TheraRadar
Data updated: May 26, 2026

TAMIFLU (oseltamivir phosphate)

Trial Activity: Declining
Infectious Disease Approved 1999-10-27
Jump to: Indications Approvals Trials Competitors Safety Patents

Development Insights

Hoffmann-La Roche conducting 2 trials (33%)
4 indications explored (Focused)
→ influenza (3 trials)
→ virus diseases (1 trials)
→ influenza, human (1 trials)
8
Indications
--
Phase 3 Trials
6
Priority Reviews
26
Years on Market

Details

Status
Discontinued
First Approved
1999-10-27
Routes
ORAL
Dosage Forms
CAPSULE, FOR SUSPENSION

Companies

Roche
Active Ingredient: OSELTAMIVIR PHOSPHATE

TAMIFLU Approval History

2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
288 FDA actions from 1999 to 2021 · 5 indication expansions
Aug 2021 SUPPL
Mfg · Manufacturing (CMC)
FDA Letter
Aug 2019 SUPPL
Efficacy
FDA Letter Label
Dec 2018 SUPPL
Label · Labeling
FDA Letter Label

What TAMIFLU Treats

8 FDA approvals

Originally approved for its first indication in 1999 . Covers 8 distinct patient populations.

  • Other (8)
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Clinical Trial Registry

5 trials
Trial Sponsor ID Phase Status Title
NCT02469298 results posted 201682 Ph 2 completed Safety, Tolerability and Clinical Effect of Danirixin in Adults With Influenza
NCT00803595 MARVEL results posted CS8958-A-J301 Ph 3 completed A Multinational Phase III Study of CS-8958 (MARVEL)
NCT00988325 results posted WP22849 2009-014365-12 Ph 1 completed A Pharmacokinetic/Pharmacodynamic (PK/PD) and Safety Evaluation of Oseltamivir [Tamiflu] in the Treatment of Infants 0 to <12 Months of Age With Confirmed Flu Infection
NCT01053663 results posted NP25138 Ph 1 terminated A Study of Intravenous Oseltamivir [Tamiflu] in Infants With Influenza
NCT00979251 PO206 ADS-TCAD-PO206 Ph 2 completed Oral Triple Combination Antiviral Drug Therapy for Treatment of Influenza A in Immunocompromised Subjects
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Active Pipeline

Pro

Ongoing clinical trials by development phase

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Key Completed Trials

Pro

Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

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.

TAMIFLU FDA Label Details

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Data Sources

FDA Approval: NDA021087 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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