Filters
Custom request?
Type
Production region
Qualifications
Country of origin
Itopride API Manufacturers & Suppliers
9 verified results
All Itopride data. Full access. Full negotiation power
Commercial-scale Suppliers
Employees: 50+
All certificates
Employees: 19
All certificates
Employees: 150
All certificates
Employees: +250
All certificates
All certificates
All certificates
All certificates
Employees: 4,000
All certificates
All certificates
Total market transparency
Supplier trade data access
Buyer / supplier flow comparison
Itopride | CAS No: 122898-67-3 | GMP-certified suppliers
A medication that supports management of functional gastrointestinal disorders by helping improve gastric motility, offering sourcing teams a reliable API option for related formulations.
Therapeutic categories
Primary indications
- Investigated for use/treatment in gastrointestinal diseases and disorders (miscellaneous)
Product Snapshot
- Itopride is an oral small‑molecule product supplied in multiple tablet presentations
- It is investigated for functional and motility‑related gastrointestinal disorders
- It currently holds investigational status with no major regulatory approvals
Clinical Overview
Pharmacologically, itopride enhances cholinergic activity within the gastrointestinal tract. Dopamine present in enteric pathways normally downregulates acetylcholine release through D2 receptor signaling, reducing lower esophageal sphincter tone and intragastric pressure. By blocking D2 receptors on myenteric motor neurons, itopride counteracts this inhibitory influence and promotes acetylcholine release.
Itopride also inhibits acetylcholinesterase, limiting enzymatic breakdown of acetylcholine in the synaptic space. The resulting increase in acetylcholine availability supports activation of M3 receptors on gastrointestinal smooth muscle, facilitating coordinated contractions, improved gastric emptying, and enhanced gastro-duodenal motility. This combined mechanism distinguishes itopride from agents that either modulate dopamine signaling or cholinergic pathways alone.
Absorption, distribution, metabolism, and excretion data are not fully characterized in publicly available sources. However, studies indicate that the compound undergoes metabolic transformation and is eliminated through renal and biliary pathways, with limited central nervous system penetration due to physicochemical properties. Detailed kinetic parameters vary across reports and are not consistently established.
Safety findings available from early clinical and nonclinical evaluations suggest potential for dopaminergic and cholinergic class effects, including gastrointestinal symptoms and rare extrapyramidal reactions. No definitive toxicity profile is established, and global regulatory agencies have not granted full marketing approval. Some regions have used itopride-containing products in the context of functional dyspepsia under local regulatory frameworks.
For API procurement, sourcing teams should verify identity, purity, and impurity limits consistent with regional regulatory expectations, and confirm that manufacturing sites maintain robust GMP controls given the limited global approval status of the molecule.
Identification & chemistry
| Generic name | Itopride |
|---|---|
| Molecule type | Small molecule |
| CAS | 122898-67-3 |
| UNII | 81BMQ80QRL |
| DrugBank ID | DB04924 |
Pharmacology
| Summary | Itopride acts as a prokinetic agent through dual mechanisms: antagonism of dopamine D2 receptors and inhibition of acetylcholinesterase. These actions increase acetylcholine availability in the gastrointestinal tract, enhancing smooth‑muscle contractility and promoting coordinated gastric motility. Its pharmacodynamic profile centers on removing dopaminergic inhibition of acetylcholine release while reducing ACh breakdown. |
|---|---|
| Mechanism of action | Itopride has anticholinesterase (AchE) activity as well as dopamine D2 receptor antagonistic activity. It is well established that M3 receptors exist on the smooth muscle layer throughout the gut and acetylcholine (ACh) released from enteric nerve endings stimulates the contraction of smooth muscle through M3 receptors. The enzyme AChE hydrolyses the released ACh, inactivates it and thus inhibits the gastric motility leading to various digestive disorders. Besides ACh, dopamine is present in significant amounts in the gastrointestinal tract and has several inhibitory effects on gastrointestinal motility, including reduction of lower esophageal sphincter and intragastric pressure. These effects appear to result from suppression of ACh release from the myenteric motor neurons and are mediated by the D2 subtype of dopamine receptors. Itopride, by virtue of its dopamine D2 receptor antagonism, removes the inhibitory effects on Ach release. It also inhibits the enzyme AchE which prevents the degradation of ACh. The net effect is an increase in ACh concentration, which in turn, promotes gastric motility, increases the lower esophageal sphincter pressure, accelerates gastric emptying and improves gastro-duodenal coordination. This dual mode of action of Itopride is unique and different from the actions of other prokinetic agents available in the market. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Dopamine D2 receptor | Humans | |
| Acetylcholinesterase | Humans | inhibitor |
ADME / PK
| Metabolism | Flavin-containing monooxygenase (FMO) is involved in N-oxygenation, the major metabolic pathway of itopride (PMID: 10997945). |
|---|
Formulation & handling
- Low aqueous solubility and moderate lipophilicity may require solubility‑enhancing approaches for oral solid dosage forms.
- Stable as a solid small molecule; standard handling for non‑hygroscopic benzamide derivatives is generally adequate.
- Intended for oral delivery only, with no parenteral use indicated due to limited water solubility.
Regulatory status
Itopride 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.
Itopride API manufacturers & distributors
Compare qualified Itopride API suppliers worldwide. We currently have 9 companies offering Itopride API, with manufacturing taking place in 4 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 |
|---|---|---|---|---|---|
| Chr. Olesen Group | Distributor | Denmark | India | CoA, USDMF | 252 products |
| Kukjeon Pharm | Producer | Japan | Japan | CoA, JDMF | 3 products |
| SEDANAH | Distributor | Jordan | World | CoA, GMP | 70 products |
| SETV Global | Producer | India | India | CoA, FDA, GMP | 515 products |
| Sinoway industrial Co.,Lt... | Distributor | China | China | CoA, ISO9001, USDMF, WC | 762 products |
| Symed Labs | Producer | India | India | CoA, GMP, WC | 28 products |
| Vasudha Pharma Chem Ltd. | Producer | India | India | CoA, GMP, KDMF, MSDS, USDMF, WC | 37 products |
| Zhejiang Genebest Pharmac... | Producer | China | China | CoA | 3 products |
| Zhuhai Rundu | Producer | China | China | CoA, WC | 11 products |
When sending a request, specify which Itopride 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 Itopride 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 Itopride API
Sourcing
Which documents are typically required when sourcing Itopride API?
Which manufacturers are known to produce Itopride API?
How can I request quotes for Itopride API from GMP suppliers?
Is a GMP audit report available for Itopride manufacturers?
How many suppliers offer Itopride API on Pharmaoffer?
Which countries are known to manufacture Itopride API?
Which certifications do suppliers of Itopride usually hold?
Technical
What is Itopride (CAS 122898-67-3) used for?
Which therapeutic class does Itopride fall into?
What conditions is Itopride mainly prescribed for?
How does Itopride work?
What should someone know about the safety or toxicity profile of Itopride?
What are important formulation and handling considerations for Itopride as an API?
Is Itopride a small molecule?
Are there special stability concerns for oral Itopride?
Pharmaoffer
How does Pharmaoffer’s Smart Sourcing Service help with Itopride procurement?
Is Itopride included in the PRO Data Insights coverage?
Where can I access the API market report for Itopride?
