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Methylthioninium chloride

(Methylene Blue)

ApprovedSmall molecule

PProvepharm SAS

Methylene blue is used to treat a condition called methemoglobinemia, where the blood loses its ability to carry oxygen properly. It's also sometimes used as a dye during surgery to help doctors identify certain tissues, and has been studied for memory and cognitive issues.[2] Methylthioninium chloride is currently approved and in use across 27 indications[4].[1]

Methylthioninium chloride is one of 483 small molecule programs targeting Respiratory Aspiration. It is currently in Approved.

27

Indications

63

Total Trials

9

Active Trials

482

Competitors

1

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Respiratory AspirationActive, not recruiting

Drug-Induced MethemoglobinemiaActive, not recruiting

Periodontal DisorderActive, not recruiting

Neuropathic PainActive, not recruiting

Post-Operative DeliriumActive, not recruiting

Breast CancerActive, not recruiting

Urinary Tract InfectionActive, not recruiting

HyperparathyroidismActive, not recruiting

DysuriaApproved

Tooth DiseaseApproved

Respiratory AspirationPreclinical

Active, not recruiting

Drug-Induced MethemoglobinemiaApproved

Active, not recruiting

Periodontal DisorderPreclinical

Active, not recruiting

Neuropathic PainPreclinical

Active, not recruiting

Post-Operative DeliriumPreclinical

Active, not recruiting

Breast CancerPreclinical

Active, not recruiting

Urinary Tract InfectionApproved

Active, not recruiting

HyperparathyroidismPreclinical

Active, not recruiting

DysuriaApproved

Approved

Tooth DiseaseApproved

Approved

Showing 10 of 26 indications

Competition

Competitive Landscape

744 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Methylthioninium chloride

PProvepharm SAS

Adenocard

Lexiscan

Voltaren

Zolymbus

Blenoxane

Bristol-Myers Squibb

MS Contin

HHikma Pharmaceuticals LLC

Duragesic-100

MS Contin

HHikma Pharmaceuticals LLC

Spravato

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

Timeline

Expected Milestones

Q4 2026

Phase 2/3Recruiting

Septic Shock

NCT07264543

Q1 2027

Phase 2/3Not yet recruiting

Septic Shock

NCT06306001

Q2 2027

Phase 2Recruiting

Chronic HBV Infection

NCT06887036

Phase 1Active, not recruiting

HNSCC

NCT07435415

Q2 2030

Phase 1Recruiting

Immunotherapy

NCT07169487

Clinical

Trials by Indication[1]

Septic Shock10 trials

Early Methylene Blue in the Microhemodynamics of Septic Shock Patients

Recruiting·CCentro de Estudos e Pesquisa em Emergencias Medicas e Terapia Intensiva·Phase 2/3·NCT07264543·50 enrolled

Methylene Blue as a Third-line Vasopressor in Septic Shock

Unknown status·CCarilion Clinic·Phase 2·NCT04089072·250 enrolled

Methylene Blue Versus Vasopressin Analogue for Treatment of Septic Shock in Preterm Neonate

Unknown status·—·Phase 2·NCT04110418·36 enrolled

Show 7 more trials

What Should be the Next Vasopressor for Severe Septic Shock? Methylene Blue or Terlipressin

Unknown status·RRamathibodi Hospital·Phase 3·NCT03038503·60 enrolled

The Effect of Early Use of Methylene Blue on Hemodynamics in Septic Shock

Unknown status·XXiangya Hospital of Central South University·N/A·NCT04970602·106 enrolled

Methylene Blue and Microcirculation in Septic Shock

Unknown status·—·Phase 3·NCT04295993·32 enrolled

Adjunctive Methylene Blue in Septic Shock

Completed·—·Phase 3·NCT06900140·50 enrolled

Methylene Blue in Early Septic Shock

Completed·HHospital Civil de Guadalajara·Phase 2/3·NCT04446871·91 enrolled

Methylene Blue for the Treatment of Septic Shock

Completed·NNorthern Jiangsu People's Hospital·Phase 3·NCT06532240·88 enrolled

Intravenous Methylene Blue for Treating Refractory Neonatal Septic Shock

Not yet recruiting·PPost Graduate Institute of Medical Education and Research, Chandigarh·Phase 2/3·NCT06306001·130 enrolled

