Enrollment in Phase II Clinical Trial for ACCRUFeR

Shield Therapeutics PLC

27 April 2026

 

Shield Therapeutics plc

("Shield" or the "Company" or the "Group")

 Enrollment commenced in Phase II Clinical Trial for ACCRUFeR® (Ferric Maltol) in Japan.

London, UK, 27 April 2026: Shield Therapeutics plc (LSE: STX), a commercial-stage pharmaceutical company specialising in iron deficiency, announces that its partner, MEDLEAP Pharma, a subsidiary of Vital KSK Holdings Inc. has confirmed its first patient enrollment for the Phase II clinical trial for ACCRUFeR® (ferric maltol), a new drug candidate for Pulmonary Arterial Hypertension (PAH), for patients in Japan.

This clinical trial is an exploratory study intended to support a planned Phase III trial. It follows the Pharmaceuticals and Medical Devices Agency's (PMDA) confirmation of the development plan for the drug as a PAH treatment in Japan, based on the drug's prior clinical results from trials in Europe, the UK, and the USA.

Trial Details:

Trial Name:                        An Exploratory Phase II Study to Evaluate the Efficacy and Safety of Ferric Maltol in Patients with Pulmonary Arterial Hypertension

Target Disease:                 Pulmonary Arterial Hypertension

Trial Location:                   Japan

Anders Lundstrom, CEO of Shield, commented: "Shield is pleased to see the continued progress being made by our partner MEDLEAP Pharma as they advance the Japanese clinical program for ACCRUFeR® in this exciting new indication. This is a meaningful step forward, not only for our partnership, but for the patients in Japan who may one day benefit from this treatment. We are proud to be working alongside MEDLEAP Pharma on this journey and remain confident in the potential of ACCRUFeR® to make a real difference in this new therapeutic area."

For further information please contact:

Shield Therapeutics plc	www.shieldtherapeutics.com
Anders Lundstrom, CEO Santosh Shanbhag, CFO Stephanie Hicks, Investor Relations	[phone] [e-mail]
https://shieldtherapeutics.com/link/egGLRe Nominated Adviser and Joint Broker
Peel Hunt LLP
James Steel	[phone]
Joint Broker Cavendish Ltd Geoff Nash/ Isaac Hooper/Nigel Birks/Harriet Ward	[phone]

About Iron Deficiency and ACCRUFeR®/FeRACCRU®

Clinically low iron levels (aka iron deficiency, ID) can cause serious health problems for adults of all ages, across multiple therapeutic areas. Together, ID and ID with anemia (IDA) affect about 20 million people in the US and represent a $2.3B market opportunity. As the first and only FDA approved oral iron to treat ID/IDA, ACCRUFeR® has the potential to meet an important unmet medical need for both physicians and patients and is now the #1 branded prescription oral iron the market today (*data source - IQVIA Xponent PlanTrak).

ACCRUFeR®/FeRACCRU® (ferric maltol) is a novel, stable, non-salt-based oral therapy for patients suffering from iron deficiency, with or without anemia.. The drug has a novel mechanism of absorption compared to other oral iron therapies and has been shown to be an efficacious and well-tolerated therapy in a range of clinical trials. More information about ACCRUFeR®/FeRACCRU®, including the product label, can be found at: www.accrufer.com and www.feraccru.com.

PAH (Pulmonary Arterial Hypertension) market in 2024 is estimated to be worth over $230M in Japan. Iron supplementation is strongly recommended for PAH patients with iron deficiency anemia according to both European and Japanese guidance (ESC/ERS Guidelines for the diagnosis and treatment of pulmonary hypertension 2022 and Japan Pulmonary Hypertension and Pulmonary Circulation Society Guidance 2024) [Recommendation Class I]. (1) Humbert M, et al. 2022 ESC/ERS Guidelines for the diagnosis and treatment of pulmonary hypertension. Eur Respir J. 2023; 61(1):2200879. (2) Japanese Pulmonary Hypertension and Pulmonary Circulation Society. Pulmonary Hypertension Treatment Guidance2024.

About Shield Therapeutics plc

Shield is a commercial stage specialty pharmaceutical company that delivers ACCRUFeR®/FeRACCRU® (ferric maltol), an innovative and differentiated pharmaceutical product, to address a significant unmet need for patients suffering from iron deficiency, with or without anemia. The Company has launched ACCRUFeR® in the U.S. to include pediatric patients 10 years of age and older with an exclusive, multi-year collaboration agreement with Viatris. Outside of the U.S., the Company has licensed the rights to five specialty pharmaceutical companies. FeRACCRU® is commercialised in the UK and European Union by Norgine B.V., to include pediatric patients 12 years of age and older and also have marketing rights in Australia and New Zealand. FeRACCRU® is also commercialised in Canada by Kye Pharmaceuticals Inc. Shield also has an exclusive license agreement with Beijing Aosaikang Pharmaceutical Co., Ltd., for the development and commercialisation of ACCRUFeR®/FeRACCRU® in China, Hong Kong, Macau and Taiwan, with Korea Pharma Co., Ltd. for the Republic of Korea, and with Medleap Pharma Company Limited, a subsidiary of VITAL-NET Inc. for Japan.

ACCRUFeR®/FeRACCRU® has patent coverage until the mid-2030s.

ACCRUFeR®/FeRACCRU® are registered trademarks of Shield Therapeutics. 

About MEDLEAP PHARMA COMPANY LIMITED

MEDLEAP PHARMA COMPANY LIMITED ("MEDLEAP") is a fully owned subsidiary of VITAL-NET, INC. which focuses on pharmaceutical research and development.

Under its philosophy of "Bringing innovation to Japan's medical future through the creation of original pharmaceuticals," MEDLEAP contributes to reducing drug lag in Japan through new drug introduction support business, delivering a healthy future to patients and their families. The company promotes competitive new drug creation through collaboration with domestic and international research institutions and companies.

 

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