Chlorthalidone
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | HYGROTON | — | 1960-04-07 | fda.gov ↗ |
Trials 57
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 15 trials | ||||||
| Phase 1 | NCT05077475 | Sep 2021 → Apr 2022 | hypertensive disorder | AJU Pharm Co., Ltd. | Unknown | No outcome recorded |
| Phase 1 | NCT05077462 | Sep 2021 → Apr 2022 | hypertensive disorder | AJU Pharm Co., Ltd. | Unknown | No outcome recorded |
| Phase 1 | NCT04757532 | Dec 2020 → Mar 2021 | — | Parc de Salut Mar | Completed | No outcome recorded |
| Phase 1 | NCT03662620 | Oct → Dec 2018 | hypertensive disorder | Yuhan Corporation | Completed | No outcome recorded |
| Phase 1 | NCT02152969 | May → Aug 2014 | hypertensive disorder | Yuhan Corporation | Completed | No outcome recorded |
| Phase 28 trials · 2 met primary | ||||||
| Phase 2 | NCT07645300 | Oct 2026 → Mar 2032 expected | chronic kidney disease | VA Office of Research and Development | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT05370599 | Apr 2022 → Jan 2026 | hypertensive disorder | University of California, San Francisco | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT05222191 | Feb 2022 → Dec 2023 | chronic kidney disease, hypertensive disorder | Indiana Institute for Medical Research | Unknown | No outcome recorded |
| Phase 2 | NCT03325114 | Jun 2019 → Jun 2020 | idiopathic hypercalciuria, type 1 diabetes mellitus | University of Rochester | Terminated | No outcome recorded |
| Phase 2 | NCT03923933 | Jun → Oct 2019 | chronic kidney disease | Hospital General de México Dr. Eduardo Liceaga | Completed | Met primary |
| Phase 2 | NCT02841280 | Jul 2016 → Apr 2021 | chronic kidney disease, hypertensive disorder | Indiana University | Completed | Met primary |
| Phase 2 | NCT00000522 | Aug 1985 → May 1994 | heart disorder, hypertensive disorder | University of Minnesota | Completed | No outcome recorded |
| Phase 2 | NCT00000499 | Sep 1980 → May 1983 | heart disorder, hypertensive disorder | National Heart, Lung, and Blood Institute (NHLBI) | Completed | No outcome recorded |
| Phase 328 trials · 10 met primary · 2 missed | ||||||
| Phase 3 | NCT06348576 | May 2024 → Feb 2025 | essential hypertension | Addpharma Inc. | Unknown | Met primary |
| Phase 3 | NCT05920005 | Aug 2023 → Mar 2025 | hypertensive disorder | Hospital Israelita Albert Einstein | Completed | Met primary |
| Phase 3 | NCT04927299 | Jun 2022 → Aug 2023 | essential hypertension | Laboratorios Silanes S.A. de C.V. | Completed | No outcome recorded |
| Phase 3 | NCT07116863 | Jun 2022 → Jun 2024 | essential hypertension | Kyungdong Pharmaceutical Co., Ltd. | Completed | Met primary |
| Phase 3 | NCT03928145 | Nov 2019 → Jul 2021 | essential hypertension | Hospital de Clinicas de Porto Alegre | Unknown | No outcome recorded |
| Phase 3 | NCT02521233 | Nov 2016 → May 2017 | essential hypertension | EMS | Withdrawn | No outcome recorded Stop: Business |
| Phase 3 | NCT02521246 | Nov 2016 → May 2017 | essential hypertension | EMS | Withdrawn | No outcome recorded Stop: Business |
| Phase 3 | NCT02620163 | Dec 2015 → Dec 2016 | essential hypertension | Yuhan Corporation | Completed | No outcome recorded |
| Phase 3 | NCT02916602 | Apr 2015 → Sep 2016 | hypertensive disorder | Hanmi Pharmaceutical Company Limited | Completed | Met primary |
| Phase 3 | NCT02896621 | Dec 2014 → Feb 2016 | hypertensive disorder, obstructive sleep apnea syndrome | Hospital de Clinicas de Porto Alegre | Completed | No outcome recorded |
| Phase 3 | NCT01896661 | Dec 2014 → Dec 2015 | hypertensive disorder, obstructive sleep apnea syndrome | Hospital de Clinicas de Porto Alegre | Completed | Missed primary |
| Phase 3 | NCT01850160 | Apr 2013 → Mar 2015 | hypertensive disorder | Farma de Colombia SA | Completed | No outcome recorded |
| Phase 3 | NCT02644395 | Jan 2013 → Dec 2015 | secondary hypertension | Erasmus Medical Center | Completed | No outcome recorded |
| Phase 3 | NCT01456169 | Oct 2011 → Dec 2012 | essential hypertension | Takeda | Completed | Met primary |
| Phase 3 | NCT01191450 | Aug 2011 → Aug 2013 | hypertensive disorder | Eurofarma Laboratorios S.A. | Completed | No outcome recorded |
| Phase 3 | NCT01309828 | Mar 2011 → Oct 2012 | — | Takeda | Completed | No outcome recorded |
| Phase 3 | NCT00970931 | Jul 2010 → Sep 2014 | hypertensive disorder | Hospital de Clinicas de Porto Alegre | Completed | Met primary |
| Phase 3 | NCT01033071 | Jan → Oct 2010 | essential hypertension | Takeda | Completed | Met primary |
| Phase 3 | NCT00996281 | Oct 2009 → Nov 2011 | essential hypertension | Takeda | Completed | No outcome recorded |
| Phase 3 | NCT00846365 | Mar 2009 → Jun 2010 | essential hypertension | Takeda | Completed | Met primary |
| Phase 3 | NCT00818883 | Feb → Nov 2009 | essential hypertension | Takeda | Completed | Met primary |
| Phase 3 | NCT00847626 | Jan 2009 → May 2010 | hypertensive disorder | Takeda | Completed | Met primary |
| Phase 3 | NCT00000542 | Aug 1993 → Mar 2002 | coronary artery disorder, diabetes mellitus, heart failure, hyperlipidemia +3 | National Heart, Lung, and Blood Institute (NHLBI) | Completed | Missed primary |
| Phase 3 | NCT00000525 | Jul 1986 → Sep 1989 | cardiac arrest, hypertensive disorder, sudden arrhythmia death syndrome | University of California, San Francisco | Completed | No outcome recorded |
| Phase 3 | NCT00000514 | Jun 1984 → Oct 1996 | cerebrovascular disorder, heart disorder, hypertensive disorder | National Heart, Lung, and Blood Institute (NHLBI) | Completed | No outcome recorded |
| Phase 3 | NCT00000513 | Apr 1984 → Nov 1994 | heart disorder, hypertensive disorder | National Heart, Lung, and Blood Institute (NHLBI) | Completed | No outcome recorded |
| Phase 3 | NCT02483936 | ? → Jun 2025 | essential hypertension | EMS | Withdrawn | No outcome recorded |
| Phase 3 | NCT02493322 | ? → Jun 2025 | essential hypertension | EMS | Withdrawn | No outcome recorded |
| Phase 414 trials · 1 met primary · 1 missed | ||||||
| Phase 4 | NCT07225764 | Oct 2025 → Jun 2027 expected | nephrolithiasis, calcium oxalate | Icahn School of Medicine at Mount Sinai | Recruiting | No outcome recorded |
| Phase 4 | NCT06041529 | Oct 2023 → Feb 2026 overdue | essential hypertension | Yuhan Corporation | Active not recruiting | No outcome recorded |
| Phase 4 | NCT05915286 | May 2023 → Feb 2025 | end stage renal failure | University of Alberta | Terminated | No outcome recorded |
| Phase 4 | NCT05171686 | Feb 2023 → Oct 2025 | chronic kidney disease, hypertensive disorder | VA Office of Research and Development | Completed | No outcome recorded |
| Phase 4 | NCT05411991 | Jun 2022 → Jul 2024 | heart failure | Vrije Universiteit Brussel | Completed | Missed primary |
| Phase 4 | NCT04192110 | Aug 2020 | chronic kidney disease | VA Office of Research and Development | Withdrawn | No outcome recorded |
| Phase 4 | NCT04330300 | Apr 2020 → Jul 2021 | COVID-19, essential hypertension | National University of Ireland, Galway, Ireland | Suspended | No outcome recorded Stop: Business |
| Phase 4 | NCT03666351 | Oct 2018 → Jul 2022 | aortic valve insufficiency, aortic valve stenosis, hypertensive disorder | Hanmi Pharmaceutical Company Limited | Completed | Met primary |
| Phase 4 | NCT03226340 | Dec 2015 → Mar 2018 | essential hypertension | Seoul National University Bundang Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT02100462 | Mar 2014 → Dec 2016 | hypertensive disorder | Creighton University | Unknown | No outcome recorded |
| Phase 4 | NCT02030314 | Jul 2013 → Apr 2017 | resistant hypertension | Virginia Commonwealth University | Withdrawn | No outcome recorded |
| Phase 4 | NCT01822860 | Mar 2013 → Feb 2015 | hypertensive disorder | Creighton University | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT01750294 | Aug 2012 → Aug 2013 | chronic kidney disease, hypertensive disorder | Indiana University | Completed | No outcome recorded |
| Phase 4 | NCT01203852 | Aug 2010 → Apr 2014 | hypertensive disorder | University of Florida | Completed | No outcome recorded |
| Phase not applicable2 trials | ||||||
| — | NCT02357004 | Feb 2015 → Jan 2020 | hypertensive disorder | University of Alabama at Birmingham | Withdrawn | No outcome recorded |
| — | NCT02711670 | Feb 2014 → Jun 2017 | urolithiasis | VA New York Harbor Healthcare System | Completed | No outcome recorded |
| Comparator or background therapy24 trials | ||||||
| Phase 0 | NCT06287580 Comparator | Aug 2024 → Feb 2026 | essential hypertension | University of Texas Southwestern Medical Center | Completed | No outcome recorded |
| Phase 1 | NCT05090449 Comparator | May 2019 → Apr 2020 | — | Laboratorios Silanes S.A. de C.V. | Completed | No outcome recorded |
