Drugs / Evogliptin
Trials 24
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 111 trials | ||||||
| Phase 1 | NCT04195919 | Jul 2020 → May 2021 | — | Dong-A ST Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT03766724 | Nov 2018 → Jan 2019 | type 2 diabetes mellitus | Dong-A ST Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT02954822 | Nov 2016 → Jan 2017 | type 2 diabetes mellitus | Dong-A ST Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT02754219 | Sep 2016 → Jan 2018 | liver disorder | Dong-A ST Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT02753803 | Jul → Oct 2016 | type 2 diabetes mellitus | Dong-A ST Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT02375139 | Apr → Jun 2015 | type 2 diabetes mellitus | Dong-A ST Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT02267902 | Sep 2014 → Jan 2015 | — | Dong-A ST Co., Ltd. | Unknown | No outcome recorded |
| Phase 1 | NCT02214693 | Jul 2014 → Mar 2015 | impaired renal function disease | Dong-A ST Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT02167061 | Jul → Nov 2014 | type 2 diabetes mellitus | Dong-A ST Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT01941199 | Jul → Nov 2013 | type 2 diabetes mellitus | Dong-A Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT00961025 | May 2009 → Feb 2010 | type 2 diabetes mellitus | Dong-A Pharmaceutical Co., Ltd. | Unknown | No outcome recorded |
| Phase 22 trials · 1 met primary · 1 missed | ||||||
| Phase 2 | NCT04055883 | Aug 2019 → Feb 2023 | aortic valve calcification | Dong-A ST Co., Ltd. | Completed | Missed primary |
| Phase 2 | NCT02689362 | Aug 2017 → Aug 2018 | type 2 diabetes mellitus | Eurofarma Laboratorios S.A. | Completed | Met primary |
| Phase 33 trials · 1 met primary | ||||||
| Phase 3 | NCT04170998 | Jan 2020 → Jun 2021 | type 2 diabetes mellitus | Dong-A ST Co., Ltd. | Completed | Met primary |
| Phase 3 | NCT02946541 | Jul 2013 → Oct 2014 | type 2 diabetes mellitus | Dong-A ST Co., Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT02949193 | May 2013 → Nov 2014 | type 2 diabetes mellitus | Dong-A ST Co., Ltd. | Completed | No outcome recorded |
| Phase 48 trials | ||||||
| Phase 4 | NCT04706637 | Feb 2021 → Jan 2022 | metabolic bone disorder, type 2 diabetes mellitus | Kyung Hee University Hospital at Gangdong | Unknown | No outcome recorded |
| Phase 4 | NCT04653779 | Dec 2020 → May 2021 | kidney disorder, type 2 diabetes mellitus | Dong-A ST Co., Ltd. | Unknown | No outcome recorded |
| Phase 4 | NCT05473806 | Sep 2020 → Jan 2023 | chronic hepatitis B virus infection, fibrotic liver disease, type 2 diabetes mellitus | Seung Up Kim | Unknown | No outcome recorded |
| Phase 4 | NCT04584242 | Sep 2020 → May 2022 | chronic hepatitis B virus infection | Yonsei University | Unknown | No outcome recorded |
