Ibandronic acid
As of the edition of 20 October 2026, Ibandronic acid is a small molecule: marketed, first approved in 1996 (EU); acts on FDPS.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2013
- Kind
- Small molecule
- Brand name
- Boniva
- First approved
- 25 June 1996 (EU)
- Approvals on record
- 7 in 3 regions
- Holder of the most recent approval
- Roche; 3 holders in all
- Withdrawn from market
- 9 January 2024 (in some regions)
- Registered trials
- 64, 10 stopped early
- Disease areas
- Bones, joints and muscles; Nutrition and metabolism; Cancer; Skin and connective tissue; Immune system; Blood and lymph
US protection
No US approval on record.
With no US approval on record there are no listed US patents or exclusivities.
This is the US only.
Companies that need a new molecule because of this drug
1 company on route B because of this drug.
Companies on route B for this drug
In the product1 company is on route B because of Ibandronic acid.
See the 1 company 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 | 6 | 0 | 1 |
| Phase 1 | 2 | 2 | 0 | 0 |
| Phase 2 | 4 | 2 | 0 | 1 |
| Phase 3 | 23 | 16 | 0 | 5 |
| Phase 4 | 26 | 22 | 1 | 3 |
| All trials | 64 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Atnahs Pharma | Applicant | 1996 to now |
| Roche | Applicant and Lead sponsor of trials | 2003 to now |