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allisartan + indapamide

Tablets, sustained release (SR) 240 mg + 1.5 mg

Dossier type
CTD
Dossier status
Ready to file
Country of origin
China
GMP approvals
China
Manufacturer #1026
A pharmaceutical manufacturer operating under global standards with WHO-GMP certified plants, offering a wide portfolio of branded generics and innovative medicines. Their pharmaceutical products cover therapeutic areas including cardiovascular, metabolism, anti-infectives and dermatology. They serve numerous international markets across Africa, Central America, East Asia, Europe, the Middle East, North America, Oceania, South Asia and Southeast Asia.

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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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