NDAORALSOLUTION
Approved
Jul 1995
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
5/8 — Partial
NEORAL (cyclosporine) by Novartis is calcineurin inhibitors [moa]. Approved for calcineurin inhibitor immunosuppressant [epc]. First approved in 1995.
Drug data last refreshed 7h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
NEORAL (cyclosporine) is an oral calcineurin inhibitor immunosuppressant approved in 1995 for transplant rejection prevention and autoimmune conditions. It works by inhibiting T-cell activation and cytokine production, suppressing the immune response. The product is formulated as an oral solution for improved bioavailability compared to earlier cyclosporine formulations.
$0.001BPart D
LOE ApproachingDeclining
Mature product nearing loss of exclusivity with minimal Part D market activity; commercial teams are likely small and defensive.
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.