L-Arginine

ApprovedSmall molecule

Mario Negri Institute for Pharmacological Research

L-Arginine is one of 522 small molecule programs targeting Essential Hypertension. It is currently in Approved.

Indications

Total Trials

Active Trials

521

Competitors

Pipeline

Status by Indication[3][1]

Indication

Essential HypertensionActive, not recruiting

Erectile DysfunctionActive, not recruiting

OligohydramniosActive, not recruiting

Type 2 Diabetes MellitusActive, not recruiting

Pulmonary HypertensionActive, not recruiting

Myocardial InfarctionActive, not recruiting

Pulmonary TuberculosisActive, not recruiting

AnemiaActive, not recruiting

Peripheral Arterial DiseaseActive, not recruiting

HypertensionActive, not recruiting

Essential HypertensionPhase 2/Phase 3

Active, not recruiting

Erectile DysfunctionApproved

Active, not recruiting

OligohydramniosPhase 2

Active, not recruiting

Type 2 Diabetes MellitusPhase 3

Active, not recruiting

Pulmonary HypertensionApproved

Active, not recruiting

Myocardial InfarctionPreclinical

Active, not recruiting

Pulmonary TuberculosisPhase 3

Active, not recruiting

AnemiaPhase 1

Active, not recruiting

Peripheral Arterial DiseasePreclinical

Active, not recruiting

HypertensionPhase 3

Active, not recruiting

Showing 10 of 19 indications

Competition

Competitive Landscape

1399 competitors in Prostate Cancer

#DrugCompanyPhaseTrials

L-Arginine

Mario Negri Institute for Pharmacological Research

Approved

1 2

Trexall

Alnylam Pharmaceuticals

Duragesic

1 4

Ranexa

MMenarini International Operations Luxembourg SA

Preclinical

1 5

Prednisone/prednisolone

Roche

Preclinical

3 6

Triptorelin Pamoate

Ipsen

Preclinical

2 7

Ifex

BBaxter Healthcare Corporation

Preclinical

—8

Xylocaine

CCitius Pharmaceuticals, Inc.

Preclinical

—9

Precedex

MMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Xylocaine

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

Timeline

Expected Milestones

Q4 2026

Post-ApprovalRecruiting

CKD

NCT03982160

Q3 2027

Phase 2Not yet recruiting

Heart Failure

NCT07394270

Q4 2027

Phase 1Recruiting

Intermittent Claudication

NCT04800692

Clinical

Trials by Indication[1]

Sickle Cell Disease3 trials

Arginine Therapy for Sickle Cell Disease Pain

Completed·EEmory University·Phase 2·NCT02536170·108 enrolled

L-Arginine and Sickle Cell Disease

Completed·HHospital de Clinicas de Porto Alegre·Phase 3·NCT01142219·40 enrolled

L-Arginine in Children Having Sickle Cell Disease With Increased Tricuspid Regurgitant Jet Velocity

Completed·TTanta University·Phase 3·NCT05470998·50 enrolled

Hypertension3 trials

HaemoDYNAMICs in Primary and Secondary Hypertension

Unknown status·TTampere University··NCT01742702·2,000 enrolled

L-arginine Effects on Chronic Hypertension in Pregnancy

Completed·UUniversity of Modena and Reggio Emilia·Phase 3·NCT00974714·80 enrolled

Effects of Oral L-Arginine on Chronic Hypertension in Pregnancy

Completed·UUniversity of Modena and Reggio Emilia·Phase 3·NCT00571766·80 enrolled

Erectile Dysfunction2 trials

Safety And Efficacy Of L-Arginine Monotherapy Versus Tadalafil Monotherapy Versus Their Combination In Men With Erectile Dysfunction; A Prospective Randomized Study

Completed·FFayoum University Hospital·Phase 4·NCT06947265·180 enrolled

L-Arginine and Erectile Dysfunction

Completed·HHannover Medical School·Phase 4·NCT00777075·57 enrolled

Schizophrenia2 trials

L-arginine in Treatment as Usual in Schizophrenia

Completed·UUniversity of Alberta·N/A·NCT00718510·13 enrolled

L-arginine Study for Persistent Symptoms of Schizophrenia

Withdrawn·UUniversity of Massachusetts, Worcester·Phase 2·NCT04054973

Asthma2 trials

Effects of L-arginine Supplementation in Adults With Moderate to Severe Asthma

Completed·UUniversity of California, Davis·Phase 2·NCT00280683·20 enrolled

L-arginine in Severe Asthma Patients Grouped by Exhaled Nitric Oxide Levels

Completed·NNicholas Kenyon·Phase 2·NCT01841281·54 enrolled

36 more indications

Vasoconstriction1 trial

The Effect of Endothelin and L-Arginine on Racial Differences in Vasoconstriction

Completed·TThe University of Texas at Arlington·Phase 1·NCT03679780·19 enrolled

Peripheral Arterial Disease1 trial

L-Arginine in the Treatment of Peripheral Arterial Disease

Completed·SStanford University·N/A·NCT00284076

Preeclampsia1 trial

L-Arginine in Pre-Eclampsia

Completed· Mario Negri Institute for Pharmacological Research logo

Mario Negri Institute for Pharmacological Research·Phase 3·NCT00157521·30 enrolled

Prevention1 trial

Prevention of Cardiac and Vascular Events in Patients With NGT/IGT.

