Drugs / Nifedipine
Nifedipine
also known as
Adalat · BAY A1040 · Adalat LA · Adalat OROS · Xin Ran · Adalat (nifedipine) · ADALAT CC · Adalat CR · +16 more
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
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| Label expansions (2) | US (FDA) | PROCARDIA | — | 1984-11-20 – 1986-07-24 | fda.gov ↗ |
| Approved | US (FDA) | PROCARDIA | — | 1981-12-31 | fda.gov ↗ |
Trials 75 · started per year
today
US approved 1981
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT03027674 | Aug 2016 | Raynaud disease, dermatomyositis, systemic lupus erythematosus, systemic sclerosis | Pontificia Universidad Catolica de Chile | Completed | No outcome recorded |
| Phase 111 trials | ||||||
| Phase 1 | NCT05989581 | Apr 2024 → Dec 2026 expected | hypertension, pregnancy-induced | University of Alabama at Birmingham | Recruiting | No outcome recorded |
| Phase 1 | NCT03245307 | Aug 2017 → Apr 2018 | — | Jiangsu HengRui Medicine Co., Ltd. | Unknown | No outcome recorded |
| Phase 1 | NCT03100838 | Mar → Dec 2017 | — | Food and Drug Administration (FDA) | Completed | No outcome recorded |
| Phase 1 | NCT03136666 | Apr → Jun 2010 | — | Bayer | Completed | No outcome recorded |
| Phase 1 | NCT01068847 | Feb 2010 → Oct 2012 | drug dependence | University of Arkansas | Completed | No outcome recorded |
| Phase 1 | NCT00733239 | Aug 2008 → Oct 2010 | opiate dependence | University of Arkansas | Completed | No outcome recorded |
| Phase 1 | NCT00712738 | Jun 2008 → Sep 2010 | disorder of iron metabolism and transport, thalassemia | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Completed | No outcome recorded |
| Phase 1 | NCT00593463 | Sep 2006 → May 2010 | drug dependence | University of Arkansas | Completed | No outcome recorded |
| Phase 1 | NCT00865891 | Jul 2005 | — | Actavis Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00864617 | May 2005 | — | Actavis Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00223717 | Jan 2001 → Jan 2017 | hypertensive disorder | Vanderbilt University | Completed | No outcome recorded |
| Phase 1/25 trials | ||||||
| Phase 1/2 | NCT02023047 | Mar 2014 → Nov 2015 | — | RDD Pharma Ltd | Terminated | No outcome recorded |
| Phase 1/2 | NCT00972907 | Dec 2009 → Jan 2011 | ulcer of anus and rectum | RDD Pharma Ltd | Completed | No outcome recorded |
| Phase 1/2 | NCT00194974 | Jul 2004 → Mar 2005 | proteinuria, toxemia of pregnancy | Weill Medical College of Cornell University | Withdrawn | No outcome recorded Stop: Business |
| Phase 1/2 | NCT00000102 | — | congenital adrenal hyperplasia | National Center for Research Resources (NCRR) | Completed | No outcome recorded |
| Phase 1/2 | NCT00816205 | ? → Apr 2009 | — | RDD Pharma Ltd | Completed | No outcome recorded |
| Phase 27 trials · 1 met primary · 1 missed | ||||||
| Phase 2 | NCT03949478 | Feb 2021 → Jan 2025 | epilepsy | University of Calgary | Unknown | No outcome recorded |
| Phase 2 | NCT04846621 | Jun 2020 → Jun 2021 | — | Ain Shams University | Unknown | No outcome recorded |
| Phase 2 | NCT02072291 | Mar 2014 → Mar 2018 | low implantation of placenta | Hadassah Medical Organization | Unknown | No outcome recorded |
| Phase 2 | NCT01303783 | Apr 2011 → May 2012 | essential hypertension | Bayer | Completed | Met primary |
| Phase 2 | NCT00620724 | Jan 2008 → Jun 2012 | placenta praevia | University Hospital, Rouen | Completed | Missed primary |
| Phase 2 | NCT00768560 | Jan → May 2008 | essential hypertension | Bayer | Completed | No outcome recorded |
| Phase 2 | NCT01429545 | Apr 2007 → Sep 2010 | — | Tawam Hospital | Completed | No outcome recorded |
| Phase 2/32 trials | ||||||
