TheraRadar
Data updated: Nov 8, 2026

LYRFIGTU (lirafugratinib hydrochloride) · ELEVAR

Approved 2026-09-23
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
1
Priority Reviews
0
Years on Market

Details

Status
Prescription
First Approved
2026-09-23
Routes
ORAL
Dosage Forms
CAPSULE

Companies

ELEVAR
Active Ingredient: LIRAFUGRATINIB HYDROCHLORIDE

LYRFIGTU Approval History

Original
New Indication
New Form
Label Update
2 FDA actions from 2026 to 2026
Sep 2026 ORIGINAL Priority
New Drug · Type 1 - New Molecular Entity
FDA Letter Label

What LYRFIGTU Treats

1 FDA approvals

Originally approved for its first indication in 2026 .

  • Other (1)
🔬

Active Pipeline

Pro

Ongoing clinical trials by development phase

Loading...
⭐

Key Completed Trials

Pro

Completed studies with published results, ranked by significance

Loading...
📊

Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

|
Loading...
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.

LYRFIGTU FDA Label Details

Track LYRFIGTU with TheraRadar Pro

Watchlist alerts, full database access, CSV exports across 14,000+ drugs.

Upgrade to Pro

Data Sources

FDA Approval: NDA220425 → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.