Drugs / JM-010
Trials 4
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 2 | NCT05516875 | Jan → May 2024 | movement disorder | Contera Pharma A/S | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT04377945 | Apr 2021 → Feb 2024 | Parkinson disease, movement disorder | Bukwang Pharmaceutical | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT03956979 | Jul 2019 → Mar 2024 | movement disorder | Contera Pharma | Completed | Missed primary |
| Phase 2 | NCT02439203 | May → Dec 2015 | Parkinson disease, drug-induced dyskinesia | Bukwang Pharmaceutical | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 10
| Date | Issuer | Release |
|---|---|---|
| 2024-05-21 | Bukwang Pharmaceutical | Results 콘테라파마 “JM-010 후기 2상 시험, 1차 평가 변수 미충족” bukwang.co.kr ↗
부광약품 자회사 콘테라파마는 JM-010 의 후기 2 상 ASTORIA 임상시험에서 1 차 평가변수 목표를 충족하지 못했다고 이달 21 일 ( 한국시간 ) 밝혔다 . |
| 2024-05-21 | Contera Pharma A/S | Results Contera Pharma reports topline results from its Phase IIb clinical trial ASTORIA, evaluating JM-010 for treatment of Parkinson’s disease dyskinesia conterapharma.com ↗
The primary efficacy endpoint, reduction of dyskinesia as assessed by the Unified Dyskinesia Rating Scale (UDysRS) was not met. |
| 2022-11-07 | Bukwang Pharmaceutical | Regulatory 부광약품, 파킨슨병 이상운동증치료제 JM-010 2상임상 기관 확대 bukwang.co.kr ↗
임상 진행 속도를 촉진하기 위하여 한국의 임상기관을 추가하는 IND를 한국 식약처에 제출하였고 11월 7일 승인되었다. |
| 2020-02-14 | Contera Pharma A/S | Regulatory Bukwang receives US FDA approval for JM-010 phase 2 clinical study IND conterapharma.com ↗
Bukwang has recently received the investigational new drug (IND) clearance from the US Food and Drug Administration (FDA) to proceed with phase 2 clinical study of JM-010. |
| 2018-10-22 | Bukwang Pharmaceutical | Regulatory 부광약품, JM-010 유럽 임상 2상 승인 bukwang.co.kr ↗
부광약품은 신약후보물질 'JM-010'이 프랑스 당국으로부터 이달 초 2상 임상시험계획을 승인받았다고 22일 밝혔다. |
| 2018-10-22 | Contera Pharma A/S | Regulatory Bukwang Announces approval of Clinical Trial Application by European authority to initiate Phase 2 study of JM-010 conterapharma.com ↗
Bukwang Pharmaceutical announces that the company’s application to conduct phase 2 clinical study for new CNS drug candidate ‘JM-010’ has recently been approved by French authority. |
| 2017-01-05 | Bukwang Pharmaceutical | Regulatory 부광약품, LID치료제 ‘JM-010’, 개발단계 희귀의약품으로 지정 승인 bukwang.co.kr ↗
부광약품은 최근 자회사인 덴마크 CNS (중추신경계) 전문 바이오벤처 ‘콘테라파마 (Contera Pharma)’에서 개발한 ‘레보도파로 유발된 이상운동증 (LID)’ 치료제인 'JM-010'이 식품의약품안전처로부터 '개발단계 희귀의약품'으로 지정받았다고 밝혔다. |
| 2017-01-05 | Contera Pharma A/S | Regulatory Bukwang Pharmaceutical Co., Ltd. LID treatment ‘JM-010’ is approved for Orphan Drug Designation conterapharma.com ↗
Bukwang recently announced that Ministry of Food and Drug Safety (MFDS) has granted JM-010 for the treatment of levodopa-induced dyskinesia (LID). |
| 2016-09-07 | Bukwang Pharmaceutical | Results 부광약품, LID 치료제 JM-010 개념증명 임상시험에서 유효성과 안전성 입증 bukwang.co.kr ↗ |
| 2016-09-07 | Contera Pharma A/S | Results Press release, JM-010CS01, Phase IIa/cPoC study conterapharma.com ↗
The primary study objectives concerning efficacy and safety were fulfilled. |
All press releases naming this drug 28 releases
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 4 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | JM-010 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02439203 ↗ |
| Route | Oral | “will be administered orally” NCT05516875 ↗ |