Methylene blue

Generic Name: Methylene blue

Brand Names: Hyophen, Phosphasal, Provayblue, Proveblue, Urelle, Uribel, Urimar Reformulated Oct 2013, Urin DS, Urogesic Blue Reformulated Apr 2012, Ustell, Utira, Lumeblue (previously known as Methylthioninium chloride Cosmo), Methylthioninium chloride Proveblue

Drug Type: Small Molecule

Chemical Formula: C_₁₆H_₁₈ClN_₃S

CAS Number: 61-73-4

Unique Ingredient Identifier: 8NAP7826UB

Background: Methylene blue is an oxidation-reduction agent. The intravenous form of methylene blue is approved by the FDA for the treatment of pediatric and adult patients with acquired methemoglobinemia. Historically, it has been widely used in Africa to treat malaria, but now it disappeared when chloroquine (CQ) and other drugs entered the market. Its use as an urinary tract antiseptic has also been investigated.

Methylthioninium chloride (INN, or methylene blue, proposed trade name Rember) is an investigational drug being developed by the University of Aberdeen and TauRx Therapeutics that has been shown in early clinical trials to be an inhibitor of Tau protein aggregation. The drug is of potential interest for the treatment of patients with Alzheimer's disease.

Indication: Indicated for the treatment of pediatric and adult patients with acquired methemoglobinemia.

Other clinical applications of methylene blue include improvement of hypotension associated with various clinical states, an antiseptic in urinary tract infections, treatment of hypoxia and hyperdynamic circulation in cirrhosis of liver and severe hepatopulmonary syndrome, and treatment of ifofosamide induced neurotoxicity.

Associated Conditions: Cystitis, Methemoglobinemia, Nephritis, Urethritis, Urinary tract inflammation

Associated Therapies: Diuresis

Clinical Trials

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

Phase 3

Conditions: Mixed Hemorrhoids

Interventions: Drug: Methylene Blue

First Posted Date: 2024-10-28

Last Posted Date: 2024-10-28

Lead Sponsor: The Second Affiliated Hospital of Anhui University of Traditional Chinese Medicine

Target Recruit Count: 60

Registration Number: NCT06660680

Locations: 🇨🇳
Second hospital affiliated Anhui University of Chinese Medicine, Hefei, Anhui, China

Methylene Blue for the Treatment of Septic Shock

Phase 3

Recruiting

Conditions: Septic Shock

Interventions: Drug: Methylene Blue
Drug: Placebo

First Posted Date: 2024-08-01

Last Posted Date: 2024-08-09

Lead Sponsor: Northern Jiangsu People's Hospital

Target Recruit Count: 76

Registration Number: NCT06532240

Locations: 🇨🇳
Northern Jiangsu people's hospital, Yangzhou, Jiangsu, China

Intravenous Methylene Blue for Treating Refractory Neonatal Septic Shock

Phase 2

Not yet recruiting

Conditions: Neonatal Sepsis
Shock, Septic

Interventions: Other: Placebo
Drug: Methylene Blue

First Posted Date: 2024-03-12

Last Posted Date: 2024-03-12

Lead Sponsor: Post Graduate Institute of Medical Education and Research, Chandigarh

Target Recruit Count: 130

Registration Number: NCT06306001

Locations: 🇮🇳
Post Graduate Institute of Medical Education and Research (PGIMER), Chandigarh, India

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

Phase 2

Not yet recruiting

Conditions: Abscess

Interventions: Drug: Methylene Blue
Drug: Lipid Emulsion
Device: Insertion of optical fiber
Device: Laser Illumination (pre-defined dose)
Device: Optical Spectroscopy Measurement
Procedure: Standard of care abscess drainage
Device: Laser Illumination (patient-specific dose)

First Posted Date: 2023-09-25

Last Posted Date: 2024-05-16

Lead Sponsor: University of Rochester

Target Recruit Count: 90

Registration Number: NCT06052956

Locations: 🇺🇸
Highland Hospital, Rochester, New York, United States
🇺🇸
University of Rochester Medical Center, Rochester, New York, United States

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

Completed

Conditions: Breast Cancer

First Posted Date: 2023-09-06

Last Posted Date: 2024-05-10

Lead Sponsor: BTG International Inc.

Target Recruit Count: 101

Registration Number: NCT06024213

Locations: 🇫🇷
Hôpital Européen Georges-Pompidou Paris, Paris, Île-de-France, France
🇫🇷
Institut de Cancérologie de Lorraine, Vandœuvre-lès-Nancy, Meurthe-et-Moselle, France
🇫🇷
CHU de Saint-Etienne, Saint-Etienne, Loire, France

and more 3 locations

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

Early Phase 1

Recruiting

Conditions: Diabetic Foot Ulcers
Diabetic Wound

Interventions: Other: Milk and Platelet-Rich Plasma-Fibrin Glue (control)
Drug: Methylene Blue and Platelet-Rich Plasma-Fibrin Glue
Other: Milk (control)
Drug: Methylene Blue