초록

- 생강나무 추출물로부터 유효성분 및 지표성부 정량 완료, 약물상호 작용과 대사체 규명 연구 수행 완료
- 녹내장 동물모델을 통한 안압하강 효능과 시신경세포 보호 효력 우수 검증
- 임상시험용 의약품 Formulation 완료 및 안정성 시험(3개월 안정성 확보)
- 약동학 시험 연구 완료
- 임상 2상 시험 계획 승인 신청서 제출 완료(승인 대기중)

Abstract ▼

1. Background and significance
- The cost for the treatment of eye diseases is rapidly increasing because aging society has being developed. In case of Glaucoma, it was reported that the incidence had the growth rate of 1% a year in the population below age 60 and 5% a year in the population over

1. Background and significance
- The cost for the treatment of eye diseases is rapidly increasing because aging society has being developed. In case of Glaucoma, it was reported that the incidence had the growth rate of 1% a year in the population below age 60 and 5% a year in the population over 60.
- About 150,000 people in Korea are suffering from the blindness and 70% among blindness population are acquired blindness. 4 major eye diseases are glaucoma, cataract, macular degeneration and diabetic retinopathy.
- In Korea, the basic research of the treatment and the functional food application for eye diseases and health have not performed substantially so far. The development of the science and technology for eye diseases is essential and will be the blue ocean in medicinal industry.
- Most of current medicines for glaucoma are eye-drop formulations and have poor compliance for patients. Thus, there is unmet need for the develoment of oral formulation.

2. Specific aims of the research
- Verification of the reducing effect on Intra-Ocular Pressure and the protection of optic nerve cells using animal model of glaucoma
- Research of mode of action using animal model of glaucoma
- Formulation and CMC
- Analysis of active ingredients
- Drug-drug interation of active or functional ingredients
- Study on metabolites of active ingredients
- Pharmacokinetics study
- IND for clinical trial in Korea

3. The results of the research
- Quantitative analysis, drug-drug interaction and metabolite study of active or functional ingredients from the extract of Lindera obtusiloba
- Verification of the reducing effect on Intra-Ocular Pressure and the protection of optic nerve cells using animal model of glaucoma
- Formulation and production of Investigational Products(IP) for clinical study
- The stability study of IP for 3 months
- Pharmcokinetics study
- IND submission to Korea MFDS for clinical trial II

4. The subsequent plan
- The subsequent research for the development of global new drug based ton the results from this project
- The study on additional indication
- Clinical trial 2 study in Korea