Numerous clinical trials spanning Early Phase 1 through Phase 4 evaluate Methylene Blue across diverse therapeutic areas, including infectious and inflammatory diseases (such as malaria, periodontitis, healthcare-associated infections, and COVID-19), dermatological conditions like lichen amyloidosis, and functional brain activity mapping. Sponsored by academic institutions, healthcare systems, and corporate entities, these investigations encompass various operational statuses, ranging from actively recruiting and completed protocols to terminated studies and trials enrolling by invitation.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT07179003 | NOT_YET_RECRUITING | Breast Abscess |
University of Rochester |
2027-07 | PHASE2 |
| NCT06052956 | NOT_YET_RECRUITING | Abscess |
University of Rochester |
2026-07-15 | PHASE2 |
| NCT07169487 | RECRUITING | Cytokine Release Syndrome; ICANS |
Institute of Hematology & Blood Diseases Hospital, China |
2025-06-28 | PHASE1 |
| NCT07494773 | NOT_YET_RECRUITING | Burns; Wound Infection |
University of Oklahoma |
2026-06 | EARLY_PHASE1 |
| NCT07749794 | NOT_YET_RECRUITING | Prostatic Hyperplasia; Lower Urinary Tract Symptoms |
Benha University |
2026-08-15 | |
| NCT07736339 | NOT_YET_RECRUITING | Chromogenic Extrinsic Tooth Stains |
Cairo University |
2026-09-01 | |
| NCT06887036 | RECRUITING | Chronic HBV Infection |
Fondazione Epatocentro Ticino |
2025-09-01 | PHASE2 |
| NCT07532096 | NOT_YET_RECRUITING | Breast Cancer |
Xijing Hospital |
2026-04-25 | |
| NCT05830630 | RECRUITING | Perineural; Methylene Blue; Lower Limb Amputation |
Tanta University |
2023-05-01 | |
| NCT07324954 | RECRUITING | Total Knee Arthroplasty; Prosthetic-joint Infection; Irrigation |
University of Miami |
2026-02-04 | PHASE1 |
| NCT07463859 | RECRUITING | Type 2 Diabetes; Halitosis; Periodontitis |
University of Sao Paulo |
2026-04-02 | |
| NCT07435415 | ACTIVE_NOT_RECRUITING | Head and Neck Cancer; Local Recurrent Tumor |
China Medical University Hospital |
2025-08-01 | EARLY_PHASE1 |
| NCT07264543 | RECRUITING | Septic Shock; Hypoperfusion |
Centro de Estudos e Pesquisa em Emergencias Medicas e Terapia Intensiva |
2026-01-09 | PHASE2; PHASE3 |
| NCT07164807 | NOT_YET_RECRUITING | Mixed Hemorrhoids; Milligan-Morgan Hemorrhoidectomy; Methylene Blue |
The Affiliated Hospital of Putian University |
2025-08-30 | PHASE4 |
| NCT07012343 | ACTIVE_NOT_RECRUITING | Onychomycosis of Toenails; Onychomycosis of Fingernail |
Chulalongkorn University |
2025-01-13 | |
| NCT06481410 | UNKNOWN | Septic Shock; Methylene Blue; Sepsis |
First Affiliated Hospital of Zhejiang University |
2024-06-22 | |
| NCT07040657 | RECRUITING | Endometrial Neoplasms; Endometrial Cancer Stage I; Sentinel Lymph Node; Metastasis |
Dokuz Eylul University |
2025-05-01 | |
| NCT06306001 | NOT_YET_RECRUITING | Neonatal Sepsis; Shock, Septic |
Post Graduate Institute of Medical Education and Research, Chandigarh |
2024-03-15 | PHASE2; PHASE3 |
| NCT06900140 | COMPLETED | Septic Shock |
Dr. Shannon M. Fernando |
2025-06-02 | PHASE3 |
| NCT06426550 | COMPLETED | Periodontitis; Periodontitis, Adult |
