Methylthioninium chloride
(Methylene Blue)ApprovedSmall molecule
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 34 indications[4].[1]
Methylthioninium chloride is one of 692 small molecule programs targeting Abscess. It is currently in Approved.
34
Indications
63
Total Trials
9
Active Trials
691
Competitors
1
FDA Application
NDA/BLA/ANDA regulatory filings
Pipeline
Status by Indication[4][1]
Indication
Showing 10 of 33 indications
Competition
Competitive Landscape
2828 competitors in Breast Cancer
#DrugCompanyPhaseTrials
1Methylthioninium chloride
PProvepharm SAS
Approved
Tykerb
GSKPreclinical
Adriamycin
GGynecologic Oncology Group
Preclinical
Avastin
BBio-Thera Solutions
Preclinical
Voltaren
NovartisPreclinical
Nubain
AAultman Health Foundation
Preclinical
Tricor
JJagotec
Preclinical
Beta Blocker
WWeill Medical College of Cornell University
Preclinical
Diuretic
RReprieve Cardiovascular, Inc
Preclinical
Citalopram Hydrobromide
TTorrent Pharmaceuticals Limited
Preclinical
Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.
Timeline
Expected Milestones
Clinical
Trials by Indication[1]
Septic Shock10 trials
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
Show 7 more trials
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 Versus Vasopressin Analogue for Treatment of Septic Shock in Preterm Neonate
Unknown status·—·Phase 2·NCT04110418·36 enrolled
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
Abscess3 trials
Breast Cancer3 trials
COVID-193 trials
Sepsis2 trials
Methylene Blue and Ozone in Early Sepsis
Unknown status·—·Phase 4·NCT02910765·40 enrolled
38 more indications
Hemoglobin2 trials
Acquired Methemoglobinemia Observational Registry
Completed·—··NCT03542760·24 enrolled
Intravenous1 trial
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
Cardiac Surgery1 trial
Hemodynamic Effects of Methylene Blue vs Hydroxocobalamin in Patients at Risk of Vasoplegia During Cardiac Surgery
Withdrawn·—·Phase 2·NCT03446599
Cardiopulmonary Bypass1 trial
Surgery1 trial
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
Inflammation1 trial
Acute Respiratory Distress Syndrome1 trial
Obstructive Jaundice1 trial
Effect of Methylene Blue on Perioperative Organ Function in Patients With Obstructive Jaundice
Unknown status·—·Phase 1·NCT04109859·64 enrolled
Chronic Hepatitis B Virus Infection1 trial
Diabetic Foot1 trial
Indocyanine Green1 trial
Use of Indocyanine Green Cholangiography and Methylene Blue to Detect Postoperative Biliary Fistula After Hepatectomy
Completed·—·Phase 3·NCT01847612·150 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
Liver Transplant1 trial
Delirium1 trial
Cervical Cancer1 trial
Resistance1 trial
Lymphedema1 trial
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
Unspecified3 trials
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]
- [2]MedlinePlus Drug Information — Methylthioninium chloride drug information. U.S. National Library of Medicine, National Institutes of Health.
- [3]
- [4]Open Targets Platform — Drug–disease associations for Methylene Blue. EMBL-EBI & Wellcome Sanger Institute.
- [5]
- [6]
Details
Drug Info
Quick Facts
- Modality
- Small molecule[3]
- Highest Phase
- Approved[1]
- Company
- PProvepharm SAS