Drugs / sitokiren
last change May 2026 re-read 2 minutes ago

sitokiren

also known as SPH3127 · SITOKIRENE · SITOKIRENO

Small molecule targets REN via inhibition

Developed for
essential hypertension · ulcerative colitis · diabetic kidney disease
Investigated by
Shanghai Pharmaceuticals Holding Co., Ltd · R&G Pharma Studies Co.,Ltd. · Shanghai Pharma Biotherapeutics USA Inc.

Trials 10 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
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
Phase 2 NCT03756103 Jan 2019 → Jun 2020 essential hypertension Shanghai Pharmaceuticals Holding Co., Ltd Completed No outcome recorded
Phase 31 trial
Phase 3 NCT05359068 Jun 2021 → Dec 2023 essential hypertension Shanghai Pharmaceuticals Holding Co., Ltd Completed No outcome recorded

Evidence & citations 8 cited values

Every value below carries the sentence it was read from. 13 sources stand behind the page.

FieldValueCited 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 NCT03249753
9

NCT05593562

NCT05770609

NCT05019742

NCT05359068

NCT03255993

NCT05593575

NCT03128138

NCT05359055

NCT03756103

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