ZOLYMBUS (bimatoprost)
ZOLYMBUS is indicated for the treatment of Open-Angle Glaucoma; Ocular Hypertension.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2025-09-09
- Patent Cliff
- 2036
- Routes
- OPHTHALMIC
- Dosage Forms
- GEL
ZOLYMBUS Approval History
What ZOLYMBUS Treats
2 indicationsZOLYMBUS is approved for 2 conditions since its original approval in 2025. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Open-Angle Glaucoma
- Ocular Hypertension
ZOLYMBUS 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 ZOLYMBUS's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications ZOLYMBUS treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to ZOLYMBUS
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
13 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT02390284 STOP-RGCD results posted | 20140587 R01EY014957 | Ph 3 | terminated | Stop Retinal Ganglion Cell Dysfunction Study |
| NCT06122090 | 00006189 | Ph 2 | recruiting | Treatment of Hypopigmented Scars With Bimatoprost |
| NCT03825380 results posted | LT4032-301 | Ph 3 | completed | Efficacy and Safety Assessment of T4032 Versus Lumigan® in Ocular Hypertensive or Glaucomatous Patients |
| NCT02358369 results posted | FSV5-004 | Ph 2 | completed | Dose-Ranging Study of the Bimatoprost Ocular Insert |
| NCT02537015 OLE2 results posted | FSV5-005 OLE 2 | Ph 2 | completed | An Open-label Extension Study to Evaluate the Safety of the 13 mg Bimatoprost Ocular Insert |
| NCT02143843 results posted | FSV5-003 | Ph 2 | completed | An Open-Label Extension Study to Evaluate the Safety of the ForSight VISION5 Product |
| NCT02742649 results posted | FSV5-FC-001 | Ph 1, Ph 2 | completed | A Study to Evaluate Efficacy and Safety of a Fixed Combination Ocular Insert in Participants With Open-angle Glaucoma or Ocular Hypertension |
| NCT01915940 results posted | FSV5-002 | Ph 2 | completed | Bimatoprost Ocular Insert Compared to Topical Timolol Solution in Patients With Glaucoma or Ocular Hypertension |
| NCT02676310 | 192024-085 | Ph 1 | terminated | Safety, Tolerability, and Pharmacokinetics of Bimatoprost in Men With Androgenetic Alopecia (AGA) |
| NCT02059655 BIMA | SPON 1266-14 | Ph 4 | completed | Prostaglandin F2-alpha Eye Drops in Thyroid Eye Disease (Bima Study) |
| NCT00705757 results posted | Pfizer GA6111AX | Ph 4 | completed | The Effects of Xalatan, Travatan and Lumigan on Skin Pigmentation Near the Eye |
| NCT02170662 results posted | Pro00017573 | Ph 2 | completed | Topical Bimatoprost Effect on Androgen Dependent Hair Follicles |
| NCT01291108 results posted | 210669-013 | Ph 2 | completed | Safety and Efficacy of AGN-210669 Ophthalmic Solution Compared With Bimatoprost Ophthalmic Solution in Patients With Open-Angle Glaucoma or Ocular Hypertension |
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.
ZOLYMBUS FDA Label Details
Indications & Usage
FDA Label (PDF)ZOLYMBUS is indicated for the treatment of Open-Angle Glaucoma; Ocular Hypertension.
ZOLYMBUS Patents & Exclusivity
Patents (1 active)
Exclusivity
Pro Intelligence Preview
Deep insights for ZOLYMBUS
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2036
- • 1 active patents
Trial Analysis
- • 13 total trials
- • Stage: Declining
Competitive Landscape
- • 20 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