CK Regeon Selected for Korea’s Deep Tech TIPS Program to Advance Hair Loss Drug Candidate CKR-051 Toward Phase 2

CK Regeon, the tissue-regeneration drug developer behind DermaRegeon, has been selected for the Deep Tech TIPS program run by Korea’s Ministry of SMEs and Startups. Over the next three years, the company will invest a total of KRW 2.0 billion, including KRW 1.5 billion in government funding, to move its hair loss drug candidate CKR-051 toward Phase 2 clinical trials.

From Ointment to Topical Solution

The project centers on reformulating CKR-051 from an ointment, used in the Phase 1 study, into a topical solution designed for scalp application. A solution spreads evenly and absorbs without running, making it easier for patients to use every day and better suited to reaching deep into the hair follicle. CK Regeon will run non-clinical bridging studies to confirm that the safety profile established for the ointment carries over to the new formulation, with the goal of obtaining Phase 2 IND approval.

Phase 1 Safety Data in Hand

In January 2024, CK Regeon completed a Phase 1 study in 52 healthy adults, covering both single-dose and 21-day repeat-dose administration. The results showed very low systemic exposure to the drug from the ointment formulation.

A Different Approach to Hair Loss

CKR-051 targets the WNT signaling pathway, which governs hair follicle regeneration and hair growth. In balding scalp, levels of a protein called CXXC5 rise abnormally and suppress this pathway by binding to a signaling protein, Dishevelled (Dvl). CKR-051 selectively blocks that interaction, restoring WNT signaling and promoting the formation of new hair follicles. Rather than broadly activating the WNT pathway, this targeted mechanism is designed to keep the risk of abnormal cell growth under control.

This approach differs from current options. Oral finasteride and dutasteride work by blocking the hormone DHT, which raises concerns about systemic side effects. Minoxidil has limited effect in areas where follicles have already regressed.

Next Steps

CK Regeon will focus on optimizing the topical formulation, completing the bridging studies, and preparing for Phase 2, where CKR-051’s efficacy will be evaluated in patients.

👉 Read the full article (in Korean): Donghaeng Ilbo

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