Universidade Federal Fluminense |
2024-05-06 | |
| NCT07311057 | ENROLLING_BY_INVITATION | SCC - Squamous Cell Carcinoma; SCC - Squamous Cell Carcinoma of Skin; Inoperable Disease |
Daryoush Hamidi Alamdari, PhD |
2025-12-20 | PHASE3 |
| NCT07311070 | ENROLLING_BY_INVITATION | Advanced Basal Cell Carcinoma (BCC); Inoperable Disease; Morpheaform Basal Cell Carcinoma; Noduloulcerative Basal Cell Carcinoma; Infiltrative Basal Cell Carcinoma |
Daryoush Hamidi Alamdari, PhD |
2025-10-21 | PHASE3 |
| NCT07395388 | COMPLETED | Benign Multinodular Goiter; Thyroidectomy; Recurrent Laryngeal Nerve Injury; Hypoparathyroidism |
Services Hospital, Lahore |
2022-01-10 | |
| NCT05092165 | COMPLETED | Acute Kidney Injury; Shock; Intradialytic Hypotension; Intradialytic Hypertension in Hemodialysis Patients |
Federal University of São Paulo |
2021-10-21 | PHASE2 |
| NCT06532240 | COMPLETED | Septic Shock |
Northern Jiangsu People's Hospital |
2024-08-05 | PHASE3 |
| NCT06660680 | ENROLLING_BY_INVITATION | Mixed Hemorrhoids |
The Second Affiliated Hospital of Anhui University of Traditional Chinese Medicine |
2024-10-25 | PHASE3 |
| NCT06834087 | ENROLLING_BY_INVITATION | Physiological Gingival Pigmentation |
Roaa Hadi Hussein Jasem |
2025-03-15 | |
| NCT01847612 | COMPLETED | Liver Disease |
Centre Hospitalier Universitaire, Amiens |
2013-07-08 | PHASE3 |
| NCT06801938 | RECRUITING | Incontinence Stress |
Gaziosmanpasa Research and Education Hospital |
2025-01-01 | |
| NCT06413836 | UNKNOWN | Periodontitis; Fistula |
University of Nove de Julho |
2024-05-01 | |
| NCT07067814 | COMPLETED | Time Taken for Identification of Single Recurrent Laryngeal Nerve; Intra-operative Blood Loss |
Ain Shams University |
2023-06-01 | PHASE2; PHASE3 |
| NCT05878405 | COMPLETED | Hematopoietic and Lymphoid System Neoplasm; Malignant Solid Neoplasm; Stomatitis |
Mayo Clinic |
2023-06-06 | PHASE3 |
| NCT06133699 | UNKNOWN | Testicular Germ Cell Tumor |
N.N. Petrov National Medical Research Center of Oncology |
2023-11-08 | |
| NCT06469294 | COMPLETED | Diabetes Mellitus, Type 2; Periodontitis, Adult; Periodontitis |
Universidade Federal Fluminense |
2024-05-30 | |
| NCT04089072 | UNKNOWN | Septic Shock |
Carilion Clinic |
2019-12-01 | PHASE2 |
| NCT06520306 | UNKNOWN | Femoral Neck Disease |
Wang wanxia |
2024-03-15 | |
| NCT04354012 | COMPLETED | Hidradenitis Suppurativa (HS) |
Wake Forest University Health Sciences |
2021-02-04 | PHASE2 |
| NCT07129135 | COMPLETED | Placenta Accreta Spectrum; Abnormal Placentation; Cesarean Hysterectomy; Urinary Tract Injury; Bladder Injury |
Usama Ahmed Elsaeed Salem, MD |
2023-01-22 | |
| NCT05990569 | UNKNOWN | Hemorrhoids; Anal Fissure and Fistula; Perianal Abscess; Perianal Fistula; Pilonidal Sinus; Perianal Skin Tags |
Nepal Mediciti Hospital |
2023-08-12 | |
| NCT06005558 | COMPLETED | Septic Shock |
National Cancer Institute, Egypt |
2023-08-01 | PHASE2; PHASE3 |
| NCT03576105 | COMPLETED | Pericoronitis |
University of Nove de Julho |
2019-12-01 | |
| NCT06284941 | COMPLETED | Femoral Neck Disease |
Wang wanxia |
