NDAOPHTHALMICEMULSIONPriority Review
Approved
Dec 2002
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
5/8 — Partial
Priority Review
RESTASIS (cyclosporine) by AbbVie is calcineurin inhibitors [moa]. First approved in 2002.
Drug data last refreshed 14h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
RESTASIS is a cyclosporine ophthalmic emulsion approved in 2002 for dry eye disease, a chronic inflammatory condition affecting tear production. It works as a calcineurin inhibitor, suppressing local immune activation to restore tear secretion. The product remains a cornerstone therapy in ophthalmology with sustained clinical use.
$1.5BPart D
PeakStable
7.6 years to LOERESTASIS is at peak commercial performance with $1.5B annual spending, suggesting a mature, well-resourced brand team focused on market maintenance and patient retention.
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.