Egrifta WR (tesamorelin) · THERATECHNOLOGIES
EGRIFTA WR is indicated for the reduction of excess abdominal fat in HIV-infected adult patients with lipodystrophy. Limitations of Use: Long-term cardiovascular safety of EGRIFTA WR has not been established. Consider risk/benefit of continuation of treatment in patients who have not had a reduction in visceral adipose tissue. There are no data to support improved compliance with anti-retroviral therapies in HIV-positive patients taking EGRIFTA WR.
Details
- Status
- Prescription
- First Approved
- 2025-03-24
- Routes
- Subcutaneous
- Dosage Forms
- For Injection
Companies
Egrifta WR Approval History
What Egrifta WR Treats
1 FDA approvalsOriginally approved for its first indication in 2025 .
- Other (1)
Other
(1 approval)- • Approved indication (Mar 2025)
THERATECHNOLOGIES's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
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| NCT02931474 | 170005 17-NR-0005 | Ph 2 | withdrawn | Impact of GHRH on Sleep Promotion and Endocrine Regulation in Service Members Who Sustained a Traumatic Brain Injury and Have Current Insomnia |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 |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
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
Indications & Usage
EGRIFTA WR is indicated for the reduction of excess abdominal fat in HIV-infected adult patients with lipodystrophy. Limitations of Use: Long-term cardiovascular safety of EGRIFTA WR has not been established. Consider risk/benefit of continuation of treatment in patients who have not had a reduction in visceral adipose tissue. EGRIFTA WR is not indicated for weight loss management as it has a weight neutral effect. There are no data to support improved compliance with anti-retroviral therapies in HIV-positive patients taking EGRIFTA WR. EGRIFTA WR is a growth hormone-releasing factor (GHRF) an...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.