Drugs / RCI001
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT07640867 | Oct 2024 → Aug 2025 | dry eye syndrome | Rudacure | Completed | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT07625124 | Sep 2027 → Jun 2028 expected | dry eye syndrome | Rudacure | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07068958 | Aug → Nov 2025 overdue | dry eye syndrome | ORA, Inc. | Not yet recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 12
| Date | Issuer | Release |
|---|---|---|
| 2025-08-12 | Rudacure | Regulatory RudaCure obtains FDA Phase 2 approval for dry eye disease drug RCI001 rudacure.com ↗
RudaCure Inc. (CEO Yongho Kim), a bio-pharmaceutical development company specializing in sensory disorder treatments, announced that it has obtained U.S. FDA Phase 2 Investigational New Drug (IND) approval for its dry eye disease treatment 'RCI001' on the 24th. |
| 2025-08-11 | Rudacure | Regulatory [Interview] RudaCure focuses on root causes of pain — developing side-effect-free chronic pain and dry eye treatments rudacure.com ↗
We recently obtained FDA Phase 2 IND approval, allowing us to begin clinical trials in the US. |
| 2024-10-23 | Rudacure | Results Efficacy of RCI001 as a Therapeutic Candidate in a Primary Sjögren Syndrome Mouse Model rudacure.com ↗
The results showed significant improvement in tear volume, corneal epithelial damage, and conjunctival goblet cell density. |
| 2024-06-01 | Rudacure | Results Efficacy of RCI001 as a therapeutic candidate of dry eye disease in a modified mixed dry eye model rudacure.com ↗
Health Korea News: Prof. Kim Dong-hyun of Anam Hospital develops 'RCI001' — effective for dry eye disease treatment |
| 2024-03-12 | Rudacure | Regulatory RCI001 dry eye disease treatment receives domestic Phase 1 clinical trial approval rudacure.com ↗
Today, RudaCure has officially entered domestic clinical trials following the final approval by the Ministry of Food and Drug Safety (MFDS) of the clinical trial protocol titled "A randomized, double-blind, placebo-controlled, single and repeated instillation, Phase 1 clinical study to explore the pharmacokinetics, safety and tolerability of RCI001 ophthalmic solution 0.25% in healthy adult males." |
| 2023-10-18 | Rudacure | Results Prof. Kim Dong-hyun at Anam Hospital demonstrates long-term safety of RCI001 rudacure.com ↗
While five weeks of RCI001 administration did not cause any elevation in intraocular pressure or changes in the ocular surface, corticosteroid administration resulted in an approximately 38% increase in intraocular pressure compared to baseline. |
| 2023-07-14 | Rudacure | Results Comparison of Corneal Epithelial Wound Healing between Topical RCI001, Solcoseryl, and Polydeoxyribo rudacure.com ↗
Both the 0.5% and 1.0% RCI001 groups showed significantly more epithelial healing compared to the control group at day 5, 7, 10, and 14 (each p < 0.05). |
| 2022-06-07 | Rudacure | Results Innovative dry eye drug compound RCI001 draws renewed attention rudacure.com ↗
In an alkali-induced mouse eye injury model, 'RCI001' showed faster corneal damage recovery compared to conventional steroid formulations. |
| 2022-05-03 | Rudacure | Results Attendance at 2022 ARVO conference rudacure.com ↗
The drug demonstrated superior efficacy in comparison with existing drugs, generating strong expectations for its potential success. |
| 2022-03-24 | Rudacure | Results Investigating the Anti-Inflammatory Effects of RCI001 for Treating Ocular Surface Diseases: Insight rudacure.com ↗
We observed that RCI001 dosedependently inhibited Rac1 activity and various inflammatory cytokines in LPSstimulated murine macrophages. |
| 2021-04-20 | Rudacure | Results Green light for domestic dry eye innovation drug — RCI001 more effective than steroids with fewer side effects (Nature Scientific Reports) rudacure.com ↗
The research results revealed that 'RCI001' was superior in efficacy and had fewer side effects compared to the existing steroid drug. |
| 2020-06-10 | Rudacure | Regulatory Selected for 2020 MOTIE R&D Rediscovery Project rudacure.com ↗ |
All press releases naming this drug 24 releases
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | RCI001 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07625124 ↗ |
| Route | Topical | “RCI001 Ophthalmic Solution is a topical ophthalmic investigational drug” NCT07625124 ↗ |