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AboutPricing
Drug ReportsMethylthioninium chloride
Methylene blue
Methylene Blue, Provayblue (methylene blue) is a small molecule pharmaceutical. Methylene blue was first approved as Provayblue on 2016-04-08. It is used to treat cyanosis, herpes simplex, lithiasis, methemoglobinemia, and poisoning amongst others in the USA.
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EMA approval date
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Study first post date
Last update post date
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Primary completion date
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Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
infectionsD007239
urogenital diseasesD000091642
hemic and lymphatic diseasesD006425
skin and connective tissue diseasesD017437
signs and symptoms pathological conditionsD013568
chemically-induced disordersD064419
Trade Name
FDA
EMA
No data
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
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Labels
FDA
EMA
Brand Name
Status
Last Update
arthcal 1% methylene blueC2002632025-03-13
hyophenunapproved drug other2017-01-05
mb capsunapproved drug other2025-02-25
methylene blueANDA2025-03-06
methylene blue injunapproved drug other2023-08-09
phosphasalunapproved drug other2017-01-24
provayblueNew Drug Application2024-12-19
urelleunapproved drug other2015-01-13
uretron d/sunapproved drug other2025-02-28
uribelunapproved drug other2017-01-24
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Indications
FDA
EMA
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Agency Specific
FDA
EMA
Expiration
Code
METHYLENE BLUE, PROVAYBLUE, PROVEPHARM SAS
2027-01-08M-303
Patent Expiration
No data
ATC Codes
V: Various drug classes in atc
— V03: All other therapeutic products
— V03A: All other therapeutic products
— V03AB: Antidotes
— V03AB17: Methylthioninium chloride
— V04: Diagnostic agents
— V04C: Other diagnostic agents in atc
— V04CG: Gastric secretion test diagnostic agents
— V04CG05: Methylthioninium chloride
HCPCS
Code
Description
Q9968
Injection, non-radioactive, non-contrast, visualization adjunct (e.g., methylene blue, isosulfan blue), 1 mg
Clinical
Clinical Trials
333 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
MethemoglobinemiaD008708—D74———1—1
Indications Phases 3
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Indications Phases 2
No data
Indications Phases 1
No data
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameMethylene blue
INNmethylthioninium chloride
Description
Methylene blue is an organic chloride salt having 3,7-bis(dimethylamino)phenothiazin-5-ium as the counterion. A commonly used dye that also exhibits antioxidant, antimalarial, antidepressant and cardioprotective properties. It has a role as an EC 1.4.3.4 (monoamine oxidase) inhibitor, an acid-base indicator, a fluorochrome, an antidepressant, a cardioprotective agent, an EC 3.1.1.8 (cholinesterase) inhibitor, a histological dye, an EC 4.6.1.2 (guanylate cyclase) inhibitor, an antioxidant, an antimicrobial agent, a neuroprotective agent, a physical tracer and an antimalarial. It contains a 3,7-bis(dimethylamino)phenothiazin-5-ium.
Classification
Small molecule
Drug class—
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
CN(C)c1ccc2nc3ccc(=[N+](C)C)cc-3sc2c1.O.O.O.[Cl-]
Identifiers
PDB—
CAS-ID61-73-4
RxCUI—
ChEMBL IDCHEMBL550495
ChEBI ID—
PubChem CID6099
DrugBankDB09241
UNII ID8NAP7826UB (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 77,015 documents
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Safety
Black-box Warning
Black-box warning for: Methylene blue, Methylene blue inj, Provayblue
Adverse Events
Top Adverse Reactions
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1,395 adverse events reported
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