COVID-193 trials

Outpatient Treatment With CoVid-19 With Prexablu

Unknown status·HHospital Reg. Lic. Adolfo Lopez Mateos·Phase 1·NCT04619290·46 enrolled

Methylene Blue Treatment of COVID-19

Completed·FFondazione Epatocentro Ticino·Phase 2·NCT04635605·29 enrolled

COVID-19 Methylene Blue Antiviral Treatment

Completed·IIrkutsk Scientific Center of the Siberian Branch of the Russian Academy of Sciences·Phase 2·NCT05004805·24 enrolled

Breast Cancer3 trials

Sentinel Lymph Node Biopsy in Breast Cancer Surgery Using ICG

Completed·CChinese Academy of Sciences·N/A·NCT03579979·130 enrolled

A French Observational Study of Indocyanine Green for Patients With Breast Cancer Having a Sentinel Lymph Node Biopsy.

Completed·BBTG International Inc.··NCT06024213·101 enrolled

Application of Surgical Navigation System in Sentinel Lymph Node of Breast Cancer Research

Completed·CChinese Academy of Sciences·N/A·NCT02084784·98 enrolled

Abscess3 trials

Efficacy of Methylene Blue Photodynamic Therapy for Treatment of Deep Tissue Abscesses

Not yet recruiting·UUniversity of Rochester·Phase 2·NCT06052956·120 enrolled

Safety and Feasibility Study of Methylene Blue Photodynamic Therapy to Sterilize Deep Tissue Abscess Cavities

Completed·UUniversity of Rochester·Phase 1·NCT02240498·21 enrolled

A Phase 2 Study of Methylene Blue Photodynamic Therapy for Treatment of Breast Abscesses

Not yet recruiting·UUniversity of Rochester·Phase 2·NCT07179003·50 enrolled

Malaria2 trials

Safety and Efficacy of Methylene Blue Combined With Artesunate or Amodiaquine for Malaria Treatment in Children of Burkina Faso: a Pilot Study

Completed·HHeidelberg University·Phase 2·NCT00354380

Methylene Blue Against Falciparum Malaria in Burkina Faso

Completed·HHeidelberg University·Phase 2·NCT02851108·100 enrolled

38 more indications

Sepsis2 trials

Methylene Blue in Sepsis: A Randomized Controlled Trial

Withdrawn·QQueen's University·N/A·NCT00486174

Methylene Blue and Ozone in Early Sepsis

Unknown status·—·Phase 4·NCT02910765·40 enrolled

Hemoglobin2 trials

Acquired Methemoglobinemia Observational Registry

Completed·—··NCT03542760·24 enrolled

MEthylene Blue In Patients With Acquired Methemoglobinemia

Completed·PProvepharm SAS·Phase 4·NCT03395223·7 enrolled

Oral Mucositis1 trial

MOM's PAIN (Methylene Blue for Oral Mucositis' PAIN)

Completed·MM.D. Anderson Cancer Center·Phase 2·NCT03469284·69 enrolled

Acute Respiratory Distress Syndrome1 trial

Studies of Acute Lung Injury (ALI) and Acute Respiratory Distress Syndrome

Terminated·NNorthern State Medical University·Phase 1·NCT00159510·28 enrolled

Imaging1 trial

Fluorescent Imaging & Methylene Blue: Ureter Study

Completed·UUniversity of Oxford·Phase 2·NCT03177070·50 enrolled

Neuropathic Pain1 trial

Methylene Blue Intravenously and Chronic Neuropathic Pain

Completed·UUppsala University·N/A·NCT02303886·10 enrolled

Cardiopulmonary Bypass1 trial

Methylene Blue-Enhanced Ultrafiltration Improves Outcomes After Cardiopulmonary Bypass