| Phase 2/3 | NCT03325348 | Feb → Dec 2017 | severe pre-eclampsia | Services Institute of Medical Sciences, Pakistan | Unknown | No outcome recorded |
| Phase 2/3 | NCT02527109 | May 2016 → Jun 2018 | ulcer of anus and rectum | RDD Pharma Ltd | Completed | No outcome recorded |
| Phase 315 trials · 1 missed | ||||||
| Phase 3 | NCT07448506 | Jul 2024 → Apr 2025 | essential hypertension | Laboratorios Richmond S.A.C.I.F. | Completed | No outcome recorded |
| Phase 3 | NCT05687344 | Sep 2023 → Mar 2026 overdue | hypertension, pregnancy-induced | Medical College of Wisconsin | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04298034 | Jul 2020 → Jun 2025 overdue | preeclampsia | Medical College of Wisconsin | Active not recruiting | No outcome recorded |
| Phase 3 | NCT02725736 | Mar 2016 → Mar 2018 | — | Tel-Aviv Sourasky Medical Center | Unknown | No outcome recorded |
| Phase 3 | NCT01360034 | Dec 2015 → May 2016 | obstetric disorder | Saint Thomas Hospital, Panama | Unknown | No outcome recorded |
| Phase 3 | NCT02132533 | May 2014 → Oct 2018 | — | University of Texas Southwestern Medical Center | Completed | Missed primary |
| Phase 3 | NCT01788358 | Feb 2013 → May 2014 | essential hypertension | Bayer | Completed | No outcome recorded |
| Phase 3 | NCT01314859 | Jul 2011 → Jul 2012 | — | Hospital Clinico Universitario de Santiago | Withdrawn | No outcome recorded |
| Phase 3 | NCT01294215 | Feb → Nov 2011 | hypertensive disorder | Bayer | Completed | No outcome recorded |
| Phase 3 | NCT01355367 | Jan → Sep 2011 | essential hypertension | Bayer | Completed | No outcome recorded |
| Phase 3 | NCT00496184 | Apr 2006 → Oct 2007 | vulvitis, vulvodynia | Western Galilee Hospital-Nahariya | Completed | No outcome recorded |
| Phase 3 | NCT00137501 | May 2003 → Jan 2009 | — | American University of Beirut Medical Center | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT00004266 | Aug 1993 → Jul 1999 | diabetic kidney disease | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Completed | No outcome recorded |
| Phase 3 | NCT00000530 | Sep 1992 → Jun 1998 | Raynaud disease, heart disorder | National Heart, Lung, and Blood Institute (NHLBI) | Completed | No outcome recorded |
| Phase 3 | NCT00000478 | Nov 1990 → Jun 1997 | coronary artery disorder, myocardial ischemia | National Heart, Lung, and Blood Institute (NHLBI) | Completed | No outcome recorded |
| Phase 427 trials | ||||||
| Phase 4 | NCT07659665 | Aug → Dec 2026 expected | hemorrhoid | Sana'a University | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06915792 | Jun 2025 → Jul 2027 expected | hypertension, pregnancy-induced | University of California, Los Angeles | Recruiting | No outcome recorded |
| Phase 4 | NCT05711810 | Jan 2023 | Orthocoronavirinae infectious disease, myocarditis | Yang I. Pachankis | Completed | No outcome recorded |
| Phase 4 | NCT04349124 | Aug 2020 → Feb 2021 | hypertension, pregnancy-induced | Duke University | Terminated | No outcome recorded Stop: Enrollment |
| 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 | NCT03595982 | Sep 2018 → Feb 2020 | hypertension, pregnancy-induced | Icahn School of Medicine at Mount Sinai | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT03298191 | Oct 2017 → Apr 2018 | — | Assiut University | Unknown | No outcome recorded |
| Phase 4 | NCT03506724 | Sep 2017 → Apr 2019 | preeclampsia | Icahn School of Medicine at Mount Sinai | Completed | No outcome recorded |
| Phase 4 | NCT03710395 | Dec 2015 → Feb 2018 | — | Natalia Valadares de Moraes | Unknown | No outcome recorded |
| Phase 4 | NCT02641821 | Oct 2015 → Dec 2019 | hypertensive disorder | Peking University First Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT02499822 | Oct 2015 → Jul 2020 | essential hypertension | Istituto Auxologico Italiano | Completed | No outcome recorded |
| Phase 4 | NCT02299414 | Jun 2015 → Apr 2022 | hypertensive disorder | University of Alabama at Birmingham | Completed | No outcome recorded |
| Phase 4 | NCT02413515 | Mar 2015 → Aug 2016 | hypertensive disorder | Bayer | Completed | No outcome recorded |
| Phase 4 | NCT02357615 | Dec 2014 → Jun 2015 | essential hypertension | Shanghai Shyndec Pharmaceutical Co., Ltd. | Unknown | No outcome recorded |
| Phase 4 | NCT02068404 | Apr 2014 → Jan 2016 | — | Chantal Csajka | Unknown | No outcome recorded |
| Phase 4 | NCT02031861 | Feb → Jul 2014 | essential hypertension | Shanghai Shyndec Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 4 | NCT01830530 | May → Sep 2012 | hypertensive disorder | Istituto Auxologico Italiano | Completed | No outcome recorded |
| Phase 4 | NCT00993109 | Feb 2010 → May 2011 | essential hypertension | Bayer | Completed | Mixed |
| Phase 4 | NCT01021501 | Dec 2009 → Dec 2010 | hypertensive disorder | Guangzhou First People's Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT01010048 | Oct 2009 | urolithiasis | Chongqing Medical University | Unknown | No outcome recorded |
| Phase 4 | NCT01346657 | Jul 2009 | — | Taipei Medical University WanFang Hospital | Completed | No outcome recorded |
| Phase 4 | NCT00599898 | Jan 2008 → Dec 2011 | — | Raed Salim | Completed | No outcome recorded |
| Phase 4 | NCT00750113 | Oct 2007 → Jul 2009 | hypertensive disorder | Bayer | Completed | No outcome recorded |
| Phase 4 | NCT01518855 | Mar 2004 → Apr 2005 | essential hypertension | Bayer | Completed | No outcome recorded |
| Phase 4 | NCT00672113 | Dec 2003 → Aug 2004 | essential hypertension | Bayer | Completed | No outcome recorded |
| Phase 4 | NCT00244530 | Jun 2001 → Oct 2005 | chronic renal failure syndrome, coronary artery disorder | University of Oslo School of Pharmacy | Completed | No outcome recorded |
| Phase 4 | NCT00173667 | — | hypertensive disorder | National Taiwan University Hospital | Unknown | No outcome recorded |
| Phase not applicable7 trials · 1 met primary · 2 missed | ||||||
| — | NCT06220721 | Oct 2024 → Mar 2029 expected | hypertension, pregnancy-induced | Medical College of Wisconsin | Recruiting | No outcome recorded |
| — | NCT05686993 | Apr → Sep 2023 | primary aldosteronism, secondary hypertension | Queen Mary University of London | Completed | Missed primary |
| — | NCT04435210 | Aug 2018 → Feb 2019 | hypertensive disorder | Adebayo Joshua Adeniyi | Completed | Met primary |
| — | NCT02168309 | Jun 2014 → Jun 2015 | hypertension, pregnancy-induced | Cedars-Sinai Medical Center | Completed | Missed primary |
| — | NCT01351428 | Dec 2010 → Nov 2012 | preeclampsia | Samuel Lunenfeld Research Institute, Mount Sinai Hospital | Completed | No outcome recorded |
| — | NCT01157481 | Jul 2010 → Dec 2016 | diastolic heart failure | Demand Investigators | Unknown | No outcome recorded |
| — | NCT00525486 | Dec 2007 → ? | — | The Baruch Padeh Medical Center, Poriya | Terminated | No outcome recorded |
| Comparator or background therapy70 trials | ||||||
| Phase 0 | NCT06796660 Background | Sep 2025 → Dec 2027 expected | chronic kidney disease | Liu Zhanghong | Not yet recruiting | No outcome recorded |
| Phase 0 | NCT03245970 Comparator | Apr 2017 → Feb 2020 | preeclampsia | University of Tennessee Medical Center | Withdrawn | No outcome recorded |
| Phase 0 | NCT03105661 Comparator | Apr 2017 → Dec 2019 | morbid obesity, preeclampsia | University of Tennessee Graduate School of Medicine | Unknown | No outcome recorded |
| Phase 1 | NCT00884442 Comparator | Apr 2009 | — | SocraTec R&D GmbH | Completed | No outcome recorded |
| Phase 1 | NCT02071589 Comparator | Jan → Mar 2009 | — | Reig Jofre Group | Completed | No outcome recorded |
