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Last Updated: December 12, 2025

CLINICAL TRIALS PROFILE FOR LITHIUM CARBONATE


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All Clinical Trials for lithium carbonate

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00000369 ↗ Maintenance Therapies in Bipolar Disorders Completed University of Pittsburgh Phase 3 1997-06-01 The purpose of this study is to see if adding a regimen of individualized psychotherapy can help bipolar I patients who are on lithium. While having a manic or depressed episode patients will be assigned randomly (like tossing a coin) to receive appropriate medication either with or without additional individual psychotherapy. If a patient responds well, he/she will again be assigned randomly to receive further preventative treatment in which medication will be managed either with continued medication clinic visits alone or with additional individual psychotherapy (the patient may not receive the same additional treatment this time). Patient response to treatment will be evaluated throughout the study. If manic/depressive symptoms return at any point during the study, the patient will be treated with appropriate medication and will continue the study. An individual may be eligible for this study if he/she: Has Bipolar I disorder, is experiencing a manic or depressed episode at the time of study entry, and is at least 18 years old.
NCT00000439 ↗ Drug Treatment for Alcoholics With Bipolar Disorder Completed University of Pittsburgh Phase 2 2000-10-01 The purpose of this study is to test the effectiveness of sodium valproate (Depacon) in treating individuals with alcohol dependence and comorbid bipolar disorder.
NCT00000439 ↗ Drug Treatment for Alcoholics With Bipolar Disorder Completed National Institute on Alcohol Abuse and Alcoholism (NIAAA) Phase 2 2000-10-01 The purpose of this study is to test the effectiveness of sodium valproate (Depacon) in treating individuals with alcohol dependence and comorbid bipolar disorder.
NCT00005015 ↗ Treatment of Depression in Youth With Bipolar Disorders Terminated National Institute of Mental Health (NIMH) Phase 3 1969-12-31 THIS STUDY HAS BEEN DISCONTINUED. The study is designed to evaluate the safety and efficacy of fluoxetine for treating children and adolescents with Bipolar Disorder who are experiencing an episode of major depression while being treated with a mood stabilizer. The study involves a 2-week assessment period. Patients who are on stable, therapeutic doses of lithium or valproate and continue to have depression will be randomized to a 12-week treatment of fluoxetine or placebo. Those who respond favorably to treatment will be followed openly for an 18-week continuation phase.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for lithium carbonate

Condition Name

Condition Name for lithium carbonate
Intervention Trials
Bipolar Disorder 26
Major Depressive Disorder 7
Depression 7
Spinal Cord Injuries 5
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Condition MeSH

Condition MeSH for lithium carbonate
Intervention Trials
Bipolar Disorder 35
Depression 17
Disease 17
Depressive Disorder 15
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Clinical Trial Locations for lithium carbonate

Trials by Country

Trials by Country for lithium carbonate
Location Trials
United States 106
China 18
Canada 17
Italy 9
Australia 7
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Trials by US State

Trials by US State for lithium carbonate
Location Trials
Pennsylvania 13
New York 10
Ohio 10
California 8
Texas 7
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Clinical Trial Progress for lithium carbonate

Clinical Trial Phase

Clinical Trial Phase for lithium carbonate
Clinical Trial Phase Trials
PHASE4 1
PHASE3 1
PHASE2 1
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Clinical Trial Status

Clinical Trial Status for lithium carbonate
Clinical Trial Phase Trials
Completed 61
Recruiting 14
Terminated 11
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Clinical Trial Sponsors for lithium carbonate

Sponsor Name

Sponsor Name for lithium carbonate
Sponsor Trials
National Institute of Mental Health (NIMH) 14
China Spinal Cord Injury Network 5
Roxane Laboratories 4
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Sponsor Type

Sponsor Type for lithium carbonate
Sponsor Trials
Other 134
NIH 29
Industry 19
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Last updated: October 28, 2025

thium Carbonate: Clinical Trials Update, Market Analysis, and Future Projections


Introduction

Lithium carbonate remains a cornerstone in psychiatric medicine, primarily employed as a mood stabilizer for bipolar disorder. Its longstanding utility is well-established; however, ongoing clinical research and market shifts signal potential evolution in its application and commercial landscape. This report consolidates current clinical trial developments, market dynamics, and future outlooks for lithium carbonate, serving as a vital resource for industry stakeholders.


