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Somatostatin | CAS No: 38916-34-6 | GMP-certified suppliers
A medication that helps control acute bleeding from esophageal varices and supports management of related endocrine and gastrointestinal disorders.
Therapeutic categories
Primary indications
- For the symptomatic treatment of acute bleeding from esophageal varices
- Other treatment options for long-term management of the condition may be considered if necessary, once initial control has been established
Product Snapshot
- Somatostatin is available as a parenteral injectable peptide formulation in powder or solution form requiring reconstitution
- It is primarily indicated for the symptomatic treatment of acute bleeding from esophageal varices
- The product is approved for use in the Canadian market and is also under investigational status
Clinical Overview
Pharmacologically, somatostatin exerts inhibitory control over the release of multiple hormones including growth hormone, thyroid-stimulating hormone (TSH), insulin, glucagon, gastrin, secretin, motilin, and vasoactive intestinal peptide among others. It also modulates neurotransmitter release and has been implicated in local immune regulation with anti-inflammatory and analgesic effects. These multifaceted roles are mediated through five subtypes of G protein-coupled somatostatin receptors (SSTR1–SSTR5), distributed across various tissues. Activation of these receptors reduces intracellular cyclic AMP and calcium influx, inhibiting hormone secretion and cell proliferation or inducing apoptosis, notably via SSTR2 and SSTR3 in endocrine and tumor tissues.
Absorption, distribution, metabolism, and excretion (ADME) data on somatostatin as a peptide hormone generally highlight a rapid clearance profile consistent with peptides, necessitating the development of stable analogues for therapeutic use. Somatostatin’s short half-life and enzymatic degradation limit its direct clinical application, thus analogues with prolonged duration are preferred for chronic conditions.
Safety considerations center on its broad inhibitory effects on endocrine and gastrointestinal functions, requiring careful monitoring to avoid hypoglycemia, hypothyroidism, or gastrointestinal disturbances. Somatostatin’s vasoconstrictive action underpins its efficacy in reducing portal hypertension and variceal bleeding but may pose risks in patients with compromised vascular function.
Notable therapeutic uses include acromegaly, neuroendocrine tumors, and acute management of esophageal variceal hemorrhage. Brands featuring somatostatin analogues, such as octreotide, offer improved pharmacokinetic properties for practical clinical administration.
From an API sourcing perspective, somatostatin’s peptide nature necessitates stringent quality controls to ensure purity, correct folding, and biological activity. Manufacturers should adhere to Good Manufacturing Practice (GMP) standards with validated processes to minimize impurities and guarantee batch-to-batch consistency. Supplier qualification should include detailed documentation of synthesis or fermentation methods, analytical characterization, and stability data to support regulatory filings and consistent therapeutic performance.
Identification & chemistry
| Generic name | Somatostatin |
|---|---|
| Molecule type | Small molecule |
| CAS | 38916-34-6 |
| UNII | 6E20216Q0L |
| DrugBank ID | DB09099 |
Pharmacology
| Summary | Somatostatin is an endogenous peptide hormone that exerts inhibitory effects on hormone and neurotransmitter secretion through activation of five Gi-protein-coupled somatostatin receptor subtypes (SSTR1-5). Its pharmacodynamic actions include suppression of endocrine and exocrine secretions, inhibition of cell proliferation and angiogenesis, and modulation of inflammatory and nociceptive pathways. Therapeutically, somatostatin receptor activation leads to reduced hormone release, vasoconstriction in splanchnic circulation, and antitumor effects in neuroendocrine and other tumors. |
|---|---|
| Mechanism of action | Somatostatin binds to 5 subtypes of somatostatin receptors (SSTRs), which are all Gi-protein-coupled transmembrane receptors that inhibits adenylyl cyclase upon activation . By inhibiting intracellular cyclic AMP and Ca2+ and by a receptor-linked distal effect on exocytosis, SSTRs block cell secretion . The common pathway shared by the receptors involve the activation of phosphotyrosine phosphatase (PTP), and modulation of mitogen-activated protein kinase (MAPK) . With the exception of SSTR3, activation of SSTRs lead to activation of voltage-gated potassium channels accompanied by increased K+ currents. This result in membrane hyperpolarization and inhibits depolarization-induced Ca2+ influx through voltage-sensitive Ca2+ channels . Depending on the receptor subtype, signalling cascades involve activation of other downstream targets such as Na+/H+ exchanger, Rho GTPase, and nitric oxide synthase (NOS) . SSTRs 1 to 4 bind both somatostatin isoforms with equal nanomolar binding affinity whereas SSTR5 exhibits a 5- to 10-fold higher binding affinity for SST-28 . **Effects of SSTR1:** Upon biding of somatostatin and activation, SSTR1 mediates an antisecretory effect on growth hormone, prolactin and calcitonin . **Effects of SSTR2:** SSTR2 subtype dominates in endocrine tissues. By binding to SST2 receptors, somatostatin exerts paracrine inhibitory actions on gastrin release from G cells, histamine release from ECL cells, and directly on parietal cell acid output . SSTR2 receptor signalling cascades also inhibit the secretion of growth hormone and that of adrenocorticotropin, glucagon, insulin, and interferon-γ . **Effects of SSTR3:** Activation of these receptors lead to reduction in cell proliferation . SSTR3 triggers PTP-dependent cell apoptosis accompanied by activation of p53 and the pro-apoptotic protein Bax . A study of the matrigel sponge assay suggests that through SSTR3-mediated inhibition of both NOS and MAPK activities may lead to the antitumor effects of somatostatin in inhibiting tumor angiogenesis . **Effects of SSTR4:** The functions of SSTR4 remain largely unknown . **Effects of SSTR5:** Like SSTR2, SSTR5 subtype also predominates in endocrine tissues. Upon activation, SSTR5 signalling cascades exert an inhibitory action on growth hormone, adrenocorticotropin, insulin, and glucagon-like peptide-1 as well as the secretion of amylase . The presence of somatostatin receptors has been identified in most neuroendocrine tumours, endocrine gastroenteropancreatic (GEP) tumors, paragangliomas, pheochromocytomas, medullary thyroid carcinomas (MTC) and small cell lung carcinomas . The antitumor effects of somatostatin were also effective in various malignant lymphomas and breast tumours . Gastrointestinal hormones, such as gastrin, secretin, and cholecystokinin (CCK), as well as growth hormones and growth factors are thought to be elevated in gastrointestinal tract and neuroendocrine tumours and are inhibited by somatostatin . _In vitro_, somatostatin inhibited epidermal growth factor (EGF)-induced DNA synthesis and replication following which suggest that somatostatin may have direct anti-proliferative effects via SSTR signalling . Acromegaly is characterized as the endocrine disorder caused by a functioning tumour of cells that secrete growth hormone from the anterior pituitary . Somatostatin analogue therapies serve to normalize the elevated levels of GH and insulin-like growth factor 1 (IGF-1) and attenuate tumour growth. In the vascular system this likely produces vasoconstriction by inhibiting adenylate cyclase leading to a lowering the concentration of cyclic adenosine monophosphate in the endothelial cells which ultimately blocks vasodilation through this pathway. This vasoconstriction is though the be responsible for reducing blood flow to the esophageal tissues and so reduces bleeding from esophageal varices . Somatostatin mediates an analgesic activity by reducing vascular and nociceptive components of inflammation . Studies indicate that somatostatin may be present in nociceptive DRG neurons with C-fibers and primary afferent neurons to inhibit the release of transmitters at the presynaptic junctions of the sensory-efferent nerve terminals . Exogenous somatostatin has shown to inhibit the release of Substance P from central and peripheral nerve ending . |