| Phase 1 | NCT02496910 Comparator | Jun → Sep 2015 | hypertensive disorder | Yuhan Corporation | Completed | No outcome recorded |
| Phase 1 | NCT01806363 Comparator | Nov 2012 → Jun 2013 | hypertensive disorder | HanAll BioPharma Co., Ltd. | Completed | No outcome recorded |
| Phase 2 | NCT07238400 Comparator | Mar 2026 → Mar 2029 expected | hypertensive disorder | Massachusetts General Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT06111885 Comparator | Oct 2024 → Jun 2027 expected | urolithiasis | Insel Gruppe AG, University Hospital Bern | Recruiting | No outcome recorded |
| Phase 2 | NCT02236520 Comparator | Sep 2014 → May 2018 | hypertensive disorder | Vanderbilt University | Completed | No outcome recorded |
| Phase 3 | NCT02185417 Comparator | Jun 2016 → Oct 2022 | hypertensive disorder | VA Office of Research and Development | Completed | No outcome recorded |
| Phase 3 | NCT00971165 Comparator | Jul 2010 → Sep 2014 | hypertensive disorder | Hospital de Clinicas de Porto Alegre | Completed | No outcome recorded |
| Phase 3 | NCT00591773 Comparator | Sep 2007 → Mar 2009 | essential hypertension | Takeda | Completed | Met primary |
| Phase 3 | NCT00696384 Background | Jun 2007 → Apr 2009 | essential hypertension | Takeda | Completed | Met primary |
| Phase 3 | NCT00695955 Background | Jun 2007 → May 2010 | essential hypertension | Takeda | Completed | No outcome recorded |
| Phase 3 | NCT00241839 Comparator | Aug 2005 → May 2011 | heart disorder, hypertensive disorder | University of Florida | Completed | No outcome recorded |
| Phase 3 | NCT00000620 Background | Sep 1999 → Jun 2009 | atherosclerosis, coronary artery disorder, hyperlipoproteinemia, hypertensive disorder +1 | National Heart, Lung, and Blood Institute (NHLBI) | Completed | Missed primary |
| Phase 4 | NCT05593055 Comparator | Aug 2023 → Apr 2027 expected | hypertensive disorder | Brigham and Women's Hospital | Recruiting | No outcome recorded |
| Phase 4 | NCT05275907 Comparator | Jul 2022 → Oct 2023 | hypertensive disorder, impaired renal function disease | Northwestern University | Withdrawn | No outcome recorded |
| Phase 4 | NCT04519164 Comparator | Dec 2020 → Sep 2025 | hypertensive disorder, metabolic syndrome X | Brigham and Women's Hospital | Completed | No outcome recorded |
| Phase 4 | NCT01748123 Comparator | Aug 2016 → Jun 2017 | hypertensive disorder | Johns Hopkins University | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT01368536 Comparator | May 2011 → Feb 2012 | hypertensive disorder, type 2 diabetes mellitus | Novartis Pharmaceuticals | Terminated | No outcome recorded |
| Phase 4 | NCT00353652 Comparator | Jan 2005 → Jan 2013 | hypertensive disorder | University of Texas Southwestern Medical Center | Completed | No outcome recorded |
| — | NCT02665117 Comparator | Jan 2015 → Nov 2022 | hypertensive disorder | University of Texas Southwestern Medical Center | Completed | No outcome recorded |
| — | NCT03560804 Comparator | Nov 2014 → Sep 2017 | arteriosclerosis disorder | AHEPA University Hospital | Completed | No outcome recorded |
| — | NCT02121041 Comparator | May 2014 → Sep 2015 | hypertensive disorder | Anthony J Viera, MD, MPH | Completed | No outcome recorded |
| — | NCT00684489 Comparator | Sep 2003 → Mar 2005 | essential hypertension | Medical University of South Carolina | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 10
| Date | Issuer | Release |
|---|---|---|
| 2025-06-13 | Hanmi Pharmaceutical Company Limited | Regulatory “고혈압 1차 치료의 새로운 길”…한미약품 ‘아모프렐’ 출격 준비 hanmi.co.kr ↗
한미약품은 최근 식품의약품안전처로부터 저용량 3제 항고혈압제 ‘아모프렐정’의 품목허가를 획득하고 출시를 위한 채비에 들어갔다고 13일 밝혔다. |
| 2024-03-22 | Hanmi Pharmaceutical Company Limited | Results 한미약품 ‘ 아모잘탄패밀리 ’ 4상 결과, 국제학술지 ‘ AHJ ’ 등재 hanmi.co.kr ↗
이는 Intensive 치료군에서 아모잘탄, 아모잘탄플러스 투여를 통한 우수한 혈압 조절이 좌심실 질량 감소에 유의한 효과를 나타낸다는 것을 입증한 결과다. |
| 2023-11-03 | Hanmi Pharmaceutical Company Limited | Results “한미 ‘아모잘탄패밀리, 로수젯, 클로잘탄’, 임상적 유용성 뚜렷” hanmi.co.kr ↗ |
| 2023-05-04 | Hanmi Pharmaceutical Company Limited | Regulatory 한미, 저용량 이뇨제 붙인 고혈압 복합제 허가...라인업 지속 확장 hanmi.co.kr ↗
한미약품은 최근 식품의약품안전처로부터 고혈압 치료 복합신약 ‘클로잘탄정 50/6.25mg’을 신규로 허가 받았으며, 오는 7월초 제품을 출시할 예정이라고 밝혔다. |
| 2022-06-02 | Hanmi Pharmaceutical Company Limited | Regulatory 한미, 고혈압 복합신약 라인업 확대...’클로잘탄’ 허가 획득 hanmi.co.kr ↗
한미약품(대표이사 우종수·권세창)은 최근 식품의약품안전처로부터 ARB 계열 성분 ‘로사르탄(Losartan)’과 Thiazide-like 계열 이뇨제 성분 ‘클로르탈리돈(Chlorthalidone)을 결합한 2제 고혈압 치료 복합제 ‘클로잘탄정’ 2개 용량(50/12.5mg, 100/12.5mg)을 허가 받았다고 2일 밝혔다. |
| 2018-05-23 | Hanmi Pharmaceutical Company Limited | Results <보도자료> “임상적 효과 입증한 아모잘탄 패밀리, 용량 선택도 다양” hanmi.co.kr ↗ |
| 2017-11-07 | Hanmi Pharmaceutical Company Limited | Results <보도자료> 한미약품, 대한고혈압학회서 ‘아모잘탄 패밀리’ 심포지엄 hanmi.co.kr ↗ |
| 2017-10-19 | Hanmi Pharmaceutical Company Limited | Results <보도자료> 한미약품 ‘아모잘탄플러스’ 3상 결과, SCI급 국제학술지 등재 hanmi.co.kr ↗
임상 결과, 아모잘탄플러스 투여군이 Amlodipine/Losartan 2제 요법 투여군과 비교하여 기저치 대비 8주 후 sitSBP를 평균 9.5mmHg 더 감소시키는 결과를 보였다. |
| 2017-10-13 | Hanmi Pharmaceutical Company Limited | Results <보도자료> 한미약품, 대한심장학회서 ‘아모잘탄 패밀리’ 심포지엄 열어 hanmi.co.kr ↗ |
| 2017-06-30 | Hanmi Pharmaceutical Company Limited | Regulatory <보도자료> 한미, 고혈압치료 3제 복합신약 ‘아모잘탄플러스’ 허가 hanmi.co.kr ↗
한미약품(대표이사 우종수·권세창, www.hanmi.co.kr)은 지난 29일 고혈압치료 3제 복합신약인 ‘아모잘탄플러스’의 시판허가를 식품의약품안전처로부터 받았다고 30일 밝혔다. |
All press releases naming this drug 10 releases
| Date | Issuer | Release |
|---|---|---|
| 2025-06-13 | Hanmi Pharmaceutical Company Limited | “고혈압 1차 치료의 새로운 길”…한미약품 ‘아모프렐’ 출격 준비 hanmi.co.kr ↗ |
| 2024-03-22 | Hanmi Pharmaceutical Company Limited | 한미약품 ‘ 아모잘탄패밀리 ’ 4상 결과, 국제학술지 ‘ AHJ ’ 등재 hanmi.co.kr ↗ |
| 2023-11-03 | Hanmi Pharmaceutical Company Limited | “한미 ‘아모잘탄패밀리, 로수젯, 클로잘탄’, 임상적 유용성 뚜렷” hanmi.co.kr ↗ |
| 2023-05-04 | Hanmi Pharmaceutical Company Limited | 한미, 저용량 이뇨제 붙인 고혈압 복합제 허가...라인업 지속 확장 hanmi.co.kr ↗ |
