FDA and NIH data · updated 2026-10-16

Tesamorelin: FDA status and clinical evidence

FDA-approved

Tesamorelin is approved by the FDA and is on the US market, first approved November 10, 2010, under 1 application. 24 studies are registered on ClinicalTrials.gov, reaching Phase 4.

Yes

FDA-approved

Registered studies

Phase 4

Highest phase

FDA applications

FDA approval status

Status

Approved

First approval

November 10, 2010

Most recent approval

November 10, 2010

Applications on file

Brand names

EGRIFTA

Clinical evidence

Registered studies

Interventional

Completed

Currently active

Studies with posted results

Highest phase reached

Phase 4

Total enrolment across studies

2,068

By phase

Phase 210

Not applicable5

Phase 32

Phase 42

Phase 12

Full trial breakdown for Tesamorelin →

Molecular identity

Substance class

Protein

FDA UNII

MQG94M5EEO

CAS number

218949-48-5

WHO ATC code

H01AC06

Amino acid sequence

YADAIFTNSYRKVLGQLSARKLLQDIMSRQQGESNQERGARARL

Sequence length

44 residues

Molecular weight

5040 g/mol

Recorded synonyms

From the FDA Global Substance Registration System, the registry that assigns every substance the FDA tracks a unique identifier.

How to read this. This page reports what federal records say about Tesamorelin, nothing more. An FDA approval covers specific uses and doses on a reviewed label. A registered trial records that research was declared, not that it succeeded. A listed patent governs who may sell a drug, not whether it works. None of this is medical advice, and none of it means a compound is safe to use outside a prescription.

Frequently asked questions

Is Tesamorelin FDA-approved?

Yes. Tesamorelin holds FDA approval and is marketed in the US. Approval covers the specific uses, doses and forms on the FDA label, not every use it is sold or discussed for.

How much clinical research is there on Tesamorelin?

24 studies are registered on ClinicalTrials.gov with Tesamorelin as an intervention, 13 of them completed. The highest phase reached is Phase 4. Registration counts research activity, not proven benefit.

What brand names is Tesamorelin sold under?

FDA records list EGRIFTA. Brand availability changes over time, and some applications on file are marked discontinued.

Where does the information on this page come from?

Four FDA and NIH sources: Drugs@FDA for approval records, the FDA Orange Book for patents and exclusivity, the FDA Global Substance Registration System for molecular identity, and ClinicalTrials.gov for trial counts. Each is refreshed on a schedule and the date above shows the last refresh.

Sources: Drugs@FDA, FDA Orange Book, FDA Global Substance Registration System and ClinicalTrials.gov. Last refreshed 2026-10-16.