2023-06-20 | |
| NCT05401370 | UNKNOWN | Parotid Tumor |
Assiut University |
2022-06 | |
| NCT02240498 | COMPLETED | Abscess |
University of Rochester |
2014-09 | PHASE1 |
| NCT07212842 | COMPLETED | Cardiopulmonary Bypass Surgery; Aortic Valve Surgery; Mitral Valve Surgery; Myocardial Revascularization Surgery With Extracorporeal Circulation |
University of Sao Paulo |
2021-04-12 | PHASE2 |
| NCT05850611 | UNKNOWN | Diabetic Foot Ulcers; Diabetic Wound |
Mashhad University of Medical Sciences |
2023-04-30 | EARLY_PHASE1 |
| NCT05111808 | UNKNOWN | Fluorescence Guided Surgery |
University College, London |
2020-06-22 | |
| NCT04970602 | UNKNOWN | Septic Shock |
Xiangya Hospital of Central South University |
2021-06-20 | |
| NCT05367869 | UNKNOWN | Impact of Intraoperative Spraying Methylene Blue In Thyroidectomy |
Qena Oncology Center |
2022-06-01 | |
| NCT03068208 | COMPLETED | Lichen Amyloidosis |
Chulalongkorn University |
2022-05-01 | |
| NCT04529265 | COMPLETED | Postoperative Delirium |
Fudan University |
2021-05-01 | |
| NCT04054999 | COMPLETED | Vasoplegic Syndrome; Liver Transplant; Complications |
Mayo Clinic |
2019-11-30 | PHASE4 |
| NCT05797818 | COMPLETED | Healthcare Associated Infection; Nosocomial Infection; Surgical Site Infection |
Ondine Biomedical Inc. |
2023-01-10 | PHASE1; PHASE2 |
| NCT04187053 | COMPLETED | DENT IMPLANTS; LASER |
The University of Texas Health Science Center, Houston |
2020-02-14 | PHASE4 |
| NCT05812521 | COMPLETED | Post Operative Pain; Thoracic Cancer |
University of Campania Luigi Vanvitelli |
2020-01-15 | |
| NCT05162417 | COMPLETED | Periodontal Diseases; Periodontal Pocket |
University of Sulaimani |
2021-11-15 | |
| NCT05547685 | UNKNOWN | Neurologic Findings |
National Taiwan University Hospital |
2020-04-10 | |
| NCT05090657 | COMPLETED | Surgical Site Infections; Nosocomial Infection; Healthcare Associated Infections |
Ondine Biomedical Inc. |
2022-02-04 | PHASE2 |
| NCT03049345 | UNKNOWN | Gastric Cancer; Sentinel Lymph Node; Early Gastric Cancer |
McGill University Health Centre/Research Institute of the McGill University Health Centre |
2016-07-01 | |
| NCT04620785 | UNKNOWN | Verruca Vulgaris |
Alexandria University |
2020-01-01 | |
| NCT05232357 | UNKNOWN | Gastrointestinal Neoplasms; Abnormality of Enteric Nervous System Morphology |
Affiliated Hospital to Academy of Military Medical Sciences |
2022-03-01 | EARLY_PHASE1 |
| NCT02380573 | COMPLETED | Mild Cognitive Impairment; MCI; Aging; Alzheimer's Disease; AD |
The University of Texas Health Science Center at San Antonio |
2015-07 | PHASE2 |
| NCT03469284 | COMPLETED | Malignant Neoplasm; Oral Pain; Stomatitis |
M.D. Anderson Cancer Center |
2019-02-28 | PHASE2 |
| NCT05004805 | COMPLETED | Covid19 |
Irkutsk Scientific Center of the Siberian Branch of the Russian Academy of Sciences |
2021-08-06 | PHASE2 |
| NCT06553144 | COMPLETED | Apical Periodontitis |
University of Gaziantep |
2021-02-01 | |
| NCT05003492 | UNKNOWN | COVID-19 |
Amr kamel khalil Ahmed |
2021-09 | PHASE1; PHASE2 |
| NCT04635605 | COMPLETED | SARS-CoV2 |
Fondazione Epatocentro Ticino |
2020-11-05 | PHASE2 |
| NCT04842968 | COMPLETED | Lymph Node Metastases; Colorectal Cancer |
St. Borbala Hospital |
2021-04-15 | |
| NCT04615936 | COMPLETED | COVID-19; Corona Virus Infection; SARS-CoV 2 |
Sunnybrook Health Sciences Centre |
2020-10-13 | |
| NCT05113628 | COMPLETED | Methylene Blue; Recurrent Laryngeal Nerve Injuries; Parathyroid Gland |
Zagazig University |
2020-01-15 | |
| NCT04621123 | COMPLETED | SARS-CoV-2 Infection; Safety and Efficacy |
Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia |
2020-11-10 | PHASE2 |
| NCT04547127 | COMPLETED | COVID-19 |
Instituto Grifols, S.A. |
2020-04-29 | PHASE2 |
| NCT04109859 | UNKNOWN | Jaundice |
Jiaolin Ning,MD |
2019-04-01 | PHASE1 |
| NCT04446871 | COMPLETED | Septic Shock |
Hospital Civil de Guadalajara |
2017-03-17 | PHASE2; PHASE3 |
| NCT04619290 | UNKNOWN | Sars Cov 2 |
Hospital Reg. Lic. Adolfo Lopez Mateos |
2020-10-12 | PHASE1 |
| NCT04370288 | UNKNOWN | Covid-19 |
Mashhad University of Medical Sciences |
2020-04-19 | PHASE1 |
| NCT04295993 | UNKNOWN | Septic Shock |
Cairo University |
2020-03-10 | PHASE3 |
| NCT03395223 | COMPLETED | Acquired Methaemoglobinaemia |
Provepharm SAS |
2018-07-06 | PHASE4 |
| NCT04376788 | UNKNOWN | COVID-19 |
Ain Shams University |
2020-05-20 | PHASE2 |
| NCT04933864 | COMPLETED | SARS-CoV-2 |
I.M. Sechenov First Moscow State Medical University |
2020-04-24 | PHASE1 |
| NCT03446599 | WITHDRAWN | Vasoplegia; Hypotension; Coronary Artery Disease; Cardiac Valve Disease |
Dartmouth-Hitchcock Medical Center |
2019-11 | PHASE2 |
| NCT04341844 | COMPLETED | Postoperative Delirium; Postoperative Cognitive Dysfunction |
Fudan University |
2019-01-14 | |
| NCT03222544 | UNKNOWN | Diabetic Extremity Lower Ulcers |
Chongqing Medical University |
2019-04-29 | |
| NCT04110418 | UNKNOWN | Neonatal Sepsis; Refractory Shock |
Ain Shams University |
2019-02-19 | PHASE2 |
| NCT05122117 | COMPLETED | Rheumatoid Arthritis; Chronic Periodontitis |
Zohaib Akram |
2019-03-04 | |
| NCT03316677 | UNKNOWN | ColoRectal Cancer; Colonic Diverticulitis; Anastomotic Leak; Anastomotic Complication; Anastomosis |
Meir Medical Center |
2017-11-01 | |
| NCT03579979 | COMPLETED | Sentinel Lymph Node; Breast Cancer |
Chinese Academy of Sciences |
2017-08-24 | |
| NCT03098342 | COMPLETED | Onychomycosis of Toenail |
Chulalongkorn University |
2017-06-01 | |
| NCT03038503 | UNKNOWN | Septic Shock; Refractory Shock |
Ramathibodi Hospital |
2016-12 | PHASE3 |
| NCT03406676 | UNKNOWN | Obstructive Jaundice |
Southwest Hospital, China |
2017-08-01 | |
| NCT03200808 | COMPLETED | Nonneoplastic Epithelial Disorders of Vulva |
Maternal and Child Health Hospital of Hubei Province |
2013-10-01 | PHASE1 |
| NCT03252210 | UNKNOWN | Thoracic Surgery, Video-Assisted |
Guangdong Provincial People's Hospital |
2017-08-16 | |
| NCT04056923 | COMPLETED | Pulmonary Nodule, Solitary; Lung Cancer |
Wen-zhao ZHONG |
2018-01-01 | |
| NCT03386201 | UNKNOWN | Bile Duct Injury |
University of Oxford |
2018-01-01 | |
| NCT03120637 | COMPLETED | Septic Shock; Vasoplegia; Cirrhosis, Liver; Refractory Shock |
