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CYCLOSPORINE
CYCLOSPORINE is a Calcineurin Inhibitor Immunosuppressant [EPC] drug. It is currently FDA-approved (first approved 1983) for Dry Eye Disease.
Cyclosporine, a calcineurin inhibitor, selectively modulates the immune system.
Cyclosporine, a calcineurin inhibitor marketed for Dry Eye Disease, holds a significant position in the ophthalmic therapeutic market. Its selective modulation of the immune system provides a key competitive advantage in managing the condition. The primary risk is the key composition patent expiry in 2028, which could lead to increased competition from generics.
At a glance
| Generic name | CYCLOSPORINE |
|---|---|
| Drug class | Calcineurin Inhibitor Immunosuppressant [EPC] |
| Target | calcineurin |
| Modality | Recombinant protein |
| Phase | FDA-approved |
| First approval | 1983 |
Mechanism of action
Cyclosporine works by inhibiting calcineurin, which helps to selectively modulate the immune system. This inhibition prevents certain immune responses, making it useful in preventing organ rejection and treating autoimmune conditions.
Approved indications
- Dry Eye Disease
Common side effects
- instillation site reactions
- temporary decreases in visual acuity
Key clinical trials
- Radiation- and Alkylator-free Bone Marrow Transplantation Regimen for Patients With Dyskeratosis Congenita (PHASE2)
- Campath/Fludarabine/Melphalan Transplant Conditioning for Non-Malignant Diseases (PHASE1, PHASE2)
- Rituximab Plus Cyclosporine in Idiopathic Membranous Nephropathy (PHASE2)
- Letermovir Prophylaxis in Children With EBV-Positive T/NK-Cell Lymphoproliferative Disease and Refractory/Relapsed EBV-Associated Hemophagocytic Lymphohistiocytosis (NA)
- A Study to Evaluate Axatilimab Versus Best Available Therapy in Participants With Chronic Graft Versus Host Disease After at Least 2 Prior Lines of Systemic Therapy (PHASE3)
- A Study to Evaluate Axatilimab Versus Best Available Therapy in Pediatric Participants With Chronic Graft-Versus-Host Disease After at Least 2 Prior Lines of Systemic Therapy (AGAVE-256) (PHASE2)
- Study on the Efficacy and Safety of the TmBU Conditioning Regimen in High-risk or Relapsed/Refractory Acute Leukemia (PHASE2)
- Effect of Anti-Psoriatic Biologics on Risk of Anogenital Warts (CONDYPSO)
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- CYCLOSPORINE CI brief — competitive landscape report
- CYCLOSPORINE updates RSS · CI watch RSS
Frequently asked questions about CYCLOSPORINE
What is CYCLOSPORINE?
How does CYCLOSPORINE work?
What is CYCLOSPORINE used for?
What drug class is CYCLOSPORINE in?
When was CYCLOSPORINE approved?
What development phase is CYCLOSPORINE in?
What are the side effects of CYCLOSPORINE?
What does CYCLOSPORINE target?
Related
- Drug class: All Calcineurin Inhibitor Immunosuppressant [EPC] drugs
- Target: All drugs targeting calcineurin
- Indication: Drugs for Dry Eye Disease
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing