TYRVAYA (varenicline tartrate)
TYRVAYA is indicated for the treatment of Dry Eye Disease.
How TYRVAYA Works
Varenicline is a cholinergic agonist that binds to heteromeric subtypes of nicotinic acetylcholine (nACh) receptors. While the exact mechanism is not fully elucidated, it is believed that binding activates the trigeminal parasympathetic pathway, which stimulates the lacrimal glands, meibomian glands, and goblet cells to increase the production of natural basal tear film.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2021-10-15
- Patent Cliff
- 2035
- Routes
- NASAL
- Dosage Forms
- SPRAY
TYRVAYA Approval History
What TYRVAYA Treats
1 indicationsTYRVAYA is approved for 1 conditions since its original approval in 2021. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Dry Eye Disease
TYRVAYA Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in TYRVAYA's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications TYRVAYA treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to TYRVAYA
3 of 5FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
10 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05703672 | STUDY00146887 | Ph 3 | recruiting | Switching to E-cigarettes in Smokers Not Interested in Quitting |
| NCT05541497 results posted | 2000032740 000 | Ph 2 | completed | Varenicline for Treatment of E-cigarette Dependence |
| NCT03235505 EFFECT | WI218780 | Ph 4 | completed | Efficacy and Safety of E-cigarettes for Smoking Cessation in Middle-aged Heavy Smokers |
| NCT03897439 results posted | Study0000142310 R01DA046576 | Ph 3 | completed | Individualizing Pharmacotherapy for African American Smokers |
| NCT01574703 CATS results posted | A3051148 2011-005513-37, CATS | Ph 4 | completed | Study To Evaluate Cardiac Assessments Following Different Treatments Of Smoking Cessation Medications In Subjects With And Without Psychiatric Disorders. |
| NCT01456936 EAGLES results posted | A3051123 2010-022914-15, EAGLES | Ph 4 | completed | Study Evaluating The Safety And Efficacy Of Varenicline and Bupropion For Smoking Cessation In Subjects With And Without A History Of Psychiatric Disorders |
| NCT00717093 results posted | A3051104 | Ph 4 | completed | Study Evaluating The Efficacy Of Varenicline In Cessation Of Oral Smokeless Tobacco Use |
| NCT01370356 results posted | A3051075 REDUCE TO QUIT | Ph 4 | completed | A Study To Evaluate The Efficacy And Safety Of Varenicline Compared To Placebo For Smoking Cessation Through Reduction |
| NCT00661765 | A3051071 | Ph 1 | completed | A Single Dose Study Investigating the Absorption and Elimination as Well as the Tolerability of Varenicline Transdermal Delivery System (e.g., a Patch) as Compared to Oral Varenicline in Adult Smokers. |
| NCT07596485 RELIEF | KT74863-101 | Ph 1, Ph 2 | recruiting | RP-008 in Combination With Daily Oral Varenicline for the Treatment of Trigeminal Neuralgia |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
TYRVAYA FDA Label Details
Indications & Usage
FDA Label (PDF)TYRVAYA is indicated for the treatment of Dry Eye Disease.
TYRVAYA Patents & Exclusivity
Patents (11 active)
Pro Intelligence Preview
Deep insights for TYRVAYA
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2035
- • 11 active patents
Trial Analysis
- • 153 total trials
- • Stage: Declining
Competitive Landscape
- • 5 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment