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RudaCure Receives Approval for Phase 2 Clinical Trial of RCI001 in Korea, Targets Completion by First Half of 2027

2026-09-22

Clinical category key visual representing the RCI001 Phase 2 approval and development progress in Korea

[Incheon] RudaCure, a membrane protein-targeted drug discovery company, received approval for the Investigational New Drug (IND) application for a Phase 2 clinical trial of RCI001, its dry eye disease treatment candidate, in Korea on September 22. Following an investigator meeting and site-level preparations, the company will begin patient enrollment and is targeting completion of the clinical trial by the first half of 2027.

Investigator Meeting to Be Held on October 1

RudaCure, together with co-development partner Hanlim Pharmaceutical, will hold an Investigator Meeting (IM) on October 1 at Salon 1&2 on the second floor of the AC Hotel by Marriott Seoul Gangnam in Gangnam-gu, Seoul. Registration begins at 6:00 PM, and the main session runs from 6:30 PM to 8:00 PM. The program includes welcoming remarks by Jung Hoon Kim of Hanlim Pharmaceutical Eye Health, a company introduction by RudaCure CEO Yongho Kim, and a briefing on the RCI001 Phase 2 clinical trial protocol by Director Yuseung Ha. The meeting will share operating procedures with site investigators and confirm site initiation readiness.

Phase 1 Results to Be Presented at ACCP 2026

Shortly after the Korean Phase 2 approval, RudaCure will present a Phase 1 poster on RCI001/HL262 at the 2026 American College of Clinical Pharmacology (ACCP) Annual Meeting, held from September 27 to 29 in North Bethesda, Maryland, USA. The poster presents safety, tolerability, and pharmacokinetic data evaluated after single and repeated administration of the 0.25% eye drop formulation. The international presentation of early clinical data coincides with preparations to initiate the Korean Phase 2 trial, demonstrating uninterrupted development progress.

View the ACCP 2026 poster presentation announcement

Raw Material Supply Payment Confirms Business Model Execution

Contract-based cash flow has also been confirmed on the commercialization front. RudaCure recently received payment for RCI001-related raw materials supplied to a technology transfer partner. By providing a research and development outcome to a partner and receiving payment in return, the transaction demonstrates that RudaCure's raw material supply-based business model (BM) is operating in practice.

RudaCure is advancing through the Korean Phase 2 approval, the ACCP presentation, and the Investigator Meeting as it pursues its goal of completing the clinical trial by the first half of 2027. The company also plans to strengthen the execution structure for raw material supply and payment collection within its global partnerships, pursuing clinical development and commercialization in parallel.

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