| 2022-06-02 | Hanmi Pharmaceutical Company Limited | 한미, 고혈압 복합신약 라인업 확대...’클로잘탄’ 허가 획득 hanmi.co.kr ↗ |
| 2018-05-23 | Hanmi Pharmaceutical Company Limited | <보도자료> “임상적 효과 입증한 아모잘탄 패밀리, 용량 선택도 다양” hanmi.co.kr ↗ |
| 2017-11-07 | Hanmi Pharmaceutical Company Limited | <보도자료> 한미약품, 대한고혈압학회서 ‘아모잘탄 패밀리’ 심포지엄 hanmi.co.kr ↗ |
| 2017-10-19 | Hanmi Pharmaceutical Company Limited | <보도자료> 한미약품 ‘아모잘탄플러스’ 3상 결과, SCI급 국제학술지 등재 hanmi.co.kr ↗ |
| 2017-10-13 | Hanmi Pharmaceutical Company Limited | <보도자료> 한미약품, 대한심장학회서 ‘아모잘탄 패밀리’ 심포지엄 열어 hanmi.co.kr ↗ |
| 2017-06-30 | Hanmi Pharmaceutical Company Limited | <보도자료> 한미, 고혈압치료 3제 복합신약 ‘아모잘탄플러스’ 허가 hanmi.co.kr ↗ |
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 84 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | chlorthalidone | “The participant's blood pressure medication regimen will then be altered to initiate a thiazide-type (hydrochlorothiazide or chlorthalidone) or loop diuretic (furosemide,...” NCT04192110 ↗80“Single oral dose C52R1M(FDC, Valsartan/Amlodipine) 160/5 mg tablet and C52R2(Chlorthalidone) 25 mg tablet taken together” NCT05077462 ↗ “Fixed-dose combination tablet containing valsartan 160 mg, amlodipine 10 mg, and chlorthalidone 25 mg.” NCT07116863 ↗ “Hydrochlorothiazide, metolazone, chlorthalidone, chlorothiazide, bendroflumethiazide, indapamide” NCT04330300 ↗ “renin guided therapeutics-chlorothiazide, chlorthalidone, hydrochlorothiazide” NCT00684489 ↗ “Chlorthalidone plus amiloride 25 and 5 mg daily, taking in the morning” NCT01896661 ↗ “telmisartan/amlodipine/chlorthalidone 20/2.5/6.25 mg” PMID 41717679 ↗ Feb 2026 “telmisartan/amlodipine/chlorthalidone 40/5/12.5 mg” NCT02620163 ↗ “amlodipine, Losartan, Chlorthalidone FDC” NCT02916602 ↗ “C52R2(Chlorthalidone) 25 mg tablet” NCT05077475 ↗ “chlorthalidone (Thalitone)” NCT00000620 ↗ |
| Known as | chlorthalidone (Thalitone) | “chlorthalidone (Thalitone)” NCT00000620 ↗ |
| Known as | CTD | “We performed 12-hour urine collections in 7 patients taking 25 mg of chlorthalidone (CTD) and 10 patients taking 25 mg of hydrochlorothiazide (HCTZ).” PMID 40194294 ↗ Apr 20254“chlorthalidone (CTD) is a thiazide-like diuretic used for treating hypertension and decreases serum K.” NCT05222191 ↗ “Chlorthalidone (CTD) is a thiazide-like diuretic and an effective antihypertensive drug” PMID 32663820 ↗ Jul 2020 “Chlorthalidone (CTD) may be superior to hydrochlorothiazide (HCTZ)” PMID 36067089 ↗ Sep 2022 “Chlorthalidone (CTD)” NCT02185417 ↗ |
| Known as | HIGROTON 50 | “Chlorthalidone (HIGROTON® 50)” NCT05090449 ↗ |
| Known as | Hygroton (brand name for chlorthalidone) | “Hygroton (brand name for chlorthalidone)” NCT05411991 ↗ |
| Modality | Other / unclassified | “Chlorthalidone is a thiazide-like diuretic” NCT00591773 ↗ |
| Route | Oral | “chlorthalidone 25 mg, tablets, orally, once daily” NCT00591773 ↗ |