| Pharmacodynamics | Somatostatin is an endogenous peptide hormone that is secreted by the central nervous system, gastrointestinal tract, retina, peripheral neurons and pancreatic D cells of the islets of Langerhans. It exhibits several biological roles but predominantly exerts an inhibitory effect on secretion of other hormones and transmitters . While distribution of two active isoforms of somatostatin is similar, SST-14 is more predominant in the enteric neurons and peripheral nerves whereas SST-28 is more prominent in the retina and intestinal mucosal cells . **Anterior pituitary gland and brain:** It inhibits the release of growth hormones and thyroid-stimulating hormones, such as thyroid stimulating hormone (TSH) and thyrotrophin, from the anterior pituitary while inhibiting the release of dopamine from the midbrain, norepinephrine, TRH and corticotrophin-releasing hormone in the brain . **Pancreas:** In the pancreas, somatostatin reduces the secretion of glucagon and insulin as well as bicarbonate ions and other enzymes [A20384, T28]. **Thyroid gland:** Somatosatin reduces secretion of T3, T4, and calcitonin . Somatostatin regulates the thyroid function by reducing basal TSH release . **Gastrointestinal tract:** It attenuates the release of most gastrointestinal hormones such as gastrin, secretin, motilin, gastric acid, enteroglucagon, cholecystokinin (CCK), vasoactive intestinal peptide (VIP), gastric inhibitory polypeptide (GIP), intrinsic factor, pepsin, neurotensin, as well as bile secretion and colonic fluid secretion . **Adrenal gland:** It inhibits angiotensin II-stimulated aldosterone secretion and acetylcholine-induced medullary catecholamine secretion . **Eye/retina:** Somatostatin inhibits the production of vascular endothelial growth factor . **Inflammatory cells and sensory nerves:** The expression of somatostatin has been found in inflammatory cells such as lymphocytes, monocytes, macrophages and endothelial cells to act as an autocrine or paracrine regulator in local immune responses. Findings suggest that somatostatin may play a role in exerting local and systemic anti-inflammatory and antinociceptive effects . On primary afferent neurons, somatostatin reduces the responses to thermal stimulation in C-mechanoheat sensitive fibers in a dose-dependent fashion and reduces the responses of C-mechanoheat fibers to bradykinin-induced excitation and sensitization to heat . Somatostatin is reported to elicit an analgesic effect when applied intrathecally; there is evidence supporting that similar effects may occur when systemically used to treat endocrine disorders . Somatostatin is thought to reduce bleeding from esophageal varices by causing splanchnic vasoconstriction . Somatostatin elicits anti-neoplastic actions on various tumours via direct or indirect effects, or a combination of both . |
Targets
| Target | Organism | Actions |
|---|---|---|
| Somatostatin receptor type 1 | Humans | agonist |
| Somatostatin receptor type 2 | Humans | agonist |
| Somatostatin receptor type 3 | Humans | agonist |
ADME / PK
| Absorption | This pharmacokinetic data is irrelevant. |
|---|---|
| Half-life | The half-life of endogenous somatostatin is 1-3 minutes due to rapid degradation by peptidase enzymes present in the plasma and tissues . |
| Protein binding | This pharmacokinetic data is irrelevant. |
| Metabolism | Somatostatin is rapidly degraded by peptidase enzymes present in cells and plasma . |
| Route of elimination | As a polypeptide chain, somatostatin is primarily eliminated via metabolism by peptidase enzymes . |
| Volume of distribution | This pharmacokinetic data is irrelevant. |
| Clearance | Following intravenous administration of 3H-labeld endogenous somatostatin, the total body clearance was approximately 50 mL/min . In man, the value was calculated to be as high as 3000 mL/minutes, which is greatly exceeds the hepatic blood flow. This suggests that rapid enzymatic breakdown in the circulation and other tissues serves as a critical route of elimination . |
Formulation & handling
- Somatostatin is formulated primarily as a lyophilized powder for reconstitution and intravenous injection, requiring aseptic handling prior to administration.
