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Provayblue (methylthioninium chloride)
Provayblue works by inhibiting the enzyme amine oxidase [flavin-containing] A, which is involved in the breakdown of certain amines in the body.
At a glance
| Generic name | methylthioninium chloride |
|---|---|
| Drug class | Monoamine Oxidase Inhibitors |
| Target | Amine oxidase [flavin-containing] A |
| Therapeutic area | Rare Disease |
| Phase | FDA-approved |
Mechanism of action
Methylene blue is water soluble thiazine dye that promotes non-enzymatic redox conversion of metHb to hemoglobin. In situ, methylene blue is first converted to leucomethylene blue (LMB) via NADPH reductase. It is the LMB molecule which then reduces the ferric iron of metHb to the ferrous state of normal hemoglobin.
Approved indications
- Methemoglobinemia
Boxed warnings
- WARNING: SEROTONIN SYNDROME WITH CONCOMITANT USE OF SEROTONERGIC DRUGS AND OPIOIDS PROVAYBLUE may cause serious or fatal serotonergic syndrome when used in combination with serotonergic drugs and opioids. Avoid concomitant use of PROVAYBLUE with selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), monoamine oxidase inhibitors (MAOIs) and opioids. [see Warnings and Precautions ( 5.1 ) and Drug Interactions ( 7.1 )]. WARNING: SEROTONIN SYNDROME WITH CONCOMITANT USE OF SEROTONERGIC DRUGS AND OPIOIDS See full prescribing information for complete boxed warning. PROVAYBLUE may cause serious or fatal serotonergic syndrome when used in combination with serotonergic drugs and opioids. Avoid concomitant use of PROVAYBLUE with selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), monoamine oxidase inhibitors (MAOIs) and opioids. ( 5.1 , 7.1 )
Common side effects
- headache
- hypokalemia
- diarrhea
- hypomagnesemia
- myoclonus
- nausea
- seizure-like phenomena
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
- Topical Methylene Blue-Photodynamic Therapy (MB-PDT) for Burn Wound Infection (PHASE1,PHASE2)
- Early Methylene Blue in the Microhemodynamics of Septic Patients (PHASE2,PHASE3)
- 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)
- Clinical and Microbiologic Outcomes of Adjunctive Antimicrobial Photodynamic Therapy in the Non-surgical and Surgical Treatment of Teeth With Periodontal Disease (NA)
- Light-Activated Antimicrobial Therapy to Prevent Surgical Site Infections (PHASE3)
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:
- Provayblue CI brief — competitive landscape report
- Provayblue updates RSS · CI watch RSS
- portfolio CI