Completed·UUniversity of Sao Paulo·Phase 2·NCT07212842·124 enrolled

Surgery1 trial

The Influence of Endotracheal Tube Design on Fluid Leakage Into the Lungs During Surgery

Completed·MMedtronic - MITG·N/A·NCT01539135·80 enrolled

Interaction1 trial

Interaction Between Anaesthetics and Methylene Blue

Completed·UUniversity Hospital, Geneva··NCT00513032·22 enrolled

Immunotherapy1 trial

Adjunctive Methylene Blue for Immunotherapy-related CRS and ICANS: Phase I Study

Recruiting·IInstitute of Hematology & Blood Diseases Hospital, China·Phase 1·NCT07169487·18 enrolled

AIN1 trial

Effects of USP Methylene Blue on Cognitive and fMRI Brain Activity

Completed·TThe University of Texas Health Science Center at San Antonio·Phase 1·NCT01836094·36 enrolled

HNSCC1 trial

Local Injection Methylene Blue Combined With Radiation in HNSCC Patients

Active, not recruiting·—·Phase 1·NCT07435415·10 enrolled

Fluorescence1 trial

FLuorescence Cholangiography Using Methylene Blue

Unknown status·UUniversity of Oxford·N/A·NCT03386201·40 enrolled

Cervical Cancer1 trial

Lymph Node Mapping and Sentinel Lymph Node Identification in Patients With Stage IB1 Cervical Cancer

Terminated·GGynecologic Oncology Group·N/A·NCT00070317·102 enrolled

Periodontal Disease1 trial

Dose Parameters for Photodynamic Therapy on Periodontal Disease

Completed·UUniversity of Nove de Julho·N/A·NCT03262077·30 enrolled

General Anesthesia1 trial

Evaluation of Above the Cuff Suctioning During General Anesthesia

Terminated·TThomas Jefferson University·Phase 4·NCT01386879·50 enrolled

Local1 trial

3D Printing for Nodule Localization

Completed·WWen-zhao ZHONG·N/A·NCT04056923·47 enrolled

Liver Transplant1 trial

Methylene Blue vs Cyanokit for Intraoperative Vasoplegic Syndrome in Liver Transplant Patients

Completed·MMayo Clinic·Phase 4·NCT04054999·19 enrolled

Randomized1 trial

The Effect of Methylene Blue Infiltrating Injection on Anal Pain After Milligan-Morgan Surgery: a Randomized Controlled Clinical Study

Enrolling by invitation·TThe Second Affiliated Hospital of Anhui University of Traditional Chinese Medicine·Phase 3·NCT06660680·60 enrolled

Cognitive Disorder1 trial

Methylene Blue and Postoperative Neurocognitive Disorders

Completed·FFudan University·N/A·NCT04529265·314 enrolled

Delirium1 trial

Intraoperative Infusion of Methylene Blue for Prevention of Postoperative Delirium and Cognitive Dysfunction in Elderly Patients Undergoing Major Elective Noncardiac Surgery

Completed·FFudan University·N/A·NCT04341844·248 enrolled

Inflammation1 trial

Clinical and Microbiologic Outcomes of aPDT in the Non-surgical Treatment of Implant Inflammation

Completed·TThe University of Texas Health Science Center, Houston·Phase 4·NCT04187053·56 enrolled

Laparoscopic1 trial

Laparoscopic Tubal Patency Assessment

Completed·PPourmatroud, Elham, M.D.·N/A·NCT01725477·30 enrolled

Efficacy1 trial

Phase 2 Efficacy Study of Primaquine and Methylene Blue

Completed·UUniversity of California, San Francisco·Phase 2·NCT02831023·80 enrolled

Obstructive Jaundice1 trial

Effect of Methylene Blue on Perioperative Organ Function in Patients With Obstructive Jaundice

Unknown status·—·Phase 1·NCT04109859·64 enrolled

Bipolar Disorder1 trial

Methylene Blue for Cognitive Dysfunction in Bipolar Disorder

Completed·NNova Scotia Health Authority·Phase 3·NCT00214877·40 enrolled

Cardiac Surgery1 trial

Hemodynamic Effects of Methylene Blue vs Hydroxocobalamin in Patients at Risk of Vasoplegia During Cardiac Surgery

Withdrawn·—·Phase 2·NCT03446599

MPA1 trial

Comparing the Antibacterial Effect of 810 nm Diode Laser and Photodynamic Therapy

Unknown status·SShahid Beheshti University·Phase 2·NCT02555488·20 enrolled

Diabetic Foot1 trial

The Effect of Combination Therapy of Oral MB and PRP-FG in Patients With Non-healing Diabetic Foot Ulcer

Unknown status·MMashhad University of Medical Sciences·Phase 1·NCT05850611·20 enrolled

Indocyanine Green1 trial

Use of Indocyanine Green Cholangiography and Methylene Blue to Detect Postoperative Biliary Fistula After Hepatectomy

Completed·—·Phase 3·NCT01847612·150 enrolled

Hypotension1 trial

Methylene Blue for the Prevention of Hypotension During Hemodialysis

Recruiting·FFederal University of São Paulo·Phase 2·NCT05092165·260 enrolled

Resistance1 trial

Pre-treatment With Methylene Blue Prevent Peri-operative Reduced Systemic Vascular Resistance

Unknown status·SSouthwest Hospital, China·N/A·NCT03406676·70 enrolled

Lymphedema1 trial

Sentinel and/or Axillary Lymph Node Biopsy With or Without Axillary Reverse Mapping in Reducing Incidence and Severity of Arm Lymphedema in Stage 0-2 Patients.

Terminated·UUniversity of Southern California·Phase 2·NCT01276054·4 enrolled

Refractory1 trial

Evaluating in Cirrhotics With Refractory Vasoplegia the Effect of Methylene Blue

Completed·IInstitute of Liver and Biliary Sciences, India·Phase 4·NCT03120637·111 enrolled

Intravenous1 trial

Safety, Tolerability, and Pharmacokinetic Study of Methylene Blue Following a 1 mg/kg Intravenous Dose in Healthy Adults

Completed·AAmerican Regent, Inc.·Phase 1·NCT02478281·12 enrolled

Cognitive impairment1 trial

Effects of Methylene Blue in Healthy Aging, Mild Cognitive Impairment and Alzheimer's Disease

Completed·TThe University of Texas Health Science Center at San Antonio·Phase 2·NCT02380573·117 enrolled

Chronic HBV Infection1 trial

Methylene Blue Treatment of Chronic Hepatitis B Virus Infection: a Pilot Study

Recruiting·FFondazione Epatocentro Ticino·Phase 2·NCT06887036·10 enrolled

Unspecified3 trials

Identification of Sentinel Lymph Nodes With Methylene Blue and Isotope

Completed·UUniversity Hospital, Strasbourg, France·N/A·NCT00314405·100 enrolled

Infrared Lymphangiography as a Method of Sentinel Node Identification

Completed·MMilton S. Hershey Medical Center·N/A·NCT02057393·89 enrolled

Feasibility of One-Step Sentinel Lymph Node (SLN) Biopsy With Radiolabeled Methylene Blue (IND 70,627)

Completed·LLouisiana State University Health Sciences Center in New Orleans·Phase 2·NCT00784849·62 enrolled

Regulatory

FDA Approval Timeline[5]

Jul 18, 2019

PROVAYBLUE

NDA NDA204630

Sources

References

[1]
ClinicalTrials.gov — 63 trial records for Methylene Blue. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Methylthioninium chloride drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Methylene Blue compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Methylene Blue. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA204630). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Provepharm SAS company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: PProvepharm SAS

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