NDAORALCAPSULEPriority Review
Approved
Mar 1990
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
4/8 — Partial
Priority Review
SANDIMMUNE (cyclosporine) by Novartis is calcineurin inhibitors [moa]. Approved for calcineurin inhibitor immunosuppressant [epc]. First approved in 1990.
Drug data last refreshed 8h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
SANDIMMUNE (cyclosporine) is an oral calcineurin inhibitor immunosuppressant approved in 1990 for preventing organ rejection and treating autoimmune conditions. It works by inhibiting T-cell activation, suppressing the immune response to allow transplanted organs to engraft and reducing inflammation in autoimmune diseases. The drug is indicated for immunosuppression in organ transplant recipients and select dermatologic and ophthalmologic autoimmune conditions.
LOE Approaching
As LOE approaches, the brand team is likely contracting with focus shifting to lifecycle extension, generics defense, or portfolio transition initiatives.
Mechanism of Action
Calcineurin Inhibitors
Pharmacologic Class:
Calcineurin Inhibitor Immunosuppressant
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
A Study to Learn if Study Medicines Called Cyclosporine and Clarithromycin Affect How the Body Processes the Other Study Medicine Called PF-07328948 in Healthy Adults
Started Mar 2025
26 enrolled
Healthy Adults
Effect of Cyclosporine Drug Interaction on the Absorption, Metabolism and Elimination of CHF6001 in Healthy Volunteers. Drug-Drug Interaction 2 (DDI2) Study
Started Mar 2025
30 enrolled
Chronic Obstructive Pulmonary Disease (COPD)
Cyclosporine In Takotsubo Syndrome
Started Feb 2025
204 enrolled
Takotsubo Cardiomyopathy
A Study to Learn if the Study Medicines Called Itraconazole and Cyclosporine Change How the Body Processes the Other Study Medicine Called Danuglipron in Healthy Adults.
Started Dec 2024
16 enrolled
Healthy
Efficacy and Safety of rhTPO in Combination With Cyclosporine Versus Cyclosporine Alone in the Treatment of TD-NSAA
Started Jul 2024
54 enrolled
Aplastic AnemiaTransfusion-dependent Anemia
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.