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Tesamorelin | CAS No: 218949-48-5 | GMP-certified suppliers
A medication that helps reduce excess abdominal fat in HIV-associated lipodystrophy, supporting improved management of visceral adiposity when lifestyle interventions are insufficient.
Amino Acids, Peptides, and ProteinsAnterior Pituitary Lobe Hormones and AnaloguesGrowth Hormone Releasing Factor AnalogGrowth Hormone-Releasing HormoneGrowth SubstancesHormones
Generic name
Tesamorelin
Molecule type
biotech
CAS number
218949-48-5
DrugBank ID
DB08869
Approval status
Approved drug, Investigational drug
ATC code
H01AC06
Primary indications
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
Product Snapshot
Tesamorelin is an injectable peptide supplied as a subcutaneous powder-for-solution kit It is used for reduction of excess abdominal fat associated with HIV‐related lipodystrophy It holds market approvals in the US and Canada, with additional investigational status in some regions
Clinical Overview
Tesamorelin (CAS 218949-48-5) is a stabilized synthetic peptide analogue of human Growth Hormone Releasing Hormone developed for the management of excess abdominal fat in HIV‐infected adults with lipodystrophy. This syndrome arises in the context of antiretroviral therapy and is characterized by visceral adiposity, insulin resistance, and dyslipidemia. Tesamorelin acetate is approved for inducing and maintaining reductions in visceral adipose tissue in this population when lifestyle modification alone is insufficient.
Tesamorelin acts as a growth hormone secretagogue. By binding GHRH receptors on anterior pituitary somatotrophs, it stimulates pulsatile growth hormone release, which subsequently increases circulating insulin‐like growth factor 1 and its binding protein IGFBP‐3. These endocrine changes modulate lipid and glucose metabolism and contribute to reductions in visceral fat. The peptide does not replace endogenous GHRH but mimics its activity with enhanced stability against proteolytic degradation.
Absorption and disposition characteristics reflect those of a synthetic peptide administered by the subcutaneous route, with systemic exposure dependent on injection-site absorption and rapid enzymatic clearance. As with other GHRH analogues, tesamorelin is expected to undergo peptide hydrolysis to inactive fragments. It does not accumulate with repeated dosing due to its short plasma half-life, while pharmacodynamic effects persist through downstream growth hormone and IGF‐1 stimulation.
Safety considerations focus on glucose metabolism. Tesamorelin may worsen glucose intolerance and increase the risk of progression to type 2 diabetes, necessitating periodic monitoring of fasting glucose and HbA1c. Caution is advised in patients with pre-existing glucose abnormalities, and use is contraindicated in pregnancy because of potential endocrine effects. Hypersensitivity reactions have been reported, particularly in individuals with known sensitivities to excipients.
Tesamorelin is marketed in several regions as an injectable formulation for HIV‐associated lipodystrophy. For API procurement, sourcing should prioritize manufacturers with validated peptide synthesis processes, stringent control of impurities and stereochemistry, and complete documentation supporting regulatory compliance and stability expectations for peptide drug substances.
Generic name Tesamorelin Molecule type Biotech CAS 218949-48-5 UNII MQG94M5EEO DrugBank ID DB08869
Summary Tesamorelin is a synthetic analogue of human growth hormone–releasing factor that activates growth hormone–releasing hormone receptors on pituitary cells. This stimulates growth hormone secretion and raises downstream IGF‐1 and IGFBP‐3 levels, producing metabolic effects that reduce excess visceral adipose tissue. Its therapeutic intent is to address abdominal fat accumulation in HIV‐associated lipodystrophy. Mechanism of action By acting on the pituitary cells in the brain, tesamorelin stimulates production and release of the endogenous hormone (hGRF). Tesamorelin therapy predisposes the patient to glucose intolerance and can also increase the risk of type 2 diabetes, so the drug is contraindicated in pregnancy. Pharmacodynamics Tesamorelin stimulates growth hormone secretion, and subsequently increases IGF-1 and IGFBP-3 levels.
Targets
Target Organism Actions Growth hormone-releasing hormone receptor Humans binder
Absorption The absolute bioavailability was determined to be less than 4% in healthy adult subjects following a 2 mg subcutaneous dose. Half-life 26 and 38 minutes in healthy subjects and HIV-infected patients, respectively. Metabolism No formal metabolism studies have been performed in humans. Volume of distribution 9.4±3.1 L/kg in healthy subjects. 10.5±6.1 L/kg in HIV-infected patients.
Tesamorelin is a peptide biologic supplied mainly as a lyophilized powder for subcutaneous injection, requiring aseptic reconstitution before use. As a biotech peptide, it is sensitive to temperature and agitation, with solutions needing protection from degradation after reconstitution. Formulation development focuses on maintaining peptide stability in aqueous media, with no applicability for oral delivery due to enzymatic and GI degradation.
