TheraRadar
Data updated: May 26, 2026

TAFLUPROST

Prostaglandin Receptor Agonists Trial Activity: Declining
Ophthalmology Approved 2019-08-19

Tafluprost is an ophthalmic solution used to lower high pressure inside the eye. It helps patients with open-angle glaucoma or ocular hypertension manage their condition by reducing intraocular pressure. This medication belongs to the prostaglandin analog class and is prescribed to prevent potential eye damage caused by these elevated pressure levels.

Source: FDA Label • Novartis • Prostaglandin Analog

How TAFLUPROST Works

This drug works by acting as a selective agonist for FP prostanoid receptors in the eye. When it binds to these receptors, it is believed to increase the drainage of fluid through the uveoscleral pathway. This increased outflow effectively lowers the overall pressure within the eye.

Source: FDA Label

Development Insights

Santen Oy conducting 2 trials (67%)
4 indications explored (Focused)
ocular hypertension (2 trials)
open-angle glaucoma (2 trials)
glaucoma (1 trials)
3
Indications
--
Phase 3 Trials
6
Years on Market

Details

Status
Prescription
First Approved
2019-08-19
Routes
OPHTHALMIC
Dosage Forms
SOLUTION/DROPS

TAFLUPROST Approval History

2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
3 FDA actions from 2019 to 2024
Apr 2024 ORIGINAL
Update
Jan 2022 ORIGINAL
Update
Aug 2019 ORIGINAL
Update

What TAFLUPROST Treats

2 indications

TAFLUPROST is approved for 2 conditions since its original approval in 2019. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Open-Angle Glaucoma
  • Ocular Hypertension
Source: FDA Label

TAFLUPROST Competitive Set

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

Drugs Similar to TAFLUPROST

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PADAGIS US
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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.

TAFLUPROST FDA Label Details

Indications & Usage

TAFLUPROST is indicated for the treatment of Open-Angle Glaucoma; Ocular Hypertension.

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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