Risedronic acid
As of the edition of 20 October 2026, Risedronic acid is a small molecule: marketed, first approved in 1998 (US); acts on FDPS; no US protection is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2012
- Kind
- Small molecule
- Brand name
- Actonel
- First approved
- 27 March 1998 (US)
- Approvals on record
- 16 in 5 regions
- Holder of the most recent approval
- Takeda; 8 holders in all
- Registered trials
- 64, 8 stopped early
- Disease areas
- Bones, joints and muscles; Nutrition and metabolism; Cancer; Skin and connective tissue; Injuries; Nervous system
US protection
No US protection is listed.
The FDA registers list no drug-substance patent or exclusivity that counts for this drug.
This is the US only.
Companies that need a new molecule because of this drug
2 companies on route B because of this drug.
Companies on route B for this drug
In the product2 companies are on route B because of Risedronic acid.
See the 2 companies on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| FDPS | Farnesyl pyrophosphate synthase | P14324 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 9 | 8 | 0 | 1 |
| Phase 1 | 6 | 6 | 0 | 0 |
| Phase 2 | 7 | 6 | 1 | 0 |
| Phase 3 | 24 | 20 | 1 | 3 |
| Phase 4 | 18 | 13 | 1 | 4 |
| All trials | 64 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Procter And Gamble | Originator and Applicant | 1998 to now |
| Warner Chilcott | Later holder and Lead sponsor of trials | 2002 to now |
| AbbVie | Applicant and Acquired holder | 2002 to now |
| Takeda | Later holder and Lead sponsor of trials | 2008 to now |
| Ajinomoto | Applicant | 2012 to now |