PROVAYBLUE (methylene blue)
PROVAYBLUE helps patients with acquired methemoglobinemia, a condition that affects both children and adults. It is used to restore the blood's ability to carry oxygen properly by acting as an oxidation-reduction agent. This medication is prescribed to convert abnormal hemoglobin back into its functional form.
How PROVAYBLUE Works
This drug works by first converting into leucomethylene blue through a specific enzyme in the body. This active form then reduces the ferric iron in methemoglobin back to the ferrous state found in normal hemoglobin. This process allows for the non-enzymatic conversion of abnormal hemoglobin into a functional state.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2016-04-08
- Patent Cliff
- 2027
- Routes
- INTRAVENOUS
- Dosage Forms
- SOLUTION
PROVAYBLUE Approval History
What PROVAYBLUE Treats
1 indicationsPROVAYBLUE is approved for 1 conditions since its original approval in 2016. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Methemoglobinemia
PROVAYBLUE Boxed Warning
SEROTONIN SYNDROME WITH CONCOMITANT USE OF SEROTONERGIC DRUGS AND OPIOIDS PROVAYBLUE may cause serious or fatal serotonergic syndrome when used in combination with serotonergic drugs and opioids. Avoid concomitant use of PROVAYBLUE with selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), monoamine oxidase inhibitors (MAOIs) and opioids. [see Warnings and Precautions ( 5.1 ) and Drug Interactions ( 7.1 )]. WARNING: SEROTONIN SYNDROME WITH CONCOMI...
WARNING: SEROTONIN SYNDROME WITH CONCOMITANT USE OF SEROTONERGIC DRUGS AND OPIOIDS PROVAYBLUE may cause serious or fatal serotonergic syndrome when used in combination with serotonergic drugs and opioids. Avoid concomitant use of PROVAYBLUE with selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), monoamine oxidase inhibitors (MAOIs) and opioids. [see Warnings and Precautions ( 5.1 ) and Drug Interactions ( 7.1 )]. WARNING: SEROTONIN SYNDROME WITH CONCOMITANT USE OF SEROTONERGIC DRUGS AND OPIOIDS See full prescribing information for complete boxed warning. PROVAYBLUE may cause serious or fatal serotonergic syndrome when used in combination with serotonergic drugs and opioids. Avoid concomitant use of PROVAYBLUE with selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), monoamine oxidase inhibitors (MAOIs) and opioids. ( 5.1 , 7.1 )
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Clinical Trial Registry
29 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05092165 BLUE | BLUE | Ph 2 | completed | Methylene Blue for the Prevention of Hypotension During Hemodialysis |
| NCT02240498 | RSRB00049677 | Ph 1 | completed | Safety and Feasibility Study of Methylene Blue Photodynamic Therapy to Sterilize Deep Tissue Abscess Cavities |
| NCT07494773 | HSC19626 | Ph 1, Ph 2 | not yet recruiting | Topical Methylene Blue-Photodynamic Therapy (MB-PDT) for Burn Wound Infection |
| NCT06900140 BLUSH | LHICU123 | Ph 3 | completed | Adjunctive Methylene Blue in Septic Shock |
| NCT06052956 | STUDY00008702 | Ph 2 | not yet recruiting | Efficacy of Methylene Blue Photodynamic Therapy for Treatment of Deep Tissue Abscesses |
| NCT06532240 | 2024ky202 | Ph 3 | completed | Methylene Blue for the Treatment of Septic Shock |
| NCT07212842 | 2.462.520 | Ph 2 | completed | Methylene Blue-Enhanced Ultrafiltration Improves Outcomes After Cardiopulmonary Bypass |
| NCT07179003 | STUDY00010960 | Ph 2 | not yet recruiting | A Phase 2 Study of Methylene Blue Photodynamic Therapy for Treatment of Breast Abscesses |
| NCT07169487 | IIT2025072 | Ph 1 | recruiting | Adjunctive Methylene Blue for Immunotherapy-related CRS and ICANS: Phase I Study |
| NCT06887036 MB_HBV | Methylene Blue in chronic HBV | Ph 2 | recruiting | Methylene Blue Treatment of Chronic Hepatitis B Virus Infection |
| NCT04635605 | MB treatment of COVID19 | Ph 2 | completed | Methylene Blue Treatment of COVID-19 |
| NCT01847612 CAMFIB | PI2013_843_0003 2013-000408-40 | Ph 3 | completed | Use of Indocyanine Green Cholangiography and Methylene Blue to Detect Postoperative Biliary Fistula After Hepatectomy |
| NCT02478281 results posted | 1MBL12002 | Ph 1 | completed | Safety, Tolerability, and Pharmacokinetic Study of Methylene Blue Following a 1 mg/kg Intravenous Dose in Healthy Adults |
| NCT06660680 MBI | HFBH2021011 (No. 2023AH050848) | Ph 3 | enrolling by invitation | The Effect of Methylene Blue Infiltrating Injection on Anal Pain After Milligan-Morgan Surgery: A Randomized Controlled Clinical Study |
| NCT02380573 MB2 results posted | HSC20150410H | Ph 2 | completed | Effects of Methylene Blue in Healthy Aging, Mild Cognitive Impairment and Alzheimer's Disease |
| NCT04054999 results posted | 18-006247 | Ph 4 | completed | Methylene Blue vs Cyanokit for Intraoperative Vasoplegic Syndrome in Liver Transplant Patients |
| NCT06306001 | IIRP-2023-1820/F1 | Ph 2, Ph 3 | not yet recruiting | Intravenous Methylene Blue for Treating Refractory Neonatal Septic Shock |
| NCT04187053 results posted | HSC-DB-19-0873 | Ph 4 | completed | Clinical and Microbiologic Outcomes of aPDT in the Non-surgical Treatment of Implant Inflammation |
| NCT03469284 results posted | 2016-1051 NCI-2018-00822, 2016-1051 | Ph 2 | completed | MOM's PAIN (Methylene Blue for Oral Mucositis' PAIN) |
| NCT03395223 MEBIPAM results posted | PVP-2016003 2017-000290-37 | Ph 4 | completed | MEthylene Blue In Patients With Acquired Methemoglobinemia |
| NCT04446871 SHOCKEM-Blue | HCG/CEI-0252/17 | Ph 2, Ph 3 | completed | Methylene Blue in Early Septic Shock |
| NCT01386879 results posted | 11D.48 | Ph 4 | terminated | Evaluation of Above the Cuff Suctioning During General Anesthesia |
| NCT05004805 COMBAT | COMBAT | Ph 2 | completed | COVID-19 Methylene Blue Antiviral Treatment |
| NCT02851108 BlueACTn results posted | UniHD008 | Ph 2 | completed | Methylene Blue Against Falciparum Malaria in Burkina Faso |
| NCT03446599 | D17173 | Ph 2 | withdrawn | Hemodynamic Effects of Methylene Blue vs Hydroxocobalamin in Patients at Risk of Vasoplegia During Cardiac Surgery |
| NCT03120637 CRuMBS | ILBS-Septic Shock-01 | Ph 4 | completed | Evaluating in Cirrhotics With Refractory Vasoplegia the Effect of Methylene Blue |
| NCT03177070 | 10871 | Ph 2 | completed | Fluorescent Imaging & Methylene Blue: Ureter Study |
| NCT02831023 | UCSF CHR # 15-16839 | Ph 2 | completed | Phase 2 Efficacy Study of Primaquine and Methylene Blue |
| NCT01276054 results posted | 1B-09-12 NCI-2010-02323 | Ph 2 | terminated | Sentinel and/or Axillary Lymph Node Biopsy With or Without Axillary Reverse Mapping in Reducing Incidence and Severity of Arm Lymphedema in Stage 0-2 Patients. |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
PROVAYBLUE FDA Label Details
Indications & Usage
FDA Label (PDF)PROVAYBLUE is indicated for the treatment of Methemoglobinemia.
WARNING: SEROTONIN SYNDROME WITH CONCOMITANT USE OF SEROTONERGIC DRUGS AND OPIOIDS PROVAYBLUE may cause serious or fatal serotonergic syndrome when used in combination with serotonergic drugs and opioids. Avoid concomitant use of PROVAYBLUE with selective serotonin reuptake inhibitors (SSRIs), serot...
PROVAYBLUE Patents & Exclusivity
Exclusivity
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment