Korean Firm Daewoong gets Indian patent for specific crystalline form of Abeprazan Succinate.
Abeprazan (DWP14012) is a potassium-competitive acid blocker. Abeprazan inhibits H+, K+– ATPase by reversible potassium-competitive ionic binding with no acid activation required. Abeprazan is developed as a potential alternative to a proton pump inhibitor for the treatment of acid-related diseases.
Abeprazan also known as Fexuprazan . Fexuprazan is a novel potassium-competitive acid blocker (P-CAB) developed by Daewoong, which reversibly blocks the proton pump that secretes gastric acids located in the canalicular membrane. It is a next-generation of proton pump inhibitors (PPI), which are widely used for gastroesophageal reflux disease (GERD). A phase 3 clinical trial of Fexuprazan was conducted in Korea in patients with erosive esophagitis, and additional clinical trials are ongoing for other acid-related diseases.
The phase 3 clinical trial in patients with erosive esophagitis was conducted in 25 hospitals in Korea. Fexuprazan showed a 99% of mucosal healing rate at week 8 and was well tolerated in the patients. Fexuprazan also showed improved symptom relief. Particularly, in the patients with moderate to severe symptoms, Fexuprazan exhibited significantly faster and better heartburn relief compared to Esomeprazole and this heartburn relief was shown to be maintained during nighttime. Furthermore, an atypical symptom such as cough was also improved with the treatment of Fexuprazan.
Highest Development Phase :
Preregistration – Gastro-oesophageal reflux
Phase III – Erosive oesophagitis; Gastritis; Peptic ulcer
Phase I – Unspecified
Recent Event Involved :
- Indian Patent IN382620 (IN202018016114) – The specific crystalline form of Abeprazan Succinate is granted to Daewoong. The patent also discloses other forms of Abeprazan tartrate and fumarate.
- Abeprazan HCl salt crystalline form – also granted with same patent family IN350796 (IN201817033546) family to US10683268.
- Product Patent filed – IN324737B (IN201717034333A) – Est. Exp. April 27, 2036.
- 19 Nov 2021 – Daewoong Pharmaceutical intends to launch fexuprazan in South Korea in 2022
- 26 Aug 2021 – Neurogastrx announces intention to initiate phase III clinical development for fexuprazan in the US in 2022
- 14 Jun 2021 – Neurogastrx and Daewoong Pharmaceutical announce commercialisation agreement for Fexuprazan for Erosive esophagitis (EE) in USA and Canada
About Daewoong Pharmaceuticals
Daewoong Pharmaceutical Co., Ltd is a Seoul, South Korea-based bioengineering company operating as a subsidiary of Daewoong Co., Ltd., a global health care group. Daewoong Pharmaceutical primarily engages in the manufacture of pharmaceutical products in South Korea, including prescription and over-the-counter healthcare products.
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