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Neoral® (Cyclosporine)
Neoral® (Cyclosporine) is a Calcineurin inhibitor Small molecule drug developed by Wyeth is now a wholly owned subsidiary of Pfizer. It is currently FDA-approved for Organ transplant rejection prophylaxis (kidney, heart, liver, pancreas), Severe active rheumatoid arthritis, Severe psoriasis.
Cyclosporine inhibits T-cell activation by binding to cyclophilin and blocking calcineurin-mediated transcription of interleukin-2 and other cytokines.
Cyclosporine inhibits T-cell activation by blocking calcineurin, a phosphatase required for IL-2 production and T-cell proliferation. Used for Organ transplant rejection prophylaxis (kidney, heart, liver, pancreas), Rheumatoid arthritis, Psoriasis.
At a glance
| Generic name | Neoral® (Cyclosporine) |
|---|---|
| Sponsor | Wyeth is now a wholly owned subsidiary of Pfizer |
| Drug class | Calcineurin inhibitor |
| Target | Calcineurin (via cyclophilin binding) |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | FDA-approved |
Mechanism of action
Cyclosporine forms a complex with the intracellular protein cyclophilin, which then inhibits the phosphatase calcineurin. This prevents dephosphorylation and nuclear translocation of NFAT (nuclear factor of activated T cells), thereby suppressing the transcription of IL-2 and other pro-inflammatory cytokines essential for T-cell proliferation and activation. The result is selective immunosuppression without affecting B-cell or antibody production directly.
Approved indications
- Organ transplant rejection prophylaxis (kidney, heart, liver, pancreas)
- Severe active rheumatoid arthritis
- Severe psoriasis
- Nephrotic syndrome (minimal change disease)
- Severe atopic dermatitis
- Uveitis
Common side effects
- Nephrotoxicity/renal dysfunction
- Hypertension
- Tremor
- Gingival hyperplasia
- Hirsutism
- Headache
- Hyperkalemia
- Infections
- Neurotoxicity (encephalopathy)
- Hepatotoxicity
Key clinical trials
- Efficacy of Vevye Ophthalmic Solution for the Treatment of Meibomian Gland Dysfunction (PHASE4)
- A Non-interventional Study to Evaluate the Anti-inflammatory Effects and the Clinical Efficacy of Topical Water Free Cyclosporin 0.1% Eye Drops in Patients With Dry Eye Disease and Associated Ocular Surface Inflammation Non-responding to Artificial Tears: the FOCUS Study (PHASE4)
- Tocilizumab in Cardiac Transplantation (PHASE2)
- Efficacy + Safety of Liposome Cyclosporine A to Treat Bronchiolitis Obliterans Post Double Lung Transplant (BOSTON-2) (PHASE3)
- TRACK-TBI Precision Medicine Part 3 - Option II (PHASE2)
- Co-infusion of Treg-enriched Donor Lymphocytes With CD3-depleted Hematopoietic Stem Cell Graft to Prevent Graft-versus Host Disease After Allogeneic Hematopoietic Stem Cell Transplantation Among Children With Hematologic Malignancies (PHASE2, PHASE3)
- Comparison of Conjunctival Goblet Cell Density in Dry Eye Patients Treated With Cyclosporine 0.1% Dissolved in Perfluorobutylpentane (Vevye®) or Generic 0.05% Cyclosporine Emulsion for 8 Weeks (PHASE4)
- Study to Evaluate Safety and Efficacy of Cenegermin (Oxervate®) vs Vehicle in Severe Sjogren's Dry Eye Disease (PHASE3)
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 |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Neoral® (Cyclosporine) CI brief — competitive landscape report
- Neoral® (Cyclosporine) updates RSS · CI watch RSS
- Wyeth is now a wholly owned subsidiary of Pfizer portfolio CI
Frequently asked questions about Neoral® (Cyclosporine)
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Related
- Drug class: All Calcineurin inhibitor drugs
- Target: All drugs targeting Calcineurin (via cyclophilin binding)
- Manufacturer: Wyeth is now a wholly owned subsidiary of Pfizer — full pipeline
- Therapeutic area: All drugs in Immunology
- Indication: Drugs for Organ transplant rejection prophylaxis (kidney, heart, liver, pancreas)
- Indication: Drugs for Severe active rheumatoid arthritis
- Indication: Drugs for Severe psoriasis
- Compare: Neoral® (Cyclosporine) vs similar drugs
- Pricing: Neoral® (Cyclosporine) cost, discount & access