Riociguat
As of the edition of 20 October 2026, Riociguat is a small molecule: marketed, first approved in 2013 (CA); acts on GUCY1A1, GUCY1A2 and GUCY1B1 and 1 more; US protection ends in 2034.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2014
- Kind
- Small molecule
- Brand name
- Adempas
- First approved
- 19 September 2013 (CA)
- Approvals on record
- 15 in 5 regions
- Holder of the most recent approval
- Bayer; 3 holders in all
- Registered trials
- 50, 8 stopped early
- Disease areas
- Lungs and airways; Heart and blood vessels; Skin and connective tissue; Inherited and neonatal; Nervous system; Blood and lymph
US protection
US protection ends in 2034.
The last listed US drug-substance patent ends in 2034. The application that gives this date is held by Bayer.
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 product25 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 Riociguat.
See the 1 company-target row on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Targets
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 8 | 7 | 0 | 0 |
| Phase 1 | 12 | 12 | 0 | 0 |
| Phase 2 | 16 | 8 | 0 | 7 |
| Phase 3 | 7 | 5 | 2 | 0 |
| Phase 4 | 7 | 4 | 1 | 1 |
| All trials | 50 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Bayer | Applicant and Lead sponsor of trials | 2010 to now |