Drugs / Methylene Blue
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Methylene Blue

Diagnostic / imaging agent

Developed for
infectious disease with sepsis · COVID-19 · abscess · delirium · disease of bone structure · hemorrhoid · malaria · obstructive jaundice
+31 more · periodontitis · ulcer of lower limbs · Alzheimer disease · bipolar disorder · breast abscess · CADINS disease · chronic hepatitis B virus infection · chronic periodontitis · cognitive impairment with or without cerebellar ataxia · cytokine release syndrome · head and neck cancer · hidradenitis suppurativa · hyperpigmentation of the skin · methemoglobinemia · morpheaform basal cell carcinoma · neonatal sepsis · nodular basal cell carcinoma · nosocomial infection · oral sensibility, disturbance of · periapical periodontitis · pericoronitis · Plasmodium falciparum malaria · post-traumatic stress disorder · rectal cancer · skin infection · skin infiltrative basal cell carcinoma · skin squamous cell carcinoma · stomatitis · urethral syndrome · vascular disorder · neuropathy, painful
Investigated by
University of Rochester · Heidelberg University · University of Oxford · Chinese Academy of Sciences · Chinese University of Hong Kong · Daryoush Hamidi Alamdari, PhD
+97 more · Fondazione Epatocentro Ticino · Fudan University · Mashhad University of Medical Sciences · Ondine Biomedical Inc. · The University of Texas Health Science Center at San Antonio · University of Nove de Julho · University of Sao Paulo · Wang wanxia · Academy of Laser Dentistry · Affiliated Cancer Hospital of Shantou University Medical College · Affiliated Hospital to Academy of Military Medical Sciences · Ain Shams University · American Regent, Inc. · Amr kamel khalil Ahmed · Beijing Digital Precesion Medicine Company · Beijing Friendship Hospital · Bill and Melinda Gates Foundation · Cairo University · Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Carilion Clinic · Centre de Recherche en Sante de Nouna, Burkina Faso · Centro de Estudos e Pesquisa em Emergencias Medicas e Terapia Intensiva · China Medical University Hospital · China Medical University, Taiwan · Chinese PLA General Hospital · Chongqing Medical University · Dartmouth-Hitchcock Medical Center · Dr. Shannon M. Fernando · EMS · First Affiliated Hospital of Zhejiang University · First Affiliated Hospital, Sun Yat-Sen University · GUI LIN PEOPLE'S HOSPITAL · Gynecologic Oncology Group · Hangzhou Yuhang District Second People's Hospital · Hospital Civil de Guadalajara · Hospital Reg. Lic. Adolfo Lopez Mateos · I.M. Sechenov First Moscow State Medical University · Imperial College London · Institute of Hematology & Blood Diseases Hospital, China · Institute of Liver and Biliary Sciences, India · Irkutsk Scientific Center of the Siberian Branch of the Russian Academy of Sciences · Irkutsk State Medical University · Irmandade da Santa Casa de Misericordia de Curitiba · Jiaolin Ning,MD · Kafrelsheikh University · King's College London · London School of Hygiene and Tropical Medicine · Louisiana State University Health Sciences Center in New Orleans · M.D. Anderson Cancer Center · Malaria Research and Training Center, Bamako, Mali · McGill University Health Centre/Research Institute of the McGill University Health Centre · Milton S. Hershey Medical Center · National Cancer Institute (NCI) · National Institute of Mental Health (NIMH) · Ningbo Medical Center Lihuili Hospital · Northern Jiangsu People's Hospital · Nova Scotia Health Authority · Oxford University Hospitals NHS Trust · Peking University Cancer Hospital & Institute · People's Hospital of Guangxi Zhuang Autonomous Region · Post Graduate Institute of Medical Education and Research, Chandigarh · Prokhorov General Physics Institute of the Russian Academy of Sciences (GPI RAS) · Provepharm Life Solutions · Provepharm SAS · Radboud University Medical Center · Ramathibodi Hospital · Roaa Hadi Hussein Jasem · Sandra Kalil Bussadori · Seoul National University Hospital · Shahid Beheshti University · Southwest Hospital, China · Stanley Medical Research Institute · São Paulo Research Foundation · Taizhou Enze Medical Center Group · all 103 on the full record

