Methylene blue cation
As of the edition of 20 October 2026, Methylene blue cation is a small molecule: marketed, first approved in 1951 (CA); acts on GUCY1A1, GUCY1A2 and GUCY1B1 and 1 more; US protection ends in 2027.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2016
- Kind
- Small molecule
- Brand name
- Provayblue
- First approved
- 31 December 1951 (CA)
- Approvals on record
- 5 in 3 regions
- Holder of the most recent approval
- Cosmo Technologies; 3 holders in all
- Registered trials
- 73, 4 stopped early
- Disease areas
- Infections; Cancer; Skin and connective tissue; Digestive system; Lungs and airways; Mental health
US protection
US protection ends in 2027.
The last listed US exclusivity ends in 2027. The application that gives this date is held by Provepharm.
This is the US only, and it is not the date generics or biosimilars can enter.
The exact date and the listings behind it
In the product2 listings count towards this date. The exact date and each listing are in the product.
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Companies that need a new molecule because of this drug
1 company-target row on route B because of this drug.
Companies on route B for this drug
In the product1 company-target row is on route B because of Methylene blue cation.
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Targets
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 22 | 15 | 1 | 1 |
| Phase 1 | 12 | 4 | 4 | 0 |
| Phase 2 | 21 | 12 | 4 | 2 |
| Phase 3 | 11 | 5 | 3 | 0 |
| Phase 4 | 7 | 4 | 2 | 1 |
| All trials | 73 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Provepharm | Applicant and Lead sponsor of trials | 2011 to now |
| Cosmo Technologies | Later holder | 2020 to now |