TheraRadar
Data updated: May 26, 2026

ZIOPTAN (tafluprost)

Prostaglandin Receptor Agonists Trial Activity: Declining
Ophthalmology Approved 2012-02-10

ZIOPTAN is indicated for reducing elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.

Source: FDA Label • THEA PHARMA

Development Insights

Santen Oy conducting 2 trials (67%)
4 indications explored (Focused)
ocular hypertension (2 trials)
open-angle glaucoma (2 trials)
glaucoma (1 trials)
1
Indication
--
Phase 3 Trials
14
Years on Market

Details

Status
Prescription
First Approved
2012-02-10
Patent Cliff
2029

Pro Metrics

Patent cliff and revenue data

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Routes
OPHTHALMIC
Dosage Forms
SOLUTION/DROPS

Companies

Active Ingredient: TAFLUPROST

ZIOPTAN Approval History

2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
6 FDA actions from 2012 to 2026
Feb 2026 SUPPL
Label · Labeling
Sep 2015 SUPPL
Label · Labeling
Aug 2013 SUPPL
Mfg · Manufacturing (CMC)

What ZIOPTAN Treats

1 FDA approvals

Originally approved for its first indication in 2012 .

  • Other (1)

ZIOPTAN Competitive Set

Pro

Three rings of competition based on shared molecular targets and treated indications.

MoA expansion candidates

2

Same target(s), different indications — where else is this mechanism being explored?

Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

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Clinical Trial Registry

3 trials
Trial Sponsor ID Phase Status Title
NCT02802137 16/5.3.2015 Ph 4 completed 24-hour Efficacy and Ocular Surface With Talfuprost and Triple Combined Therapy
NCT01087671 77553 Ph 3 completed Ocular Signs and Symptoms in Glaucoma Patients Switched From Latanoprost to Preservative Free Tafluprost Eye Drops
NCT00596791 Santen-77552 EudraCT number 2007-004872-37 Ph 3 completed Ocular Signs and Symptoms in Glaucoma Patients Switched From Latanoprost 0.005% to Preservative Free Tafluprost Eye Drops
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

Full development history with FDA approval milestones

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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.

ZIOPTAN FDA Label Details

Indications & Usage

FDA Label (PDF)

ZIOPTAN® is indicated for reducing elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. ZIOPTAN is a prostaglandin analog indicated for reducing elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.

View full patent landscape →
2 OB patents · 1 families · 106 international docs across 27 countries

ZIOPTAN Patents & Exclusivity

Latest Patent: May 2029

Patents (2 active)

US10864159 Expires May 28, 2029
US9999593 Expires May 28, 2029
Source: FDA Orange Book

Pro Intelligence Preview

Deep insights for ZIOPTAN

Revenue Insights

  • Quarterly revenue tracking
  • Historical trend analysis

Patent Timeline

  • Cliff: 2029
  • 2 active patents

Trial Analysis

  • 3 total trials
  • Stage: Declining

Competitive Landscape

  • Competitor tracking
  • Same target/indication analysis
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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