Overview
Methylene blue is an oxidation-reduction agent. The intravenous form of methylene blue is approved by the FDA for the treatment of pediatric and adult patients with acquired methemoglobinemia. Historically, it has been widely used in Africa to treat malaria, but now it disappeared when chloroquine (CQ) and other drugs entered the market. Its use as an urinary tract antiseptic has also been investigated. Methylthioninium chloride (INN, or methylene blue, proposed trade name Rember) is an investigational drug being developed by the University of Aberdeen and TauRx Therapeutics that has been shown in early clinical trials to be an inhibitor of Tau protein aggregation. The drug is of potential interest for the treatment of patients with Alzheimer's disease.
Indication
Indicated for the treatment of pediatric and adult patients with acquired methemoglobinemia. Other clinical applications of methylene blue include improvement of hypotension associated with various clinical states, an antiseptic in urinary tract infections, treatment of hypoxia and hyperdynamic circulation in cirrhosis of liver and severe hepatopulmonary syndrome, and treatment of ifofosamide induced neurotoxicity.
Associated Conditions
- Cystitis
- Methemoglobinemia
- Nephritis
- Urethritis
- Urinary tract inflammation
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/10/08 | Not Applicable | Completed | |||
2025/09/17 | Not Applicable | Not yet recruiting | |||
2025/09/11 | Not Applicable | Recruiting | |||
2025/03/28 | Phase 3 | Recruiting | Dr. Shannon M. Fernando | ||
2025/03/20 | Phase 2 | Recruiting | |||
2024/10/28 | Phase 3 | ENROLLING_BY_INVITATION | The Second Affiliated Hospital of Anhui University of Traditional Chinese Medicine | ||
2024/08/01 | Phase 3 | Recruiting | Northern Jiangsu People's Hospital | ||
2024/03/12 | Phase 2 | Not yet recruiting | Post Graduate Institute of Medical Education and Research, Chandigarh | ||
2023/09/25 | Phase 2 | Not yet recruiting | |||
2023/09/06 | N/A | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| American Regent, Inc. | 0517-0125 | INTRAVENOUS | 5 mg in 1 mL | 11/1/2021 | |
| Meda Pharmaceuticals | 0037-6321 | ORAL | 10.8 mg in 1 1 | 1/13/2015 | |
| Star Pharmaceuticals, LLC | 0076-0111 | ORAL | 10 mg in 1 1 | 1/24/2017 | |
| A.G. Marin Pharmaceutical | 12539-144 | ORAL | 10.8 mg in 1 1 | 10/7/2022 | |
| American Regent, Inc. | 0517-0374 | INTRAVENOUS | 5 mg in 1 mL | 11/1/2021 | |
| Star Pharmaceuticals LLC | 0076-0903 | ORAL | 10 mg in 1 1 | 1/10/2017 | |
| Mission Pharmacal Company | 0178-0745 | ORAL | 10.8 mg in 1 1 | 1/22/2024 | |
| BPI LABS LLC | 54288-159 | INTRAVENOUS | 10 mg in 1 mL | 10/5/2023 | |
| Vilvet Pharmaceuticals Inc | 71186-000 | ORAL | 10.8 mg in 1 1 | 2/21/2019 | |
| Method Pharmaceuticals, LLC | 58657-456 | ORAL | 10 mg in 1 1 | 12/12/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 8/19/2020 | ||
Authorised | 5/6/2011 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| PROVEBLUE SOLUTION FOR INJECTION 5MG/ML | SIN16319P | INJECTION, SOLUTION | 5mg/ml | 9/3/2021 | |
| Nutritrace Concentrate for solution for infusion | SIN14341P | INFUSION, SOLUTION CONCENTRATE | 0.0530mg/10ml | 4/22/2013 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| Methylene Blue 50mg/5mL | 320908 | Medicine | A | 7/26/2019 | |
| PROVEBLUE methylene blue 50 mg/10 mL injection ampoule | 224639 | Medicine | A | 7/23/2015 | |
| Phebra METHYLENE BLUE 50 mg/5 mL injection vial | 223583 | Medicine | A | 10/1/2014 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| METHYLENE BLUE INJECTION, USP | Mylan Pharmaceuticals ULC | 02094665 | Solution - Intravenous | 10 MG / ML | 12/31/1994 |
| METHYLENE BLUE INJECTION USP | alveda pharmaceuticals inc | 02302756 | Solution - Intravenous | 10 MG / ML | 8/28/2008 |
| BLUE COLLYRIUM | 02171937 | Liquid - Ophthalmic | 0.2 MG / ML | 5/13/1997 | |
| NAZOPHYL DARVA | produits francais labs inc. | 00166375 | Ointment - Nasal | .1014 MG / 30 G | 12/31/1930 |
| METHYLENE BLUE INJECTION, USP | hospira healthcare ulc | 02137194 | Liquid - Intravenous | 1 % | 6/23/1999 |
| METHYLENE BLEU LIQ 2% | laboratoire atlas inc | 00050474 | Liquid - Oral | 2 % | 12/31/1951 |
| COLLYRE BLEU | sabex inc | 00787043 | Drops - Ophthalmic | 0.2 MG / ML | 12/31/1991 |
| METHYLENE BLUE SOLUTION 1% | rougier pharma division of ratiopharm inc | 00524476 | Liquid - Topical
,
Oral | 1 % | 12/31/1981 |
| METHYLENE BLEU LIQ 1% | laboratoire atlas inc | 00050466 | Liquid - Oral | 1 % | 12/31/1951 |
| EAU RESOLUTIVE SOKER | produits francais labs inc. | 00166278 | Liquid - Topical | .1365 MG / 30 G | 12/31/1930 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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