# Tesamorelin



## PRIDE (Oct 12, 2011)

By: SBC

Tesamorelin is a possible treatment for muscle wasting.
Theratechnologies, a Canada-based developer of therapeutic peptide products, has started screening of patients in a Phase 2 trial to assess tesamorelin as a treatment for muscle wasting in patients with chronic obstructive pulmonary disease (COPD).

Tesamorelin is a growth hormone-releasing factor (GRF) analogue that induces growth hormone production and its anabolic properties have led Theratechnologies to pursue its development in muscle wasting in patients with COPD as a second indication for the compound.

A previously concluded phase 2 trial in stable ambulatory COPD patients has demonstrated a statistically significant increase in lean body mass (LBM).

The study will evaluate the efficacy and safety of a daily administration of either a 2mg or 3mg dose of a new formulation of tesamorelin for a period of 26 weeks.

The double-blind, multi-center, placebo-controlled, randomized trial is expected to be conducted in 25 centers across US and Canada.

The company expects to enroll about 200 patients and the trial results are expected before the end of 2012.


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## PRIDE (Oct 12, 2011)

*More*

Brand Name: Egrifta
Other Name(s): TH9507
Drug Class: Opportunistic Infection and Other Drugs

Tesamorelin, also known as TH9507, is a type of medicine called a growth hormone-releasing factor (GHRF). GHRF causes growth hormone to be created and spread in the body, which helps control metabolism, body shape, and use of energy.


*Indications and Usage*
Tesamorelin was approved by the U.S. Food and Drug Administration (FDA) on November 10, 2010 for the treatment of lipodystrophy in HIV-infected individuals. Lipodystrophy is a condition that causes changes in placement of body fat, including wasting and fat accumulation, and changes in metabolism. Individuals with lipodystrophy may develop excess fat most notably around the liver, stomach, and other abdominal organs (visceral body fat).


*Dosage Form/Administration*
Always take this medicine as your doctor instructs.


*Dosage Forms and Strengths*
Tesamorelin is given as a daily shot (injection).


*Recommended Daily Dose*
Tesamorelin has been studied in clinical trials as a once-daily 2-mg injection.


*Possible Side Effects*
Tesamorelin may cause side effects.

The following life-threatening or serious side effects have been reported. Contact your doctor immediately if you experience:

    Sensory loss
    Pain
    Muscle weakness or pain
    Wasting of muscle in the hands, legs, or feet
    Diarrhea with fever and dehydration
    Loss of mobility
    Congestive heart failure
    Rash at the injection site
    Joint pain
    Swelling


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