Tesamorelin — compound monograph
Growth-hormone-releasing hormone analogue. Approved. The Institute assesses 3 outcomes for this compound and grades the strongest at moderate certainty.
§1Identification and status
§1.1Nomenclature
- Preferred name
- Tesamorelin
- Compound class
- Growth-hormone-releasing hormone analogue
- Assessment series
- Growth-hormone axis
- Synonyms and codes
- TH9507 · tesamorelin (INN) · Egrifta (trade)
- Route as evaluated
- Subcutaneous once daily
§1.2Chemistry
Chemical identifiers are reproduced where they are public. Where a structure has not been published the monograph records not disclosed rather than constructing one.[1]
- CAS registry number
- 218949-48-5
- Molecular formula
- C221H366N72O67S
- Average mass
- 5135.86
- Monoisotopic mass
- 5132.66
- ATC classification
- H01AC06
§1.3Sequence and structural notes
A 44-residue analogue of human growth-hormone-releasing hormone (1-44) bearing a trans-3-hexenoyl group on the N-terminal tyrosine. The acyl group protects against dipeptidyl peptidase-4 cleavage at the Tyr1-Ala2 bond, which otherwise inactivates native GHRH within minutes.
§1.4Assessment status
The Institute assesses Tesamorelin across 3 indications and grades the strongest of them at moderate certainty. Holds a marketing authorisation for at least one indication in at least one jurisdiction.
Table 1. Assessed outcomes for Tesamorelin, ordered by certainty. Each row links to the per-indication evidence extract.
| Indication | Effect as recorded | Certainty | Trials |
|---|---|---|---|
| Growth hormone deficiency and growth-hormone secretagogue pharmacology | IGF-1 rose by a mean of 81 ng/mL, with 34 % of participants exceeding the upper limit of normal at some point | Moderate | 1 |
| HIV-associated lipodystrophy and excess visceral adiposity | Visceral adipose tissue reduced by 15.2 % versus 5.0 % increase with placebo at 26 weeks | Moderate | 2 |
| Metabolic dysfunction-associated steatohepatitis | Liver fat fraction reduced by 4.1 percentage points versus 0.9 with placebo at 12 months in people with HIV and hepatic steatosis | Low | 1 |
| Effects are reproduced as the contributing trials reported them. Where a confidence interval is held it appears on the per-indication extract rather than in this summary table. | |||
References cited on this page
References are numbered in order of first citation in this document. Each superscript in the text links to its entry below.
- International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. ICH Q6B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products. ICH Harmonised Tripartite Guideline 1999;Step 4 version. identifier not held by the Institute
Identifiers are reproduced only where the Institute holds them. Where a digital object identifier or PubMed identifier is not shown, the Institute has recorded the journal and year and has not constructed an identifier.