Alpha Lipoic Acid

Phase 3Small molecule

NNational Center for Complementary and Integrative Health (NCCIH)

Alpha Lipoic Acid is one of 190 small molecule programs targeting Ischemic Cardiomyopathy. It is currently in Phase 3.

Indications

Total Trials

Active Trials

189

Competitors

Pipeline

Status by Indication[3][1]

Indication

Ischemic CardiomyopathyActive, not recruiting

Cardiovascular DiseaseActive, not recruiting

Burning Mouth SyndromeActive, not recruiting

Colorectal CancerRecruiting

Diabetic Peripheral NeuropathyNot yet recruiting

Polycystic Ovary SyndromeRecruiting

Breast CancerRecruiting

HemodialysisEnrolling by invitation

Ischemic CardiomyopathyPreclinical

Active, not recruiting

Cardiovascular DiseasePreclinical

Active, not recruiting

Burning Mouth SyndromePreclinical

Active, not recruiting

Colorectal CancerPreclinical

Recruiting

Diabetic Peripheral NeuropathyPreclinical

Not yet recruiting

Polycystic Ovary SyndromePhase 2

Recruiting

Breast CancerPhase 3

Recruiting

HemodialysisPhase 3

Enrolling by invitation

Competition

Competitive Landscape

744 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Alpha Lipoic Acid

NNational Center for Complementary and Integrative Health (NCCIH)

Phase 3

1 2

Voltaren

Novartis

Preclinical

1 3

Blenoxane

Bristol-Myers Squibb

Preclinical

1 4

Duragesic

CCephalon

Preclinical

1 5

Tricor

JJagotec

Preclinical

1 6

Feraheme

AAzurity Pharmaceuticals

Preclinical

1 7

Rilvegostomig

AstraZeneca

Preclinical

1 8

Neoadjuvant Treatment

SShanghai Zhongshan Hospital

Preclinical

1 9

Bisphosphonate

Amgen

Preclinical

2 10

Naltrexone/bupropion

Novo Nordisk

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

PreclinicalRecruiting

Colorectal Cancer

NCT07736495

Q3 2027

PreclinicalNot yet recruiting

Diabetic Peripheral Neuropathy

NCT07785544

Q1 2030

Phase 2Not yet recruiting

Insulin Resistance

NCT05713799

Clinical

Trials by Indication[1]

Diabetic Neuropathy2 trials

Alpha Lipoic Acid for Treatment of Diabetic Neuropathy

Completed·—·Phase 4·NCT02439879·45 enrolled

Clinical Study Evaluating the Safety and Efficacy of Roflumilast in Type 2 Diabetic Patients With Diabetic Neuropathy

Completed·TTanta University·Phase 3·NCT05369793·60 enrolled

Neuropathy2 trials

Painful HIV Neuropathy and Alpha-Lipoic Acid

Completed·NNational Center for Complementary and Integrative Health (NCCIH)·Phase 1/2·NCT00079807·60 enrolled

Alpha-lipoic Acid in Patients at Risk for Paclitaxel Induced Neuropathy

Completed·NNorthwestern University·Phase 1/2·NCT01313117·9 enrolled

Burning Mouth Syndrome2 trials

Photobiomodulation Therapy vs. Alpha-Lipoic Acid in Burning Mouth Syndrome Treatment

Active, not recruiting·LLu Jiang·N/A·NCT07381361·60 enrolled

Caffeine vs. ALA in BMS Treatment. (BMS: Burning Mouth Syndrome. ALA: Alpha-Lipoic Acid.)

