Friday, July 10, 2026

Drug profile · INN

methylene blue

methylene blue (METHYLENE BLUE) is a reducing agent. Route of administration: intravenous. Current US regulatory status: approved.

FDA: approved
US status approved
Patents linked 1
Pipeline programs 2
News articles 0
Drug details — methylene blue
US status
approved
Class
Route
INTRAVENOUS
Patents
1
Programs
2
Data quality
0.84

Quick answer

methylene blue (METHYLENE BLUE) is a reducing agent. Route of administration: intravenous. Current US regulatory status: approved.

Key facts

INN methylene blue
Brand METHYLENE BLUE
Mechanism Reducing agent
Route INTRAVENOUS
Formulation SOLUTION

Mechanism of action

Reducing agent

Approval history

Authority Status Date
FDA approved

Pipeline programs

  1. Intravenous methylene blue administration Phase 3 · Hospital Authority · Severe Sepsis
  2. Methylene Blue (50 mg/10ml) Phase 1 · Chinese Academy of · Head and Neck Cancer

Related patents

  1. US 11413240

    Methylene blue solution for the treatment of oral lesions

    Expires Mon Aug 11 2042 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

Frequently asked questions

What is methylene blue?

methylene blue (METHYLENE BLUE) is a reducing agent. Route of administration: intravenous. Current US regulatory status: approved.

What is the brand name for methylene blue?

METHYLENE BLUE is a marketed brand name for methylene blue. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of methylene blue?

methylene blue has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.