Regulatory milestones approvals, filings & regulatory actions · 4 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Filed methemoglobin reductase deficiency 1 milestone
Filed Japan (PMDA) — methemoglobin reductase deficiency 2014-03-17

“announced today that it has filed an NDA for the manufacture and marketing in Japan of the methaemoglobinaemia injection Methylene Blue” daiichisankyo.com ↗

Approved Indication not stated 3 milestones
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 78 · started per year

today
EU approved 2011
US approved 2016
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2004200520062007200820092010201120122013201420152016201720182019202020212022202320242025202620272028
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 05 trials
Phase 0 NCT07494773 Jun 2026 → May 2028 expected skin infection University of Oklahoma Not yet recruiting No outcome recorded
Phase 0 NCT07435415 Aug 2025 → Dec 2026 expected head and neck cancer China Medical University Hospital Active not recruiting No outcome recorded
Phase 0 NCT05850611 Apr → Aug 2023 ulcer of lower limbs Mashhad University of Medical Sciences Unknown No outcome recorded
Phase 0 NCT05232357 Mar → May 2022 digestive system neoplasm Affiliated Hospital to Academy of Military Medical Sciences Unknown No outcome recorded
Phase 0 NCT01836094 Aug 2013 → Mar 2016 — The University of Texas Health Science Center at San Antonio Completed No outcome recorded
Phase 18 trials
Phase 1 NCT07169487 Jun 2025 → Jun 2028 expected CADINS disease, cytokine release syndrome Institute of Hematology & Blood Diseases Hospital, China Recruiting No outcome recorded
Phase 1 NCT04619290 Oct → Nov 2020 COVID-19 Hospital Reg. Lic. Adolfo Lopez Mateos Unknown No outcome recorded
Phase 1 NCT04933864 Apr → May 2020 COVID-19 I.M. Sechenov First Moscow State Medical University Completed No outcome recorded
Phase 1 NCT04370288 Apr → Sep 2020 COVID-19 Mashhad University of Medical Sciences Unknown No outcome recorded
Phase 1 NCT04109859 Apr 2019 → Jan 2021 obstructive jaundice Jiaolin Ning,MD Unknown No outcome recorded
Phase 1 NCT02240498 Sep 2014 → Sep 2023 abscess University of Rochester Completed No outcome recorded
Phase 1 NCT01668433 Jul 2013 → Oct 2014 G6PD deficiency University of Oxford Completed No outcome recorded
Phase 1 NCT02478281 Oct 2012 hereditary methemoglobinemia American Regent, Inc. Completed No outcome recorded
Phase 1/21 trial
Phase 1/2 NCT05003492 Sep → Oct 2021 COVID-19 Amr kamel khalil Ahmed Unknown No outcome recorded
Phase 221 trials · 2 met primary · 1 missed
Phase 2 NCT06052956 Jul 2026 → Jun 2031 expected abscess University of Rochester Not yet recruiting No outcome recorded
Phase 2 NCT07179003 Apr 2026 → Mar 2031 expected breast abscess University of Rochester Not yet recruiting No outcome recorded
Phase 2 NCT07833319 Nov 2025 → Jul 2027 expected rectal cancer Peking University Cancer Hospital & Institute Recruiting No outcome recorded
Phase 2 NCT06887036 Sep 2025 → Oct 2026 expected chronic hepatitis B virus infection Fondazione Epatocentro Ticino Recruiting No outcome recorded
Phase 2 NCT05090657 Feb → Aug 2022 nosocomial infection Ondine Biomedical Inc. Completed No outcome recorded
Phase 2 NCT05004805 Aug → Dec 2021 COVID-19 Irkutsk Scientific Center of the Siberian Branch of the Russian Academy of Sciences Completed No outcome recorded
Phase 2 NCT07212842 Apr 2021 → Aug 2023 aortic valve disorder, cardiac valvular defect University of Sao Paulo Completed No outcome recorded
Phase 2 NCT04354012 Feb 2021 → Aug 2024 hidradenitis suppurativa Wake Forest University Health Sciences Completed No outcome recorded
Phase 2 NCT04635605 Nov 2020 → Aug 2021 COVID-19 Fondazione Epatocentro Ticino Completed No outcome recorded
Phase 2 NCT04376788 May → Jul 2020 COVID-19 Ain Shams University Unknown No outcome recorded
Phase 2/33 trials · 1 met primary
Phase 2/3 NCT07264543 Jan → Nov 2026 expected brain hypoxia - ischemia, infectious disease with sepsis Centro de Estudos e Pesquisa em Emergencias Medicas e Terapia Intensiva Recruiting No outcome recorded
Phase 2/3 NCT06306001 Mar 2024 → Mar 2026 overdue neonatal sepsis Post Graduate Institute of Medical Education and Research, Chandigarh Not yet recruiting No outcome recorded
Phase 2/3 NCT04446871 Mar 2017 → Dec 2020 infectious disease with sepsis Hospital Civil de Guadalajara Completed Met primary
Phase 311 trials
Phase 3 NCT07311057 Dec 2025 → Jan 2026 overdue skin squamous cell carcinoma Daryoush Hamidi Alamdari, PhD Enrolling by invitation No outcome recorded
Phase 3 NCT07311070 Oct 2025 → Jan 2026 overdue morpheaform basal cell carcinoma, nodular basal cell carcinoma, skin infiltrative basal cell carcinoma Daryoush Hamidi Alamdari, PhD Enrolling by invitation No outcome recorded
Phase 3 NCT06900140 Jun 2025 → Mar 2026 infectious disease with sepsis Dr. Shannon M. Fernando Completed No outcome recorded
Phase 3 NCT06702878 Dec 2024 → Apr 2026 infectious disease Ondine Biomedical Inc. Completed No outcome recorded
Phase 3 NCT06660680 Oct 2024 → Oct 2025 overdue hemorrhoid The Second Affiliated Hospital of Anhui University of Traditional Chinese Medicine Enrolling by invitation No outcome recorded
Phase 3 NCT06532240 Aug 2024 → Oct 2025 infectious disease with sepsis Northern Jiangsu People's Hospital Completed No outcome recorded
Phase 3 NCT04295993 Mar → Sep 2020 infectious disease with sepsis Cairo University Unknown No outcome recorded
Phase 3 NCT03038503 Dec 2016 → Dec 2018 infectious disease with sepsis Ramathibodi Hospital Unknown No outcome recorded
Phase 3 NCT01657448 Jun → Nov 2016 urethral syndrome EMS Completed No outcome recorded
Phase 3 NCT01797978 Feb 2013 → Jan 2016 infectious disease with sepsis Seoul National University Hospital Unknown No outcome recorded
Phase 46 trials
Phase 4 NCT07835932 Oct 2026 → Oct 2028 expected — Chinese University of Hong Kong Not yet recruiting No outcome recorded
Phase 4 NCT07861815 Oct 2026 → Oct 2027 expected colorectal cancer, ureteral disorder Chinese University of Hong Kong Not yet recruiting No outcome recorded
Phase 4 NCT07164807 Aug 2025 → Aug 2026 overdue hemorrhoid The Affiliated Hospital of Putian University Not yet recruiting No outcome recorded
Phase 4 NCT04187053 Feb 2020 → Dec 2022 — The University of Texas Health Science Center, Houston Completed No outcome recorded
Phase 4 NCT03395223 Jul 2018 → Aug 2020 methemoglobinemia Provepharm SAS Completed No outcome recorded
Phase 4 NCT03120637 Jan 2017 → Jan 2018 cirrhosis of liver, infectious disease with sepsis, vascular disorder Institute of Liver and Biliary Sciences, India Completed No outcome recorded
Phase not applicable23 trials · 1 met primary
— NCT06834087 Mar → Sep 2025 hyperpigmentation of the skin Roaa Hadi Hussein Jasem Completed No outcome recorded
— NCT06481410 Jun 2024 → Jun 2026 infectious disease with sepsis First Affiliated Hospital of Zhejiang University Unknown No outcome recorded
— NCT06520306 Mar → Aug 2024 overdue disease of bone structure Wang wanxia Enrolling by invitation No outcome recorded
— NCT06284941 Jun 2023 → Feb 2024 disease of bone structure Wang wanxia Completed Met primary
— NCT05830630 May 2023 → Feb 2027 expected — Tanta University Recruiting No outcome recorded
— NCT05664087 Feb → Nov 2023 periodontitis The Dental Hospital of Zhejiang University School of Medicine Completed No outcome recorded
— NCT04970602 Jun 2021 → Jun 2023 infectious disease with sepsis Xiangya Hospital of Central South University Unknown No outcome recorded
— NCT04529265 May 2021 → Apr 2023 delirium Fudan University Completed No outcome recorded
— NCT07866833 Jun 2020 → Aug 2025 psychotic disorder King's College London Completed No outcome recorded
— NCT03576105 Dec 2019 → Apr 2024 pericoronitis University of Nove de Julho Unknown No outcome recorded
Comparator or background therapy25 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 Stop: Enrollment
Phase 2 NCT05092165 Comparator Oct 2021 → Dec 2025 acute kidney injury Federal University of São Paulo Completed No outcome recorded

News releases announcing trial results or a regulatory action · 4

DateIssuerRelease
2022-09-20 Ondine Biomedical Inc. Results Photodisinfection successfully eradicates pathogens associated with replacement joint infections ondinebio.com ↗
A research team in Zurich, Switzerland has presented results from an in vitro study showing that photodisinfection achieved >99.99% eradication (4-7 log 10 kill) of the key pathogens in biofilms associated with implantable joint infections, with no reported regrowth.
2022-04-05 Ondine Biomedical Inc. Results Photodisinfection effective against SARS-CoV-2 ondinebio.com ↗
Our results show that photodisinfection with methylene blue is highly effective against in vitro isolates of SARS-CoV-2.
2015-01-05 Daiichi Sankyo Regulatory Daiichi Sankyo Receives Approval in Japan for the Manufacture and Marketing of Methemoglobinemia Treatment Methylene Blue Injection 50 mg daiichisankyo.com ↗
Daiichi Sankyo Receives Approval in Japan for the Manufacture and Marketing of Methemoglobinemia Treatment Methylene Blue Injection 50 mg
2014-03-17 Daiichi Sankyo Regulatory Daiichi Sankyo Files NDA in Japan for Methaemoglobinaemia Injection Methylene Blue daiichisankyo.com ↗
Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) announced today that it has filed an NDA for the manufacture and marketing in Japan of the methaemoglobinaemia injection Methylene Blue ( INN: Methylthioninium chloride).

Evidence & citations 34 cited values

Every value below carries the sentence it was read from. 107 sources stand behind the page.

FieldValueCited text
Known as Methylene Blue “Bacterial or Viral infection treatment may include: Doxycycline, Minocycline, Nitazoxanide, Hydroxychloroquine, Rifampin, Dapsone, Azithromycin, Tetracycline, Benzathine...” NCT05894954 ↗
99

“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 ↗

NCT02295774 ↗

NCT02555488 ↗

NCT03200808 ↗

NCT07311057 ↗

NCT03406676 ↗

Show 89 more sources

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 2019
1

“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 ↗

NCT01657448 ↗

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 ↗