NDAINTRAVENOUSSOLUTION
Approved
Apr 2016
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
14
Data completeness
3/8 — Basic
PROVAYBLUE (methylene blue) by Chengdu New Radiomedicine is non-enzymatic redox conversion of methb to hemoglobin. First approved in 2016.
Drug data last refreshed 2h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
PROVAYBLUE (methylene blue) is an intravenous solution approved in 2016 for the treatment of methemoglobinemia. It works via non-enzymatic redox conversion, where methylene blue is reduced to leucomethylene blue by NADPH reductase, which then reduces ferric iron in methemoglobin back to functional hemoglobin. This is a niche acute-care therapeutic indicated for a rare but critical blood oxygen disorder.
LOE Approaching7mo to LOE
Peak market phase in 2024 transitioning to loss-of-exclusivity in January 2027; team likely stabilized with contingency planning for generic entry.
Mechanism of Action
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.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (14)
Efficacy and Safety of Methylene Blue in the Treatment of Severe Septic Shock
Started Jun 2024
488 enrolled
Septic ShockMethylene BlueSepsis
A Study to Evaluate Safety and Efficacy of Convalescent Methylene Blue Treated (MBT) Plasma From Donors Recovered From Coronavirus Disease 2019 (COVID-19)
Started Apr 2020
200 enrolled
COVID-19
Methylene Blue Against Falciparum Malaria in Burkina Faso
Started Oct 2016
100 enrolled
Malaria, Falciparum
Phase 2 Efficacy Study of Primaquine and Methylene Blue
Started Jul 2016
80 enrolled
Malaria
Methylene Blue Against Vivax Malaria in Ethiopia
Started Apr 2016
0Vivax Malaria
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.