Cyclophosphamide anhydrous
As of the edition of 20 October 2026, Cyclophosphamide anhydrous is a small molecule: marketed, first approved in 1959 (ES).
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2019
- Kind
- Small molecule
- Brand name
- Cytoxan (lyophilized)
- First approved
- 1 December 1959 (ES)
- Approvals on record
- 48 in 6 regions
- Holder of the most recent approval
- Eugia Pharma Specialities; 8 holders in all
- Registered trials
- 3,396, 564 stopped early
- Disease areas
- Cancer; Blood and lymph; Immune system; Skin and connective tissue; Heart and blood vessels; Urinary and reproductive
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.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 171 | 69 | 20 | 33 |
| Phase 1 | 741 | 230 | 270 | 153 |
| Phase 2 | 1,885 | 907 | 458 | 329 |
| Phase 3 | 540 | 282 | 113 | 46 |
| Phase 4 | 59 | 29 | 6 | 3 |
| All trials | 3,396 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Baxter Healthcare | Applicant and Acquired holder | 1960 to now |
| Bristol Myers Squibb | Applicant and Lead sponsor of trials | 2006 to now |
| Hikma Pharmaceuticals | Later holder | 2013 to now |
| Shionogi | Applicant | 2019 to now |
| Eugia Pharma Specialities | Later holder | 2021 to now |
| Sandoz | Later holder | 2023 to now |
| Avyxa | Acquired holder | 2024 to now |
| Dr. Reddy's | Acquired holder | 2024 to now |