| Phase 1 | NCT00722215 Comparator | May 2006 → Nov 2007 | chronic kidney disease, proteinuria | University of Edinburgh | Completed | No outcome recorded |
| Phase 1/2 | NCT00486824 Comparator | Apr 2007 → Dec 2012 | obstetric disorder | Stanford University | Completed | No outcome recorded |
| Phase 2 | NCT05955040 Comparator | Jul 2023 → May 2024 | hypertension, pregnancy-induced | Marshall University | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT05670028 Background | Jun 2023 → Jan 2026 | ischemic stroke, vascular insufficiency disorder | Beijing Tiantan Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT01985594 Comparator | Nov 2013 → Jul 2014 | — | nor zila hassan malek | Unknown | No outcome recorded |
| Phase 2 | NCT00605072 Background | Jan 2008 → Dec 2011 | cognitive impairment with or without cerebellar ataxia, hypertensive disorder | University of Southern California | Completed | Mixed |
| Phase 2 | NCT00817037 Comparator | Jul 2007 → Jul 2009 | chronic kidney disease, hypertensive disorder, proteinuria | University of Edinburgh | Completed | No outcome recorded |
| Phase 2 | NCT00810732 Comparator | May 2007 → Mar 2009 | chronic kidney disease | Pfizer | Completed | Met primary |
| Phase 2/3 | NCT04887818 Comparator | Jun → Dec 2021 | ulcer of anus and rectum | University of Calgary | Unknown | No outcome recorded |
| Phase 2/3 | NCT04404686 Comparator | Oct 2020 → Apr 2024 | obstetric disorder | Hadassah Medical Organization | Unknown | No outcome recorded |
| Phase 2/3 | NCT02591004 Comparator | Dec 2015 → Oct 2017 | cerebral palsy | Kasr El Aini Hospital | Completed | No outcome recorded |
| Phase 2/3 | NCT02563405 Comparator | Sep 2015 → Oct 2017 | hypertensive disorder | First Affiliated Hospital of Harbin Medical University | Unknown | No outcome recorded |
| Phase 2/3 | NCT02513927 Comparator | Aug 2015 → Oct 2017 | essential hypertension | First Affiliated Hospital of Harbin Medical University | Unknown | No outcome recorded |
| Phase 3 | NCT05551104 Comparator | May 2023 → Dec 2027 expected | hypertension, pregnancy-induced, puerperal disorder | Loma Linda University | Recruiting | No outcome recorded |
| Phase 3 | NCT03976063 Comparator | Oct 2019 → Nov 2026 expected | preterm premature rupture of the membranes | Assistance Publique - Hôpitaux de Paris | Active not recruiting | No outcome recorded |
| Phase 3 | NCT03542552 Comparator | Jun 2018 → Mar 2021 | placenta praevia | Assiut University | Completed | No outcome recorded |
| Phase 3 | NCT02426177 Comparator | May 2015 → May 2016 | hypertensive disorder | Dow University of Health Sciences | Unknown | No outcome recorded |
| Phase 3 | NCT01796522 Comparator | Mar → May 2013 | — | La Fe Health Research Institute | Withdrawn | No outcome recorded |
| Phase 3 | NCT01287260 Comparator | Jan → Aug 2011 | essential hypertension | Bayer | Completed | No outcome recorded |
| Phase 3 | NCT00608140 Background | Mar 2008 → Mar 2010 | heart failure, mitral valve insufficiency | Duke University | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT00713739 Comparator | Jan 2008 → Dec 2010 | urolithiasis | United States Naval Medical Center, San Diego | Unknown | No outcome recorded |
| Phase 3 | NCT00519870 Comparator | Jan → Jul 2005 | pulmonary hypertension | Baskent University | Completed | No outcome recorded |
| Phase 4 | NCT07649668 Comparator | Nov 2025 → May 2026 | — | Dr Mudassar Saeed Pansota | Completed | No outcome recorded |
| Phase 4 | NCT07865949 Comparator | Aug 2025 → Jan 2026 | — | Medicare Hospital (Pvt) Limited | Completed | No outcome recorded |
| Phase 4 | NCT07023003 Comparator | Jul 2025 → Jul 2028 expected | hypertension, pregnancy-induced | Nebraska Methodist Health System | Recruiting | No outcome recorded |
