Drugs / sitokiren
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | China (NMPA) | — | essential hypertension | 2023-06-16 | “I001片（SPH3127）治疗高血压适应症的NDA上市申请已于2024年4月获得CDE受理” sphchina.com ↗ ““SPH3127片”的药品上市许可申请获国家药监局受理” sphchina.com ↗ “此次获得上市许可申请受理的是其高血压适应症” sphchina.com ↗ |
Trials 10
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT03255993 | Oct 2017 → Sep 2018 | hypertensive disorder | Shanghai Pharmaceuticals Holding Co., Ltd | Completed | No outcome recorded |
| Phase 1 | NCT03249753 | Sep 2017 → Sep 2018 | hypertensive disorder | Shanghai Pharmaceuticals Holding Co., Ltd | Completed | No outcome recorded |
| Phase 1 | NCT03128138 | Dec 2016 → Jun 2018 | hypertensive disorder | Shanghai Pharmaceuticals Holding Co., Ltd | Completed | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT05593562 | Oct 2022 | essential hypertension | Shanghai Pharmaceuticals Holding Co., Ltd | Completed | No outcome recorded |
| Phase 1/2 | NCT05359055 | Dec 2021 → Jan 2022 | — | Shanghai Pharmaceuticals Holding Co., Ltd | Completed | No outcome recorded |
| Phase 24 trials | ||||||
| Phase 2 | NCT05770609 | Jun 2023 → Sep 2024 | ulcerative colitis | Shanghai Pharmaceuticals Holding Co., Ltd | Completed | No outcome recorded |
| Phase 2 | NCT05593575 | Mar 2023 → Dec 2024 | diabetic kidney disease | Shanghai Pharmaceuticals Holding Co., Ltd | Completed | No outcome recorded |
| Phase 2 | NCT05019742 | Mar → Nov 2022 | ulcerative colitis | Shanghai Pharma Biotherapeutics USA Inc. | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT03756103 | Jan 2019 → Jun 2020 | essential hypertension | Shanghai Pharmaceuticals Holding Co., Ltd | Completed | No outcome recorded |
| Phase 31 trial · 1 met primary | ||||||
| Phase 3 | NCT05359068 | Jun 2021 → Dec 2023 | essential hypertension | Shanghai Pharmaceuticals Holding Co., Ltd | Completed | Met primary |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2023-06-19 | SPH-BIOCAD (HK) Limited | Regulatory 上海医药1类新药“SPH3127片”上市申请获得受理 sphchina.com ↗
2023年6月16日，上海医药集团股份有限公司开发的“SPH3127片”的药品上市许可申请获国家药监局受理。 |
| 2021-08-03 | SPH-BIOCAD (HK) Limited | Regulatory 上海医药SPH3127片新适应症获得II期临床试验批准通知书 sphchina.com ↗
近日，该项目获得了国家药监局核准签发的《药物临床试验批准通知书》，同意按照已提交的方案开展新药临床试验。 |
All press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2023-06-19 | SPH-BIOCAD (HK) Limited | 上海医药1类新药“SPH3127片”上市申请获得受理 sphchina.com ↗ |
| 2021-08-03 | SPH-BIOCAD (HK) Limited | 上海医药SPH3127片新适应症获得II期临床试验批准通知书 sphchina.com ↗ |
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 13 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | sitokiren | “To evaluate the efficacy and safety of sitokiren (SPH3127) tablet in patients with mild-to-moderate essential hypertension in comparison to valsartan capsule.” PMID 42165988 ↗ May 2026 |
| Known as | SITOKIRENE | ChEMBL registry synonym — accepted as the source's own label CHEMBL4110551 ↗ |
| Known as | SITOKIRENO | ChEMBL registry synonym — accepted as the source's own label CHEMBL4110551 ↗ |
| Known as | SPH3127 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05019742 ↗ |
| Action | Inhibit | “plasma renin activity inhibition of up to 90%” PMID 33653620 ↗ Feb 2021 |
| Modality | Small molecule | — CHEMBL4110551 ↗ |
| Route | Oral | “single oral dose” NCT03128138 ↗ |
| Target | REN | “a Novel Direct Renin Inhibitor” PMID 42165988 ↗ May 2026 |