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Inositol | CAS No: 87-89-8 | GMP-certified suppliers
A medication that supports management of polycystic ovary syndrome, metabolic disorders, psychiatric conditions, and serves as a nutrient supplement in specialized dietary formulations.
Therapeutic categories
Primary indications
- Inositol may be used in food without any limitation
- As a drug, inositol is used as a nutrient supplement in special dietary foods and infant formula
- As it presents a relevant role in ensuring oocyte fertility, inositol has been studied for its use in the management of polycystic ovaries
- Inositol is also being researched for the treatment of diabetes, prevention of metabolic syndrome, aid agent for weight loss, treatment of depression, psychiatric disorder and anxiety disorder and for prevention of cancer
Product Snapshot
- Inositol is available primarily as oral small molecule formulations including tablets, capsules, powders, solutions, and also injectable forms
- It is utilized mainly as a nutrient supplement in special dietary foods and infant formulas, with investigational uses in managing polycystic ovary syndrome, diabetes, metabolic syndrome, psychiatric disorders, and cancer prevention
- Inositol products have approval status ranging from approved to investigational in key regulatory markets such as the US and Canada
Clinical Overview
Clinically, inositol has been studied across a range of indications including polycystic ovary syndrome (PCOS), diabetes mellitus, metabolic syndrome, weight management, psychiatric disorders such as depression and anxiety, as well as cancer prevention research. Inositol’s mechanism of action involves modulation of intracellular signaling pathways through the phosphatidylinositol cycle, acting as a precursor molecule influencing neurotransmitter synthesis and receptor sensitivity, including serotonin and gamma-aminobutyric acid (GABA) systems. In PCOS and metabolic conditions, it improves insulin signaling by acting as a second messenger to enhance glucose uptake, thereby addressing insulin resistance and its downstream effects on androgen production and lipid metabolism.
Pharmacodynamically, inositol promotes glucose uptake in skeletal muscle and reduces hyperglycemia indicators such as urinary glucose. Its effects extend to reproductive health by enhancing oocyte quality and sperm parameters. Neuropsychological benefits are postulated to arise from increased neurotransmitter receptor sensitivity, potentially alleviating symptoms of anxiety and obsessive-compulsive disorders. The antioxidative and anti-inflammatory properties of inositol and its phosphate derivatives are of interest in oncology, with possible modulation of malignant cell growth and differentiation.
From an absorption, distribution, metabolism, and excretion (ADME) perspective, detailed human pharmacokinetic data remain limited. As a micronutrient, inositol exhibits renal excretion and is considered safe with recognition as Generally Recognized As Safe (GRAS) by the US FDA. Safety profiles from clinical investigations indicate low toxicity, though high doses should be monitored, especially in vulnerable populations.
For API procurement, quality control should focus on stereoisomeric purity, absence of contaminants, and compliance with pharmacopeial standards where applicable. Given its use in nutritional supplements and investigational therapies, source traceability and manufacturing under Good Manufacturing Practices (GMP) are essential to ensure batch consistency and regulatory compliance.
Identification & chemistry
| Generic name | Inositol |
|---|---|
| Molecule type | Small molecule |
| CAS | 87-89-8 |
| UNII | 4L6452S749 |
| DrugBank ID | DB13178 |
Pharmacology
| Summary | Inositol functions as a precursor in the phosphatidylinositol signaling pathway, modulating neurotransmitter activity and insulin signaling. It enhances glucose uptake in peripheral tissues, contributing to improved metabolic regulation in conditions such as polycystic ovary syndrome and diabetes. Additionally, inositol exhibits antioxidant properties and influences cell growth and differentiation, supporting its investigation in neurological and oncological contexts. |
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| Mechanism of action | The mechanism of action of inositol in brain disorders is not fully understood but it is thought that it may be involved in neurotransmitter synthesis and it is a precursor to the phosphatidylinositol cycle. The change that occurs in the cycle simulates when the postsynaptic receptor is activated but without activating the receptor. This activity provokes a fake activation which regulated the activity of monoamines and other neurotransmitters. Reports have shown that insulin resistance plays a key role in the clinical development of PCOS. The presence of hyperinsulinemia can induce an excess in androgen production by stimulating ovaries to produce androgens and by reducing the sex hormone binding globulin serum levels. One of the mechanisms of insulin deficiency is thought to be related to a deficiency in inositol in the inositolphosphoglycans. The administration of inositol allows it to act as a direct messenger of the insulin signaling and improves glucose tissue uptake. This mechanism is extrapolated to its functions in diabetes treatment, metabolic syndrome, and weight loss. In cancer, the mechanism of action of inositol is not fully understood. It is hypothesized that the administration of inositol increases the level of lower-phosphate inositol phosphates why can affect cycle regulation, growth, and differentiation of malignant cells. On the other hand, the formation of inositol hexaphosphate after administration of inositol presents antioxidant characteristics by the chelation of ferric ions and suppression of hydroxyl radicals. |
