What is Egrifta WR used for?

Egrifta WR is an FDA-approved medication. See full prescribing information for approved uses.

Is Egrifta WR FDA approved?

Yes, Egrifta WR is FDA approved (first approved 2025-03-24) and manufactured by Theratechnologies Inc..

Who makes Egrifta WR?

Egrifta WR is manufactured by Theratechnologies Inc..

Is Egrifta WR a biologic?

Yes, Egrifta WR is a biologic (BLA).

Data updated: May 26, 2026

Egrifta WR (tesamorelin)

Approved 2025-03-24

Jump to: Indications Approvals Trials Competitors Safety Patents

Indication

Phase 3 Trials

Years on Market

Details

Status: Prescription
First Approved: 2025-03-24
Routes: Subcutaneous
Dosage Forms: For Injection

Companies

Theratechnologies Inc.

Active Ingredient: tesamorelin , tesamorelin , tesamorelin , tesamorelin

Egrifta WR Approval History

2026

Original

New Indication

New Form

Label Update

1 FDA actions from 2025 to 2025

Mar 2025 ORIGINAL

Update · CBER biologic (Purple Book)

What Egrifta WR Treats

1 FDA approvals

Originally approved for its first indication in 2025 .

Other (1)

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Clinical Trial Registry

9 trials

Trial	Sponsor ID	Phase	Status	Title
NCT07481734 TESA-LIVER	TESA-MASLD-201	Ph 2	recruiting	Tesamorelin for Reduction of Liver Fat in Adults With Fatty Liver Disease (Mock Study)
NCT02572323 results posted	R01AG048650	Ph 2	completed	Phase II Trial of Tesamorelin for Cognition in Aging HIV-Infected Persons
NCT03375788 results posted	R01DK114144	Ph 2	completed	Growth Hormone Releasing Hormone Analog to Improve Nonalcoholic Fatty Liver Disease and Associated Cardiovascular Risk
NCT06554717 TRIUMPH	2024P001703	Ph 2	recruiting	Tesamorelin as an Adjunct to Exercise for Improving Physical Function in HIV
NCT03226821 results posted	AAAR2634 R01DK110771	Ph 4	terminated	Body Composition and Adipose Tissue in HIV
NCT01388920 results posted	TH9507-CTR-1025	Ph 2	terminated	Efficacy and Safety Study of Tesamorelin in Chronic Obstructive Pulmonary Disease (COPD) Subjects With Muscle Wasting
NCT02931474	170005 17-NR-0005	Ph 2	withdrawn	Impact of GHRH on Sleep Promotion and Endocrine Regulation in Service Members Who Sustained a Traumatic Brain Injury and Have Current Insomnia
NCT01591902	EMR200147-500	Ph 4	terminated	Diabetic Retinopathy in HIV Subjects Treated With EGRIFTA®
NCT02012556	TH9507-CTR-1015	Ph 1	completed	Pharmacokinetic and Pharmacodynamic Study of TH9507, a Growth Hormone-Releasing Factor Analog, in HIV Positive Patients

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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

| Show all trials (incl. adjuvant)

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 WR FDA Label Details

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Data Sources

FDA Approval: BLA022505 → Trials: ClinicalTrials.gov →

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

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