**Summary**
Shield Therapeutics plc announced on November 7, 2025, that its iron deficiency treatment, ACCRUFeRยฎ (Ferric Maltol), has received marketing authorization from the Korean Ministry of Food and Drug Safety (MFDS) for the treatment of iron deficiency in adults in South Korea. This approval follows a successful pharmacokinetic study and the submission of a New Drug Application by Korea Pharma in 2024. The milestone expands access to ACCRUFeRยฎ in South Korea, where 5.2 million people suffer from iron deficiency or iron deficiency anemia (IDA).
Shield is eligible for payments upon the first sale, performance-based milestones, and royalties on net sales in South Korea. CEO Anders Lundstrom highlighted the approval as a significant step in global accessibility and praised Korea Pharmas role in the regulatory process. ACCRUFeRยฎ is the first and only FDA-approved oral iron treatment for ID/IDA, addressing a substantial unmet medical need in a $2.3B market. The drug is already commercialized in the U.S., UK, EU, and other regions through partnerships with companies like Viatris, Norgine B.V., and Beijing Aosaikang Pharmaceutical. ACCRUFeRยฎ has patent protection until the mid-2030s and is a registered trademark of Shield Therapeutics.