A Randomized, Balanced, Phase 1/2A, Multiple-dose, Open-label, Two-treatment, Two-period, Two-sequence, Crossover, Relative Bioavailability Study to Investigate Lithium Brain/Plasma Pharmacokinetics and Safety of an AL001 Oral Capsule Compared to a Marketed Immediate-release Lithium Carbonate Capsule in Subjects With Bipolar I Disorder

The goal of this clinical trial is to assess the safety and effects of a crystallized form of lithium, AL001, when compared to commonly used lithium carbonate in individuals diagnosed with bipolar I disorder. The main questions this study aims to answer are:
* How safe is AL001 when compared to lithium carbonate?
* How is AL001 broken down in the brain and body compared to lithium carbonate?
Participants will be asked to:
* Take both the study drug (AL001) and lithium carbonate each for a period of 14 days.
* Stay overnight at MGH's research unit for two separate 2-week periods.
* Participate in two separate 24 hour periods of multiple MRIs and blood draws.

Start Date11 May 2026

Sponsor / Collaborator

Alzamend Neuro, Inc.

[+1]

ChiCTR2600121292

/ Not yet recruitingPhase 1/2IIT

An international multicenter clinical trial on the prevention and treatment of radiation-induced oral mucositis and taste disorders with lithium salt water gel

Start Date07 Mar 2026

Sponsor / Collaborator

West China Stomatological Hospital of Sichuan University

ChiCTR2500113193

/ SuspendedPhase 2IIT

Toripalimab in combination with chemotherapy and lithium carbonate for first-line treatment of extensive-stage small cell lung cancer in stage Ib/II clinical research

Start Date30 Sep 2025

Sponsor / Collaborator-

100 Clinical Results associated with Lithium carbonate

100 Translational Medicine associated with Lithium carbonate

100 Patents (Medical) associated with Lithium carbonate

13,378

Literatures (Medical) associated with Lithium carbonate

01 Sep 2026·BIOSENSORS & BIOELECTRONICS

Highly specific aptamer-based structure-switching sensor for detection of the smallest alkali metal ion Li+ in serum

Article

Author: Yin, Jiye ; Zhou, Boting ; Yu, Yujia ; Wang, Jin ; Guo, Chengxian ; Lei, Hongtao ; Tan, Hongyi ; Yang, Chao

Lithium carbonate, a frontline drug for bipolar disorder (BD), requires strict therapeutic drug monitoring (TDM) due to its narrow therapeutic window (0.6-1.2 mM). Existing methods like inductively coupled plasma mass spectrometry (ICP-MS) and ion-selective electrodes (ISE) struggle to balance point-of-care testing (POCT) demands with interference in complex matrices. Here, we isolated a highly specific Li⁺ DNA aptamer (Li-1) via a Capture-SELEX strategy and constructed a sensitive structure-switching fluorescent sensor. Isothermal titration calorimetry (ITC) and circular dichroism (CD) spectroscopy were utilized to perform thermodynamic and structural analyses of its molecular recognition process, revealing that the binding of Li-1 to Li⁺ is dominated by an "enthalpy-driven" conformational rearrangement. Based on a 5-carboxyfluorescein (FAM)-labeled DNA strand displacement strategy, the established sensor achieved a dynamic linear response of 6.2 - 60 μM with a limit of detection (LOD) of 1.8 μM. It exhibited no obvious cross-recognition to Na⁺, K⁺, Ca²⁺, and Mg²⁺. The spiked recovery rates ranged from 88.76% to 102.33%. In double-blind tests of clinical BD patient serum, the method showed strong statistical agreement (Pearson's r > 0.92) with the clinical gold standard ICP-MS. This work develops a DNA aptamer targeting the smallest alkali metal ion, Li⁺, providing a highly specific and sensitive method for POCT blood lithium monitoring in psychiatric practice.

