7 registrations that name methylene blue as a study arm and are recruiting or about to, as ClinicalTrials.gov listed them on Oct 20, 2026. Read each listing for its full criteria and current status.
Kymata never assesses eligibility. Each listing names its own criteria; only its study team can say whether someone can join. Trial doses are given under the trial's monitoring and are not a schedule for anyone outside it.
Filter 7 registrations
Status
Phase
4US sites across 2 states
1
2 to 4
5 to 19
20 or more
All 7 registrations
RecruitingNCT07169487
Adjunctive Methylene Blue for Immunotherapy-related CRS and ICANS: Phase I Study
Phase 1
Institute of Hematology & Blood Diseases Hospital, China
About 18 people
Started Jun 28, 2025
In plain words A Phase 1 study of methylene blue in people 18 and older, run by Institute of Hematology & Blood Diseases Hospital, China. It plans to enroll about 18 people at 1 site, none in the US.
Who it lists and where
Who the trial lists, as registered
Lists people 18 and older. Conditions: Cytokine Release Syndrome; ICANS.
Diagnosed with hematologic malignancies based on cytomorphology and immunophenotyping; age ≥18 years.
Received immunotherapy (e.g., CAR-T cells, bispecific antibodies) and developed CRS or ICANS of ASTCT Grade ≥1.
Estimated life expectancy ≥3 months.
Male and female participants of childbearing potential agree to use effective contraception.
2 more inclusion criteria and the exclusion criteria are on the listing.
What it tests, as registered
Methylene Blue
Registered summary
This Phase I, prospective, single-arm clinical study aims to evaluate the efficacy and safety of adjunctive methylene blue (MB) in patients experiencing cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS) following CAR-T cell therapy or bispecific antibody treatment. Preclinical studies demonstrated that MB alleviates CRS/ICANS-related symptoms, preserves the antitumor function of T cells, and modulates neuroinflammation without compromising immune efficacy. The full summary is on the listing.
Where, as registered
No US site; China (1).
RecruitingNCT06887036
Methylene Blue Treatment of Chronic Hepatitis B Virus Infection
Phase 2
Fondazione Epatocentro Ticino
About 10 people
Started Sep 1, 2025
In plain words A Phase 2 study of methylene blue in people 18 to 79, run by Fondazione Epatocentro Ticino. It plans to enroll about 10 people at 1 site, none in the US.
Who it lists and where
Who the trial lists, as registered
Lists people 18 to 79. Conditions: Chronic HBV Infection.
Signed informed consent
Age ≥ 18 and < 80 years
Microbiologically confirmed chronic Hepatitis B Virus infection (according to the old terminology "inactive HBV carrier")
HBsAg levels within 20-15'000 IU/ml measured at the at least twice at 6-18 months apart
2 more inclusion criteria and the exclusion criteria are on the listing.
What it tests, as registered
Methylene Blue
Registered summary
HBV infection is a global public health problem. It is estimated that there are more than 250 million HBV carriers worldwide, of whom approximately 600,000 die each year from HBV-related liver disease. Diagnosis and treatment depend on the stage of infection, the degree of liver inflammation, and the progression of fibrosis. Patients with HBeAg-positive or -negative hepatitis are usually treated with nucleos(-t)ide analogues. This treatment inhibits HBV reverse transcriptase and reduces viral replication, but does not affect HBsAg production. The full summary is on the listing.
Where, as registered
No US site; Switzerland (1).
Not yet recruitingNCT06052956
Efficacy of Methylene Blue Photodynamic Therapy for Treatment of Deep Tissue Abscesses
Phase 2
University of Rochester
About 120 people
Starts Jul 15, 2026 (estimated)
In plain words A Phase 2 study of methylene blue in people 18 and older, run by University of Rochester. It plans to enroll about 120 people at 2 US sites.
Who it lists and where
Who the trial lists, as registered
Lists people 18 and older. Conditions: Abscess.
Adults 18 years or older
All patients with clinical symptoms (ex: fever, chills, pain, tachycardia, hypotension), laboratory (leukocytosis) and radiologic findings (thick walled, rim-enhancing collection with gas bubbles or air-fluid levels) compatible with an…
Approval by the primary care team to pursue PDT and discuss enrollment with the patient
The exclusion criteria are on the listing.
What it tests, as registered
Methylene Blue; Lipid Emulsion; Insertion of optical fiber; Laser Illumination (pre-defined dose); Optical Spectroscopy Measurement; Laser Illumination (patient-specific dose); Standard of care abscess drainage
Registered summary
The objective of this Phase 2 study is to evaluate the efficacy of methylene blue photodynamic therapy (MB-PDT) performed at the time of percutaneous abscess drainage for disinfection of deep tissue abscesses. The study includes three arms: (1) MB-PDT at a fixed drug/light dose plus standard of care abscess drainage , (2) MB-PDT at a patient-specific dose determined by pre-treatment optical measurements plus standard of care abscess drainage , and (3) standard of care abscess drainage. The primary endpoint is reduction in time to removal of the drainage catheter.
Where, as registered
2 US sites in 1 state.
Not yet recruitingNCT07179003
A Phase 2 Study of Methylene Blue Photodynamic Therapy for Treatment of Breast Abscesses
Phase 2
University of Rochester
About 50 people
Starts Jul 2027 (estimated)
In plain words A Phase 2 study of methylene blue in people 18 and older, run by University of Rochester. It plans to enroll about 50 people at 1 US site.
Who it lists and where
Who the trial lists, as registered
Lists people 18 and older. Conditions: Breast Abscess.
Adults 18 years or older
Clinical signs of breast abscess, including pain, redness, and/or heat of the breast
Approval by the primary care team to pursue PDT and discuss enrollment with the patient
The exclusion criteria are on the listing.
What it tests, as registered
Standard of care breast abscess drainage; Methylene Blue; Lipid Emulsion; Insertion of optical fiber; Laser illumination; Photodynamic therapy
Registered summary
The objective of this Phase 2 study is to evaluate the efficacy of methylene blue photodynamic therapy (MB-PDT) performed at the time of percutaneous breast abscess drainage for disinfection of breast abscesses. The study includes two arms: (1) standard of care breast abscess drainage and (2) MB-PDT plus standard of care breast abscess drainage. The primary endpoint is time to resolution of clinical symptoms. Secondary endpoints include imaging evidence of abscess resolution, abscess recurrence, need for repeated intervention, and cure rate across treatment groups. The full summary is on the listing.
Where, as registered
1 US site in 1 state.
Not yet recruitingNCT07494773
Topical Methylene Blue-Photodynamic Therapy (MB-PDT) for Burn Wound Infection
Early phase 1
University of Oklahoma
About 50 people
Starts Jun 2026 (estimated)
In plain words An early phase 1 study of methylene blue in people 18 and older, run by University of Oklahoma. It plans to enroll about 50 people at 1 US site.
Who it lists and where
Who the trial lists, as registered
Lists people 18 and older. Conditions: Burns; Wound Infection.
Age ≥18
Partial- or full-thickness burn with partial-thickness component
Expected ≥7 days dressing changes
Able to consent
5 more inclusion criteria and the exclusion criteria are on the listing.
What it tests, as registered
Methylene Blue; Blue Light Illumination
Registered summary
Burn wound infections remain a major source of morbidity in patients with thermal injuries and contribute to delayed healing, graft loss, and prolonged hospitalization. The emergence of antimicrobial-resistant organisms further complicates management and highlights the need for non-antibiotic antimicrobial strategies. Photodynamic therapy (PDT) is an antimicrobial approach that combines a photosensitizing agent with visible light to generate reactive oxygen species capable of killing bacteria. The full summary is on the listing.
Where, as registered
1 US site in 1 state.
Not yet recruitingNCT07164807
Efficacy of Methylene Blue Plus Ropivacaine for Post-Hemorrhoidectomy Pain.
Phase 4
The Affiliated Hospital of Putian University
About 177 people
Starts Aug 30, 2025 (estimated)
In plain words A Phase 4 study of methylene blue in people 18 to 75, run by The Affiliated Hospital of Putian University. It plans to enroll about 177 people at 1 site, none in the US.
Who it lists and where
Who the trial lists, as registered
Lists people 18 to 75. Conditions: Mixed Hemorrhoids; Milligan-Morgan Hemorrhoidectomy; Methylene Blue.
Aged between 18 and 75 years.
Diagnosed with Grade III-IV hemorrhoids according to the Goligher classification.
Scheduled to undergo standard Milligan-Morgan hemorrhoidectomy.
Procedure performed under spinal anesthesia alone.
The exclusion criteria are on the listing.
What it tests, as registered
Methylene Blue (0.3%) with Ropivacaine Hydrochloride (0.75%); Methylene Blue (0.1%) with Ropivacaine Hydrochloride (0.75%)
Registered summary
Revised Translation (Academic English): As one of the most prevalent anorectal disorders, mixed hemorrhoids continue to rely on the Milligan-Morgan hemorrhoidectomy as the gold-standard surgical approach. While this technique demonstrates well-established efficacy, managing acute postoperative pain-particularly during the critical 24-72-hour peak pain window-remains a persistent clinical challenge. Recent advancements in multimodal analgesia have highlighted the potential of local nerve blockers, with methylene blue (MB) gaining scientific interest due to its prolonged analgesic properties. The full summary is on the listing.
Where, as registered
No US site; China (1).
Not yet recruitingNCT06306001
Intravenous Methylene Blue for Treating Refractory Neonatal Septic Shock
Phase 2 and 3
Post Graduate Institute of Medical Education and Research, Chandigarh
About 130 people
Starts Mar 15, 2024 (estimated)
In plain words A Phase 2 and 3 study of methylene blue in people 0 days to 28 days, run by Post Graduate Institute of Medical Education and Research, Chandigarh. It plans to enroll about 130 people at 1 site, none in the US.
Who it lists and where
Who the trial lists, as registered
Lists people 0 days to 28 days. Conditions: Neonatal Sepsis; Shock, Septic.
Definite/probable sepsis :Clinical syndrome of sepsis for which bedside neonatologist starts intravenous antibiotics AND either a positive culture of otherwise sterile body fluid OR presence of any 2 or more of the following five markers…
Shock: adapted from the definition given by Davis et al 2017
Either SBP < age and gestation appropriate cut-off OR
Presence of any 2 of the following 6 parameters i. HR >205/min ii. Central pulses either week OR bounding iii. CRT >3 sec OR flash refill (<1 sec) iv. skin mottled/cool OR flushed v. urine output <0.5 ml/kg/h in the preceding 6 hours vi.
1 more inclusion criterion and the exclusion criteria are on the listing.
What it tests, as registered
Methylene Blue; Placebo
Registered summary
Preterm infants (born at less than 37 weeks of pregnancy) sometimes develop a serious blood infection leading to low blood pressure, which does not respond to saline or to the standard medicines for increasing blood pressure, such as dopamine and epinephrine. The goal of this research study is to compare the effect of giving an injectable medicine called Methylene blue (MB) versus not giving MB to such preterm infants who are unresponsive to standard treatment. The main questions that this study aims to answer is: 1. The full summary is on the listing.