Drugs / S-amlodipine
S-amlodipine
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | CONJUPRI | — | 2019-12-19 | fda.gov ↗ |
Trials 21
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 112 trials | ||||||
| Phase 1 | NCT04667624 | Feb → Apr 2020 | hypertensive disorder | Hanlim Pharm. Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT03657550 | May → Sep 2018 | hypertensive disorder | Conjupro Biotherapeutics, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02955498 | Apr → May 2014 | — | Hanlim Pharm. Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT03648333 | Dec 2013 → Feb 2014 | — | Hanlim Pharm. Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT01842256 | Apr → May 2013 | essential hypertension, hyperlipidemia | Chong Kun Dang Pharmaceutical | Completed | No outcome recorded |
| Phase 1 | NCT01842230 | Apr → May 2013 | essential hypertension, hyperlipidemia | Chong Kun Dang Pharmaceutical | Completed | No outcome recorded |
| Phase 1 | NCT01819779 | Mar → May 2013 | — | Hanlim Pharm. Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT01652339 | Jul → Aug 2012 | — | Hanlim Pharm. Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT01356017 | Jun → Sep 2011 | — | Chong Kun Dang Pharmaceutical | Completed | No outcome recorded |
| Phase 1 | NCT01352689 | Apr → May 2011 | hypertensive disorder | Chong Kun Dang Pharmaceutical | Completed | No outcome recorded |
| Phase 1 | NCT01340131 | Jan → Mar 2011 | essential hypertension | Chong Kun Dang Pharmaceutical | Completed | No outcome recorded |
| Phase 1 | NCT01246193 | Nov → Dec 2010 | hypertensive disorder | Chong Kun Dang Pharmaceutical | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT04740840 | May 2010 → Apr 2012 | hypertensive disorder | Affiliated Hospital of North Sichuan Medical College | Completed | No outcome recorded |
| Phase 35 trials | ||||||
| Phase 3 | NCT07618806 | Nov 2026 → Dec 2027 expected | hypertensive disorder | Zentiva, k.s. | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT06771245 | Jan 2025 → Mar 2026 overdue | essential hypertension | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT01634295 | Jul 2012 → May 2013 | hypertensive disorder | Chong Kun Dang Pharmaceutical | Completed | No outcome recorded |
| Phase 3 | NCT01426100 | Aug 2011 → May 2012 | hypertensive disorder | Chong Kun Dang Pharmaceutical | Completed | No outcome recorded |
| Phase 3 | NCT00289406 | Jan → Feb 2006 | hypertensive disorder | SK Chemicals Co., Ltd. | Completed | No outcome recorded |
| Phase 43 trials · 1 met primary | ||||||
| Phase 4 | NCT02231788 | Jun 2014 → Mar 2018 | hypertensive disorder | Chong Kun Dang Pharmaceutical | Completed | Met primary |
| Phase 4 | NCT03038451 | Mar 2013 → Feb 2017 | hypertensive disorder | Neutec Ar-Ge San ve Tic A.Ş | Completed | No outcome recorded |
| Phase 4 | NCT01131546 | Dec 2009 → Mar 2011 | essential hypertension | Jiangsu Simcere Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Comparator or background therapy9 trials | ||||||
| Phase 1 | NCT02358824 Comparator | Feb → May 2015 | hypertensive disorder | Chong Kun Dang Pharmaceutical | Completed | No outcome recorded |
| Phase 1 | NCT02250833 Comparator | Sep → Dec 2014 | hypertensive disorder | Chong Kun Dang Pharmaceutical | Completed | No outcome recorded |
| Phase 1 | NCT01356043 Comparator | May → Aug 2011 | — | Chong Kun Dang Pharmaceutical | Completed | No outcome recorded |
| Phase 2 | NCT01128322 Comparator | Jul 2010 → Mar 2011 | essential hypertension | Chong Kun Dang Pharmaceutical | Completed | No outcome recorded |
| Phase 3 | NCT03814109 Comparator | Apr 2022 → Nov 2023 | hypertensive disorder | EMS | Withdrawn | No outcome recorded Stop: Business |