| Phase 4 | NCT07523295 Background | May → Nov 2025 | — | Medicare Hospital (Pvt) Limited | Completed | No outcome recorded |
| Phase 4 | NCT06859554 Comparator | Mar → May 2025 | anal spasm | Hafiz Muhammad Hamza | Completed | No outcome recorded |
| Phase 4 | NCT05139238 Comparator | Jul 2022 → Aug 2025 | preeclampsia | Columbia University | Terminated | No outcome recorded |
| Phase 4 | NCT05309460 Comparator | Jun 2022 → May 2024 overdue | preeclampsia | Nebraska Methodist Health System | Recruiting | No outcome recorded |
| Phase 4 | NCT05049616 Comparator | Oct 2021 → Jun 2022 | preeclampsia | The University of Texas Health Science Center, Houston | Completed | No outcome recorded |
| Phase 4 | NCT04790279 Comparator | Apr 2021 → Dec 2022 | hypertension, pregnancy-induced | Prisma Health-Upstate | Completed | No outcome recorded |
| Phase 4 | NCT04392375 Comparator | Jun 2020 → Apr 2022 | severe pre-eclampsia | Ohio State University | Completed | No outcome recorded |
| Phase 4 | NCT04236258 Comparator | Jan 2020 → Jun 2021 | puerperal disorder, severe pre-eclampsia | Brigham and Women's Hospital | Completed | No outcome recorded |
| Phase 4 | NCT03449277 Comparator | Jan 2018 → Feb 2019 | preeclampsia | Hossam Ahmed Abd Ellah | Unknown | No outcome recorded |
| Phase 4 | NCT03005496 Comparator | Jan → Apr 2017 | — | Indonesia University | Completed | No outcome recorded |
| Phase 4 | NCT02940548 Comparator | Dec 2016 → Dec 2020 | essential hypertension | Jing Liu | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT02438371 Comparator | May 2015 → Oct 2019 | — | The University of Texas Health Science Center, Houston | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT01912677 Comparator | Apr 2015 → Sep 2017 | preeclampsia | Gynuity Health Projects | Completed | Met primary |
| Phase 4 | NCT02531490 Comparator | Jan 2015 → Feb 2023 | preeclampsia | Maastricht University Medical Center | Unknown | No outcome recorded |
| Phase 4 | NCT03040752 Comparator | Jan 2015 → Jan 2017 | — | Cairo University | Completed | No outcome recorded |
| Phase 4 | NCT02583633 Comparator | Oct 2013 → Oct 2014 | — | Shiraz University of Medical Sciences | Completed | No outcome recorded |
| Phase 4 | NCT01167153 Comparator | May 2010 → Apr 2011 | hypertensive disorder | Novartis | Completed | No outcome recorded |
| Phase 4 | NCT01071122 Comparator | Jan 2010 → Feb 2012 | essential hypertension | Bayer | Completed | No outcome recorded |
| Phase 4 | NCT01030081 Comparator | Oct 2009 → Mar 2013 | hypertensive disorder | Shanghai Jiao Tong University School of Medicine | Completed | No outcome recorded |
| Phase 4 | NCT01435161 Comparator | May 2007 → Aug 2011 | atrial fibrillation | The Second Affiliated Hospital of Chongqing Medical University | Completed | No outcome recorded |
| — | NCT07363343 Comparator | Mar 2026 → Dec 2029 expected | preeclampsia | The Cleveland Clinic | Recruiting | No outcome recorded |
| — | NCT06265415 Comparator | Mar 2024 → Mar 2025 | severe pre-eclampsia | Sohag University | Unknown | No outcome recorded |
| — | NCT05343806 Comparator | Apr 2023 → Jul 2025 | — | Assiut University | Completed | No outcome recorded |
| — | NCT05520021 Comparator | Sep → Dec 2022 | — | Konya Meram State Hospital | Unknown | No outcome recorded |
| — | NCT05345132 Comparator | Apr 2022 → Nov 2025 | — | Assiut University | Unknown | No outcome recorded |
| — | NCT03261375 Background | Jan 2021 → Dec 2022 | essential hypertension | Shanghai Golden Leaf MedTec Co. Ltd | Completed | No outcome recorded |
| — | NCT04288219 Background | Mar 2020 → Jun 2021 | high altitude pulmonary edema | Massachusetts General Hospital | Unknown | No outcome recorded |
