Methylene Blue Solution: molecular data, studies & sources

Molecular formula, weight & structure

Molecular formula (MF)

C16H18ClN3S

Molecular weight (MW)

319.9 g/mol

PubChem compound ID

6099

Record title

Methylene Blue

Values describe the selected PubChem molecular entity. Counterions, salt forms, hydration and sequence changes can alter the supplied material. Confirm the exact identity against the supplier specification.

Source: PubChem CID 6099 · retrieved 2026-09-21

US regulatory status & drug development

Methylene Blue Solution (methylene blue) is the active ingredient of PROVAYBLUE, approved by the FDA under NDA 204630 (PROVEPHARM SAS) on April 8, 2016; Drugs@FDA lists it as a marketed prescription product (checked October 7, 2026). Drugs@FDA also lists 7 approved generic (ANDA) applications. Research-labelled Methylene Blue Solution listings are not PROVAYBLUE and are not FDA-approved drugs.

Drugs@FDA also lists 7 approved generic (ANDA) applications for this active ingredient.

An FDA approval covers a defined medicine, formulation and labelled use. It does not extend to research-labelled material sold under the same compound name. Identity basis: Same active ingredient name (methylene blue). The research listing is a laboratory solution, not the approved injection.

Source: Drugs@FDA via openFDA (application records; DailyMed label set IDs) · checked 2026-10-07. openFDA data are not intended for clinical decisions.

Registered clinical trials

Studies registered on ClinicalTrials.gov that list Methylene blue as an intervention. Studies that only measure the molecule as a biomarker, or use it only as a comparator or background arm for another drug, are excluded. A registration describes a planned or completed protocol; it does not report a result. Active studies are listed first.

40 registered studies matched, 12 currently active or recruiting, 2 with results posted on ClinicalTrials.gov.

By highest phase

Phase 4 · 1Phase 3 · 9Phase 2 · 6Phase 1 · 3Early phase 1 · 3Not applicable · 18

By registry status

Completed · 17Unknown · 11Recruiting · 6Not Yet Recruiting · 4Enrolling By Invitation · 2

Registry check 2026-10-09 · Run this search on ClinicalTrials.gov

Human intervention studies

Selected studies in which participants received Methylene blue, with their indexed or reviewed study type. Check the original article for the formulation, population and controls. Studies that only measured the molecule, or used it as a comparator, are listed separately below and are not counted as intervention studies.

1. Human study · PubMed trial index Compound given to participants

   Early adjunctive methylene blue in patients with septic shock: a randomized controlled trial.

   Ibarra-Estrada M, Kattan E, Aguilera-González P et al. · Critical care (London, England) · 2023

   PMID 36915146 · DOI: 10.1186/s13054-023-04397-7

2. Human study · PubMed trial index Compound given to participants

   Infusion of methylene blue in human septic shock: a pilot, randomized, controlled study.

   Kirov MY, Evgenov OV, Evgenov NV et al. · Critical care medicine · 2001

   PMID 11588440 · DOI: 10.1097/00003246-200110000-00002

Preclinical research, reviews & other publications

Animal studies, laboratory experiments, reviews and other indexed papers answer different questions. A review is secondary evidence; a case report does not estimate how often an outcome occurs.

1. Review · secondary evidence

   The Potentials of Methylene Blue as an Anti-Aging Drug.

   Xue H, Thaivalappil A, Cao K et al. · Cells · 2021

   PMID 34943887 · DOI: 10.3390/cells10123379

2. Review · secondary evidence

   Methylene-blue-associated encephalopathy.

   Sweet G, Standiford SB · Journal of the American College of Surgeons · 2007

   PMID 17324781 · DOI: 10.1016/j.jamcollsurg.2006.12.030

3. Research publication · design requires review

   Methylene blue: revisited.

   Ginimuge PR, Jyothi SD · Journal of anaesthesiology, clinical pharmacology · 2010

   PMID 21547182

Methylene Blue Solution supplier sources

Scientific sources describe molecules and experiments. The commercial links below identify recorded supplier packages. A publication or chemical database entry does not verify the seller, purity, sterility or contents of a lot. Some links are affiliate links; see our disclosure.

Methylene Blue Solution for sale: compare prices, sizes and forms from every tracked supplier →

Reference sources & further reading

• PubChem compound record 6099 — chemical identity and structure.
• ChEMBL drug record CHEMBL405110 — development stage, mechanism and synonyms.
• FDA Global Substance Registration System: UNII 8NAP7826UB — substance identity, names and codes.
• Drugs@FDA: NDA 204630 — US approval record for a medicine with the same active ingredient.
• Wikipedia: Methylene blue — Background encyclopedia; not a primary clinical source.

The citations above link directly to publication records. Encyclopedia links are background reading and are not used to establish clinical effectiveness.

Research information is not a dosing guide or a recommendation for personal use. Study findings are specific to the formulation, population and methods tested. Read our source and correction policy.

Related research profiles