Zoledronic acid anhydrous
As of the edition of 20 October 2026, Zoledronic acid anhydrous is a small molecule: marketed, first approved in 2000 (BR); acts on FDPS.
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
- Zometa
- First approved
- 10 November 2000 (BR)
- Approvals on record
- 13 in 5 regions
- Holder of the most recent approval
- Asahi Kasei Therapeutics; 8 holders in all
- Withdrawn from market
- 13 March 2026 (in some regions)
- Registered trials
- 287, 44 stopped early
- Disease areas
- Cancer; Bones, joints and muscles; Nutrition and metabolism; Skin and connective tissue; Urinary and reproductive; 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
4 companies on route B because of this drug.
Companies on route B for this drug
In the product4 companies are on route B because of Zoledronic acid anhydrous.
See the 4 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 | 38 | 18 | 6 | 7 |
| Phase 1 | 23 | 12 | 5 | 5 |
| Phase 2 | 70 | 46 | 5 | 15 |
| Phase 3 | 95 | 66 | 5 | 12 |
| Phase 4 | 61 | 43 | 4 | 5 |
| All trials | 287 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Novartis | Applicant and Lead sponsor of trials | 1998 to now |
| Phoenix | Applicant | 2001 to now |
| Sandoz | Later holder | 2005 to now |
| Asahi Kasei Therapeutics | Applicant and Lead sponsor of trials | 2012 to now |
| Bausch Health | Acquired holder | 2014 to now |
| Pfizer | Later holder | 2015 to now |
| Inforlife | Acquired holder | 2018 to now |