Institute of Liver and Biliary Sciences, India |
2017-01-01 | PHASE4 |
| NCT03178747 | UNKNOWN | Herpes Simplex; Herpes Zoster; Varicella Zoster |
Chulalongkorn University |
2017-03-07 | PHASE3 |
| NCT02696928 | WITHDRAWN | Vivax Malaria |
Heidelberg University |
2016-04 | PHASE2 |
| NCT03262077 | COMPLETED | Chronic Periodontitis |
University of Nove de Julho |
2016-10-11 | |
| NCT03177070 | COMPLETED | Ureteric Injury; Surgery; Surgery--Complications |
University of Oxford |
2016-05-09 | PHASE2 |
| NCT02910765 | UNKNOWN | Sepsis |
Assiut University |
2016-10 | PHASE4 |
| NCT02831023 | COMPLETED | Malaria |
University of California, San Francisco |
2016-07 | PHASE2 |
| NCT02982148 | UNKNOWN | Breast Cancer Female; Early-Stage Breast Cancer; Sentinel Lymph Node |
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University |
2015-05 | PHASE4 |
| NCT02851108 | COMPLETED | Malaria, Falciparum |
Heidelberg University |
2016-10 | PHASE2 |
| NCT02938988 | COMPLETED | Periodontal Diseases |
University of Sao Paulo |
2013-10 | |
| NCT01694966 | COMPLETED | Colorectal Cancer |
Cosmo Technologies Ltd |
2013-09 | PHASE3 |
| NCT05085509 | COMPLETED | Foreign Bodies; Ultrasound |
Yuxi Su |
2016-05-01 | |
| NCT01836094 | COMPLETED | Brain Activity |
The University of Texas Health Science Center at San Antonio |
2013-08 | EARLY_PHASE1 |
| NCT02057393 | COMPLETED | Melanoma; Sentinel Node |
Milton S. Hershey Medical Center |
2014-06 | |
| NCT01797978 | UNKNOWN | Severe Sepsis; Septic Shock |
Seoul National University Hospital |
2013-02 | PHASE3 |
| NCT02555488 | UNKNOWN | Periradicular Disease |
Shahid Beheshti University |
2015-01 | PHASE2 |
| NCT02084784 | COMPLETED | Sentinel Lymph Node; Breast Cancer |
Chinese Academy of Sciences |
2014-01 | |
| NCT02368067 | UNKNOWN | Endometrial Carcinoma |
Southeastern Regional Medical Center |
2014-06 | |
| NCT02969005 | COMPLETED | Bone Diseases |
Children's Hospital of Chongqing Medical University |
2010-01 | |
| NCT02295774 | COMPLETED | Colorectal Cancer |
Cosmo Technologies Ltd |
2013-02 | PHASE2 |
| NCT01668433 | COMPLETED | G6PD Normal; G6PD Deficient; Healthy |
University of Oxford |
2013-07 | PHASE1 |
| NCT00159510 | TERMINATED | Sepsis |
Northern State Medical University |
2004-04 | PHASE1 |
| NCT01725477 | COMPLETED | Methylene Blue; Laparoscopy; Tubal Patency |
Pourmatroud, Elham, M.D. |
2012-09 | |
| NCT01823172 | COMPLETED | Breast Cancer; Melanoma |
Mayo Clinic |
2013-04 | |
| NCT01981460 | COMPLETED | Light; Therapy, Complications |
Massachusetts General Hospital |
2013-05 | |
| NCT01539135 | COMPLETED | Respiratory Aspiration |
Medtronic - MITG |
2012-04 | |
| NCT01188694 | COMPLETED | Chronic Posttraumatic Stress Disorder |
University of Washington |
2009-09 | PHASE2 |
| NCT00070317 | TERMINATED | Cervical Adenocarcinoma; Cervical Adenosquamous Carcinoma; Cervical Squamous Cell Carcinoma; Stage I Cervical Cancer |
Gynecologic Oncology Group |
2004-06 | |
| NCT01386879 | TERMINATED | Secretion Removal Above ETT Cuff |
Thomas Jefferson University |
2011-07 | PHASE4 |
| NCT02478281 | COMPLETED | Methemoglobinemia; Congenital Methemoglobinemia |
American Regent, Inc. |
2012-10 | PHASE1 |
| NCT01520324 | COMPLETED | Ulcerative Colitis |
Cosmo Technologies Ltd |
2012-01 | PHASE2 |
| NCT02303886 | COMPLETED | Neuropathic Pain |
Uppsala University |
2009-03 | |
| NCT01513382 | COMPLETED | Pilonidal Sinus |
Bezmialem Vakif University |
2012-01 | |
| NCT03287219 | COMPLETED | Colon Staining in Preparation for Colonoscopy |
Cosmo Technologies Ltd |
2011-05-02 | PHASE2 |
| NCT01276054 | TERMINATED | Lymphedema; Recurrent Breast Cancer; Stage IA Breast Cancer; Stage IB Breast Cancer; Stage II Breast Cancer |
University of Southern California |
2010-12 | PHASE2 |
| NCT01407887 | COMPLETED | Uncomplicated Falciparum Malaria |
Heidelberg University |
2011-08 | PHASE2 |
| NCT00784849 | COMPLETED | Breast Cancer |
Louisiana State University Health Sciences Center in New Orleans |
2004-11 | PHASE2 |
| NCT00235183 | COMPLETED | Bleeding in Liver Transplantation |
Etablissement Français du Sang |
2005-06 | PHASE4 |
| NCT01073124 | COMPLETED | Traumatic Knee Arthrotomy |
United States Naval Medical Center, San Diego |
2008-05 | |
| NCT00314405 | COMPLETED | Infiltrative Breast Cancer |
University Hospital, Strasbourg, France |
2006-04 | |
| NCT00917202 | COMPLETED | Malaria |
Heidelberg University |
PHASE2 | |
| NCT00486174 | WITHDRAWN | Sepsis |
Queen's University |
2007-06 | |
| NCT00354380 | COMPLETED | Malaria |
Heidelberg University |
2006-09 | PHASE2 |
| NCT00214877 | COMPLETED | Bipolar Disorder |
Nova Scotia Health Authority |
2003-11 | PHASE3 |
| NCT00545935 | COMPLETED | Malaria |
Heidelberg University |
2007-07 | PHASE2 |
(data from https://clinicaltrials.gov, updated on 2026-08-19)
Check the
Methylene Blue
product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.
Mechanism and Biochemical Profile
Appendix RUO and cGMP Quality Standards
| Quality Dimension | RUO (Research Use Only) | cGMP (Current Good Manufacturing Practice) |
|---|---|---|
| Clinical Applicability | Prohibited in human clinical trials or medical diagnostics. | Mandatory for human clinical trials (Phase I–III) and therapies. |
| Regulatory Status | Non-regulated grade; exempt from drug manufacturing laws. | Legally enforced by health authorities (e.g., FDA, EMA, NMPA). |
| Facility Environment | Unclassified analytical or research laboratories. | Validated Cleanrooms (ISO Class 5–8) with continuous monitoring. |
| Quality Control | Basic purity and activity testing. | Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma). |
| Process Validation | Basic equipment calibration; no process validation required. | Full qualification (IQ/OQ/PQ) and complete batch records. |
| Quality Assurance | Vendor self-declared without required formal QMS. | Mandatory QA/QC unit, Change Control, CAPA, and vendor audits. |
| Regulatory Impact | High risk of IND rejection if used as a critical raw material. | Required for IND/NDA filings, supported by Drug Master Files (DMF). |
Footnotes
Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).
Note: Technical data last updated: Sep 1, 2026.