Last reviewed · How we verify
Neoral
At a glance
| Generic name | Neoral |
|---|---|
| Also known as | Cyclosporine, cyclosporine, Cyclosporine microemulsion |
| Sponsor | Novartis Pharmaceuticals |
| Target | Calcineurin subunit B type 1, Canalicular multispecific organic anion transporter 1, Canalicular multispecific organic anion transporter 2 |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | FDA-approved |
Approved indications
- Kawasaki's disease
- Keratoconjunctivitis sicca
- Prevention of Cardiac Transplant Rejection
- Prevention of Kidney Transplant Rejection
- Prevention of Liver Transplant Rejection
- Rheumatoid arthritis
- Severe Recalcitrant Psoriasis
- Tear film insufficiency
Common side effects
- Hypertension
- Renal dysfunction
- Tremor
- Hirsutism
- Gum hyperplasia
- Infection
- Lack of efficacy
- Acute tubular necrosis
- Allergic reactions
- Anemia
- Anorexia
- Confusion
Serious adverse events
- Glomerular capillary thrombosis
- Hepatotoxicity
- Liver failure
- Progressive multifocal leukoencephalopathy (PML)
- Polyoma virus-associated nephropathy (PVAN)
- BK virus infection with graft loss
- Lymphoproliferative disorders
- Myocardial infarction
- Upper GI bleeding
- Pancreatitis
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)
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 CI brief — competitive landscape report
- Neoral updates RSS · CI watch RSS
- Novartis Pharmaceuticals portfolio CI