| Pharmacodynamics | Inositol can stimulate glucose uptake in skeletal muscle cells which allows the decrease in blood sugar levels. This effect is later seen as a reduction in urine glucose concentration and indicates a decrease in high blood sugar levels. In PCOS, the administration of inositol has produced the remission of symptoms as well as a reduction in male hormone secretion, a regulation of the cholesterol level, and a more efficient fat breakdown which allow to a significant reduction on body mass and appetite. In the cases of infertility, inositol has been proven to increase sperm count and motility, as well as increase the overall quality of oocytes and embryos. In the brain, inositol has been shown to produce an increase in serotonin receptor sensitivity. This activity produces an increase in GABA release. Some of the effects observed in the brain produced a relief in symptoms of anxiety and obsessive-compulsive disorders. In high doses, it has been shown to even reduce panic attacks. In cancer research, inositol has gained interest as it can act as an antioxidant, anti-inflammatory and it seems to enhance immune properties. |
ADME / PK
| Absorption | Inositol is absorbed from the small intestine. In patients with inositol deficiency, the maximal plasma concentration after oral administration of inositol is registered to be of 4 hours. Inositol is taken up by the tissues via sodium-dependent inositol co-transporter which also mediates glucose uptake. Oral ingestion of inositol is registered to generate a maximal plasma concentration of 36-45 mcg. |
|---|---|
| Half-life | The pharmacokinetic profile of inositol was studied in preterm infants and the estimated elimination half-life was reported to be of 5.22 hours. |
| Protein binding | It is thought that inositol can be found bound to plasma proteins. |
| Metabolism | It is thought that inositol is metabolized to phosphoinositol and then converted to phosphatylinositol-4,5-biphosphate which is a precursor of the second-messenger molecules. Inositol can be transformed to D-chiro-inositol via the actions of an epimerase. The normal modifications to inositol structure seem to be between all the different isomers. |
| Route of elimination | Most of the administered dose is excreted in urine. |
| Volume of distribution | The pharmacokinetic profile of inositol was studied in preterm infants and the estimated volume of distribution was reported to be 0.5115 L/kg. |
| Clearance | The pharmacokinetic profile of inositol was studied in preterm infants and the estimated clearance rate was reported to be 0.0679 L.kg/h. |
Formulation & handling
- Inositol is a small molecule suitable for oral, intramuscular, and vaginal administration in various dosage forms including tablets, capsules, liquids, and creams.
- Due to its high water solubility and low LogP, formulations should consider rapid dissolution and absorption characteristics for oral dosage forms.
- Stability considerations for inositol include maintaining dry storage conditions to preserve its solid state and prevent moisture-induced degradation.
Regulatory status
| Lifecycle | The active pharmaceutical ingredient is marketed in Canada and the US, with patents expiring in the US in 2025 and in Canada in 2026, indicating varying stages of market exclusivity and approaching generic competition. |
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| Markets | Canada, US |
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Supply Chain
| Supply chain summary | The manufacturing and supply landscape for Inositol includes multiple originator companies producing various branded products primarily available in the US and Canadian markets. With at least 24 multivitamin and mineral formulations and additional specialized brands, there is a well-established presence in these regions. Patent expiry status is not indicated, suggesting that generic competition may already be present or established in the marketplace. |
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Safety
| Toxicity | Consumption of high doses of inositol is reported to only cause some gastrointestinal effects. |
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- Exposure to high doses of inositol may cause mild gastrointestinal disturbances
- Inositol has a low toxicity profile and is generally regarded as safe for use in food applications
- Standard handling procedures should minimize ingestion and inhalation to prevent unnecessary exposure
Inositol is a type of Gastrointestinal Agents
Gastrointestinal Agents belong to the pharmaceutical API category that focuses on treating disorders and ailments related to the digestive system. These agents play a crucial role in addressing various gastrointestinal conditions, such as acid reflux, ulcers, irritable bowel syndrome (IBS), and inflammatory bowel disease (IBD).
One of the key types of gastrointestinal agents is proton pump inhibitors (PPIs), which work by reducing the production of stomach acid. PPIs help in treating conditions like gastroesophageal reflux disease (GERD) and peptic ulcers. Another essential class of agents is antacids, which neutralize excessive stomach acid, providing relief from heartburn and indigestion.
Gastrointestinal agents also include antispasmodics that alleviate abdominal cramps and spasms associated with conditions like IBS. These drugs work by relaxing the smooth muscles of the digestive tract. Additionally, there are drugs categorized as laxatives that aid in relieving constipation by promoting bowel movements.
Moreover, certain gastrointestinal agents act as antiemetics, effectively reducing nausea and vomiting. These drugs are particularly useful for patients undergoing chemotherapy or experiencing motion sickness.
Pharmaceutical companies develop and manufacture a wide range of gastrointestinal agents in various forms, including tablets, capsules, suspensions, and injections. These agents are typically formulated using active pharmaceutical ingredients (APIs) and other excipients to ensure their efficacy and safety.
In conclusion, gastrointestinal agents form a vital category of pharmaceutical APIs, providing relief from digestive disorders and improving overall gastrointestinal health. The availability of diverse agents catering to different conditions ensures that patients can receive targeted treatment for their specific gastrointestinal needs.
Inositol API manufacturers & distributors
Compare qualified Inositol API suppliers worldwide. We currently have 2 companies offering Inositol 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 |
|---|---|---|---|---|---|
| Changzhou Comwin Fine Che... | Producer | China | China | BSE/TSE, CoA, HALAL, ISO14001, ISO9001, Kosher, MSDS | 235 products |
| SETV Global | Producer | India | India | CoA, FDA, GMP | 515 products |
When sending a request, specify which Inositol 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.).
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