Tesamorelin: Peptide Profile, CAS & Properties
CAS 218949-48-5 · 5135.86 g/mol
Tesamorelin (CAS 218949-48-5) is a 44-amino-acid stabilised analogue of growth-hormone-releasing hormone (GRF 1-44), classed as a GHRH analogue. It is approved by the US FDA (since 2010) for reducing excess visceral abdominal fat in HIV-associated lipodystrophy. This page provides reference information on Tesamorelin.
- CAS Number
- 218949-48-5
- Molecular Formula
- C221H366N72O67S
- Molecular Weight
- 5135.86 g/mol
- Drug Class
- GHRH analogue
What is Tesamorelin?
Tesamorelin is a stabilised analogue of human growth-hormone-releasing hormone (GHRH), built on the full 44-amino-acid GRF(1-44) sequence and modified at the N-terminus with a trans-3-hexenoyl (hexenoic acid) group. This lipophilic modification confers greater resistance to enzymatic degradation — including by dipeptidyl peptidase-4 (DPP-4) — than endogenous GHRH. Mechanistically, tesamorelin acts on pituitary somatotroph cells to stimulate the synthesis and pulsatile release of endogenous growth hormone.
As an active pharmaceutical ingredient, tesamorelin (CAS 218949-48-5, molecular formula C221H366N72O67S, ~5135.86 g/mol) is typically presented as a lyophilised powder for formulation into injectable finished dosage forms. It is approved by the US FDA (since 2010) for the reduction of excess visceral abdominal fat in patients with HIV-associated lipodystrophy.
How Tesamorelin Is Produced & Characterised
Tesamorelin is a long, synthetically demanding 44-mer peptide: the extended chain length, the N-terminal hexenoyl acylation and several difficult coupling regions all create opportunities for deletion sequences, diastereomers and incomplete modification. For this peptide class, production is typically carried out by Fmoc solid-phase peptide synthesis (SPPS) with controlled N-terminal acylation, followed by purification on preparative dynamic axial compression (DAC) HPLC columns that isolate the target sequence from closely related impurities.
The purified peptide is generally lyophilised to a stable, uniform powder and released against a defined specification for batch-to-batch consistency. Characterisation usually combines UPLC/HPLC for purity, LC-MS for sequence and impurity profiling, and tests for water content, counter-ion (acetate) content, residual solvents and peptide content. This reflects the general industry and analytical approach for stabilised GHRH-class peptides, not the activity of any single supplier.
Typical Quality Specifications & Impurity Control
Pharmaceutical-grade tesamorelin is commonly released against a defined specification documented in a Certificate of Analysis. For peptides of this complexity, target release purity is frequently ≥99.0% by UPLC/HPLC, with individual impurities controlled below roughly 0.10%, and the sequence and minor structural variants confirmed by LC-MS impurity profiling.
Stability is typically supported by ICH Q1A(R2) long-term and accelerated data, with analytical methods validated to ICH Q2(R1). Full traceability from raw materials and resins through to final batch-release records is characteristic of regulated peptide production. These values are presented as typical reference specifications for the molecule rather than a commercial offer.
Regulatory & Documentation Context
Tesamorelin is an approved active ingredient: the US FDA cleared it in 2010 for the reduction of excess visceral abdominal fat in patients with HIV-associated lipodystrophy. For regulated finished products, the API is generally supported by CMC documentation such as US-DMF Type II dossiers and CTD Module 3 sections, analytical validation packages to ICH Q2(R1), and stability data — the standard filing materials referenced in IND/NDA/ANDA submissions.
Manufacturing for regulated markets is typically built around pre-approval-inspection (PAI) readiness aligned to FDA, EMA and PMDA expectations. This section describes the general regulatory and documentation context for the molecule for educational reference and does not represent advice on any specific product or programme.
Tesamorelin API — Specifications
| Compound | Tesamorelin |
|---|---|
| CAS Number | 218949-48-5 |
| Molecular Formula | C221H366N72O67S |
| Molecular Weight | 5135.86 g/mol |
| Sequence | 44 amino acids (GRF 1-44, N-terminal trans-3-hexenoyl) |
| Drug Class | GHRH analogue |
| Appearance | White to off-white lyophilised powder |
| Typical Purity (HPLC) | ≥ 99.0% (single impurity < 0.10%) |
| Synthesis Route | Fmoc SPPS + DAC prep-HPLC purification |
| Regulatory Status | US FDA approved active ingredient (since 2010) |
| Form | Lyophilised powder for injectable formulation |
| Storage | Store at -20°C, protected from light & moisture |
Reference data only — WinHyCare neither supplies nor manufactures this compound; see our Semaglutide API for the product we supply. Regulatory status: Approved as an active ingredient by the US FDA (since 2010) for the reduction of excess visceral abdominal fat in patients with HIV-associated lipodystrophy.
Tesamorelin API — Frequently Asked Questions
What is Tesamorelin?
Tesamorelin is a stabilised analogue of human growth-hormone-releasing hormone (GHRH), based on the full 44-amino-acid GRF(1-44) sequence with an N-terminal trans-3-hexenoyl modification that increases resistance to enzymatic degradation. It stimulates the pituitary to release endogenous growth hormone.
What is the CAS number and molecular weight of Tesamorelin?
Tesamorelin's CAS number is 218949-48-5, its molecular formula is C221H366N72O67S, and its molecular weight is approximately 5135.86 g/mol. It is a 44-amino-acid GHRH (GRF 1-44) analogue with an N-terminal trans-3-hexenoyl modification.
Is Tesamorelin approved?
Yes. Tesamorelin is approved as an active ingredient by the US FDA (since 2010) for the reduction of excess visceral abdominal fat in patients with HIV-associated lipodystrophy.
What class of peptide is Tesamorelin?
Tesamorelin is a growth-hormone-releasing hormone (GHRH) analogue — specifically a stabilised analogue of the GRF(1-44) sequence. It belongs to the growth and metabolism peptide class.
What is Tesamorelin studied or used for?
Tesamorelin's approved use is the reduction of excess visceral abdominal fat in patients with HIV-associated lipodystrophy. Its mechanism — stimulating endogenous growth hormone release via pituitary somatotroph cells — has also made it a subject of research interest in metabolic and related contexts.
How is Tesamorelin produced?
Peptides of this class are typically produced by optimised Fmoc solid-phase peptide synthesis (SPPS) with controlled N-terminal acylation, followed by preparative dynamic axial compression (DAC) HPLC purification and lyophilisation to a stable powder. Purity and identity are confirmed by UPLC/HPLC and LC-MS.
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Technical Reference Page
WinHyCare neither supplies nor manufactures Tesamorelin; this page is provided as a technical reference. The peptide API we supply is Semaglutide.