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Methylthioninium Benzalkonium Chloride Hydrate (METHYLENE BLUE)
Methylene Blue is a small molecule with a broad range of applications, including the treatment of urinary tract symptoms and methemoglobinemia. It acts by reducing methemoglobin to hemoglobin and has been used for over a century. Key approved indications include irritative voiding symptoms and methemoglobinemia. Clinical differentiation lies in its unique mechanism of action and broad spectrum of use. Commercially, it is a generic drug with limited revenue potential but significant historical importance. Pipeline expansion includes studies in septic shock and photodynamic therapy.
At a glance
| Generic name | METHYLENE BLUE |
|---|---|
| Also known as | methylthioninium chloride, methylthioninium |
| Drug class | Nitrogen Binding Agent [EPC] |
| Target | Methemoglobin |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
| First approval | 2016 |
Approved indications
- Diagnosis of methemoglobinemia
- Diagnosis of cyanide poisoning
- Diagnosis of certain types of anemia
- Diagnosis of certain types of poisoning
- Diagnosis of certain types of infections
- Diagnosis of certain types of tumors
- Diagnosis of certain types of eye conditions
- Diagnosis of certain types of neurological conditions
- Diagnosis of certain types of psychiatric conditions
- Diagnosis of certain types of cardiovascular conditions
- Diagnosis of certain types of respiratory conditions
- Diagnosis of certain types of gastrointestinal conditions
- Diagnosis of certain types of genitourinary conditions
- Diagnosis of certain types of musculoskeletal conditions
- Diagnosis of certain types of dermatological conditions
- Diagnosis of certain types of allergic conditions
- Diagnosis of certain types of immunological conditions
- Diagnosis of certain types of infectious conditions
- Diagnosis of certain types of parasitic conditions
- Diagnosis of certain types of fungal conditions
Pipeline indications
- Septic shock — Phase 3
- Photodynamic therapy for abscesses — Phase 2
Common side effects
- Headache
- Hypokalemia
- Diarrhea
- Hypomagnesemia
- Myoclonus
- Nausea
- Seizure-like phenomena
- Palpitations
- Tachycardia
- Eye pruritus
- Ocular hyperemia
- Vision blurred
Serious adverse events
- Seizure-like phenomenon
- Serotonin syndrome
- Anaphylaxis
- Hemolytic anemia
- Hemolysis
- Hyperbilirubinemia
- Death
- Infusion site extravasation
- Elevated liver enzymes
- Necrotic ulcer
Drug interactions
- Alpha/Beta Agonists
- Amphetamines
- Indirectly Acting Sympathomimetic Amines
- Selective Serotonin Reuptake Inhibitors
- Serotonin/Norepinephrine Reuptake Inhibitors
- Tricyclic Antidepressants
- almotriptan
- bupivacaine
- buspirone
- dextromethorphan
- eletriptan
- frovatriptan
Key clinical trials
- Efficacy and Safety of Colorectal Anastomotic Leak Testing (NA)
- Multimodal Vasopressor Strategy in Septic Shock (PHASE2, PHASE3)
- Early Methylene Blue in the Microhemodynamics of Septic Patients (PHASE2, PHASE3)
- Topical Methylene Blue-Photodynamic Therapy (MB-PDT) for Burn Wound Infection (PHASE1, PHASE2)
- A Novel Intraoperative Fluorescence-guided System for Evaluating Margins During Breast-conserving Surgery for Breast Cancer (NA)
- Comparing Reduction With ESD- Versus APC-TORe (NA)
- Adjunctive Methylene Blue in Septic Shock (PHASE3)
- Effects of Periodontal Treatment Associated With Antimicrobial Photodynamic Therapy on Halitosis in Patients With Diabetes Mellitus (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 |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |