Drugs / Methylene Blue
Methylene Blue
also known as
Methylene Blue MMX · methylthioninium chloride · MB-MMX · TRx0014 · Basic blue 9 · Basic blue 9 trihydrate · C.I. 52015 · C.i. basic blue 9 · +22 more
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | PROVAYBLUE | — | 2024-01-08 | fda.gov ↗ |
| Approved | US (FDA) | PROVAYBLUE | — | 2016-04-08 | fda.gov ↗ |
| Approved | EU (EMA) | Methylthioninium chloride Proveblue | — | 2011-05-06 | europa.eu ↗ |
Trials 74 · started per year
today
EU approved 2011
US approved 2016
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Also used as a comparator or background therapy in 25 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 14 trials | ||||||
| Phase 1 | NCT07324954 Background | Feb 2026 → Feb 2027 expected | periprosthetic joint infection | University of Miami | Recruiting | No outcome recorded |
| Phase 1 | NCT05753878 Background | Nov 2022 → Jan 2023 | COVID-19 | Huahui Health | Completed | No outcome recorded |
| Phase 1 | NCT03200808 Background | Oct 2013 → Oct 2018 | vulvar disease | Maternal and Child Health Hospital of Hubei Province | Completed | No outcome recorded |
| Phase 1 | NCT00159510 Comparator | Apr 2004 → Sep 2014 | infectious disease with sepsis | Northern State Medical University | Terminated | No outcome recorded |
| Phase 28 trials | ||||||
| Phase 2 | NCT05092165 Comparator | Oct 2021 → Dec 2025 | acute kidney injury | Federal University of São Paulo | Completed | No outcome recorded |
| Phase 2 | NCT04110418 Comparator | Feb 2019 → Feb 2020 | neonatal sepsis | Ain Shams University | Unknown | No outcome recorded |
| Phase 2 | NCT02295774 Comparator | Feb 2013 → Dec 2014 | colorectal cancer | Cosmo Technologies Ltd | Completed | No outcome recorded |
| Phase 2 | NCT01407887 Comparator | Aug 2011 | Plasmodium falciparum malaria | Heidelberg University | Completed | No outcome recorded |
| Phase 2 | NCT03287219 Comparator | May 2011 → Jan 2012 | — | Cosmo Technologies Ltd | Completed | No outcome recorded |
| Phase 2 | NCT01276054 Background | Dec 2010 → Oct 2011 | female breast carcinoma, lymphedema | University of Southern California | Terminated | No outcome recorded |
| Phase 2 | NCT00684944 Comparator | Sep 2007 → Dec 2010 | Alzheimer disease | TauRx Therapeutics Ltd | Completed | No outcome recorded |
| Phase 2 | NCT00515333 Comparator | Aug 2004 → Dec 2007 | Alzheimer disease | TauRx Therapeutics Ltd | Completed | No outcome recorded |
| Phase 2/32 trials | ||||||
| Phase 2/3 | NCT06005558 Comparator | Aug 2023 → Apr 2024 | infectious disease with sepsis | National Cancer Institute, Egypt | Completed | No outcome recorded |
| Phase 2/3 | NCT07067814 Comparator | Jun 2023 → Feb 2025 | — | Ain Shams University | Completed | No outcome recorded |
| Phase 33 trials | ||||||
| Phase 3 | NCT05894954 Background | Jul 2023 → Oct 2025 | cognitive impairment with or without cerebellar ataxia, dementia | Alzheimer's Prevention and Reversal Project, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT01694966 Comparator | Sep 2013 → Oct 2016 | colorectal cancer | Cosmo Technologies Ltd | Completed | No outcome recorded |
| Phase 3 | NCT01847612 Comparator | Jul 2013 → Jul 2025 | liver disorder | Centre Hospitalier Universitaire, Amiens | Completed | No outcome recorded |
| Phase 43 trials | ||||||
| Phase 4 | NCT04054999 Comparator | Nov 2019 → Feb 2023 | — | Mayo Clinic | Completed | No outcome recorded |
| Phase 4 | NCT02910765 Comparator | Oct 2016 → Mar 2017 | infectious disease with sepsis | Assiut University | Unknown | No outcome recorded |
| Phase 4 | NCT01386879 Background | Jul 2011 → Oct 2012 | — | Thomas Jefferson University | Terminated | No outcome recorded |
| Phase not applicable5 trials | ||||||
| — | NCT06731881 Background | Jun 2025 → Jun 2026 overdue | nasal disorder | Guy's and St Thomas' NHS Foundation Trust | Recruiting | No outcome recorded |
| — | NCT01725477 Background | Sep 2012 → Feb 2014 | fallopian tube disorder | Pourmatroud, Elham, M.D. | Completed | No outcome recorded |
| — | NCT01539135 Background | Apr 2012 → May 2013 | lung disorder | Medtronic - MITG | Completed | No outcome recorded |
| — | NCT02303886 Comparator | Mar 2009 → Jun 2012 | neuropathy, painful | Uppsala University | Completed | No outcome recorded |
| — | NCT00486174 Comparator | Jun 2007 → ? | infectious disease with sepsis | Queen's University | Withdrawn | No outcome recorded |
Press releases naming this drug 3 releases
| Date | Issuer | Release |
|---|---|---|
| 2015-03-20 | Daiichi Sankyo | Daiichi Sankyo Launches Methemoglobinemia Treatment Methylene Blue Injection 50mg daiichisankyo.com ↗ |
| 2015-01-05 | Daiichi Sankyo | Daiichi Sankyo Receives Approval in Japan for the Manufacture and Marketing of Methemoglobinemia Treatment Methylene Blue Injection 50 mg daiichisankyo.com ↗ |
| 2014-03-17 | Daiichi Sankyo | Daiichi Sankyo Files NDA in Japan for Methaemoglobinaemia Injection Methylene Blue daiichisankyo.com ↗ |
Evidence & citations 34 cited values
Every value below carries the sentence it was read from. 103 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Methylene Blue | “Bacterial or Viral infection treatment may include: Doxycycline, Minocycline, Nitazoxanide, Hydroxychloroquine, Rifampin, Dapsone, Azithromycin, Tetracycline, Benzathine...” NCT05894954 ↗95“A saturated swab containing 0.01% methylene blue and 0.25% chlorhexidine gluconate will be applied to nares, which is then activated by light.” NCT06731881 ↗ “Methylene Blue 1 mg/kg water solution. Participants will orally receive Methylene Blue solution of 1 mg/kg concentration one time if any.” NCT05003492 ↗ “Application of NF-031 solution (methylene blue 0.01% USP (methylthioninium chloride) and 0.25% chlorhexidine gluconate) in the nares” NCT06702878 ↗ “A single dose of HH-120 nasal spray premixed with 1mg/ml methylene blue injection.” NCT05753878 ↗ “The tooth extraction sockets were filled with photosensitizer methylene blue.” NCT05664087 ↗ |
| Known as | Basic blue 9 | ChEMBL registry synonym — accepted as the source's own label CHEMBL191083 ↗ |
| Known as | Basic blue 9 trihydrate | ChEMBL registry synonym — accepted as the source's own label CHEMBL191083 ↗ |
| Known as | C.I. 52015 | ChEMBL registry synonym — accepted as the source's own label CHEMBL191083 ↗ |
| Known as | C.i. basic blue 9 | ChEMBL registry synonym — accepted as the source's own label CHEMBL191083 ↗ |
| Known as | C.i. basic blue 9 trihydrate | ChEMBL registry synonym — accepted as the source's own label CHEMBL191083 ↗ |
| Known as | Chlorure de methylthioninium | ChEMBL registry synonym — accepted as the source's own label CHEMBL191083 ↗ |
| Known as | Cloruro de metiltioninio | ChEMBL registry synonym — accepted as the source's own label CHEMBL191083 ↗ |
| Known as | Dndi1417128 | ChEMBL registry synonym — accepted as the source's own label CHEMBL191083 ↗ |
| Known as | Investigational Product: Methylene Blue MMX modified release tablets | “Investigational Product: Methylene Blue MMX® modified release tablets” NCT01694966 ↗ |
| Known as | Lowacryl blue 9 | ChEMBL registry synonym — accepted as the source's own label CHEMBL191083 ↗ |
| Known as | Lumeblue (previously known as methylthioninium chloride cosmo) | ChEMBL registry synonym — accepted as the source's own label CHEMBL191083 ↗ |
| Known as | MB-MMX | “When combined with a pH- and time-dependent multimatrix structure, a per-oral methylene blue formulation (MB-MMX) can be delivered directly to the colorectal mucosa.” PMID 30742834 ↗ Feb 20191“An oral formulation of methylene blue with colonic delivery (MB-MMX) has been developed to increase detection of colorectal polys during colonoscopy.” PMID 29906809 ↗ Jun 2018 |
| Known as | MBD | “methylene blue dye (MBD)” PMID 19846959 ↗ Oct 2009 |
| Known as | metheylne blue | “metheylne blue with normal saline” NCT01725477 ↗ |
| Known as | methylen blue | “Drug: methylen blue &normal saline” NCT01725477 ↗ |
| Known as | METHYLENE BLUE ANHYDROUS | ChEMBL registry synonym — accepted as the source's own label CHEMBL191083 ↗ |
| Known as | methylene blue dye | “methylene blue dye (MBD)” PMID 19846959 ↗ Oct 2009 |
| Known as | Methylene Blue MMX | “Methylene Blue MMX 25 mg modified release tablets administered with a full dose regimen of a 4-L PEG-based bowel cleansing preparation.” NCT03287219 ↗2“To evaluate the effect of oral 200 mg Methylene Blue MMX® tablets” NCT02295774 ↗ “Oral dose, 8 Methylene Blue MMX® tablets over a 4hr schedule” NCT01694966 ↗ |
| Known as | Methylene Blue Oral Product | “Drug: Methylene Blue Oral Product” NCT03262077 ↗ |
| Known as | Methylene blue trihydrate | ChEMBL registry synonym — accepted as the source's own label CHEMBL191083 ↗ |
| Known as | Methylenium ceruleum | ChEMBL registry synonym — accepted as the source's own label CHEMBL191083 ↗ |
| Known as | methylthioninium chloride | “Participants in the experimental sample received methylthioninium chloride, Methylene Blue (SamaraMedProm, Russia, Registration number: MP-001834, 13.09.2012) orally in...” NCT04933864 ↗2“Application of NF-031 solution (methylene blue 0.01% USP (methylthioninium chloride) and 0.25% chlorhexidine gluconate) in the nares” NCT06702878 ↗ |
| Known as | Methylthioninium chloride proveblue | ChEMBL registry synonym — accepted as the source's own label CHEMBL191083 ↗ |
| Known as | NSC-215213 | ChEMBL registry synonym — accepted as the source's own label CHEMBL191083 ↗ |
| Known as | NSC-617593 | ChEMBL registry synonym — accepted as the source's own label CHEMBL191083 ↗ |
| Known as | NSC-759135 | ChEMBL registry synonym — accepted as the source's own label CHEMBL191083 ↗ |
| Known as | Provayblue | ChEMBL registry synonym — accepted as the source's own label CHEMBL191083 ↗ |
| Known as | PROVAYBLUETM | “Methylene blue (PROVAYBLUETM), 2 mg/kg IV bolus administered over 15 minutes” NCT04054999 ↗ |
| Known as | TRx0014 | “Drug: TRx0014” NCT00515333 ↗ |
| Known as | Urolene blue | ChEMBL registry synonym — accepted as the source's own label CHEMBL191083 ↗ |
| Action | Inhibit | “methylene blue (MB), an inhibitor of NO pathway” NCT00159510 ↗ |
| Modality | Diagnostic / imaging agent | “using isotope and methylene blue dye injection to localize precisely Sentinel Lymph Node (SLN)” NCT00314405 ↗ |
| Route | Other | “MB will be injected as a bolus” NCT00159510 ↗ |