Completed·LLu Jiang·N/A·NCT06195137·130 enrolled

Polycystic Ovary Syndrome2 trials

Effects of Adding Quercetin or Alpha Lipoic Acid to Usual Care on Symptoms and Blood Markers in Iraqi Women With Polycystic Ovary Syndrome

Recruiting·—·Phase 2·NCT07182526·150 enrolled

Effect of Alpha-Lipoic Acid Supplementation on Polycystic Ovary Syndrome Clinical Outcome in Infertile Females Treated With Letrozole

Completed·AAin Shams University·Phase 3·NCT06418347·150 enrolled

Peripheral Neuropathy2 trials

Alpha-Lipoic Acid in Preventing Peripheral Neuropathy in Patients Receiving Chemotherapy for Cancer

Completed·MM.D. Anderson Cancer Center·Phase 3·NCT00112996·244 enrolled

Alpha Lipoic Acid and Diabetes Mellitus: Potential Effects on Peripheral Neuropathy

Completed·—·N/A·NCT04322240·90 enrolled

38 more indications

Multiple Sclerosis2 trials

Comparing Tolerability and Absorption of Racemic and R-lipoic Acid in Progressive Multiple Sclerosis

Completed·RRebecca Spain·Phase 1·NCT03493841·20 enrolled

Natural Antioxidants in the Treatment of Multiple Sclerosis

Completed·NNational Center for Complementary and Integrative Health (NCCIH)·Phase 1/2·NCT00010842

Hemodialysis2 trials

Alpha Lipoic Acid in Pediatrics on Hemodialysis

Enrolling by invitation·—·Phase 3·NCT06286098·50 enrolled

Provision of Antioxidant Therapy in Hemodialysis (PATH) Study

Completed·VVanderbilt University·Phase 2·NCT00237718·385 enrolled

Beta-Thalassemia1 trial

Evaluating the Effect of N-Acetyl Cysteine and Alpha Lipoic Acid in Patients With Beta Thalassemia

Not yet recruiting·TTanta University·Phase 3·NCT07157722·66 enrolled

Chronic Obstructive Pulmonary Disease1 trial

Effect of Low-Dose Versus High-Dose Alpha-Lipoic Acid on Oxidative Stress, Inflammation, and Clinical Outcomes in Acute Exacerbations of Chronic Obstructive Pulmonary Disease

Not yet recruiting·—·Phase 3·NCT07456176·75 enrolled

Lip1 trial

Metabolic and Clinical Effect of Alpha-lipoic Acid Administration in Schizophrenic Subjects

Completed·UUniversity of Messina·N/A·NCT06787781·15 enrolled

Atrial Fibrillation1 trial

Effect of Alpha-Lipoic Acid Supplementation on the Incidence of Postoperative Atrial Fibrillation in Cardiac Surgery Patients

Unknown status·—·Phase 4·NCT06151652·350 enrolled

Poisoning1 trial

Alpha Lipoic Acid as an Adjuvant Treatment in Acute Phosphide Poisoning

Unknown status·HHeba Allah Ali Abd El-Halim Mabrouk·Phase 2·NCT02760823·50 enrolled

Obstructive Sleep Apnea1 trial

A Pilot Study of Antioxidant Therapy in Obstructive Sleep Apnea Patients

Unknown status·UUniversity of British Columbia·Phase 2/3·NCT05009901·80 enrolled

Migraine1 trial

Evaluation of Efficacy and Safety of add-on Alpha-lipoic Acid on Migraine Prophylaxis in Adolescent Population

Completed·—·Phase 4·NCT04064814·60 enrolled

Ischemic Cardiomyopathy1 trial

Alpha-lipoic Acid in Diabetic Patients With Ischemic Cardiomyopathy

Completed·—·N/A·NCT06056687·60 enrolled

Breast Cancer1 trial

Effect of Alpha Lipoic Acid on Chemotherapy Induced Neurological Changes in Breast Cancer Patients

Recruiting·—·Phase 4·NCT06406127·92 enrolled

Mitochondria1 trial

Vestibular Function Using Mitochondrial Antioxidant Therapy

Withdrawn·TThe University of Texas Health Science Center at San Antonio·Phase 1·NCT05945160

Diabetes1 trial

Role of Alpha-lipoic Acid in Diabetes Melitus Type 1

Unknown status·TTanta University·Phase 3·NCT05679037·52 enrolled

Oral Mucositis1 trial

The Effect of Alpha Lipoic Acid on the Incidence and Severity of Radiotherapy-Induced Oral Mucositis in Head and Neck Cancer Patients