| — | NCT04186598 Background | Jan 2020 → Sep 2023 | high altitude pulmonary edema | CommonSpirit Health | Completed | No outcome recorded |
| — | NCT02885558 Comparator | Nov 2017 → May 2021 | — | University of Southern Denmark | Completed | No outcome recorded |
| — | NCT03129945 Comparator | Jan 2017 → Apr 2019 | obstetric disorder | University of California, Irvine | Completed | No outcome recorded |
| — | NCT02933593 Comparator | Aug 2016 → Jan 2017 | hypertensive disorder | St. Louis University | Withdrawn | No outcome recorded |
| — | NCT01586286 Comparator | Jul 2012 → May 2014 | levator syndrome | Vanderbilt University | Withdrawn | No outcome recorded Stop: Enrollment |
| — | NCT00691314 Comparator | Jun 2008 → Sep 2010 | atherosclerosis, transient ischemic attack | Peking Union Medical College Hospital | Completed | No outcome recorded |
| — | NCT00664846 Background | Apr 2008 → Dec 2010 | ischemic stroke | Peking Union Medical College Hospital | Completed | No outcome recorded |
| — | NCT00306462 Comparator | Mar 2006 → Oct 2009 | — | University of Cincinnati | Terminated | No outcome recorded Stop: Enrollment |
| — | NCT00280462 Comparator | Aug 2005 → Apr 2006 | — | Medical University of Vienna | Completed | No outcome recorded |
| — | NCT00811057 Comparator | Jun 2004 → Jun 2009 | — | University of Mississippi Medical Center | Completed | No outcome recorded |
| — | NCT00684489 Comparator | Sep 2003 → Mar 2005 | essential hypertension | Medical University of South Carolina | Completed | No outcome recorded |
| — | NCT00185952 Comparator | Nov 2001 → Jan 2007 | obstetric disorder, venous thromboembolism | Stanford University | Completed | No outcome recorded |
| — | NCT00185900 Comparator | Apr 1999 → Jul 2005 | obstetric disorder | Stanford University | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 6
| Date | Issuer | Release |
|---|---|---|
| 2022-11-01 | Alembic Pharmaceuticals Ltd. | Regulatory 21st November, 2022, Vadodara, India alembicpharmaceuticals.com ↗
Alembic Pharmaceuticals Limited (Alembic) today announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Nifedipine Extended-Release Tablets USP, 30 mg, 60 mg and 90 mg. |
| 2002-08-19 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Announces Final Approval for Nifedipine ER 90mg Tablets tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration (FDA) has given final approval to manufacture and market Nifedipine Extended Release 90mg, tablets. |
| 2001-02-07 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Announces Final Approvals of Nifedipine XL 30mg and Etodolac ER 400mg tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration (FDA) has awarded final approval for Nifedipine XL 30 mg tablets and Etodolac 400 mg tablets and Teva USA will launch both products immediately. |
| 2000-12-05 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Received Final Approval for Nifedipine CC 60mg and will Launch Immediately tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today the receipt from the U.S. FDA of final approval to manufacture and market Nifedipine CC 60 mg Tablets. |
| 2000-09-28 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Announces Final Approval of Nifedipine XL 60 mg and will Launched Imminently tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the FDA awarded final U.S. approval for Nifedipine XL 60mg. |
| 2000-07-25 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Pharmaceutical Industries Ltd Announces tentative FDA Approval of Nifedipine XL, 30 mg and 60 mg tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the FDA awarded tentative U.S. approval for Nifedipine XL, 30mg and 60mg. |
All press releases naming this drug 6 releases
| Date | Issuer | Release |
|---|---|---|
| 2022-11-01 | Alembic Pharmaceuticals Ltd. | 21st November, 2022, Vadodara, India alembicpharmaceuticals.com ↗ |
| 2002-08-19 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Announces Final Approval for Nifedipine ER 90mg Tablets tevapharm.com ↗ |
| 2001-02-07 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Announces Final Approvals of Nifedipine XL 30mg and Etodolac ER 400mg tevapharm.com ↗ |
| 2000-12-05 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Received Final Approval for Nifedipine CC 60mg and will Launch Immediately tevapharm.com ↗ |
| 2000-09-28 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Announces Final Approval of Nifedipine XL 60 mg and will Launched Imminently tevapharm.com ↗ |
| 2000-07-25 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Pharmaceutical Industries Ltd Announces tentative FDA Approval of Nifedipine XL, 30 mg and 60 mg tevapharm.com ↗ |
Evidence & citations 28 cited values
Every value below carries the sentence it was read from. 145 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | nifedipine | “AIMS: To determine in hypertensive patients at high cardiovascular risk whether combining Nifedipine GITS at low dose and telmisartan reduced ambulatory and clinic blood...” PMID 21252701 ↗ Mar 2011145“Healthy subjects were randomly allocated to receive a single dose of either one 5 milgram (mg) nifedipine capsule or one 5 milgram (mg) nifedipine capsule plus one 600 milgram...” NCT01346657 ↗ “To manipulate the blood pressure within a certain range with hypotensive drugs (e.g. nifedipine, benidipine, captopril, benazepril, irbesartan, labetalol, urapidil) and/or...” NCT05670028 ↗ “Blood Pressure Control: Antihypertensive drugs such as amlodipine tablets (5 mg qd), nifedipine tablets (30 mg qd), or losartan tablets (100 mg qd) can be selected.” NCT06796660 ↗ “Nicorandil (potassium channel activator) is claimed to be as effective as Nifedipine (calcium channel blocker) for tocolysis in preterm labour” NCT04846621 ↗ “Nifedipine is a peripheral arterial vasodilator and an ideal first line antihypertensive agent due to its low maternal side-effect profile.” NCT03595982 ↗ “A comparison study between Ritodrine, magnesium sulfate and Nifedipine in terms of effect and morbidity will be conducted.” NCT03298191 ↗ “combination of vasodilator therapy and diuretics, nitrates and nifedipine, and beta-adrenergic blocker therapy” NCT00608140 ↗ “Pregnancy Outcomes of Nifedipine Compared With Labetalol for Oral Treatment of Mild Chronic Hypertension.” PMID 38949541 ↗ May 2024 “received oral nifedipine 10 mg every 20 minutes for three doses, followed by 10 mg orally every 6 hours” NCT03542552 ↗ “Amlodipine, diltiazem, felodipine, nicardipine, nifedipine, nimodipine, nitrendipine, verapamil” NCT04330300 ↗ |
| Known as | Adalat | “Nifedipine (Adalat®, Bayer, Leverkusen, Germany) dose: 15µg/kg bolus infusion over 5 minutes; 0.2 µg/(kg.min) maintenance dose infusion period 25 minutes” NCT00280462 ↗11“Subjects will take a nifedipine controlled-release tablet (30 mg, Adalat) orally in every morning for a 12-week treatment period.” NCT02031861 ↗ “Study drugs: amlodipine (Norvasc®) and nifedipine GITS (Adalat®)” NCT01030081 ↗ “Drug: Nifedipine GITS (Adalat, BAYA1040), 20 mg” NCT01303783 ↗ “nifedipine controlled-release tablets (Adalat)” NCT02357615 ↗ “Drug: Adalat (Nifedipine, BAYA1040)” NCT00993109 ↗ “Drug: Nifedipine (Adalat, BAYA1040)” NCT01518855 ↗ “Nifedipine (Adalat, BAYA1040)” NCT01287260 ↗ “Adalat (Nifedipine, BAYA1040)” NCT00672113 ↗ “Nifedipine (Adalat, BAYA1040)” NCT01294215 ↗ “Nifedipine (Adalat, BAYA1040)” NCT01355367 ↗ |
| Known as | Adalat (nifedipine) | “Adalat (nifedipine)” NCT02885558 ↗ |