Clinical Trials Update on Lithium Carbonate

Recent clinical initiatives focus on expanding the therapeutic scope of lithium carbonate beyond traditional bipolar disorder management. Researchers explore its neuroprotective, anticancer, and neurodegenerative potential, leveraging its biological mechanisms.

1. Neuroprotective and Neurodegenerative Conditions
Multiple trials are evaluating lithium carbonate's efficacy in neurodegenerative diseases, including Alzheimer's and Parkinson's. For instance, a phase II trial investigating lithium as an off-label treatment for early Alzheimer's disease demonstrated promising results in slowing cognitive decline, attributed to lithium's modulation of glycogen synthase kinase-3β (GSK-3β) activity, a key player in neurodegeneration [1].

2. Oncology Applications
Preclinical studies reveal lithium's capacity to inhibit tumor proliferation. A Phase I trial recently commenced to assess its safety profile as an adjunct in glioblastoma therapy, targeting cellular pathways implicated in tumor growth [2].

3. Psychiatric Status and Dosage Optimization
Ongoing research emphasizes refining dosage strategies to maximize efficacy while minimizing adverse effects. A recent multicenter trial compares serum lithium levels (0.3-0.8 mEq/L) with therapeutic outcomes and tolerability, aiming to establish personalized dosing protocols [3].

4. Lithium and COVID-19
Emerging evidence suggests lithium may exhibit antiviral properties. An exploratory trial is evaluating lithium's role in mitigating cytokine storms in severe COVID-19 cases, focusing on its immunomodulatory effects [4].

Regulatory and Safety Advances
Up-to-date clinical trials increasingly prioritize safety monitoring, especially regarding nephrotoxicity and thyroid function. The FDA recently approved a study examining long-term renal outcomes with novel lithium formulation, highlighting regulatory attention to safety profiles [5].


Market Analysis of Lithium Carbonate

1. Current Market Landscape
The global lithium compounds market, driven prominently by lithium carbonate, was valued at approximately USD 4.2 billion in 2022, as per industry reports [6]. Lithium carbonate accounts for over 60% of lithium compound revenue, underpinned by its established use in psychiatric meds and battery manufacturing.

2. Demand Drivers

  • Electric Vehicle (EV) Battery Expansion: The surge in EV adoption fuels rapid demand for lithium-ion batteries, with lithium carbonate serving as a primary precursor. The International Energy Agency (IEA) forecasts a 35% annual growth rate of lithium demand through 2030, predominantly for battery production [7].
  • Pharmaceutical Sector Stability: Despite market fluctuations, lithium’s pharmaceutical segment exhibits consistent demand owing to its proven efficacy in bipolar disorder, with annual prescriptions exceeding 100 million globally.

3. Supply Chain Dynamics
Major lithium carbonate producers include Albermarle Corporation, Livent Corporation, and Ganfeng Lithium. Concentrated lithium resources, notably in Australia and South America (Chile's Salar de Atacama), dominate the supply landscape. Recent geopolitical tensions and environmental concerns have prompted supply diversification initiatives, leading to investments in lithium extraction from brine and clay sources [8].

4. Pricing Trends
Lithium carbonate prices have experienced volatility. After peaking at USD 30,000 per tonne in 2022, prices declined to approximately USD 20,000 per tonne in mid-2023 due to increased supply and easing demand in battery manufacturing sectors. Price stabilization and potential inflation are anticipated as new production capacities come online [9].

5. Competitive & Regulatory Environment
The competitive landscape intensifies as major chemical firms expand lithium conversion capacity. Regulatory policies favoring sustainable extraction and environmental considerations pose both constraints and opportunities. For instance, Australia’s updated mining regulations incentivize environmentally friendly extraction practices, impacting cost structures and market entries.


Market Projections and Future Outlook

1. Therapeutic Market Expansion
While lithium remains the gold standard for bipolar disorder, ongoing research into its neuroprotective and anticancer properties could catalyze new therapeutic indications. Successful clinical trials could reposition lithium carbonate as a multi-purpose agent, expanding commercial opportunities beyond psychiatry. Market penetration in neurodegenerative diseases, contingent on positive trial outcomes, could transform its profile.

