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Methylene blue (1%)
Methylene blue (1%) is a Redox agent; monoamine oxidase inhibitor Small molecule drug developed by University Hospital, Strasbourg, France. It is currently FDA-approved for Methemoglobinemia (acute treatment), Ifosfamide-induced encephalopathy (off-label), Cognitive impairment and depression (investigational).
Methylene blue acts as a redox agent and monoamine oxidase inhibitor, helping to restore cellular electron transport and reduce oxidative stress.
Methylene blue acts as a redox agent and monoamine oxidase inhibitor, helping to restore cellular electron transport and reduce oxidative stress. Used for Methemoglobinemia (acute treatment), Ifosfamide-induced encephalopathy (off-label), Urinary tract infections (antiseptic).
At a glance
| Generic name | Methylene blue (1%) |
|---|---|
| Sponsor | University Hospital, Strasbourg, France |
| Drug class | Redox agent; monoamine oxidase inhibitor |
| Target | Mitochondrial electron transport chain; monoamine oxidase; methemoglobin reductase |
| Modality | Small molecule |
| Therapeutic area | Multiple (Toxicology, Psychiatry, Infectious Disease, Hematology) |
| Phase | FDA-approved |
Mechanism of action
Methylene blue functions as a reversible oxidation-reduction (redox) compound that can accept and donate electrons, facilitating mitochondrial electron transport and ATP production. It also inhibits monoamine oxidase and has antimicrobial properties. Additionally, it can reduce methemoglobin back to hemoglobin, making it useful in treating methemoglobinemia.
Approved indications
- Methemoglobinemia (acute treatment)
- Ifosfamide-induced encephalopathy (off-label)
- Cognitive impairment and depression (investigational)
- Urinary tract infections (antimicrobial use)
Common side effects
- Blue discoloration of urine and skin
- Nausea and gastrointestinal upset
- Headache
- Dizziness
- Serotonin syndrome (rare, with serotonergic agents)
Key clinical trials
- Comparing Reduction With ESD- Versus APC-TORe (NA)
- Anti-Reflux Endoscopic TX Using APC (AREA) in GERD Patients: (The AREA Study) (NA)
- Impact Of Laparoscopic Sleeve Gastrectomy On Obesity-Related Comorbidities In Patients Over 65 Years (NA)
- Action of Photodynamic Therapy on Wound Quality and Tissue Repair in the Diabetic Foot (NA)
- Efficacy of Methylene Blue Photodynamic Therapy for Treatment of Deep Tissue Abscesses (PHASE2)
- Methylene Blue for the Treatment of Septic Shock (PHASE3)
- Sentinel Node Biopsy in Endometrial Cancer (PHASE3)
- Modified Double Snare Assisted EMR (mDS-EMR) VS ESD for Rectal Neuroendocrine Tumors Smaller Than 1cm (NA)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Methylene blue (1%) CI brief — competitive landscape report
- Methylene blue (1%) updates RSS · CI watch RSS
- University Hospital, Strasbourg, France portfolio CI
Frequently asked questions about Methylene blue (1%)
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Related
- Drug class: All Redox agent; monoamine oxidase inhibitor drugs
- Target: All drugs targeting Mitochondrial electron transport chain; monoamine oxidase; methemoglobin reductase
- Manufacturer: University Hospital, Strasbourg, France — full pipeline
- Therapeutic area: All drugs in Multiple (Toxicology, Psychiatry, Infectious Disease, Hematology)
- Indication: Drugs for Methemoglobinemia (acute treatment)
- Indication: Drugs for Ifosfamide-induced encephalopathy (off-label)
- Indication: Drugs for Cognitive impairment and depression (investigational)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing