Tesamorelin - Theratechnologies
Alternative Names: EGRIFTA; EGRIFTA MDVTM; EGRIFTA SV; F4; F8; Tesamorelin acetate; TH-9507; ThGRF 1-44Latest Information Update: 26 Feb 2024
At a glance
- Originator Theratechnologies
- Developer National Heart, Lung and Blood Institute; National Institute on Aging; Theratechnologies
- Class Antidementias; Hepatoprotectants; Pituitary hormone releasing hormones; Sleep disorder therapies
- Mechanism of Action Growth hormone releasing factor agonists
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Orphan Drug Status
Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.
- New Molecular Entity Yes
- Available For Licensing Yes - Non-alcoholic steatohepatitis
Highest Development Phases
- Marketed Lipodystrophy
- Phase II Mild cognitive impairment; Non-alcoholic steatohepatitis
- Discontinued Insomnia; Lipid metabolism disorders; Muscular atrophy
Most Recent Events
- 21 Feb 2024 Theratechnologies announces intention to resubmit the sBLA to the US FDA for new F8 formulation for Lipodystrophy before the end of 2024
- 21 Feb 2024 Theratechnologies anticipates approval and launch of tesamorelin before end of 2024
- 21 Feb 2024 Theratechnologies plans a Type A meeting with the US FDA for the F8 formulation of tesamorelin sBLA