Completed·IIRCCS San Raffaele·Phase 3·NCT00408577·150 enrolled

Alzheimer's Disease1 trial

Endothelial Facilitation in Alzheimer's Disease

Completed·UUniversity of Massachusetts, Worcester·Phase 2·NCT01439555·11 enrolled

Postmenopausal Women1 trial

Vascular and Metabolic Effects of Hormone Therapy Combined With L-Arginine in Postmenopausal Women

Completed·NNational Heart, Lung, and Blood Institute (NHLBI)·Phase 2·NCT00001752·30 enrolled

Nitric Oxide1 trial

Role of Nitric Oxide in the Impact of Aging on Myocardial Remodeling

Completed·WWashington University School of Medicine·N/A·NCT00603720·54 enrolled

Pulmonary Tuberculosis1 trial

L-arginine and Vitamin D Adjunctive Therapy in Pulmonary Tuberculosis (TB)

Completed·MMenzies School of Health Research·Phase 3·NCT00677339·200 enrolled

Duchenne Muscular Dystrophy1 trial

Improved Muscle Function in Duchenne Muscular Dystrophy Through L-Arginine and Metformin

Completed·UUniversity Hospital, Basel, Switzerland·Phase 1·NCT02516085·5 enrolled

Endothelial Function1 trial

Endothelial Function in Human Arteries

Completed·TThe Cleveland Clinic·Phase 1·NCT00848302·25 enrolled

Diabetic Foot1 trial

Immunonutrition for Diabetic Foot Ulcers

Terminated·PPrisma Health-Midlands·Phase 2/3·NCT05281562·1 enrolled

Oligohydramnios1 trial

Comparison Between Treatments of Oligohydramnios

Recruiting·KKafrelsheikh University·Phase 2·NCT07135037·40 enrolled

Smokers1 trial

The Effect of Orally Administered L- Arginine on Quadriceps Strenght in Healthy Smokers

Unknown status·GGoranka Radmilović·Phase 4·NCT04643600·163 enrolled

Humans1 trial

Protective Effects of L-arginine During Reperfusion by Femoropopliteal Bypass for Lower Limb Ischemic Syndrome in Humans

Completed·UUniversity Hospital, Strasbourg, France·Phase 4·NCT02117206·60 enrolled

Heart Failure1 trial

Effect of Add-on L-Arginine Therapy on Heart Failure Patients

Not yet recruiting·GGerman University in Cairo·Phase 2·NCT07394270·200 enrolled

Randomized1 trial

L-Arginine Role for Stone Lower Ureter : A Randomized Control Study

Completed·SSohag University·Phase 4·NCT06753526·153 enrolled

Prostate Cancer1 trial

L-Arginine Supplementation With or Without Enzyme Inhibitors Treating Erectile Function of Prostate Cancer Survivors

Completed·WWake Forest University Health Sciences·Phase 2·NCT01105130·140 enrolled

Essential Hypertension1 trial

L-Arginine Metabolism in Essential Hypertension

Completed·UUniversity of Erlangen-Nürnberg Medical School·Phase 2/3·NCT00137124·120 enrolled

Anemia1 trial

Evaluation of Hydroxyurea Plus L-arginine or Sildenafil to Treat Sickle Cell Anemia

Completed·NNational Institutes of Health Clinical Center (CC)·Phase 1·NCT00056433·39 enrolled

Oral1 trial

Maximal Use Study to Determine the Pharmacokinetics of L-arginine After Exaggerated Oral Use of COL101

Completed·CColgate Palmolive·Phase 1·NCT06182267·29 enrolled

Rheumatoid Arthritis1 trial

Role of L-Arginine Supplementation in the Treatment of Rheumatoid Arthritis

Unknown status·RRenJi Hospital·Phase 2·NCT04535427·144 enrolled

Pulmonary Hypertension1 trial

L-arginine Versus Sildenafil in Children With Beta Thalassemia Associated With Pulmonary Hypertension

