TheraRadar
Data updated: Nov 8, 2026

EGRIFTA (tesamorelin acetate) · THERATECHNOLOGIES

Endocrine Approved 2010-11-10

EGRIFTA is FDA-approved to treat 1 condition.

1
Indication
--
Phase 3 Trials
16
Years on Market

Details

Status
Prescription
First Approved
2010-11-10
Routes
SUBCUTANEOUS
Dosage Forms
POWDER

Companies

Active Ingredient: TESAMORELIN ACETATE

EGRIFTA Approval History

2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
24 FDA actions from 2010 to 2025
Mar 2025 SUPPL
Mfg · Manufacturing (CMC)
Feb 2024 SUPPL
Label · Labeling
Jul 2019 SUPPL
Label · Labeling

What EGRIFTA Treats

1 indications

EGRIFTA is approved for 1 conditions since its original approval in 2010. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Lipodystrophy
Source: FDA Label

THERATECHNOLOGIES's other novel FDA approvals

Other CDER-designated drugs from the same sponsor (2016–2025).

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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.

EGRIFTA FDA Label Details

Indications & Usage

FDA Label (PDF)

EGRIFTA is FDA-approved to treat 1 condition.

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Data Sources

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