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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Commercial
Trade Name
FDA
EMA
Provayblue
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Methylene blue
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| PROVAYBLUE | Provepharm | N-204630 RX | 2016-04-08 | 2 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| provayblue | New Drug Application | 2021-12-07 |
| urneva | unapproved drug other | 2023-05-24 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
METHYLENE BLUE, PROVAYBLUE, PROVEPHARM SAS | |||
| 2023-04-08 | ODE*, ODE-113 | ||
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
93 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Septic shock | D012772 | A48.3 | — | 2 | 4 | 1 | 1 | 7 | |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | — | 2 | — | 1 | 4 | 7 |
| Shock | D012769 | R57.1 | — | 2 | 1 | 1 | — | 4 | |
| Sepsis | D018805 | A41.9 | 1 | — | 1 | 1 | 1 | 4 | |
| Vasoplegia | D056987 | — | 1 | — | 2 | — | 3 | ||
| Dental implants | D015921 | — | — | — | 1 | — | 1 | ||
| Lasers | D007834 | — | — | — | 1 | — | 1 | ||
| Liver cirrhosis | D008103 | EFO_0001422 | K74.0 | — | — | — | 1 | — | 1 |
| Male breast neoplasms | D018567 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Colorectal neoplasms | D015179 | — | 1 | 1 | — | 1 | 3 | ||
| Herpes zoster | D006562 | EFO_0006510 | B02 | — | — | 1 | — | — | 1 |
| Herpes simplex | D006561 | B00 | — | — | 1 | — | — | 1 | |
| Liver diseases | D008107 | EFO_0001421 | K70-K77 | — | — | 1 | — | — | 1 |
| Dysuria | D053159 | EFO_0003901 | R30 | — | — | 1 | — | — | 1 |
| Bipolar disorder | D001714 | EFO_0000289 | F30.9 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Covid-19 | D000086382 | U07.1 | 1 | 2 | — | — | 1 | 4 | |
| Alzheimer disease | D000544 | EFO_0000249 | F03 | — | 3 | — | — | — | 3 |
| Falciparum malaria | D016778 | EFO_0007444 | B50 | — | 2 | — | — | — | 2 |
| Malaria | D008288 | EFO_0001068 | B54 | — | 2 | — | — | — | 2 |
| Severe acute respiratory syndrome-related coronavirus | D045473 | NCBITaxon_227859 | — | 1 | — | — | — | 1 | |
| Hidradenitis suppurativa | D017497 | L73.2 | — | 1 | — | — | — | 1 | |
| Neonatal sepsis | D000071074 | HP_0040187 | — | 1 | — | — | — | 1 | |
| Neoplasms | D009369 | C80 | — | 1 | — | — | — | 1 | |
| Stomatitis | D013280 | EFO_1001904 | K12.1 | — | 1 | — | — | — | 1 |
| Hypotension | D007022 | EFO_0005251 | I95 | — | 1 | — | — | — | 1 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Sars-cov-2 | D000086402 | 2 | — | — | — | 1 | 3 | ||
| Methemoglobinemia | D008708 | D74 | 1 | — | — | — | 1 | 2 | |
| Glucosephosphate dehydrogenase deficiency | D005955 | EFO_0007287 | 1 | — | — | — | — | 1 | |
| Healthy volunteers/patients | — | 1 | — | — | — | — | 1 | ||
| Jaundice | D007565 | HP_0000952 | R17 | 1 | — | — | — | — | 1 |
| Abscess | D000038 | EFO_0003030 | 1 | — | — | — | — | 1 | |
| Gastrointestinal neoplasms | D005770 | C26.9 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Postoperative cognitive complications | D000079690 | — | — | — | — | 2 | 2 | ||
| Delirium | D003693 | R41.0 | — | — | — | — | 2 | 2 | |
| Chronic periodontitis | D055113 | EFO_0006343 | K05.3 | — | — | — | — | 2 | 2 |
| Periodontal diseases | D010510 | K05.6 | — | — | — | — | 2 | 2 | |
| Melanoma | D008545 | — | — | — | — | 2 | 2 | ||
| Lung neoplasms | D008175 | C34.90 | — | — | — | — | 1 | 1 | |
| Solitary pulmonary nodule | D003074 | R91.1 | — | — | — | — | 1 | 1 | |
| Pericoronitis | D010497 | EFO_1001098 | — | — | — | — | 1 | 1 | |
| Obstructive jaundice | D041781 | EFO_1001068 | — | — | — | — | 1 | 1 | |
| Onychomycosis | D014009 | B35.1 | — | — | — | — | 1 | 1 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | METHYLENE BLUE |
| INN | methylthioninium 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) | |
| Structure (InChI/SMILES or Protein Sequence) | CN(C)c1ccc2nc3ccc(=[N+](C)C)cc-3sc2c1.O.O.O.[Cl-] |
Identifiers
| PDB | — |
| CAS-ID | 61-73-4 |
| RxCUI | — |
| ChEMBL ID | CHEMBL550495 |
| ChEBI ID | — |
| PubChem CID | 6099 |
| DrugBank | DB09241 |
| UNII ID | 8NAP7826UB (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
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Trends
PubMed Central
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Safety
Black-box Warning
Black-box warning for: Provayblue
Adverse Events
Top Adverse Reactions
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198,907 adverse events reported
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