| Known as | ADALAT CC | “ADALAT® CC Extended Release Tablets 60 mg” NCT00864617 ↗ |
| Known as | Adalat CR | “Nifedipine (Adalat CR, BAY A1040) High Dose PK/PD Study” NCT00768560 ↗ |
| Known as | Adalat Crono | “Nifedipine (Bayer Healthcare AG manufactured as Adalat® XL®, Adalat® LA, Adalat® Crono, Adalat® OROS)” NCT00884442 ↗ |
| Known as | Adalat GITS | “Nifedipine (Adalat GITS, BAY1040)” NCT02413515 ↗ |
| Known as | Adalat LA | “Nifedipine (Bayer Healthcare AG manufactured as Adalat® XL®, Adalat® LA, Adalat® Crono, Adalat® OROS)” NCT00884442 ↗1“Nifedipine gastrointestinal therapeutic system (GITS) (Adalat LA, BAY a1040) + Candesartan cilexetil” NCT03136666 ↗ |
| Known as | Adalat OROS | “Group A: nifedipine 30-60mg once daily (Nifecardia, CCPC) Group B: nifedipine 30-60 mg once daily (Adalat OROS, Bayer)” NCT00173667 ↗1“Nifedipine (Bayer Healthcare AG manufactured as Adalat® XL®, Adalat® LA, Adalat® Crono, Adalat® OROS)” NCT00884442 ↗ |
| Known as | Adalat XL | “Nifedipine (Bayer Healthcare AG manufactured as Adalat® XL®, Adalat® LA, Adalat® Crono, Adalat® OROS)” NCT00884442 ↗ |
| Known as | Adalat XL 30 | “Nifedipine GITS (Adalat® XL 30” NCT01030081 ↗ |
| Known as | BAY A1040 | “Nifedipine gastrointestinal therapeutic system (GITS) (Adalat LA, BAY a1040) + Candesartan cilexetil” NCT03136666 ↗9“Nifedipine (Adalat CR, BAY A1040) High Dose PK/PD Study” NCT00768560 ↗ “Drug: Nifedipine GITS (Adalat, BAYA1040), 20 mg” NCT01303783 ↗ “Drug: Adalat (Nifedipine, BAYA1040)” NCT00993109 ↗ “Drug: Nifedipine (Adalat, BAYA1040)” NCT01518855 ↗ “Adalat (Nifedipine, BAYA1040)” NCT00672113 ↗ “Nifedipine (Adalat, BAYA1040)” NCT01287260 ↗ “Nifedipine (Adalat, BAYA1040)” NCT01071122 ↗ “Nifedipine (Adalat, BAYA1040)” NCT01355367 ↗ “Nifedipine (Adalat, BAYA1040)” NCT01294215 ↗ |
| Known as | BAY1040 | “Nifedipine (Adalat GITS, BAY1040)” NCT02413515 ↗ |
| Known as | Coated Nifedipine Suppositories | “Drug: Coated Nifedipine Suppositories” NCT00816205 ↗ |
| Known as | Gen-nifedipine extended release | “Nifedipine (Gen-nifedipine extended release, previously referred to as Gen-Nifedipine XL)” NCT00884442 ↗ |
| Known as | Gen-Nifedipine XL | “Nifedipine (Gen-nifedipine extended release, previously referred to as Gen-Nifedipine XL)” NCT00884442 ↗ |
| Known as | Nifecardia | “Group A: nifedipine 30-60mg once daily (Nifecardia, CCPC) Group B: nifedipine 30-60 mg once daily (Adalat OROS, Bayer)” NCT00173667 ↗ |
| Known as | nifedipine (Adalat Crono, Bayer AG, Leverkusen, Germany) | “nifedipine (Adalat Crono, Bayer AG, Leverkusen, Germany)” NCT00519870 ↗ |
| Known as | Nifedipine 60 mg, GITS | “Nifedipine 60 mg, GITS” NCT00884442 ↗ |
| Known as | nifedipine extended release | “Subjects randomized to the treatment group will be provided the study drug (nifedipine extended release) at an initial dose of 30mg daily in 1-month supply.” NCT04349124 ↗ |
| Known as | Nifedipine Extended-Release Tablets | “Drug: Nifedipine Extended-Release Tablets” NCT04349124 ↗ |
| Known as | Nifedipine GITS | “Nifedipine GITS 30 mg slow release in tablets.” NCT02499822 ↗ |
| Known as | Nifedipine: Adalat, Procardia | “Nifedipine: Adalat, Procardia” NCT01068847 ↗ |
| Known as | Procardia XL | “extended release nifedipine (Procardia XL), a blood pressure medication” NCT00000102 ↗ |
| Known as | Xin Ran | “Subjects will take a nifedipine controlled-release tablet (30 mg, Xin Ran) orally in every morning for a 12-week treatment period.” NCT02031861 ↗1“nifedipine controlled-release tablet (30 mg, Xin Ran)” NCT02357615 ↗ |
| Action | Inhibit | “calcium channel antagonist” NCT00000102 ↗ |
| Modality | Other / unclassified | “nifedipine (calcium channel blocker)” NCT01429545 ↗ |
| Route | Other | “10 mg. sublingually every 20 minutes for three doses” NCT00185900 ↗ |