- Due to its small molecule nature with very low water solubility and high hydrophilicity (logP -8.2), careful consideration is needed for solubilization and stability in aqueous solutions.
- The API should be protected from conditions that may degrade peptides or biologics despite its small molecule classification, including temperature and moisture control during storage and handling.
Regulatory status
| Lifecycle | The API's primary patents in Canada have expired, allowing generic entry and increased market competition. As a result, the product is now in a mature lifecycle stage within the Canadian pharmaceutical market. |
|---|
| Markets | Canada |
|---|
Supply Chain
| Supply chain summary | The manufacturing landscape for Somatostatin includes originator companies producing branded products primarily available in Canada. Branded formulations such as Stilamin are present in injectable forms, including powder for intravenous use and liquid solutions. Patent expiry status is not specified, so the extent of generic competition cannot be determined from the provided data. |
|---|
Safety
| Toxicity | Data is not available. |
|---|
- Toxicity data for this active pharmaceutical ingredient is not available
- Appropriate handling precautions should be implemented
- Use personal protective equipment to minimize exposure during manufacturing and processing
Somatostatin is a type of Somatostatin Analogs
Somatostatin analogs are a subcategory of pharmaceutical active pharmaceutical ingredients (APIs) used in the treatment of various medical conditions. These analogs are synthetic versions of somatostatin, a hormone naturally produced in the body.
Somatostatin analogs are primarily used in the management of conditions such as acromegaly, a hormonal disorder characterized by excessive growth hormone production, and neuroendocrine tumors (NETs), which are tumors that arise from the neuroendocrine cells.
These analogs function by mimicking the actions of somatostatin in the body. Somatostatin normally inhibits the release of several hormones, including growth hormone, insulin, glucagon, and gastrin. By imitating somatostatin's inhibitory effects, somatostatin analogs help regulate the production and release of these hormones.
One commonly used somatostatin analog is octreotide, which is available in various formulations, including injectable and long-acting depot formulations. Octreotide is administered to control symptoms associated with acromegaly and NETs, such as excessive growth, hormone overproduction, and tumor growth.
Other somatostatin analogs like lanreotide and pasireotide have also been developed and are used for similar indications. These analogs offer an extended duration of action and can be administered via subcutaneous injections.
In summary, somatostatin analogs are a crucial category of APIs utilized in the management of conditions like acromegaly and neuroendocrine tumors. They act by replicating the inhibitory effects of somatostatin and are available in various formulations to meet different patient needs. Octreotide, lanreotide, and pasireotide are examples of commonly used somatostatin analogs in clinical practice.
Somatostatin (Somatostatin Analogs), 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.
Somatostatin API manufacturers & distributors
Compare qualified Somatostatin API suppliers worldwide. We currently have 8 companies offering Somatostatin API, with manufacturing taking place in 5 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 |
|---|---|---|---|---|---|
| Apino Pharma Co., Ltd. | Producer | China | China | BSE/TSE, CoA, GMP, MSDS, USDMF | 229 products |
| BCN Peptides | Producer | Spain | Spain | CEP, CoA, FDA, GMP, KDMF | 13 products |
| Chengdu Shengnuo Biopharm... | Producer | China | China | BSE/TSE, CoA, GMP, MSDS | 33 products |
| Hainan Shuangcheng | Producer | China | China | CoA | 11 products |
| Hemmo Pharma | Producer | India | India | CEP, CoA, FDA, WC | 13 products |
| Hybio Pharmaceutical Co L... | Producer | China | China | BSE/TSE, CEP, CoA, GMP, MSDS | 34 products |
| Polypeptide Labs | Producer | Sweden | Sweden | CEP, CoA, FDA, GMP | 21 products |
| Socosur | Distributor | France | Unknown | CoA | 21 products |
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