Drugs / Enarodustat
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | Japan (PMDA) | — | aregenerative anemia | 2019-11-29 | “JTZ-951’의 신약허가 신청서를 일본 의약품의료기기종합기구(PMDA)에 제출했다고 2일 밝혔다.” jw-pharma.co.kr ↗ |
Trials 10
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 14 trials | ||||||
| Phase 1 | NCT02805244 | Jun → Sep 2016 | anemia due to chronic disorder | Akros Pharma Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02581124 | Oct 2015 → Apr 2016 | anemia due to chronic disorder | Akros Pharma Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01978587 | Oct → Dec 2013 | anemia due to chronic disorder | Akros Pharma Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01971164 | May 2013 → May 2014 | anemia due to chronic disorder | Akros Pharma Inc. | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT06737081 | Sep 2024 → Dec 2025 overdue | anemia | Shenzhen Salubris Pharmaceuticals Co., Ltd. | Recruiting | No outcome recorded |
| Phase 33 trials | ||||||
| Phase 3 | NCT07522996 | Jun 2026 → Dec 2028 | aplastic anemia | Peking Union Medical College Hospital | Withdrawn | No outcome recorded |
| Phase 3 | NCT07548671 | Apr 2026 → Dec 2028 expected | aplastic anemia | Peking Union Medical College Hospital | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT04027517 | Jan 2019 → Feb 2021 | anemia due to chronic disorder | JW Pharmaceutical | Completed | No outcome recorded |
| Phase 42 trials | ||||||
| Phase 4 | NCT07079579 | Aug 2025 → Jun 2027 expected | aregenerative anemia | Shenzhen Salubris Pharmaceuticals Co., Ltd. | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06725810 | Mar 2025 → Jan 2029 expected | anemia due to chronic disorder | Shanghai Zhongshan Hospital | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 5
| Date | Issuer | Release |
|---|---|---|
| 2022-11-18 | JW Pharmaceutical | Regulatory [JW중외제약] 경구용 신성빈혈 치료제 ‘에나로이정’ 식약처 승인 jw-pharma.co.kr ↗
JW중외제약은 식품의약품안전처로부터 신성빈혈 치료제 ‘에나로이(성분명 : 에나로두스타트)정’의 국내 품목 허가를 취득했다고 18일 밝혔다. |
| 2020-09-28 | JW Pharmaceutical | Regulatory [JW중외제약] 신성빈혈치료제 JTZ-951 일본 신약허가 승인 jw-pharma.co.kr ↗
JW중외제약은 일본 ‘재팬 타바코(Japan Tobacco Inc., 이하 JT)’가 일본 후생노동성(MHLW)으로부터 신성빈혈치료제 JTZ-951에 대한 제조 및 판매 승인을 받았다고 28일 밝혔다. |
| 2019-12-02 | JW Pharmaceutical | Regulatory [JW중외제약] 신성빈혈치료제 JTZ-951 일본 신약허가 신청 jw-pharma.co.kr ↗
JW중외제약은 일본 ‘재팬 타바코(Japan Tobacco Inc., 이하 JT)’가 신성빈혈치료제 ‘JTZ-951’의 신약허가 신청서를 일본 의약품의료기기종합기구(PMDA)에 제출했다고 2일 밝혔다. |
| 2019-11-29 | Torii Pharmaceutical Co. Ltd. | Regulatory 2019年11月29日 HIF-PH阻害薬「エナロデュスタット（JTZ-951）」の日本国内における製造販売承認申請について（PDF:160KB） torii.co.jp ↗ |
| 2019-07-12 | Torii Pharmaceutical Co. Ltd. | Results 2019年07月12日 JTZ-951（エナロデュスタット）の腎性貧血患者を対象とした国内第Ⅲ相臨床試験（比較試験）の速報結果について（PDF:212KB） torii.co.jp ↗ |
All press releases naming this drug 5 releases
| Date | Issuer | Release |
|---|---|---|
| 2022-11-18 | JW Pharmaceutical | [JW중외제약] 경구용 신성빈혈 치료제 ‘에나로이정’ 식약처 승인 jw-pharma.co.kr ↗ |
| 2020-09-28 | JW Pharmaceutical | [JW중외제약] 신성빈혈치료제 JTZ-951 일본 신약허가 승인 jw-pharma.co.kr ↗ |
| 2019-12-02 | JW Pharmaceutical | [JW중외제약] 신성빈혈치료제 JTZ-951 일본 신약허가 신청 jw-pharma.co.kr ↗ |
| 2019-11-29 | Torii Pharmaceutical Co. Ltd. | 2019年11月29日 HIF-PH阻害薬「エナロデュスタット（JTZ-951）」の日本国内における製造販売承認申請について（PDF:160KB） torii.co.jp ↗ |
| 2019-07-12 | Torii Pharmaceutical Co. Ltd. | 2019年07月12日 JTZ-951（エナロデュスタット）の腎性貧血患者を対象とした国内第Ⅲ相臨床試験（比較試験）の速報結果について（PDF:212KB） torii.co.jp ↗ |
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 11 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Enarodustat | “Enarodustat (SAL-0951) Tablets” NCT06737081 ↗ |
| Known as | JTZ-951 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01978587 ↗ |
| Known as | SAL-0951 | “Enarodustat (SAL-0951) Tablets” NCT06737081 ↗ |
| Action | Inhibit | “Egl nine homolog 1 inhibitor” CHEMBL4297619 ↗ |
| Modality | Small molecule | — CHEMBL4297619 ↗ |
| Route | Oral | “Tablets, 1 dose per day for 15 days” NCT01971164 ↗ |
| Target | EGLN1 | “Egl nine homolog 1 inhibitor” CHEMBL4297619 ↗ |