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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Commercial
Trade Name
FDA
EMA
Provayblue (generic drugs available since 2023-12-05)
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 |
|---|---|---|
| hyophen | unapproved drug other | 2017-01-05 |
| methylene blue | unapproved drug other | 2024-07-02 |
| methylene blue inj | unapproved drug other | 2023-08-09 |
| phosphasal | unapproved drug other | 2017-01-24 |
| provayblue | New Drug Application | 2024-06-10 |
| urelle | unapproved drug other | 2015-01-13 |
| uretron d/s | unapproved drug other | 2024-05-05 |
| uribel | unapproved drug other | 2023-11-22 |
| uribel tabs | unapproved drug other | 2024-01-22 |
| urimar-t caps | unapproved drug other | 2023-07-06 |
Show 9 more
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| methemoglobinemia | — | D008708 | D74 |
| colorectal neoplasms | — | D015179 | — |
| colonoscopy | — | D003113 | — |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
METHYLENE BLUE, PROVAYBLUE, PROVEPHARM SAS | |||
| 2027-01-08 | M-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
281 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Breast neoplasms | D001943 | EFO_0003869 | C50 | — | 3 | — | 1 | 13 | 17 |
| Shock | D012769 | — | R57.1 | — | 6 | 7 | 1 | 3 | 14 |
| Septic shock | D012772 | — | A48.3 | — | 6 | 8 | 1 | 2 | 13 |
| Photochemotherapy | D010778 | — | — | — | — | — | 1 | 5 | 6 |
| Sentinel lymph node biopsy | D021701 | — | — | — | — | 1 | 1 | 4 | 6 |
| Morbid obesity | D009767 | EFO_0001074 | — | 1 | 1 | — | 1 | 4 | 6 |
| Sepsis | D018805 | HP_0100806 | A41.9 | 1 | — | 1 | 1 | 2 | 5 |
| Vasoplegia | D056987 | — | — | — | 1 | — | 2 | — | 3 |
| Methemoglobinemia | D008708 | — | D74 | 1 | — | — | 1 | 1 | 3 |
| Toxemia | D014115 | — | — | — | — | 1 | 1 | 1 | 3 |
Show 13 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Colorectal neoplasms | D015179 | — | — | — | 1 | 1 | — | 7 | 9 |
| Obesity | D009765 | EFO_0001073 | E66.9 | — | — | 1 | — | 7 | 8 |
| Endometrial neoplasms | D016889 | EFO_0004230 | — | — | 1 | 2 | — | 4 | 7 |
| Alzheimer disease | D000544 | EFO_0000249 | F03 | 1 | 3 | 2 | — | — | 6 |
| Carcinoma | D002277 | — | C80.0 | — | — | 1 | — | 4 | 5 |
| Cognitive dysfunction | D060825 | HP_0001268 | G31.84 | — | 1 | 2 | — | 2 | 5 |
| Surgical wound infection | D013530 | — | — | 1 | 2 | 1 | — | 1 | 4 |
| Fistula | D005402 | — | — | — | — | 1 | — | 3 | 4 |
| Stomatitis | D013280 | EFO_1001904 | K12.1 | — | 1 | 2 | — | — | 3 |
| Mucositis | D052016 | EFO_1001898 | — | — | 1 | 2 | — | — | 3 |
Show 24 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Covid-19 | D000086382 | — | U07.1 | 4 | 5 | — | — | 2 | 10 |
| Infections | D007239 | EFO_0000544 | — | 1 | 2 | — | — | 7 | 9 |
| Malaria | D008288 | EFO_0001068 | B54 | — | 7 | — | — | — | 7 |
| Communicable diseases | D003141 | — | — | 1 | 2 | — | — | 5 | 7 |
| Diabetes mellitus | D003920 | HP_0000819 | E08-E13 | — | 1 | — | — | 5 | 6 |
| Periapical diseases | D010483 | EFO_0010688 | — | — | 1 | — | — | 3 | 4 |
| Ulcer | D014456 | MPATH_579 | — | 1 | 1 | — | — | 2 | 4 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | — | 1 | — | — | 2 | 3 |
| Lymphedema | D008209 | HP_0001004 | Q82.0 | — | 1 | — | — | 2 | 3 |
| Abscess | D000038 | EFO_0003030 | — | 1 | 1 | — | — | 1 | 3 |
Show 33 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Nonvital tooth | D019553 | — | — | 1 | — | — | — | 2 | 3 |
| Sars-cov-2 | D000086402 | — | — | 2 | — | — | — | 1 | 3 |
| Diabetic foot | D017719 | EFO_1001459 | — | 1 | — | — | — | 2 | 3 |
| Dental caries | D003731 | EFO_0003819 | K02 | 1 | — | — | — | 1 | 2 |
| Obstructive jaundice | D041781 | EFO_1001068 | — | 1 | — | — | — | 1 | 2 |
| Jaundice | D007565 | HP_0000952 | R17 | 1 | — | — | — | 1 | 2 |
| Foot ulcer | D016523 | — | — | 1 | — | — | — | 1 | 2 |
| Glucosephosphate dehydrogenase deficiency | D005955 | EFO_0007287 | — | 1 | — | — | — | — | 1 |
| Vulvar diseases | D014845 | — | — | 1 | — | — | — | — | 1 |
| Brain waves | D058256 | EFO_0004357 | — | 1 | — | — | — | — | 1 |
Show 6 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Periodontitis | D010518 | EFO_0000649 | K05.3 | — | — | — | — | 15 | 15 |
| Chronic periodontitis | D055113 | EFO_0006343 | K05.3 | — | — | — | — | 7 | 7 |
| Periodontal diseases | D010510 | — | K05.6 | — | — | — | — | 7 | 7 |
| Polyps | D011127 | EFO_0000662 | — | — | — | — | — | 5 | 5 |
| Postoperative pain | D010149 | — | G89.18 | — | — | — | — | 4 | 4 |
| Inflammatory bowel diseases | D015212 | EFO_0003767 | — | — | — | — | — | 4 | 4 |
| Pilonidal sinus | D010864 | HP_0010769 | L05 | — | — | — | — | 4 | 4 |
| Colonic polyps | D003111 | — | K63.5 | — | — | — | — | 4 | 4 |
| Cleft lip | D002971 | EFO_0003959 | Q36 | — | — | — | — | 3 | 3 |
| Stomach neoplasms | D013274 | EFO_0003897 | C16 | — | — | — | — | 3 | 3 |
Show 152 more
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
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Variants
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Trends
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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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1,269 adverse events reported
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