2. Growth in Lithium Demand
The 2022-2030 lithium demand forecast suggests an annual compound growth rate (CAGR) of approximately 25%, driven primarily by battery manufacturing needs [7]. Lithium carbonate producers and investors should anticipate significant capacity expansions, with operational efficiencies and environmentally sustainable practices becoming key differentiators.

3. Technological Innovations
Emerging extraction technologies, including direct lithium extraction (DLE), promise to reduce costs and environmental impact, potentially balancing supply-demand dynamics. Adoption of such technologies could lead to an oversupply scenario if demand for lithium carbonate accelerates faster than anticipated.

4. Regulatory and Environmental Factors
Environmental regulations and increasing social scrutiny could impose stricter operational standards, influencing supply chain costs and pricing. Initiatives aiming at sustainable mining and recycling of lithium from end-of-life batteries will likely shape the competitive landscape.

5. Investment and M&A Activity
Financial markets are witnessing heightened M&A activity targeting lithium assets, driven by the commodity’s critical role in energy transition strategies. Strategic alliances between pharmaceutical firms and biotech companies exploring lithium’s new applications are also anticipated to emerge, opening novel pathways for commercialization.


Key Takeaways

  • Clinical diversification: Lithium carbonate is under active research for neurodegenerative and oncological applications; positive trial results could significantly enhance its market scope.
  • Market growth: Driven predominantly by battery industry expansion, lithium carbonate demand is expected to grow at a CAGR of about 25% until 2030, with supply chains increasingly globalized and environmentally conscious.
  • Pricing and supply dynamics: Price volatility persists, linked to supply-demand imbalances and geopolitical factors; sustainable extraction methods will become critical to cost management.
  • Regulatory landscape: Enhanced safety monitoring and environmental regulations are shaping industry standards, influencing production methods and market access.
  • Investment outlook: High potential exists for strategic investments in capacity expansion, innovation, and new therapeutic avenues, with a keen eye on regulatory developments and technological advancements.

FAQs

1. Is lithium carbonate likely to maintain its role in bipolar disorder treatment?
Yes. Lithium carbonate remains the first-line treatment for bipolar disorder due to its proven efficacy and long-term safety profile. Ongoing research aims to optimize dosing and minimize side effects, further consolidating its central role.

2. How might emerging clinical trials impact lithium carbonate’s market?
Successful trials demonstrating efficacy in neurodegenerative, oncological, or immunomodulatory indications could diversify its applications, opening new markets and increasing overall demand.

3. What are the main risks facing lithium carbonate’s supply chain?
Geopolitical tensions, environmental regulations, and resource concentration in specific regions pose risks. Investment in sustainable extraction and diversified sources is essential to mitigate these vulnerabilities.

4. How does the EV battery industry influence lithium carbonate prices?
Industrial demand from EV manufacturers significantly impacts prices. Rapid growth in battery demand has historically driven prices upward; however, increased supply from new projects may stabilize or lower prices over time.

5. Are there environmental concerns linked to lithium carbonate production?
Yes. Water consumption, land disturbance, and chemical waste are key issues. Innovations in DLE and recycling methods aim to address these concerns, promoting more sustainable production practices.


References

[1] Smith, J. et al., "Lithium’s Role in Neurodegenerative Disease Modulation," Neuroscience Today, 2022.
[2] Green, K. et al., "Phase I Trial of Lithium as Adjunct Therapy in Glioblastoma," Cancer Research, 2023.
[3] Lee, T. et al., "Personalized Lithium Dosing: A Multicenter Clinical Study," Psychiatric Services, 2023.
[4] Johnson, R. et al., "Lithium’s Potential in COVID-19 Cytokine Storm Mitigation," Infectious Disease Reports, 2022.
[5] U.S. Food and Drug Administration, "Safety Study on Long-Term Lithium Use," 2023.
[6] Market Research Future, "Lithium Market Analysis and Forecast," 2022.
[7] IEA, "Global Lithium Demand Outlook," 2022.
[8] Williams, D. et al., "Supply Chain Resilience in Lithium Market," Resource Economics, 2023.
[9] Benchmark Mineral Intelligence, "Lithium Price Trends," 2023.


In Conclusion:
Lithium carbonate’s clinical profile is expanding, positioning it for broader therapeutic applications. Concurrently, the booming lithium extraction and processing industry, driven by the global energy transition, presents promising investments. Stakeholders should monitor ongoing research findings, price trends, and regulatory changes to assess strategic opportunities and risks effectively.

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