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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, Lumeblue (previously Methylthioninium chloride Cosmo)
Drug Type
Small Molecule
Chemical Formula
C16H18ClN3S
CAS Number
61-73-4
Unique Ingredient Identifier
8NAP7826UB

Overview

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.

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

Clinical Trials

Phase 3
Not yet recruiting
Posted: 2025/03/28
Sponsor:
Dr. Shannon M. Ferna...
Phase 2
Not yet recruiting
Posted: 2025/03/25
Sponsor:
Andreas Cerny
Phase 3
Recruiting
Posted: 2024/08/01
Sponsor:
Northern Jiangsu Peo...
Phase 2
Not yet recruiting
Posted: 2024/03/12
Sponsor:
Post Graduate Instit...

FDA Approved Products

Methylene blue
Manufacturer:Zydus Pharmaceuticals USA Inc.
Route:INTRAVENOUS
Strength:5 mg in 1 mL
Approved: 2024/03/23
NDC:70710-1838
Me NaPhos MB Hyo 1
Manufacturer:Method Pharmaceuticals
Route:ORAL
Strength:10.8 mg in 1 1
Approved: 2023/12/09
NDC:58657-454
UROGESIC BLUE
Manufacturer:EDWARDS PHARMACEUTICALS, INC.
Route:ORAL
Strength:10.8 mg in 1 1
Approved: 2023/01/10
NDC:0485-0151
Ustell
Manufacturer:Star Pharmaceuticals LLC
Route:ORAL
Strength:10 mg in 1 1
Approved: 2017/01/10
NDC:0076-0903
URIBEL TABS
Manufacturer:Mission Pharmacal Company
Route:ORAL
Strength:10.8 mg in 1 1
Approved: 2024/01/22
NDC:0178-0745

Singapore Approved Products

PROVEBLUE SOLUTION FOR INJECTION 5MG/ML
Manufacturer:Cenexi SAS
Form:INJECTION, SOLUTION
Strength:5mg/ml
Online:Yes
Approved: 2021/09/03
Approval:SIN16319P
Nutritrace Concentrate for solution for infusion
Manufacturer:B.Braun Melsungen AG
Form:INFUSION, SOLUTION CONCENTRATE
Strength:0.0530mg/10ml
Online:Yes
Approved: 2013/04/22
Approval:SIN14341P

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