01 Aug 2026·The Lancet Psychiatry

Brain lithium temporospatial kinetics in bipolar disorder: a repeated-measures 7Li MRI study of dosing regimens in Germany

Article

Author: Edelmann, Katinka ; Bauer, Michael ; Werner, Annett ; Kavanagh, Oisín ; Boumezbeur, Fawzi ; Hall, Gerard ; Ritter, Philipp ; Cousins, David Andrew ; Thelwall, Peter Edward

BACKGROUND:

Lithium remains a first-line treatment for bipolar disorder, but practice varies regarding dosing frequency. Although once-daily and twice-daily regimens are similarly effective, they produce serum lithium profiles that differ over the day, and whether greater fluctuations with once-daily dosing are attenuated in the brain is unclear. The aim of this study was to evaluate whether brain lithium profiles differed across the day with once-daily versus twice-daily dosing regimens.

METHODS:

In this repeated-measures, cross-sectional imaging study, euthymic individuals (aged 18-50 years) with bipolar disorder type I or II receiving stable lithium carbonate treatment were recruited at four psychiatric outpatient departments in Dresden, Germany. In the week before assessment, participants received lithium at 2000 h (full once-daily dose or evening dose of the twice-daily regimen) and 0800 (twice-daily regimen only; withheld until after the 0800 h sampling on assessment day). The core assessment was a 1-day protocol in which participants underwent three consecutive ⁷Li MRI scans and matched serum sampling over a 10-h period (0800, 1400, and 1800h). Whole-brain lithium measurements across timepoints were compared according to regimen using the brain observable lithium threshold region-of-interest approach. Secondary analyses modelled tissue-specific profiles, derived from the Newcastle lithium image voxel evaluation pipeline, and examined the relationship between serum lithium concentration and brain ⁷Li MRI signal intensity using repeated-measures ANOVA, linear mixed-effects models, and population pharmacokinetics. This study was informed by people with lived experience of bipolar disorder and long-term lithium treatment through patient and public involvement and engagement activities.

FINDINGS:

Between April 19, 2022, and Dec 9, 2023, 44 eligible participants were recruited, of whom three withdrew before assessment. Therefore, 41 euthymic individuals (all White European; 21 [51%] female and 20 [49%] male; mean age 39·2 years [SD 9·8]) with bipolar disorder receiving stable lithium carbonate treatment (20 in the once-daily dosing group and 21 in the twice-daily dosing group) were evaluated. At 12 h post dose (0800 h), brain ⁷Li MRI signal intensity and serum lithium concentrations were equivalent across regimens. In the once-daily group, serum lithium declined across the day, whereas in the twice-daily group it increased after the morning dose and then decreased. Brain ⁷Li MRI signal intensity closely mirrored these regimen-specific serum profiles. Brain ⁷Li MRI signal intensity was higher in white matter than grey matter in both regimens and brain-to-serum ratios indicated more rapid equilibration in grey matter compared with cerebrospinal fluid and white matter.

INTERPRETATION:

Brain lithium concentrations followed serum concentrations closely across the day but aligned between regimens at the standard 12-h post-dose sampling timepoint. These findings directly inform ongoing discussions about the applicability of a common reference range across regimens. The difference in brain and serum profiles of lithium with once-daily and twice-daily dosing might inform regimen selection and therapeutic monitoring strategies in clinical practice.

FUNDING:

Baszucki Brain Research Foundation and Deutsche Forschungsgemeinschaft (German Research Foundation).

01 Aug 2026·JOURNAL OF AFFECTIVE DISORDERS

Real-world pharmacovigilance insights and clinical safety signal characterization of the classic mood stabilizer‑lithium carbonate: A disproportionality analysis based on FAERS data

Article

Author: Zeng, Yining ; Liu, Yuxia ; Wang, Ruixia ; Wu, Hao ; Duan, Junguo ; Tan, Xiyue ; Wang, Xueting

OBJECTIVE:

Lithium carbonate is a classic mood stabilizer for bipolar disorder, yet real-world pharmacovigilance of its safety signals (especially underrecognized systems/populations) is lacking. This study detected disproportional ADR signals via FAERS to clarify its multi-system safety profile and gender/age-specific patterns.

METHODS:

FAERS data (Q1 2004-Q3 2025) for lithium carbonate as the primary suspected drug were extracted. Duplicate reports were processed per FDA guidelines; ADRs were coded by MedDRA (PTs/SOCs). Disproportionality analysis used ROR, PRR, BCPNN and EBGM algorithms, with N ≥ 10 threshold and Bonferroni correction for false positive reduction. Sensitivity (excluding concomitant medications) and subgroup (gender: male/female; age: 12-20/>20 years) analyses were conducted.

RESULTS:

3769 reports (16,976 events) involved 27 SOCs, with Nervous (n = 3072) and Psychiatric (n = 2194) disorders top-ranked. Strong signals included Renal/urinary (ROR = 4.25) and Endocrine (ROR = 11.72) disorders; notable Cardiac signals covered nodal rhythm, sinus bradycardia, prolonged QT interval and Brugada syndrome. After rigorous screening, 161 consistent positive PT signals were identified. Top PTs by EBGM: neonatal toxicity (762.20), nephrogenic diabetes insipidus (486.42), parathyroid gland enlargement (425.61). Therapeutic agent toxicity (n = 336) was the most reported, matching lithium carbonate's narrow therapeutic window. Subgroup differences: males had higher tremor/TSH elevation risks; females, nephrogenic diabetes insipidus/hypercalcemia; adolescents, more thyroid disorders; adults, higher multi-agent toxicity.

CONCLUSION:

Key ADR signals focus on the nervous, psychiatric, renal-urinary, endocrine and cardiac systems, with distinct gender/age-specific patterns. Clinicians should control dosage, monitor serum lithium/organ function (electrocardiography) and individualize assessments for high-risk groups. This study provides real-world pharmacovigilance evidence for safe lithium carbonate use.

News (Medical) associated with Lithium carbonate

20 Aug 2026

·www.prnewswire.com

Alzamend Neuro's Phase 1/2A Lithium Neuroimaging Data Accepted for Poster Presentation at Neuroscience 2026 in Washington, DC

Neuroscience 2026, the annual meeting of the Society for Neuroscience, will be held November 14–18, 2026 in Washington, DC Presentation Title: Assessing Treatment-Associated Brain Network Changes Following a Novel Lithium Treatment Using 7T Resting-State fMRI – Results from a Randomized Phase 1/2A Clinical Trial ATLANTA, Aug. 20, 2026 /PRNewswire/ -- Alzamend Neuro, Inc. (Nasdaq: ALZN) (" Alzamend"), a clinical-stage biopharmaceutical company focused on developing novel products for the treatment of Alzheimer's disease (" Alzheimer's"), bipolar disorder type 1 (" BD"), major depressive disorder (" MDD") and post-traumatic stress disorder (" PTSD"), today announced that an abstract reporting resting-state functional magnetic resonance imaging (" fMRI") findings for AL001, Alzamend's novel organic lithium salt, has been accepted for poster presentation at Neuroscience 2026, the annual meeting of the Society for Neuroscience (" SfN"), to be held November 14–18, 2026 in Washington, DC. The abstract, titled "Assessing Treatment-Associated Brain Network Changes Following a Novel Lithium Treatment Using 7T Resting-State fMRI – Results from a Randomized Phase 1/2A Clinical Trial," will be presented as a poster in the Neuropsychiatric Disorders session (Session PSTR337) on Wednesday, November 18, 2026, from 8:00 a.m. to 12:00 p.m. Neuroscience 2026 is organized by the SfN and is the world's largest gathering dedicated to the study of the brain and nervous system, drawing tens of thousands of researchers, clinicians and industry partners spanning the full breadth of neuroscience, from molecular and cellular mechanisms to systems-level and clinical applications. The program features poster sessions, symposia, mini-symposia and workshops highlighting the latest developments in the field. "Resting-state fMRI lets us see, non-invasively, how a treatment reshapes the brain's own functional architecture over time," said Dr. Ovidiu C. Andronesi, principal investigator on Alzamend's Phase 1/2A Clinical Trial, Director of Multinuclear Magnetic Resonance Imaging, Martinos Center for Biomedical Imaging, Department of Radiology, Massachusetts General Hospital, and Associate Professor of Radiology at Harvard Medical School. "These network-level findings add an important layer of evidence to what we've already seen in blood and tissue lithium levels from this trial." "Being selected to present at Neuroscience 2026, the largest annual gathering of the neuroscience community, is a meaningful validation of this dataset," said Stephan Jackman, Chief Executive Officer of Alzamend. "Dr. Andronesi and his team continue to generate rigorous, independently reviewed evidence of how AL001 engages the brain, evidence that matters to the millions of patients worldwide living with BD and other conditions where lithium remains the gold standard. We look forward to sharing this work at Neuroscience 2026." About the Presentation The poster presentation will report findings from 7T resting-state fMRI evaluating treatment-associated changes in brain network connectivity among healthy human subjects in Alzamend's completed Phase 1/2A clinical trial of AL001, Alzamend's patented ionic cocrystal formulation of lithium. The data will be presented by Shuqing Deng, a research assistant working in the laboratory of Dr. Andronesi. Dr. Andronesi developed the underlying 7T magnetic resonance imaging (" MRI") methodology and served as the study's principal investigator. About this Study The study employed a randomized crossover design with multiple six-subject cohorts. Participants were assigned to one of two sequences: AB (AL001 then lithium carbonate) or BA (lithium carbonate then AL001). Each treatment period consisted of 14 days of three-times-daily dosing, separated by a 14-day washout. On Days 14–15, participants underwent 24-hour pharmacokinetic blood sampling alongside advanced MRI and magnetic resonance spectroscopy (" MRS") neuroimaging, a first-of-its-kind methodology. The MRI and MRS neuroimaging methods were developed by the lab of Dr. Andronesi. The study also incorporated a specialized, engineered head coil developed by Tesla Dynamic Coils BV, designed to enable high-resolution, whole-brain lithium imaging. This approach enabled simultaneous quantification of lithium concentrations in blood and brain including individual structures, as well as assessment of brain and individual brain structure chemistry, metabolism, and biomarker effects. The study specifically evaluated AL001's ability to enhance lithium delivery to targeted brain regions while reducing systemic exposure, an approach designed to address the long-standing safety and tolerability limitations associated with traditional lithium salts. The results from the study confirmed that AL001 matches blood levels of standard lithium carbonate, the reference drug, addressing U.S. Food and Drug Administration regulatory requirements for a new drug formulation, as well as providing a differentiated, potential dose-sparing benefit profile for patients. AL001: A Differentiated Lithium Therapy for a Large Unmet Need Although lithium has remained the gold standard treatment for BD for more than 55 years, its clinical utility is constrained by a narrow therapeutic window and the need for regular therapeutic drug monitoring to manage renal, thyroid, and other systemic toxicity risks. AL001 is Alzamend's patented ionic cocrystal formulation of lithium combined for delivery with L-proline and salicylate, which is designed to deliver a full therapeutic amount of lithium to the brain with less systemic exposure than lithium carbonate, potentially enabling a safer, better-tolerated therapy across Alzheimer's, BD, MDD and PTSD. About Alzamend Neuro Alzamend is a clinical-stage biopharmaceutical company developing novel therapies for Alzheimer's, BD, MDD and PTSD. Our mission is to rapidly develop and market safe and effective treatments. Our current pipeline consists of two novel therapeutic drug candidates, AL001, a patented ionic cocrystal delivering lithium with salicylate and L-proline designed to improve brain delivery and safety compared to conventional lithium, and ALZN002, a patented cell-based therapeutic vaccine designed to restore the immune system's ability to clear Alzheimer's beta-amyloid. The latter is a next-generation active-immunity approach offering potential advantages in dosing frequency and cost compared to approved passive-immunity antibody therapies. Both candidates are exclusively licensed from the University of South Florida Research Foundation under royalty-bearing worldwide licenses. Forward-Looking Statements This press release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as "believes," "plans," "anticipates," "projects," "estimates," "expects," "intends," "strategy," "future," "opportunity," "may," "will," "should," "could," "potential," or similar expressions, including statements regarding Alzamend's planned presentation at Neuroscience 2026, the annual meeting of the Society for Neuroscience. Statements that are not historical facts are forward-looking statements. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties. Forward-looking statements speak only as of the date they are made, and Alzamend undertakes no obligation to update any of them publicly in light of new information or future events. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors. More information, including potential risk factors, that could affect Alzamend's business and financial results are included in Alzamend's filings with the U.S. Securities and Exchange Commission. All filings are available at and on Alzamend's website at . SOURCE Alzamend Neuro, Inc. 21% more press release views with Request a Demo

