Cyclosporine
As of the edition of 20 October 2026, Cyclosporine is a protein: marketed, first approved in 1982 (CH); acts on PPIA; no US protection of its own is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2020
- Kind
- Protein
- Brand name
- Sandimmune
- First approved
- 28 December 1982 (CH)
- Approvals on record
- 39 in 8 regions
- Holder of the most recent approval
- Thea Pharma; 12 holders in all
- Registered trials
- 636, 91 stopped early
- Disease areas
- Blood and lymph; Immune system; Cancer; Inherited and neonatal; Heart and blood vessels; Infections
US protection
No US protection of its own is listed.
The FDA registers list no drug-substance patent or exclusivity of its own that counts for this drug.
Harrow Eye holds a later exclusivity on its own new formulation or combination product, ending 2028; it does not protect the original 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 Cyclosporine.
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 |
|---|---|---|
| PPIA | Peptidyl-prolyl cis-trans isomerase A | P62937 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 75 | 42 | 6 | 9 |
| Phase 1 | 92 | 72 | 4 | 10 |
| Phase 2 | 281 | 184 | 22 | 49 |
| Phase 3 | 101 | 67 | 8 | 17 |
| Phase 4 | 87 | 54 | 6 | 6 |
| All trials | 636 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Novartis | Applicant and Lead sponsor of trials | 1983 to now |
| AbbVie | Later holder and Lead sponsor of trials | 2002 to now |
| Santen | Applicant and Lead sponsor of trials | 2015 to now |
| Novaliq | Later holder and Lead sponsor of trials | 2016 to now |
| SUN Pharmaceutical Industries | Acquired holder and Lead sponsor of trials | 2016 to now |
| Santen Pharmaceutical | Applicant | 2016 to now |
| Harrow Eye | Acquired holder | 2023 to now |
| Laboratoires Théa | Later holder | 2024 to now |
| Thea Pharma | Later holder | 2025 to now |