Alendronic acid
As of the edition of 20 October 2026, Alendronic acid is a small molecule: marketed, first approved in 1995 (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
- Fosamax
- First approved
- 29 September 1995 (US)
- Approvals on record
- 16 in 6 regions
- Holder of the most recent approval
- Radius Health; 9 holders in all
- Registered trials
- 94, 6 stopped early
- Disease areas
- Bones, joints and muscles; Nutrition and metabolism; Injuries; Urinary and reproductive; Cancer; 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
3 companies on route B because of this drug.
Companies on route B for this drug
In the product3 companies are on route B because of Alendronic acid.
See the 3 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 | 20 | 15 | 2 | 1 |
| Phase 1 | 11 | 10 | 0 | 1 |
| Phase 2 | 20 | 14 | 3 | 2 |
| Phase 3 | 27 | 21 | 1 | 2 |
| Phase 4 | 16 | 11 | 3 | 0 |
| All trials | 94 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Merck & Co. | Originator and Lead sponsor of trials | 1995 to now |
| Organon | Applicant, Acquired holder and Lead sponsor of trials | 2001 to now |
| Teijin Pharma | Applicant | 2012 to now |
| Mission Pharmacal | Later holder | 2012 to now |
| Radius Health | Acquired holder and Lead sponsor of trials | 2012 to now |