VaccineClinical StudyClinical Result

18 Aug 2026

·www.prnewswire.com

Alzamend Neuro's Phase 1/2A Lithium Imaging Data Accepted for Oral Presentation at ISMRM Workshop on X-Nuclei MR in Barcelona, Spain

ISMRM Workshop on Beyond Protons: Challenges and Advances in X-Nuclei MR will be held September 28 – October 1, 2026 at the Universitat Oberta de Catalunya (UOC) in Barcelona, Spain Presentation will report first-of-its-kind pharmacokinetic imaging results from Phase 1/2A trial of AL001, Alzamend's novel organic lithium drug candidate, in healthy human subjects ATLANTA, Aug. 18, 2026 /PRNewswire/ -- Alzamend Neuro, Inc. (Nasdaq: ALZN) (" Alzamend"), a clinical-stage biopharmaceutical company focused on developing novel products for the treatment of Alzheimer's disease (" Alzheimer's"), bipolar disorder type 1 (" BD"), major depressive disorder (" MDD") and post-traumatic stress disorder (" PTSD"), today announced that an abstract reporting pharmacokinetic imaging data for AL001, Alzamend's novel organic lithium salt, has been accepted for oral presentation at the International Society for Magnetic Resonance in Medicine (" ISMRM") Workshop on Beyond Protons: Challenges and Advances in X-Nuclei MR, to be held from September 28 – October 1, 2026 at the Universitat Oberta de Catalunya (UOC) in Barcelona, Spain. The abstract, titled "Pharmacokinetics Imaging of Lithium at 7T – Results from a Phase 1/2A Clinical Trial with a Novel Organic Lithium Salt" (Abstract #00047), was selected following a competitive review by the workshop's organizing committee and will be presented in the "Proffered Papers" oral session on Tuesday, September 29, 2026 at 1:35 PM local time. The workshop is organized by ISMRM and the International Society for MR Radiographers & Technologists and brings together researchers, clinicians and industry partners focused on non-proton, or "X-nuclei," magnetic resonance imaging (" MRI"), covering technical advances and clinical applications in imaging nuclei such as sodium, phosphorus, carbon and lithium. The program features invited talks, proffered oral papers and poster sessions highlighting the latest developments in the field. "7T imaging finally lets us see what blood levels alone never could: how lithium actually behaves in human brain tissue over time," said Dr. Ovidiu C. Andronesi, principal investigator on Alzamend's Phase 1/2A Clinical Trial, Director of Multinuclear MRI, Martinos Center for Biomedical Imaging, Department of Radiology, Massachusetts General Hospital, and Associate Professor of Radiology at Harvard Medical School. "These pharmacokinetic data give us a much sharper picture of how AL001 reaches and persists in the brain." "An oral presentation at ISMRM's X-nuclei workshop is a strong indication that this data holds up to scientific scrutiny," said Stephan Jackman, Chief Executive Officer of Alzamend. "Dr. Andronesi's imaging work shows us, non-invasively, how AL001 delivers lithium to the brain, evidence that speaks directly to the millions of patients worldwide who could benefit from a better-tolerated lithium therapy. We look forward to Dr. Andronesi sharing these findings with the specialized X-nuclei imaging community in Barcelona." About the Presentation The 10-minute oral presentation will report pharmacokinetic imaging findings obtained at 7T from the completed Phase 1/2A clinical trial of AL001, Alzamend's patented ionic cocrystal formulation of lithium, in healthy human subjects. The data will be presented by Dr. Andronesi, who developed the underlying 7T MR imaging methodology and served as the study's principal investigator. About this Study The study employed a randomized crossover design with multiple six-subject cohorts. Participants were assigned to one of two sequences: AB (AL001 then lithium carbonate) or BA (lithium carbonate then AL001). Each treatment period consisted of 14 days of three-times-daily dosing, separated by a 14-day washout. On Days 14–15, participants underwent 24-hour pharmacokinetic blood sampling alongside