Methylene Blue clinical trials
Methylene Blue is named as an intervention in 6 current clinical trials in our China, India, Taiwan, Switzerland and Brazil registers. 4 are recruiting patients now. The most common phase is Phase 2/3. The sponsor with the most trials is Post Graduate Institute of Medical Education and Research, Chandigarh (1). The most-studied condition is Neonatal Sepsis.
Where Methylene Blue is approved
All regulators →Of the three regulators tracked here, the first to approve Methylene Blue was the US, on 8 Apr 2016.
From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.
Methylene Blue patents and exclusivity
Expiry tracker →Protections still running for marketed products containing Methylene Blue, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.
- Exclusivity M-303: Other exclusivity: information added to the clinical studies section to fulfill a post-marketing requirement, until 8 Jan 2027.
Reproduced from the FDA Orange Book and Purple Book (checked 8 Nov 2026) and the European Commission's Union Register of medicinal products (CC BY 4.0; the EU expiry date is calculated exactly as the Commission's register displays it). Listed patents and dates are as submitted to or published by the regulator and may not reflect litigation, invalidation, settlements, lapsed fees or later extensions. This is not legal advice or a freedom-to-operate opinion, and it does not say when a generic or biosimilar will launch.
What health systems spend on Methylene Blue
All medicines →From NHSBSA Prescription Cost Analysis (Open Government Licence v3.0) and CMS State Drug Utilization Data. Both are gross amounts: neither system publishes its discounts or rebates per drug. Products combining several substances are not counted here.
How Methylene Blue works
All drug targets →- SepsisPhase 3
- AnxietyPhase 3
- Basal cell carcinomaPhase 3
- Bipolar disorderPhase 3
- Depressive disorderPhase 3
- Major depressive disorderPhase 3
- Septic shockPhase 3
- Squamous cell carcinomaPhase 3
- Abdominal painPhase 2
- Alzheimer diseasePhase 2
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL550495, CC BY-SA 3.0. The Guide to Pharmacology has no record of this medicine, so its targets rest on ChEMBL alone. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.
Patient leaflets for Methylene Blue
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- UKUnited Kingdom: Search MHRA ProductsPatient information leaflets and SmPCs for UK-licensed products.
- USUnited States: Search DailyMedFDA-approved labels, including patient and medication guides.
Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.
Trials by status
Trials by phase
Clinical trials of Methylene Blue
6 trialsRegisters list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.
Conditions studied with Methylene Blue
10 conditionsSponsors
lead sponsor per trial| Lead sponsor | Trials |
|---|---|
| Post Graduate Institute of Medical Education and Research, Chandigarh | 1 |
| Peking University Cancer Hospital & Institute | 1 |
| China Medical University Hospital | 1 |
| Institute of Hematology & Blood Diseases Hospital, China | 1 |
| Fondazione Epatocentro Ticino | 1 |
| Centro de Estudos e Pesquisa em Emergencias Medicas e Terapia Intensiva | 1 |
By country register
| Register | Trials | Recruiting |
|---|---|---|
| Clinical trials in China | 3 | 2 |
| Clinical trials in India | 1 | 0 |
| Clinical trials in Taiwan | 1 | 0 |
| Clinical trials in Switzerland | 1 | 1 |
| Clinical trials in Brazil | 1 | 1 |
A trial with sites in more than one country appears in each of those registers.
Questions about Methylene Blue trials
How many clinical trials are testing Methylene Blue?
6 current trials in our China, India, Taiwan, Switzerland and Brazil registers name Methylene Blue as a drug or biological intervention, as of the registry sync on 10 November 2026. Completed and withdrawn studies are not counted.
Are Methylene Blue trials recruiting patients?
Yes. 4 of the 6 trials are recruiting: 2 with sites in China, 1 with sites in Switzerland and 1 with sites in Brazil. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Methylene Blue clinical trials?
Post Graduate Institute of Medical Education and Research, Chandigarh (1), Peking University Cancer Hospital & Institute (1), China Medical University Hospital (1) and Institute of Hematology & Blood Diseases Hospital, China (1), among 6 lead sponsors in total. The number in brackets is how many trials each organisation leads.
Where does this information come from?
Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Methylene Blue works or whether it is effective, and it is not medical advice.
How this page is built
Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Methylene Blue works or whether it is effective. Each trial links to its own record so you can check it yourself.
- ClinicalTrials.gov (U.S. National Library of Medicine) ↗ Trial IDs, titles, intervention names and synonyms, phase, overall status, lead sponsor and conditions for every trial on this page
This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Methylene Blue (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 10 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.