| Phase 4 | NCT04521452 | Sep 2020 → Sep 2024 | — | Asan Medical Center | Unknown | No outcome recorded |
| Phase 4 | NCT03910361 | Apr 2019 → Jul 2020 | NAFLD1, type 2 diabetes mellitus | Dong-A ST Co., Ltd. | Completed | No outcome recorded |
| Phase 4 | NCT02974504 | Sep 2016 → Mar 2018 | type 2 diabetes mellitus | Dong-A ST Co., Ltd. | Completed | No outcome recorded |
| Phase 4 | NCT02587975 | Jun → Nov 2016 | osteoporosis, type 2 diabetes mellitus | DongGuk University | Unknown | No outcome recorded |
| Comparator or background therapy3 trials | ||||||
| Phase 2 | NCT03667300 Comparator | Mar 2017 → May 2019 | impaired renal function disease, proteinuria, type 2 diabetes mellitus | Samsung Medical Center | Completed | No outcome recorded |
| Phase 2/3 | NCT05143177 Comparator | Jun 2022 → May 2026 | aortic valve calcification | REDNVIA Co., Ltd. | Suspended | No outcome recorded Stop: Business |
| Phase 3 | NCT04356742 Background | May 2020 → Feb 2022 | type 2 diabetes mellitus | Dong-A ST Co., Ltd. | Completed | Met primary |
News releases announcing trial results or a regulatory action · 7
| Date | Issuer | Release |
|---|---|---|
| 2023-04-18 | Dong-A ST Co., Ltd. | Regulatory 동아ST, 제2형 당뇨병 복합제 ‘슈가다파메트서방정’ 품목허가 신청 donga-st.com ↗
동아에스티(대표이사 사장 김민영)는 식품의약품안전처에 제2형 당뇨병 복합제 ‘슈가다파메트서방정’의 품목허가를 신청했다고 18일 밝혔다. |
| 2022-10-12 | Dong-A ST Co., Ltd. | Results 동아ST, 유럽당뇨병학회(EASD)서 ‘Evogliptin Add-on Therapy to Dapagliflozin/Metformin combinations’ 연구 결과 발표 donga-st.com ↗
Baseline(치료 시작점) 대비 투여 후 24주 시점의 당화혈색소의 변화는 Evogliptin군 -0.69%, 위약군 -0.04%로, Evogliptin군에서 위약군 대비 당화혈색소를 유의하게 0.65% 감소시켜 Evogliptin군의 혈당 강하 효과가 위약군 대비 우월함을 입증하였다. |
| 2022-07-29 | Dong-A ST Co., Ltd. | Regulatory 동아ST, 제2형 당뇨병 복합제 ‘슈가다파정’ 품목허가 신청 donga-st.com ↗
동아에스티(대표이사 사장 김민영)는 식품의약품안전처에 제2형 당뇨병 복합제 ‘슈가다파정’의 품목허가를 신청했다고 29일 밝혔다. |
| 2019-06-11 | Eurofarma Laboratorios S.A. | Results Eurofarma apresenta estudo brasileiro no Congresso Americano de Diabetes eurofarma.com.br ↗
Os resultados de eficácia obtidos confirmam para a população ocidental a eficácia da dose aprovada na população oriental (evogliptina 5,0mg). |
| 2018-11-27 | Dong-A ST Co., Ltd. | Results Dong-A ST presents Suganon clinical results at international conference donga-st.com ↗
In the secondary efficacy evaluation, the response rates of HbA1c < 7.0% were 68.0% and 67.3%, respectively, and the response rates of HbA1c < 6.5% were 44.0% and 36.5%, respectively, showing no statistically significant difference between the two groups. |
| 2016-06-24 | Dong-A ST Co., Ltd. | Results 동아ST, 당뇨병치료제 신약 ‘슈가논’ 런칭 심포지엄 성료 donga-st.com ↗
또한 ‘슈가논의 유효성과 안전성’ 발표에서는 ‘슈가논’의 제품 개요 및 임상 2상과 임상 3상을 통해 입증된 시타글립틴과의 비열등성, 췌장의 베타세포 보호 기능과 인슐린 저항성 개선, 중성 지방 감소, 고밀도콜레스테롤(HDL-C) 증가 등 효과가 소개됐다. |
| 2015-10-02 | Dong-A ST Co., Ltd. | Regulatory 동아ST, 자체개발신약 당뇨병치료제 ‘슈가논’ 식약처 신약 허가 승인 donga-st.com ↗
