primarily used in the treatment of manic episodes associated with manic-depressive illness, now more commonly referred to as bipolar disorder. Here, we will delve into the clinical trials, market analysis, and future projections for this drug.

Clinical Use and Mechanism of Action

Eskalith is indicated for the treatment of manic episodes and as maintenance therapy to prevent or diminish the intensity of subsequent episodes in patients with a history of mania. The drug works by altering sodium transport in nerve and muscle cells and affecting the intraneuronal metabolism of catecholamines, although the specific biochemical mechanism in humans is not fully understood[1][4].

Clinical Trials and Efficacy

Clinical trials have shown that Eskalith can produce a normalization of manic symptomatology within 1 to 3 weeks. The optimal dosage is typically established at 1,800 mg per day in divided doses, aiming for serum lithium levels between 1.0 and 1.5 mEq/L during the acute phase and 0.6 to 1.2 mEq/L for long-term control[1][4].

Monitoring and Adjustments

Regular monitoring of serum lithium levels and clinical response is crucial. Serum levels should be determined twice per week during the acute phase until the patient's condition is stabilized. Dosage must be individualized based on these parameters to minimize adverse reactions[1][4].

Market Analysis

Global Lithium Drug Market

The global lithium drug market is expected to grow at a CAGR of 4.30% from 2021 to 2028. This growth is driven by the increasing prevalence of neurological disorders such as bipolar disorder, mania, and depression. The market is segmented by disorders, drug type, dosage, end-users, and distribution channels[5].

Market Segmentation

• Disorders: Bipolar disorder, depression, schizophrenia, mania, attention-deficit hyperactivity disorder, and others.
• Drug Type: Branded (including Eskalith, Lithobid) and generics.
• Dosage: Tablets, capsules, solutions, and others.
• End-users: Hospitals, specialty clinics, and others.
• Distribution Channels: Direct tender, hospital pharmacy, retail pharmacy, online pharmacy, and others[5].

Geographical Analysis

North America currently holds the largest market share due to a high prevalence of bipolar and depressive disorders, along with significant healthcare expenditure and research activities. Europe is the second largest market, while the Asia-Pacific region is expected to grow significantly due to advancements in technology, increasing healthcare expenditure, and rising awareness programs[5].

Market Projections

Growth Drivers

• Increasing Prevalence of Neurological Disorders: Rising cases of bipolar disorder, depression, and other mental health conditions are driving the demand for lithium-based treatments.
• Advancements in Healthcare: Improved medical facilities and increased healthcare expenditure in various regions are contributing to market growth.
• Growing Elder and Geriatric Population: An aging population with higher rates of depression and other mood disorders is another factor boosting market growth[5].

Challenges

• Strict Dose Monitoring: The need for regular monitoring of serum lithium levels to avoid toxicity can be a challenge.
• Alternative Medications: The presence of alternative medications and organic products may hamper the market growth.
• Adverse Drug Reactions: Side effects associated with lithium use, such as fine hand tremor, polyuria, and mild thirst, can also impact market dynamics[5].

Future Outlook

Lithium Supply and Pricing

The global lithium market, which is closely tied to the demand for lithium-based drugs, is expected to see a decline in surplus and prices in 2025. The annual average price for lithium carbonate is projected to drop to around $10,542/mt in 2025, down from $12,374/mt in 2024 and significantly lower than the 2023 average of $40,579/mt. This could impact the production costs and pricing of lithium-based drugs like Eskalith[2].

Market Balance and Production

The lithium market is expected to return to a more balanced state by 2027 due to upcoming supply cuts. This balance, along with the secure foundation of emission reduction-related legislation and the established position of lithium-ion batteries, suggests a stable future for lithium-based treatments[2].

Key Takeaways

• Eskalith (Lithium Carbonate) Efficacy: Effective in treating manic episodes and maintaining stability in bipolar disorder patients.
• Market Growth: The global lithium drug market is growing at a CAGR of 4.30% driven by increasing neurological disorders.
• Geographical Trends: North America and Europe are significant markets, with the Asia-Pacific region expected to grow substantially.
• Challenges: Strict dose monitoring, alternative medications, and adverse drug reactions are key challenges.
• Future Outlook: The lithium market is expected to balance out by 2027, with stable demand for lithium-based treatments.

FAQs

What is Eskalith used for?

Eskalith (lithium carbonate) is used in the treatment of manic episodes of manic-depressive illness and as maintenance therapy to prevent or diminish the intensity of subsequent episodes.

How does Eskalith work?

Eskalith alters sodium transport in nerve and muscle cells and affects the intraneuronal metabolism of catecholamines, although the specific biochemical mechanism in humans is not fully understood.

What are the common side effects of Eskalith?

Common side effects include fine hand tremor, polyuria, mild thirst, transient nausea, and general discomfort during the initial phase of treatment.

How is the dosage of Eskalith determined?

The dosage must be individualized according to serum levels and clinical response. Optimal patient response is usually established with 1,800 mg per day in divided doses, aiming for serum lithium levels between 1.0 and 1.5 mEq/L.

What are the market projections for the lithium drug market?

The global lithium drug market is expected to grow at a CAGR of 4.30% from 2021 to 2028, driven by increasing neurological disorders and advancements in healthcare.

Sources

1. RxList: Eskalith (Lithium Carbonate): Side Effects, Uses, Dosage...
2. S&P Global Commodity Insights: COMMODITIES 2025: Global surplus, declining prices weigh on Europe's lithium ambitions
3. PR Newswire: AbbVie Provides Update on Phase 2 Results for Emraclidine in Schizophrenia
4. FDA: eskalith | fda
5. Data Bridge Market Research: Global Lithium Drug Market - Industry Trends and Forecast to 2028