advanced MRI and magnetic resonance spectroscopy (" MRS") neuroimaging, a first-of-its-kind methodology. The MRI and MRS neuroimaging methods were developed by the lab of Dr. Andronesi. The study also incorporated a specialized, engineered head coil developed by Tesla Dynamic Coils BV, designed to enable high-resolution, whole-brain lithium imaging. This approach enabled simultaneous quantification of lithium concentrations in blood and brain including individual structures, as well as assessment of brain and individual brain structure chemistry, metabolism, and biomarker effects. The study specifically evaluated AL001's ability to enhance lithium delivery to targeted brain regions while reducing systemic exposure, an approach designed to address the long-standing safety and tolerability limitations associated with traditional lithium salts. The results from the study confirmed that AL001 matches blood levels of standard lithium carbonate, the reference drug, addressing U.S. Food and Drug Administration regulatory requirements for a new drug formulation, as well as providing a differentiated, potential dose-sparing benefit profile for patients. AL001: A Differentiated Lithium Therapy for a Large Unmet Need Although lithium has remained the gold standard treatment for BD for more than 55 years, its clinical utility is constrained by a narrow therapeutic window and the need for regular therapeutic drug monitoring to manage renal, thyroid, and other systemic toxicity risks. AL001 is Alzamend's patented ionic cocrystal formulation of lithium combined for delivery with L-proline and salicylate, which is designed to deliver a full therapeutic amount of lithium to the brain with less systemic exposure than lithium carbonate, potentially enabling a safer, better-tolerated therapy across Alzheimer's, BD, MDD and PTSD. About Alzamend Neuro Alzamend is a clinical-stage biopharmaceutical company developing novel therapies for Alzheimer's, BD, MDD and PTSD. Our mission is to rapidly develop and market safe and effective treatments. Our current pipeline consists of two novel therapeutic drug candidates, AL001, a patented ionic cocrystal delivering lithium with salicylate and L-proline designed to improve brain delivery and safety compared to conventional lithium, and ALZN002, a patented cell-based therapeutic vaccine designed to restore the immune system's ability to clear Alzheimer's beta-amyloid. The latter is a next-generation active-immunity approach offering potential advantages in dosing frequency and cost compared to approved passive-immunity antibody therapies. Both candidates are exclusively licensed from the University of South Florida Research Foundation under royalty-bearing worldwide licenses. Forward-Looking Statements This press release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as "believes," "plans," "anticipates," "projects," "estimates," "expects," "intends," "strategy," "future," "opportunity," "may," "will," "should," "could," "potential," or similar expressions, including statements regarding Alzamend's planned presentation at the ISMRM Workshop on Beyond Protons: Challenges and Advances in X-Nuclei MR. Statements that are not historical facts are forward-looking statements. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties. Forward-looking statements speak only as of the date they are made, and Alzamend undertakes no obligation to update any of them publicly in light of new information or future events. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors. More information, including potential risk factors, that could affect Alzamend's business and financial results are included in Alzamend's filings with the U.S. Securities and Exchange Commission. All filings are available at and on Alzamend's website at . SOURCE Alzamend Neuro, Inc. 21% more press release views with Request a Demo

VaccineClinical ResultClinical Study

10 Aug 2026

·www.einpresswire.com

New Preprint Finds Lithium Ascorbate Outperforms Prescription Lithium with Fewer Side Effects