Unknown status·—·Phase 2/3·NCT05023863·70 enrolled

Hearing Loss1 trial

Alpha-Lipoic Acid in Preventing Hearing Loss in Cancer Patients Undergoing Treatment With Cisplatin

Completed·UUS Department of Veterans Affairs·Phase 2/3·NCT00477607·39 enrolled

Oxidative Stress1 trial

Assessment of Antioxidant Therapy on Oxidative Stress Biomarkers in Type 2 Diabetic Patients With Neuropathy

Completed·KKhyber Medical University Peshawar·Phase 2·NCT06131918·100 enrolled

Chronic Kidney Disease1 trial

Tocopherols and Alpha Lipoic Acid Treatment Chronic Kidney Disease (TALAT)

Completed·VVanderbilt University·Phase 2·NCT00308971·62 enrolled

Geographic Atrophy1 trial

Alpha Lipoic Acid in Geographic Atrophy

Completed·UUniversity of Pennsylvania·Phase 1/2·NCT02613572·68 enrolled

Type 2 Diabetes1 trial

Effect of Long Term α-Lipoic Acid Treatment on Endothelial Function in Patients With Type 2 Diabetes

Completed·MMedical University of Vienna·Phase 2·NCT00490867·30 enrolled

Sepsis1 trial

Alpha-Lipoic Acid in Patients With Sepsis

Unknown status·—·Phase 2/3·NCT05808946·60 enrolled

Coronary Artery Disease1 trial

Alpha-lipoic Acid Reduces Left Ventricular Mass in Normotensive Type 2 Diabetic Patients With Coronary Artery Disease

Completed·WWuhan General Hospital of Guangzhou Military Command·Phase 4·NCT01877590·66 enrolled

NASH1 trial

Effects of Rosiglitazone and Alpha-lipoic Acid on the Patients With Pathologically Proved NASH

Terminated·SSeoul St. Mary's Hospital·Phase 4·NCT01406704·26 enrolled

Cesarean Section1 trial

Effect of Alpha Lipoic Acid on Uterine Scar Healing After Cesarean Section

Completed·—·Phase 2·NCT03257514·102 enrolled

Endothelial Dysfunction1 trial

Short-Term Alpha Lipoic Acid Therapy for Prevention of Contrast-induced Acute Kidney Injury and Endothelial Dysfunction in Type 2 Diabetes

Unknown status·XXiang Guang-da·Phase 4·NCT01978405·200 enrolled

Cardiovascular Disease1 trial

Cardiovascular Disease (CVD) Risk and Prevention in Early Glucose Intolerance

Completed·EEmory University·N/A·NCT00122447·84 enrolled

Cardiotoxicity1 trial

Prevention of Doxorubicin-induced Cardiotoxicity in Breast Cancer Patients

Completed·—·Phase 2·NCT06703593·80 enrolled

Schizophrenia1 trial

Alpha-lipoic Acid Adjunctive Therapy in Schizophrenia

Completed·NNucleo De Pesquisa E Desenvolvimento De Medicamentos Da Universidade Federal Do Ceara·Phase 2/3·NCT03788759·48 enrolled

Cardiomyopathy1 trial

Sympathetic Heart Innervation in Patients With Tako-Tsubo Cardiomyopathy

Completed·UUniversity of Campania Luigi Vanvitelli·Phase 4·NCT01524861·90 enrolled

Dialysis Patients1 trial

A Novel Role of Alpha Lipoic Acid in Comparison With Selenium in Mitochondrial Resuscitation and miRNA-126 Expression in Hemodialysis Patients

Completed·—·Phase 4·NCT05266794·68 enrolled

Stroke1 trial

Impact of Lipoic Acid Use on Stroke Outcome After Reperfusion Therapy in Patients With Diabetes (IMPORTANT)