Lifecycle Most U.S. patents for the API expired between 2020 and 2023, placing the product in a post‐expiry phase. With commercialization limited to the US and Canada, the market is mature with potential for continued generic participation.
Markets US, Canada
Classification
Direct parent Peptides Kingdom Organic Compounds Superclass Organic Acids Class Carboxylic Acids and Derivatives Subclass Amino Acids, Peptides, and Analogues ATC code H01AC06
Supply Chain
Supply chain summary Tesamorelin is supplied by a single originator responsible for both development and commercial manufacturing, with branded products available primarily in the United States and Canada. The product has no broader global market footprint beyond these regions. Multiple U.S. patents have expired between 2020 and 2023, indicating that generic competition may be possible where regulatory pathways allow.
Toxicity Diarrhea, congestive heart failure, peripheral neuropathy, and loss of mobility were the four serious adverse events reported during the clinical studies
High Level Warnings:
Clinical observations include gastrointestinal disturbance (diarrhea) and neuromuscular effects such as peripheral neuropathy and mobility impairment These may indicate the need for enhanced monitoring in research or manufacturing environments Reports of congestive heart failure highlight the importance of controlling exposure and ensuring appropriate containment when handling the compound in bulk API settings
Tesamorelin is a type of Other hormonal agents
Others
Tesamorelin (Other hormonal agents), classified under Hormonal Agents
Hormonal agents are a prominent category of pharmaceutical active pharmaceutical ingredients (APIs) widely used in the medical field. These substances play a crucial role in regulating and modulating hormonal functions within the body. Hormonal agents are designed to mimic or manipulate the effects of naturally occurring hormones, allowing healthcare professionals to treat various endocrine disorders and hormonal imbalances.
Hormonal agents are commonly employed in the treatment of conditions such as hypothyroidism, hyperthyroidism, diabetes, and hormonal cancers. These APIs work by interacting with specific hormone receptors, either by stimulating or inhibiting their activity, to restore the balance of hormones in the body. They can be administered orally, intravenously, or through other routes depending on the specific medication and patient needs.
Pharmaceutical companies employ rigorous manufacturing processes and quality control measures to ensure the purity, potency, and safety of hormonal agent APIs. These APIs are synthesized using chemical or biotechnological methods, often starting from natural hormone sources or through recombinant DNA technology. Stringent regulatory guidelines are in place to guarantee the efficacy and safety of hormonal agent APIs, ensuring that patients receive high-quality medications.
As the demand for hormone-related therapies continues to grow, ongoing research and development efforts focus on enhancing the effectiveness and reducing the side effects of hormonal agent APIs. This includes the exploration of novel delivery systems, advanced formulations, and targeted drug delivery methods. By continuously advancing our understanding and capabilities in hormonal agents, the medical community can improve patient outcomes and quality of life for individuals with hormonal disorders.
Tesamorelin API manufacturers & distributors
Compare qualified Tesamorelin API suppliers worldwide. We currently have 6 companies offering Tesamorelin API, with manufacturing taking place in 2 different countries. Use the table below to review supplier type, countries of origin, certifications, product portfolio and GMP audit availability.
Supplier Type Country Product origin Certifications Portfolio Attix Pharmaceuticals Distributor United States China FDA, CoA, MSDS 7 products Hangzhou Thinheal Pharma-... Producer China China GMP, BSE/TSE, CoA, MSDS 17 products Sinoway industrial Co.,Lt... Distributor China China CoA, ISO9001, MSDS 872 products Utide Biotechnology Co.,L... Producer China China CoA, BSE/TSE, MSDS, EDMF/ASMF, CEP 7 products Yongjia Shenai E-commerce... Distributor China China CoA 17 products ZUVCHEM Distributor United States China, India CoA, MSDS, BSE/TSE, ISO14001, GMP, ISO9001, GDP, FDA 77 products
When sending a request, specify which Tesamorelin API quality you need: for example EP (Ph. Eur.), USP, JP, BP, or another pharmacopoeial standard, as well as the required grade (base, salt, micronised, specific purity, etc.).
Use the list above to find high-quality Tesamorelin API suppliers. For example, you can select GMP, FDA or ISO certified suppliers. Visit our help page to learn more about sourcing APIs via Pharmaoffer.
Frequently asked questions about Tesamorelin API What matters most when sourcing GMP-grade Tesamorelin?
Key considerations include confirming GMP compliance aligned with U.S. and Canadian regulatory expectations and ensuring the supplier can document quality, traceability, and manufacturing controls. Because Tesamorelin is supplied by a single originator, verifying authenticated supply chains and uninterrupted availability is essential. Awareness of recent U.S. patent expirations is also important, as they may influence sourcing options where regulatory pathways permit generics. Which documents are typically required when sourcing Tesamorelin API? Which manufacturers are known to produce Tesamorelin API? How can I request quotes for Tesamorelin API from GMP suppliers?
