Linaprazan is a potassium-competitive acid blocker (P-CAB) developed for the suppression of gastric acid secretion. It belongs to a newer class of acid-suppressing agents that inhibit the gastric H⁺/K⁺-ATPase proton pump through potassium-competitive binding.
Unlike conventional proton-pump inhibitors, which generally require acid activation, linaprazan directly inhibits the gastric proton pump in a potassium-competitive manner. This mechanism provides potent suppression of gastric acid secretion and makes linaprazan relevant to the development of pharmaceutical treatments for acid-related gastrointestinal disorders.
Linaprazan is a synthetic small-molecule compound with the molecular formula C19H20N4O2S and a molecular weight of approximately 368.46 g/mol. Its CAS Number is 882268-74-4.
Linaprazan has been investigated as an acid-suppressive pharmaceutical compound and is associated with the potassium-competitive acid blocker class.
Linaprazan inhibits the gastric H⁺/K⁺-ATPase proton pump by competing with potassium at the proton pump.
The H⁺/K⁺-ATPase is responsible for the final step of gastric acid secretion by gastric parietal cells. Inhibition of this enzyme reduces hydrogen-ion secretion into the stomach and therefore increases gastric pH and decreases gastric acidity.
Linaprazan has been investigated for the treatment of acid-related gastrointestinal disorders, including gastroesophageal reflux disease and other conditions in which suppression of gastric acid is therapeutically beneficial.
It has also been investigated in combination regimens for Helicobacter pylori eradication, where potent acid suppression can support antibacterial treatment.
Linaprazan API can be evaluated using validated analytical procedures for identification, assay, related substances, water content, residual solvents, elemental impurities and other applicable quality attributes.
Chromatographic and spectroscopic techniques may be used for identity, assay and purity determination. Appropriate control of process-related impurities and degradation products should be included in the applicable drug-substance specification.
Acceptance criteria should be based on the applicable manufacturer's drug-substance specification, Certificate of Analysis and relevant regulatory requirements.
Linaprazan should be stored in a tightly closed pharmaceutical-grade container under controlled conditions. The material should be protected from excessive heat, moisture and direct light.
Specific storage and transportation requirements should follow the applicable manufacturer's approved specification.
Linaprazan API may be supplied for qualified pharmaceutical manufacturing, formulation development, analytical and research applications, subject to applicable quality and regulatory requirements.
Linaprazan API is available for qualified pharmaceutical development and manufacturing requirements subject to applicable quality and regulatory standards. Customers can request product specifications, Certificate of Analysis, analytical documentation, packaging information and commercial details according to their requirements.
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 1.0% |
| Residue on Ignition | NMT 0.5% |
| Individual Impurity | ≤ 0.5% |
| Total Impurities | ≤ 1.5% |
| Water Content | NMT 1.0% |