| Phase 3 | NCT04686643 Background | Feb 2021 → Feb 2022 | hypertensive disorder | Ahn-Gook Pharmaceuticals Co.,Ltd | Unknown | No outcome recorded |
| Phase 3 | NCT01983735 Comparator | Jan → Aug 2014 | hypertensive disorder | Chong Kun Dang Pharmaceutical | Unknown | No outcome recorded |
| Phase 3 | NCT01501253 Comparator | Aug 2011 → Sep 2012 | essential hypertension | Chong Kun Dang Pharmaceutical | Completed | No outcome recorded |
| Phase 4 | NCT03226340 Background | Dec 2015 → Mar 2018 | essential hypertension | Seoul National University Bundang Hospital | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2026-06-16 | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Regulatory VOLUNTARY ANNOUNCEMENT - NMPA ACCEPTS MARKETING AUTHORISATION APPLICATION FOR VALSARTAN AND LEVAMLODIPINE MALEATE TABLETS (SYH9056 TABLETS) irasia.com ↗ |
| 2026-06-01 | Chong Kun Dang Pharmaceutical | Results 종근당, 유럽고혈압학회서 '텔미누보 20/1.25mg' 3상 임상 결과 발표 ckdpharm.com ↗
데이터에 따르면 텔미누보 20/1.25mg은 투약 8주 시점에서 수축기 혈압(msSBP)을 기저치 대비 17.6mmHg 감소시켜, 텔미사르탄 20mg 단일제(-14.15mmHg)와 에스암로디핀 1.25mg 단일제(-12.19mmHg) 대비 우수한 혈압강하 효과를 보였다. |
All press releases naming this drug 3 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-06-16 | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | VOLUNTARY ANNOUNCEMENT - NMPA ACCEPTS MARKETING AUTHORISATION APPLICATION FOR VALSARTAN AND LEVAMLODIPINE MALEATE TABLETS (SYH9056 TABLETS) irasia.com ↗ |
| 2026-06-01 | Chong Kun Dang Pharmaceutical | 종근당, 유럽고혈압학회서 '텔미누보 20/1.25mg' 3상 임상 결과 발표 ckdpharm.com ↗ |
| 2014-12-19 | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | VOLUNTARY ANNOUNCEMENT - THE GROUP'S HYPERTENSION AND DYSLIPIDEMIA COMBINATION DRUG "LEVAMLODIPINE MALEATE/ATORVASTATIN CALCIUM TABLET" COMMENCES PHASE III CLINICAL TRIAL irasia.com ↗ |
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 31 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | s-amlodipine | “The purpose of this study is to assess the pharmacokinetic characteristics of olmesartan and S-amlodipine after single oral administration of Sevikar tab. 10/40mg, a...” NCT02955498 ↗24“The purpose of this study is to evaluate the pharmacokinetic characteristics of CKD-828 (Fixed Dose Combination Tablet; Telmisartan and S-Amlodipine) in healthy volunteer.” NCT01340131 ↗ “Amlodipine is a racemic mixture consisting of equal proportions of two enantiomers: R(+)-amlodipine and S(-)-amlodipine (Levamlodipine).” NCT07618806 ↗ “Fixed dose combination of S-amlodipine 2.5mg and Telmisartan 40mg QD 2 weeks.” NCT01634295 ↗ “Drug: Telmisartan 80mg + S-Amlodipine 2.5mg(FDC) Tablet, Oral, Once Daily” NCT01246193 ↗ “CKD-828(Fixed Dose Combination Tablet; Telmisartan and S-Amlodipine)” NCT01352689 ↗ “Fixed dose combination of Telmisartan 40mg and S-Amlodipine 2.5mg” NCT01426100 ↗ “S-amlodipine nicotinate (5mg as S-amlodipine), valsartan 160mg” NCT03648333 ↗ “LodienT tablet 80/2.5mg(telmisartan/s-amlodipine)” NCT04667624 ↗ “* S-amlodipine nicotinate (5mg as S-amlodipine)” NCT01819779 ↗ “* S-amlodipine nicotinate (5mg as S-amlodipine)” NCT01652339 ↗ |
| Known as | Levamlodipine | “This 18-week study compares standard Amlodipine with a more purified version called Levamlodipine to see if it causes less ankle swelling while still effectively lowering blood...” NCT07618806 ↗ |
| Known as | S-amlodipine nicotinate | “* S-amlodipine nicotinate (5mg as S-amlodipine)” NCT01819779 ↗ |
| Known as | S-NOR | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03038451 ↗ |
| Action | Inhibit | “the calcium channel blocking (CCB) effect is confined to S-amlodipine” PMID 22721873 ↗ Jun 2012 |
| Route | Oral | “Drug: S-Amlodipine 2.5mg Tablet, Oral, Once Daily” NCT01246193 ↗ |