Overview
Tesamorelin is a stabilized synthetic peptide analogue of the hypothalamic peptide, Growth Hormone Releasing Hormone (GHRH) indicated for the reduction of excess abdominal fat in HIV-infected patients with lipodystrophy. Lipodystrophy is a metabolic condition characterized by insulin resistance, fat redistribution, and hyperlipidemia associated with antiretroviral therapy for HIV infection.
Indication
Tesamorelin acetate is a synthetic analogue of human hypothalamic Growth Hormone Releasing Factor (hGRF) indicated to induce and maintain a reduction of excess abdominal fat in HIV-infected patients with lipodystrophy.
Associated Conditions
- Lipodystrophies
Research Report
Tesamorelin: A Comprehensive Review of its Pharmacology, Efficacy, and Safety in HIV-Associated Lipodystrophy
1. Introduction to Tesamorelin
Overview
Tesamorelin is a synthetic peptide analogue of the endogenous hypothalamic peptide, Growth Hormone Releasing Hormone (GHRH), also known as Growth Hormone Releasing Factor (GRF).[1] It is classified pharmacologically as a GHRH analog and a somatotropin agonist.[1]
Chemical Structure and Modification
Tesamorelin is a polypeptide comprising the full 44 amino acid sequence of human GHRH.[2] Its structure is distinguished by a modification at the N-terminus, where a trans-3-hexenoic acid group is attached.[4] This chemical modification serves a crucial function: it enhances the peptide's stability and confers resistance to enzymatic degradation, particularly cleavage by dipeptidyl aminopeptidase (DPP-IV), compared to the native GHRH molecule.[2] This increased stability results in an improved pharmacokinetic profile, allowing for therapeutic efficacy with subcutaneous administration.[2] The Chemical Abstracts Service (CAS) Registry Number for Tesamorelin is 218949-48-5.[5] Its molecular formula is C221H366N72O67S, corresponding to a molecular weight of approximately 5135.8 g/mol.[5]
Primary Indication
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/08/15 | Phase 2 | Not yet recruiting | |||
2017/12/18 | Phase 2 | Active, not recruiting | |||
2017/07/24 | Phase 4 | Completed | |||
2017/05/12 | Phase 2 | Recruiting | |||
2016/10/13 | Phase 2 | Withdrawn | National Institute of Nursing Research (NINR) | ||
2015/10/08 | Phase 2 | Completed | |||
2014/07/22 | Not Applicable | Completed | |||
2013/12/16 | Phase 1 | Completed | |||
2013/02/11 | N/A | Withdrawn | |||
2012/07/03 | Not Applicable | Withdrawn |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
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| No FDA approvals found for this drug. | |||||
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
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| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
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| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
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| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
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| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
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