In preclinical studies, this lithium-vitamin C compound showed anti-anxiety and antidepressant-like effects across 4 stress models without weight gain. NEW YORK, NY, UNITED STATES, August 10, 2026 / EINPresswire.com / -- A new research preprint published on Research Square highlights lithium ascorbate as a potential alternative to conventional lithium carbonate, which is limited by a narrow therapeutic window and concerns about organ-related adverse effects. In preclinical studies, this organic compound combining lithium with vitamin C demonstrated anti-anxiety and antidepressant-like effects across four behavioral stress models, outperforming standard comparator treatments without causing significant weight gain. Researchers tested lithium salts’ effects on rodent behavior. The substances tested in the study were: - Lithium carbonate. - Lithium orotate. - Lithium succinate. - Lithium ascorbate. - Ascorbic acid. Lithium carbonate is an inorganic lithium salt that is traditionally used as a prescription medication for bipolar disorder and treatment-resistant depression. However, it has a narrow dosage window where lithium carbonate stays effective and doesn’t cause damage to the body. Professor Olga Gromova, M.D., a clinical pharmacologist and the chief scientific officer for Normotim, said: “Lithium carbonate is inorganic. It is easy and inexpensive to produce, so it is widely used in psychiatry. The body does not fully absorb lithium carbonate, so doctors prescribe higher doses compared to other lithium forms. The more lithium carbonate is present in the body, the more lithium the kidneys must process and excrete through urine.” Organic lithium salts such as lithium orotate and lithium ascorbate are being researched as potential alternatives to lithium carbonate. It appears that organic lithium salts are better absorbed and tolerated than inorganic forms. Dr. Gromova said: “Organic lithium salts such as lithium ascorbate, lithium citrate, and lithium orotate interact more smoothly with biological systems. The molecules bound to lithium in organic salts participate in metabolic pathways, unlike those in inorganic salts.” Lithium ascorbate is a compound of lithium and ascorbic acid (Vitamin C), which possesses distinct properties unlike carbonate or orotate. Ascorbic acid partakes in immune function, collagen production, and cellular metabolism. Experiments Conducted Open field test: Measures locomotion, exploration, and anxiety by recording how an animal navigates a novel open arena. Swimming test: Measures depression-like behavioral despair by timing how long a rodent struggles versus floats in inescapable water. Tail suspension test: Evaluates depression-like behavior by measuring active escape attempts versus passive immobility while a rodent is hung by its tail. Simulated transport stress test: Models relocation stress by exposing animals to controlled motion, vibration, and noise in a lab environment. Across all tests, lithium ascorbate showed the best results as a potential anti-anxiety and antidepressant substance. Lithium ascorbate reduced immobility, increased active or sustained coping, and enhanced locomotor and exploratory activity. It also increased center entries, reduced grooming and defecation, and lowered post-stress adrenaline and norepinephrine. Lithium ascorbate and lithium orotate went head-to-head in the open field test with one big downside for orotate – weight gain. Animals on lithium orotate gained 16.4% in body weight compared to the control group, while lithium ascorbate stayed at 3.2% Limitations of the study Limitations include small samples, unequal elemental lithium exposure, differences in species, dosing and administration, repeated-testing effects, indirect stress markers, and the inability of rodent models to establish clinical efficacy in humans. Vlada Sukhanovskaya Normopharm email us here +1 917-361-1677 Visit us on social media: LinkedIn Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

Clinical Result

100 Deals associated with Lithium carbonate

External Link

KEGG	Wiki	ATC	Drug Bank
D00801	Lithium carbonate	N05AN01	DB14509

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Bipolar I disorder	United States	Hikma Pharmaceuticals USA, Inc.	29 Jan 1982
Bipolar Disorder	United States	Pfizer Inc.	06 Apr 1970
Bipolar Disorder	United States	Solvay Pharmaceuticals, Inc.	06 Apr 1970
Schizoaffective disorder	United States	Solvay Pharmaceuticals, Inc.	06 Apr 1970
Schizoaffective disorder	United States	Pfizer Inc.	06 Apr 1970

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Kleine-Levin Syndrome	Preclinical	European Union	Laboratoires Delbert SAS	16 Aug 2023

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03185208 (Pubmed \| JAMA Neurol)	Phase 2	Mild cognitive disorder	80	Lithium carbonate	deofthzwwo(trlqrpxymh) = eemlneoppc ldikfqhbad (mzpwrigxmv ) View more	Positive	01 Apr 2026
NCT03185208 (Pubmed \| JAMA Neurol)	Phase 2	Mild cognitive disorder	80	Placebo	deofthzwwo(trlqrpxymh) = ltqhzivfsv ldikfqhbad (mzpwrigxmv ) View more	Positive	01 Apr 2026
NCT03185208 (LATTICE, CTgov)	Phase 4	Alzheimer Disease \| Mild cognitive disorder	83	Lithium Carbonate (Lithium Carbonate)	ldzhmysnyz(tvczqfjlgs) = xcbzlwnuit hlcbtnzmaw (wkjvbfhxpb, 4.0) View more	-	11 Sep 2025
NCT03185208 (LATTICE, CTgov)	Phase 4	Alzheimer Disease \| Mild cognitive disorder	83	Placebo oral capsule (Placebo)	ldzhmysnyz(tvczqfjlgs) = gqnzzafxor hlcbtnzmaw (wkjvbfhxpb, 4.6) View more	-	11 Sep 2025
NCT02862210 (Lithium, CTgov)	Phase 2	Frontotemporal Dementia	17	Lithium Carbonate (Lithium Carbonate)	aejxwkflez(gqdbiimtsf) = vwbalsmrma jaleicezie (vnhsfcnczb, 1.1) View more	-	03 Feb 2025
NCT02862210 (Lithium, CTgov)	Phase 2	Frontotemporal Dementia	17	Placebo (Placebo)	aejxwkflez(gqdbiimtsf) = srxrojayco jaleicezie (vnhsfcnczb, 1.28) View more	-	03 Feb 2025
NCT00961961 (CTgov)	Phase 4	Bipolar Disorder \| Bipolar I disorder	177	Lithium Carbonate+Fluoxetine (Lithium Plus Fluoxetine Phase I)	lhoouahjqj = kmsuepzzqo ayhptvxpsw (prftshanxz, chdutjjpjm - ngbghysreg) View more	-	19 Oct 2020
NCT00961961 (CTgov)	Phase 4	Bipolar Disorder \| Bipolar I disorder	177	Lithium / Placebo (Lithium Plus Placebo Phase I)	lhoouahjqj = qmpmwmyobi ayhptvxpsw (prftshanxz, hxdjuseikh - ztuzignfnk) View more	-	19 Oct 2020
NCT02918097 (CTgov)	Phase 4	Bipolar Disorder	78	Lithium Carbonate+risperidone+Nortriptyline+sertraline	uzgiekhqfn = lwfedbjtei tckagqvzxr (nbszcrdems, jftiowxzsy - xsssjszlci) View more	-	14 Oct 2020
NCT01820624 (Pubmed) Manual	Phase 1	Acute Myeloid Leukemia	9	lithium carbonate+tretinoin	cbeuaaxdiy(ioggtxfeda) = gkpqxrfgsq gbngkjsopc (svvrxjwdny )	Negative	10 Mar 2020
NCT01553916 (CTgov)	Phase 1/2	Small Cell Lung Cancer	19	Prophylactic cranial irradiation+Lithium Carbonate	pyizsvlgxb = adphfahoco znflxxtrsd (icihpeaodq, oktmqpwfkm - bppriwqjhr) View more	-	08 Nov 2017
NCT00501540 (CTgov)	Phase 2	Neuroendocrine Tumors	15	Lithium Carbonate	radnrsiwws = ygxxkrhkxn nwntgegtoq (erafgoazxz, nothahxeek - kzknazflcq) View more	-	03 May 2017
NCT00408681 (GVHD, CTgov)	Not Applicable	Marginal zone lymphoma recurrent \| Gestational Trophoblastic Disease \| Adult Acute Myeloblastic Leukemia ... View more	20	laboratory biomarker analysis+lithium carbonate	kdeqlozghf = evsvrqtrzr hpqrbxngun (xncmalgaft, oiygaituwm - yudkkesdsc)	-	20 Jan 2017
NCT00582712 (CTgov)	Phase 2	Thyroid Cancer, Medullary	5	Lithium carbonate	jlewdeffhq(pudssvnhgu) = dbjshdvked ljieurprds (egdmdiyuhn, zyqpfyhovl - lqicfhrxyz) View more	-	12 Dec 2016

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