About allisartan
Allisartan manufacturers are led by Shenzhen Salubris Pharmaceuticals, which markets allisartan isoproxil as Xinlitan in China. Allisartan was discovered by Shanghai Allist Pharmaceuticals. It is an angiotensin II receptor blocker (ARB) for hypertension, and it is a prodrug of EXP3174, the active metabolite of losartan. China approved it in July 2012. Pharmaceutical companies can explore licensing of allisartan tablets for markets outside China.
Allisartan key facts
|
Property |
Allisartan |
|---|---|
|
Name |
Allisartan isoproxil |
|
Molecular formula / weight |
C27H29ClN6O5 / 553.0 g/mol |
|
Active metabolite |
EXP3174 (losartan carboxylic acid) |
|
Drug class |
Angiotensin II type 1 receptor blocker (ARB) |
|
Brand name |
Xinlitan (China) |
|
Discoverer |
Shanghai Allist Pharmaceuticals |
|
Marketing company |
Shenzhen Salubris Pharmaceuticals |
|
Dosage form and strength |
Tablets 240 mg, once daily |
|
Indication |
Essential hypertension |
|
First approval |
China CFDA, July 2012 |
|
Combination |
Allisartan isoproxil / amlodipine 240 mg / 5 mg single-pill combination (Phase III completed) |
|
US / EU status |
Not approved |
Allisartan manufacturers and licensing history
Shanghai Allist Pharmaceuticals discovered allisartan isoproxil as a new ARB. China's CFDA approved it for hypertension in July 2012. Shenzhen Salubris Pharmaceuticals markets it as Xinlitan, at 240 mg once daily.
Allisartan is a prodrug. After absorption, it is converted directly to EXP3174, the active metabolite of losartan, without the liver step that losartan needs.
Salubris has developed a single-pill combination of allisartan isoproxil 240 mg with amlodipine 5 mg. A Phase III trial showed better blood pressure control than allisartan alone, with similar safety over 52 weeks. Salubris is also using EXP3174 in combination products for heart failure.
Allisartan is still a proprietary product. Buyers interested in licensing should contact Salubris directly about territories outside China.
Allisartan dosage forms and dossier types
Allisartan isoproxil is approved in China as 240 mg tablets. A combination with amlodipine has completed Phase III.
|
Form |
Strengths |
Typical dossier |
Notes |
|---|---|---|---|
|
Allisartan isoproxil tablets |
240 mg |
China NMPA |
Main form; reference Xinlitan |
|
Allisartan isoproxil / amlodipine tablets |
240 mg / 5 mg |
China NMPA |
Phase III completed; check approval status |
|
Target market |
Dossier format |
Key requirement |
|---|---|---|
|
China |
NMPA (CTD-based) |
Originator market; Salubris |
|
Other markets |
Full CTD |
New active substance outside China; clinical data needed |
Allisartan regulatory and patent status
China approved allisartan isoproxil in July 2012. It is not approved in the US or EU. As a Chinese-originated molecule, it remains under patent protection held by Allist and Salubris. Check Chinese and international patent registers before any development.
Allisartan mechanism of action and therapeutic use
Allisartan isoproxil is converted to EXP3174, which blocks the angiotensin II type 1 receptor. This relaxes blood vessels and reduces blood pressure. Because it does not need liver metabolism to become active, its effect is less affected by differences in liver enzymes. Allisartan is used for essential hypertension at 240 mg once daily, alone or with other blood pressure drugs.
Allisartan licensing and sourcing
Allisartan licensing partners typically offer regional out-licensing of the originator product. Buyers usually compare territory availability, the clinical data package and supply terms. Current offers and contacts are listed among the allisartan manufacturers on Pipelinepharma.
Frequently asked questions about allisartan
Who manufactures allisartan? Shanghai Allist Pharmaceuticals discovered allisartan isoproxil, and Shenzhen Salubris Pharmaceuticals markets it in China as Xinlitan.
When was allisartan approved? China's CFDA approved allisartan isoproxil for hypertension in July 2012.
How is allisartan different from losartan? Both act through EXP3174. Losartan needs liver metabolism to form EXP3174, while allisartan isoproxil is converted to it directly after absorption.
Is allisartan approved in the US or EU? No. Allisartan isoproxil is approved only in China.
What forms and strengths of allisartan are available? Allisartan isoproxil is available as 240 mg tablets. A 240 mg / 5 mg combination with amlodipine has completed Phase III.
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