CK Regeon (CEO Kang-Yeol Choi), a tissue regeneration drug developer, has been selected for the Ministry of SMEs and Startups’ Deep-Tech TIPS program to move its hair loss treatment candidate, CKR-051, into Phase 2 clinical development.
Program overview
- Selected in October 2026, with a total budget of KRW 2.0 billion over three years, including KRW 1.5 billion in government funding.
- The project will reformulate CKR-051 from the ointment used in Phase 1 into a liquid suited to scalp application. It will then run non-clinical bridging studies and seek Phase 2 IND approval.
Mechanism of action
- CKR-051 is a topical candidate with a different mechanism from current hair loss treatments. It does not suppress androgens or improve blood flow. Instead, it restores Wnt signaling, the pathway that drives hair follicle regeneration and hair growth.
- It is built on the company’s core “WNT ON” platform. The platform blocks the binding between CXXC5, a protein that inhibits Wnt signaling, and Dishevelled (Dvl).
- In animal models, the company observed hair regrowth and more new hair follicles. In ex vivo studies on human hair follicles, it confirmed the growth-related mechanism. These findings have been published in international journals.
Clinical progress
- Phase 1 used the ointment formulation in 52 healthy adults, with single doses and 21 days of repeated dosing. It was completed in January 2024.
- According to the company, systemic drug exposure after topical application was low.
- An early human application study of a liquid formulation showed efficacy signals, such as increased hair count. These results do not confirm therapeutic efficacy, and further trials are needed to evaluate safety and efficacy.
Next steps
- Using the Phase 1 safety data, the company will optimize the liquid formulation and run non-clinical studies to support the formulation change. It will also gather the data needed to enter Phase 2.
CEO comment
CEO Kang-Yeol Choi called CKR-051 a novel approach that restores reduced Wnt signaling by disrupting the CXXC5–Dvl interaction. He said the company will use this TIPS selection to accelerate Phase 2 entry, building on the Phase 1 safety data and the liquid formulation human study results.
About CK Regeon
Founded in October 2016, CK Regeon develops regenerative drugs that control Wnt signaling to induce repair of damaged tissue without using stem cells directly. The company also runs two scalp and hair care brands based on WNT ON technology, HAIRREGEON and HERIBON. It sells them in Korea and is pursuing expansion into Europe and the U.S.
Click the following link to see the details.
씨케이리제온, 딥테크 팁스 선정… 탈모신약 CKR-051 임상 2상 추진 < 뉴스·이슈 < 뉴스·이슈 < 기사본문 - 스타트업엔(StartupN)
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