Unknown status·—·Phase 3·NCT04041167·120 enrolled

Insulin Secretion1 trial

The Effect of A-lipoic Acid (ALA) on Fatty Acid-induced Impairment of Glucose-stimulated Insulin Secretion

Completed·UUniversity Health Network, Toronto·Phase 4·NCT01056497·15 enrolled

Side Effects1 trial

Alpha Lipoic Acid to Decrease Pain and Side Effects in Concurrent Treatment of HNSCC

Completed·UUniversity of Colorado, Denver·Phase 1·NCT04042935·5 enrolled

Women1 trial

Effects of Alpha-acid Lipoic in PCOS Women

Unknown status·—·N/A·NCT02666170·40 enrolled

Immune1 trial

Immune Restoration by Lipoic Acid in AIDS

Completed·NNational Center for Complementary and Integrative Health (NCCIH)·Phase 2·NCT00033176·33 enrolled

Carpal Tunnel Syndrome1 trial

Alpha Lipoic Acid on Clinical and Electrophysiological Recovery in Carpal Tunnel Syndrome Undergoing Surgical Release

Completed·HHospital Civil de Guadalajara·Phase 2·NCT02382328·40 enrolled

Insulin resistance1 trial

Phase II Trial of the Combination of Alpha-lipoic Acid and Mirabegron in Women and in Men With Obesity

Not yet recruiting·NNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)·Phase 2·NCT05713799·60 enrolled

Diabetic Peripheral Neuropathy1 trial

Efficacy and Safety of Low-Dose Duloxetine Plus Alpha-Lipoic Acid Versus Standard-Dose Duloxetine in Painful Diabetic Peripheral Neuropathy: An Assessor-Blinded Randomized Controlled Non-Inferiority Trial

Not yet recruiting·BBangladesh Medical University·Preclinical·NCT07785544·170 enrolled

Colorectal Cancer1 trial

Evaluation of the Protective Effect of Alpha-Lipoic Acid Against 5-Fluorouracil-Induced Oral Mucositis in Colorectal Cancer Patients

Recruiting·AAin Shams University·Preclinical·NCT07736495·50 enrolled

Sources

References

[1]
ClinicalTrials.gov — 50 trial records for Alpha Lipoic Acid. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Alpha Lipoic Acid compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Alpha Lipoic Acid. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — National Center for Complementary and Integrative Health (NCCIH) company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: NNational Center for Complementary and Integrative Health (NCCIH)

Alpha Lipoic Acid

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q3 2027

Q1 2030

Trials by Indication[1]

Diabetic Neuropathy2 trials

Neuropathy2 trials

Burning Mouth Syndrome2 trials

Polycystic Ovary Syndrome2 trials

Peripheral Neuropathy2 trials

Multiple Sclerosis2 trials

Hemodialysis2 trials

Beta-Thalassemia1 trial

Chronic Obstructive Pulmonary Disease1 trial

Lip1 trial

Atrial Fibrillation1 trial

Poisoning1 trial

Obstructive Sleep Apnea1 trial

Migraine1 trial

Ischemic Cardiomyopathy1 trial

Breast Cancer1 trial

Mitochondria1 trial

Diabetes1 trial

Oral Mucositis1 trial

Hearing Loss1 trial

Oxidative Stress1 trial

Chronic Kidney Disease1 trial

Geographic Atrophy1 trial

Type 2 Diabetes1 trial

Sepsis1 trial

Coronary Artery Disease1 trial

NASH1 trial

Cesarean Section1 trial

Endothelial Dysfunction1 trial

Cardiovascular Disease1 trial

Cardiotoxicity1 trial

Schizophrenia1 trial

Cardiomyopathy1 trial

Dialysis Patients1 trial

Stroke1 trial

Insulin Secretion1 trial

Side Effects1 trial

Women1 trial

Immune1 trial

Carpal Tunnel Syndrome1 trial

Insulin resistance1 trial

Diabetic Peripheral Neuropathy1 trial

Colorectal Cancer1 trial

References

Drug Info

Quick Facts

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