Submit quote requests through the supplier listings with your specs and required documents (specifications, target volume, delivery timeline, and destination). Providing consistent details upfront speeds comparable offers and clarifies technical feasibility. Is a GMP audit report available for Tesamorelin manufacturers?
Audit reports may be requested for Tesamorelin: 0 GMP audit reports available. Confirm the scope and recency of any audit before relying on it for qualification decisions. How many suppliers offer Tesamorelin API on Pharmaoffer?
Reported supplier count for Tesamorelin: 3 verified suppliers. Filter listings by certifications, regions, and delivery options to match your qualification plan. Which countries are known to manufacture Tesamorelin API?
Production countries reported for Tesamorelin: China (3 producers). Knowing the manufacturing geography helps anticipate logistics lead times and import compliance needs. Which certifications do suppliers of Tesamorelin usually hold? What is Tesamorelin (CAS 218949-48-5) used for?
Tesamorelin is used to reduce excess visceral abdominal fat in HIV‐infected adults with lipodystrophy when lifestyle measures are insufficient. It works as a synthetic Growth Hormone Releasing Hormone analogue that stimulates pituitary growth hormone release and increases IGF‐1, leading to metabolic changes that decrease visceral adipose tissue. Which therapeutic class does Tesamorelin fall into?
Tesamorelin belongs to the following therapeutic categories: Amino Acids, Peptides, and Proteins, Anterior Pituitary Lobe Hormones and Analogues, Growth Hormone Releasing Factor Analog, Growth Hormone-Releasing Hormone, Growth Substances. This positioning helps teams compare alternative APIs, anticipate pharmacology expectations, and align early research priorities. What conditions is Tesamorelin mainly prescribed for?
The primary indications for Tesamorelin: 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. These use cases frame the target patient populations and help prioritize formulation and safety evaluations. How does Tesamorelin work?
By acting on the pituitary cells in the brain, Tesamorelin stimulates production and release of the endogenous hormone (hGRF). Tesamorelin therapy predisposes the patient to glucose intolerance and can also increase the risk of type 2 diabetes, so the drug is contraindicated in pregnancy. What should someone know about the safety or toxicity profile of Tesamorelin?
Tesamorelin can worsen glucose intolerance and increase the risk of developing type 2 diabetes, so monitoring fasting glucose and HbA1c is important, and use is contraindicated in pregnancy. Reported adverse effects include gastrointestinal disturbance such as diarrhea, peripheral neuropathy, and mobility impairment. Hypersensitivity reactions may occur in individuals sensitive to formulation components. In bulk API handling, reports of congestive heart failure underscore the need for controlled exposure and appropriate containment. What are important formulation and handling considerations for Tesamorelin as an API?
Tesamorelin is typically formulated as a lyophilized powder for subcutaneous injection and must be reconstituted aseptically to preserve peptide integrity. Because it is sensitive to temperature and agitation, both the dry powder and reconstituted solution require controlled handling and protection from physical stress. After reconstitution, the aqueous solution should be used within recommended stability limits due to susceptibility to degradation. Oral formulations are not appropriate because the peptide is degraded enzymatically and in the gastrointestinal tract. Is Tesamorelin a biotech?
Tesamorelin is classified as a biotech. That classification shapes process design, impurity profiling, and analytical control strategies. Are there special stability concerns for oral Tesamorelin?
Tesamorelin is not suitable for oral administration because the peptide is rapidly degraded by gastrointestinal enzymes. Stability concerns therefore relate only to its established injectable form, which requires protection from heat, excessive agitation, and prolonged exposure to aqueous conditions after reconstitution. The lyophilized powder remains stable when stored as directed, while reconstituted solutions must be used promptly to limit degradation. Where is Tesamorelin approved or in use globally?
Tesamorelin is reported as approved in the following major regions: US, Canada. Understanding geographic coverage informs regulatory filings, supply planning, and risk assessments before escalating procurement. What’s the regulatory and patent landscape for Tesamorelin right now?
Tesamorelin is approved in the United States and Canada for reducing excess abdominal fat in patients with HIV‐associated lipodystrophy. In both markets, it is regulated as a prescription peptide drug. The original composition and method-of-use patents covering Tesamorelin have largely expired, and remaining protections relate primarily to specific formulations or manufacturing processes held by the innovator. How does Pharmaoffer’s Smart Sourcing Service help with Tesamorelin procurement?
Pharmaoffer's Smart Sourcing Service coordinates compliant suppliers, documentation, and competitive quotes for Tesamorelin. It centralizes outreach, follow-ups, and document validation to shorten procurement timelines. Is Tesamorelin included in the PRO Data Insights coverage?
PRO Data Insights coverage for Tesamorelin: . Use the dataset to benchmark suppliers and monitor regulatory activity where available. Where can I access the API market report for Tesamorelin?
Market report availability for Tesamorelin: Report Available. The report highlights demand trends, pricing drivers, and supplier landscape insights for procurement planning.