Drugs / CS-3150
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | Japan (PMDA) | — | essential hypertension | 2018-02-26 | “Daiichi Sankyo has submitted its regulatory application for esaxerenone (INN; code name CS-3150) as a treatment for patients with hypertension” exelixis.com ↗ “today announced the NDA submission in Japan of esaxerenone (INN; code name: CS-3150)” daiichisankyo.com ↗ |
Trials 11
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial · 1 met primary | ||||||
| Phase 1 | NCT04019652 | Nov → Dec 2015 | hypertensive disorder | Daiichi Sankyo | Completed | Met primary |
| Phase 23 trials | ||||||
| Phase 2 | NCT02448628 | May → Dec 2015 | hypertensive disorder | Daiichi Sankyo | Completed | No outcome recorded |
| Phase 2 | NCT02345044 | Jan → Aug 2015 | essential hypertension | Daiichi Sankyo | Completed | No outcome recorded |
| Phase 2 | NCT02345057 | Jan 2015 → Jun 2016 | diabetic kidney disease | Daiichi Sankyo | Completed | No outcome recorded |
| Phase 35 trials · 2 met primary | ||||||
| Phase 3 | NCT02890173 | Sep 2016 → Jul 2017 | essential hypertension | Daiichi Sankyo | Completed | Met primary |
| Phase 3 | NCT02808026 | Jun 2016 → Feb 2017 | hypertensive disorder | Daiichi Sankyo | Completed | No outcome recorded |
| Phase 3 | NCT02807987 | Jun 2016 → May 2017 | hypertensive disorder | Daiichi Sankyo | Completed | No outcome recorded |
| Phase 3 | NCT02807974 | Jun 2016 → Mar 2017 | hypertensive disorder | Daiichi Sankyo | Completed | Met primary |
| Phase 3 | NCT02722265 | Mar 2016 → Jul 2017 | essential hypertension | Daiichi Sankyo | Completed | No outcome recorded |
| Phase not applicable2 trials | ||||||
| — | NCT02885662 | Sep 2016 → Jul 2017 | primary aldosteronism | Daiichi Sankyo | Completed | No outcome recorded |
| — | NCT02848170 | Aug 2016 → Apr 2017 | essential hypertension | Daiichi Sankyo | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 6
| Date | Issuer | Release |
|---|---|---|
| 2019-11-08 | Daiichi Sankyo | Results Daiichi Sankyo Announces Positive Results from ESAX-DN Phase 3 Study in Japan of Esaxerenone in Patients with Diabetic Nephropathy daiichisankyo.com ↗
The study showed the esaxerenone-based regimen had a significantly higher Urine Albumin-to-Creatinine Ratio (UACR) remission*2 rate (esaxerenone: 22.1% vs. placebo: 4.0%) and significantly reduced UACR (esaxerenone:-58.3% vs. placebo: 8.3) compared with the placebo group. |
| 2019-01-08 | Daiichi Sankyo | Regulatory Daiichi Sankyo Announces Approval of MINNEBRO(TM) Tablets for the Treatment of Hypertension in Japan daiichisankyo.com ↗
Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today announced the receipt of marketing approval in Japan for MINNEBROTM Tablets 1.25 mg, 2.5 mg and 5 mg (generic name: esaxerenone; hereafter, the drug) for the treatment of hypertension. |
| 2018-02-27 | Daiichi Sankyo | Regulatory Daiichi Sankyo Announces NDA submission in Japan of Esaxerenone for Treatment of Hypertension daiichisankyo.com ↗
Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today announced the NDA submission in Japan of esaxerenone (INN; code name: CS-3150), a non-steroidal selective novel mineralocorticoid receptor (MR) blocker for the treatment of hypertension. |
| 2018-02-26 | Exelixis | Regulatory Exelixis Announces Collaborator Daiichi Sankyo’s Submission of Regulatory Filing for Esaxerenone (CS-3150) in Japan exelixis.com ↗
Exelixis, Inc. (NASDAQ: EXEL) today announced that its partner Daiichi Sankyo Company, Limited (“Daiichi Sankyo”) has submitted its regulatory application for esaxerenone (INN; code name CS-3150) as a treatment for patients with hypertension to the Japanese Pharmaceutical and Medical Devices Agency. |
| 2017-09-25 | Daiichi Sankyo | Results Daiichi Sankyo Announces Positive Top-line Results from Phase 3 Study in Japan of Esaxerenone for Treatment of Essential Hypertension daiichisankyo.com ↗
Tokyo, Japan （September 25, 2017）– Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today announced that the primary endpoint has been achieved from ESAX-HTN study (Phase 3 pivotal study of non-steroidal, selective novel mineralocorticoid receptor (MR) blocker, esaxerenone (INN; code name: CS-3150), for patients with essential hypertension in Japan. |
| 2017-09-24 | Exelixis | Results Exelixis Provides Update on Collaborator Daiichi Sankyo’s Phase 3 Clinical Progress with Esaxerenone (CS-3150), Including Positive Top-Line Results and Additional Pivotal Study exelixis.com ↗
With the trial achieving its primary endpoint, Daiichi Sankyo has communicated its intention to submit a Japanese regulatory application for esaxerenone for an essential hypertension indication in the first quarter of 2018. |
All press releases naming this drug 9 releases
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 12 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | CS-3150 | “Double-Blind Randomized Phase 3 Study Comparing Esaxerenone (CS-3150) and Eplerenone in Patients With Essential Hypertension (ESAX-HTN Study).” PMID 31786983 ↗ Dec 2019 |
| Known as | esaxerenone | “This post hoc exploratory substudy of a long-term phase 3 study evaluated the effect of esaxerenone monotherapy (2.5 or 5 mg/day) in treatment-naïve patients who continued the...” PMID 35976603 ↗ Aug 20221“Double-Blind Randomized Phase 3 Study Comparing Esaxerenone (CS-3150) and Eplerenone in Patients With Essential Hypertension (ESAX-HTN Study).” PMID 31786983 ↗ Dec 2019 |
| Known as | XL-550 | ChEMBL registry synonym — accepted as the source's own label CHEMBL3545393 ↗ |
| Action | Inhibit | “esaxerenone, a new selective nonsteroidal MR blocker” PMID 31786983 ↗ Dec 20191“Mineralocorticoid receptor antagonist” CHEMBL3545393 ↗ |
| Route | Oral | “administered orally” NCT02345044 ↗ |
| Target | NR3C2 | “Mineralocorticoid receptor antagonist” CHEMBL3545393 ↗ |