Unknown status·SSherief Abd-Elsalam·Phase 4·NCT03402191·60 enrolled

Vasodilation1 trial

L-arginine Therapy on Endothelium-dependent Vasodilation & Mitochondrial Metabolism in MELAS Syndrome

Completed·TThe Hospital for Sick Children·Phase 2·NCT01603446·7 enrolled

Type 2 Diabetes Mellitus1 trial

Prevention of Type 2 Diabetes Mellitus by L-Arginine in Patients With Metabolic Syndrome

Completed·IIRCCS San Raffaele·Phase 3·NCT00917449·142 enrolled

High Risk1 trial

Efficacy of Aspirin and L-arginine in High Risk Preeclamptic

Suspended·UUniversity of Guadalajara·Phase 2·NCT02838030·82 enrolled

Intermittent Claudication1 trial

The Effects of ATLAS Therapy on Nitric Oxide Bioavailability in Patients With Intermittent Claudication

Recruiting·LLouis Messina·Phase 1·NCT04800692·10 enrolled

Pre-Term1 trial

Effect of L-arginine and Glutamine on Preterm

Completed·—·Phase 2/3·NCT01263041·75 enrolled

Prospective1 trial

Prospective L-arginine Study

Terminated·UUniversity of Michigan·Phase 1·NCT01485757·3 enrolled

Polycystic Ovarian Syndrome1 trial

Myoinositol, L-arginine and Chromium With Letrozole for Ovulation Induction in Polycystic Ovarian Syndrome Patients

Not yet recruiting·—·Phase 3·NCT06405243·100 enrolled

CKD1 trial

L-arginine to Reduce Sympathetic Nerve Activity in CKD Patients

Recruiting·TThe University of Texas at Arlington·Phase 4·NCT03982160·15 enrolled

Corticosteroids1 trial

Safety, Tolerability and Effects of L-Arginine in Boys With Dystrophinopathy on Corticosteroids

Completed·MMassachusetts General Hospital·Phase 1·NCT01388764·7 enrolled

Critically Ill Patients1 trial

Directed Immuno Nutrition by L-arginine for Critically Ill Patients

Completed·AAssistance Publique - Hôpitaux de Paris·Phase 4·NCT01038622·30 enrolled

Cystic Fibrosis1 trial

The Short Term Safety and Efficacy of Inhaled L-arginine in Patients With Cystic Fibrosis

Completed·TThe Hospital for Sick Children·Phase 2·NCT00405665·20 enrolled

Myocardial Infarction1 trial

Vascular Interaction With Age in Myocardial Infarction

Completed·NNational Heart, Lung, and Blood Institute (NHLBI)·N/A·NCT00051376

ISS1 trial

L-arginine and Brown Adipose Tissue

Unknown status·MMaastricht University Medical Center·Phase 3·NCT02291458·26 enrolled

Unspecified1 trial

Effect of the Administration of L-arginine vs. Placebo in Patients Diagnosed With Presbyvestibulopathy.

Withdrawn·CCentro Universitario de Tonalá·Phase 2·NCT05932979

Sources

References

[1]
ClinicalTrials.gov — 48 trial records for L-Arginine. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — L-Arginine compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for L-Arginine. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Mario Negri Institute for Pharmacological Research company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: Mario Negri Institute for Pharmacological Research

L-Arginine

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q3 2027

Q4 2027

Trials by Indication[1]

Sickle Cell Disease3 trials

Hypertension3 trials

Erectile Dysfunction2 trials

Schizophrenia2 trials

Asthma2 trials

Vasoconstriction1 trial

Peripheral Arterial Disease1 trial

Preeclampsia1 trial

Prevention1 trial

Alzheimer's Disease1 trial

Postmenopausal Women1 trial

Nitric Oxide1 trial

Pulmonary Tuberculosis1 trial

Duchenne Muscular Dystrophy1 trial

Endothelial Function1 trial

Diabetic Foot1 trial

Oligohydramnios1 trial

Smokers1 trial

Humans1 trial

Heart Failure1 trial

Randomized1 trial

Prostate Cancer1 trial

Essential Hypertension1 trial

Anemia1 trial

Oral1 trial

Rheumatoid Arthritis1 trial

Pulmonary Hypertension1 trial

Vasodilation1 trial

Type 2 Diabetes Mellitus1 trial

High Risk1 trial

Intermittent Claudication1 trial

Pre-Term1 trial

Prospective1 trial

Polycystic Ovarian Syndrome1 trial

CKD1 trial

Corticosteroids1 trial

Critically Ill Patients1 trial

Cystic Fibrosis1 trial

Myocardial Infarction1 trial

ISS1 trial

Unspecified1 trial

References

Drug Info

Quick Facts

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