동아에스티(대표이사 사장 박찬일)는 2일 자체개발신약인 당뇨병치료제 ‘슈가논(개발코드명: DA-1229)’이 국내 26번재 신약으로 식품의약품안전처 허가 승인을 받았다고 밝혔다. |
All press releases naming this drug 9 releases
| Date | Issuer | Release |
|---|---|---|
| 2023-04-18 | Dong-A ST Co., Ltd. | 동아ST, 제2형 당뇨병 복합제 ‘슈가다파메트서방정’ 품목허가 신청 donga-st.com ↗ |
| 2022-10-12 | Dong-A ST Co., Ltd. | 동아ST, 유럽당뇨병학회(EASD)서 ‘Evogliptin Add-on Therapy to Dapagliflozin/Metformin combinations’ 연구 결과 발표 donga-st.com ↗ |
| 2022-07-29 | Dong-A ST Co., Ltd. | 동아ST, 제2형 당뇨병 복합제 ‘슈가다파정’ 품목허가 신청 donga-st.com ↗ |
| 2019-06-11 | Eurofarma Laboratorios S.A. | Eurofarma apresenta estudo brasileiro no Congresso Americano de Diabetes eurofarma.com.br ↗ |
| 2018-11-27 | Dong-A ST Co., Ltd. | Dong-A ST presents Suganon clinical results at international conference donga-st.com ↗ |
| 2016-06-24 | Dong-A ST Co., Ltd. | 동아ST, 당뇨병치료제 신약 ‘슈가논’ 런칭 심포지엄 성료 donga-st.com ↗ |
| 2015-10-02 | Dong-A ST Co., Ltd. | 동아ST, 자체개발신약 당뇨병치료제 ‘슈가논’ 식약처 신약 허가 승인 donga-st.com ↗ |
| 2015-04-14 | Dong-A ST Co., Ltd. | 동아ST, 브라질 유로파마와 당뇨병치료제 ‘Evogliptin’ 추가 라이센싱 아웃 계약 체결 donga-st.com ↗ |
| 2014-09-25 | Dong-A ST Co., Ltd. | 동아ST, 당뇨병치료제 ‘DA-1229’ 브라질 제약사와 라이센싱 아웃 계약 체결 donga-st.com ↗ |
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 30 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Evogliptin | “Amount of raw material medication (1 pill) : Evogliptin tartrate 6.869mg(5mg as evogliptin)” NCT04584242 ↗23“Effect of Evogliptin on the Progression of Aortic Valvular Calcification.” PMID 39260927 ↗ Sep 2024 “evogliptin 5mg tablet qd + placebo tablet matching to sitagliptin 100mg” NCT02949193 ↗ “evogliptin 5mg tablet qd + placebo tablet matching to linagliptin 5mg” NCT02974504 ↗ “E : Evogliptin 5 mg M : Metformin XR 1000 mg” NCT02375139 ↗ “Evogliptin 5 mg + Metformin XR 1000 mg” NCT02167061 ↗ “DA-1229(Evogliptin)” NCT02214693 ↗ “Evogliptin” NCT05143177 ↗ |
| Known as | DA-1229 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02214693 ↗ |
| Known as | EVO | “Evogliptin (EVO) is a potent and selective dipeptidyl peptidase-4 inhibitor (DPP4i) developed for the treatment of type 2 diabetes mellitus (T2DM).” PMID 31890041 ↗ Dec 2019 |
| Known as | Evogliptin tartrate | “Evogliptin tartrate. PO. 1 tablets once a day.” NCT05473806 ↗ |
| Known as | Evogliptina | ChEMBL registry synonym — accepted as the source's own label CHEMBL1779710 ↗ |
| Known as | Evogliptine | ChEMBL registry synonym — accepted as the source's own label CHEMBL1779710 ↗ |
| Action | Inhibit | “DA-1229, a dipeptidyl peptidase IV inhibitor” PMID 22943970 ↗ Sep 2012 |
| Modality | Small molecule | — CHEMBL1779710 ↗ |
| Route | Oral | “A single oral dose of DA-1229 or placebo was given to 10 subjects” PMID 22943970 ↗ Sep 2012 |
| Target | DPP4 | “Evogliptin (EVO) is a potent and selective dipeptidyl peptidase-4 inhibitor (DPP4i)” PMID 31890041 ↗ Dec 2019 |