EA Pharma Co., Ltd.

EA Pharma Co., Ltd. (President, Hidenori Yabune; Headquarters, Chuo-ku, Tokyo, Japan; "EA Pharma") announced today that Pathalys Pharma, Inc. (President, Neal Fowler; Headquarters, North Carolina, USA; “Pathalys Pharma”), which is an alliance partner of EA Pharma, presented favorable results from U.S. Phase 3 clinical studies of a secondary hyperparathyroidism treatment upacicalcet, discovered by EA Pharma (Brand name in Japan “UPASITA^® IV Injection Syringe”; EA Pharma’s development code AJT240). 

For more information, please see Pathalys Pharma’s press release:
［Pathalys Pharma Presents Positive Data from Pivotal Phase 3 Studies of Upacicalcet in Featured Oral Presentation at ASN Kidney Week 2026］

《More Information》

1. About Secondary Hyperparathyroidism
Secondary hyperparathyroidism (SHPT) is one of the common complications in patients with chronic kidney disease, particularly in patients receiving dialysis. Renal impairment causes imbalance of phosphorus, calcium and vitamin D, which accelerates excessive secretion of parathyroid hormone (PTH) leading to SHPT. It is known that progression of SHPT increases risks of bone fracture and cardiovascular complications due to vascular calcification, and appropriate control is important ^{[1] [2]}.

2. About Secondary Hyperparathyroidism Treatment “AJT240”
AJT240 is a calcium-sensing receptor (CaSR) agonist administered at the end of a dialysis session, which was discovered by Ajinomoto Pharmaceuticals Co., Ltd. (now EA Pharma). AJT240 acts on CaSR expressed on the parathyroid cell membrane and suppresses excessive secretion of PTH in SHPT.
For Japan market, EA Pharma signed a license agreement for development and marketing of AJT240 with SANWA KAGAKU KENKYUSHO CO., LTD. (“SANWA KAGAKU”). SANWA KAGAKU later signed a co-promotion agreement with Kissei Pharmaceutical Co., Ltd. and launched under the brand name “UPASITA^® IV Injection Syringe” on August 20, 2021. EA Pharma signed a worldwide license agreement with Pathalys Pharma, Inc. for the global market except Japan, Korea, China, Taiwan and ASEAN countries. Pathalys Pharma is now developing the candidate under the development code PLS240.

3. About Pathalys Pharma, Inc.
Pathalys Pharma is a private, U.S.-based biopharmaceutical company committed to supporting the unique needs of patients living with chronic kidney disease (CKD). The company’s focus is secondary hyperparathyroidism (SHPT), a common complication affecting nearly all patients with CKD undergoing hemodialysis. Pathalys Pharma is developing upacicalcet, an investigational small molecule calcimimetic studied in the Phase 3 PATH-1 and PATH-2 trials. Upacicalcet is an investigational product candidate and has not been approved by the FDA.
For more information about Pathalys Pharma, Inc., please visit https://www.pathalys.com/

4. About EA Pharma Co., Ltd.
EA Pharma Co., Ltd., a subsidiary of Eisai Co., Ltd. for gastrointestinal disease area, was established in April 2016 by integration of the gastrointestinal business unit with more than 60 years’ history of the Eisai Group and the gastrointestinal business unit of the Ajinomoto Group having amino acid as its business core. EA Pharma is a gastrointestinal specialty pharma with a full value chain covering R&D, logistics and sales & marketing.
For further information on EA Pharma Co., Ltd., please visit https://www.eapharma.co.jp/en/