Isosorbide Dinitrate
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | ISORDIL | — | 1959-11-09 | fda.gov ↗ |
Trials 15 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT02522208 | Sep 2015 → Apr 2016 | heart failure | Arbor Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01587313 | Apr → May 2012 | — | Arbor Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT00262470 | Apr 1997 → Dec 2029 expected | cardiac rhythm disease | Satish R. Raj | Active not recruiting | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT05671250 | Jul 2021 → Nov 2022 | ulcer of lower limbs | Mansoura University | Completed | No outcome recorded |
| Phase 2 | NCT04297241 | Dec 2019 → Jun 2020 | Fontan-associated liver disease | Children's Hospital Medical Center, Cincinnati | Completed | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT02343393 | Jan → Dec 2015 | cardio-renal syndrome | National University Hospital, Singapore | Unknown | 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 43 trials | ||||||
| Phase 4 | NCT02488642 | May 2008 → Sep 2013 | uterine disorder | National Institute of Perinatology | Completed | No outcome recorded |
| Phase 4 | NCT00337116 | Jan → Dec 2007 | intermediate coronary syndrome, myocardial infarction | Soroka University Medical Center | Withdrawn | No outcome recorded |
| Phase 4 | NCT00047775 | May 2001 → Aug 2004 | congestive heart failure | Nitromed | Completed | No outcome recorded |
| Phase not applicable5 trials | ||||||
| — | NCT04425993 | Jul 2020 → May 2022 | acute pancreatitis | Air Force Military Medical University, China | Unknown | No outcome recorded |
| — | NCT02718521 | Mar 2016 → Mar 2017 | cardio-renal syndrome | Chinese PLA General Hospital | Unknown | No outcome recorded |
| — | NCT02135315 | Mar 2014 → Dec 2020 | acute coronary syndrome | University of Monastir | Completed | No outcome recorded |
| — | NCT00685945 | Dec 2007 → Jan 2009 | obesity disorder | Vanderbilt University | Completed | No outcome recorded |
| — | NCT01030367 | Jan 2007 → Nov 2008 | coronary artery disorder | Julius-Maximilians University | Unknown | No outcome recorded |
Also used as a comparator or background therapy in 18 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT01478022 Comparator | Oct 2011 → Mar 2016 | Duchenne muscular dystrophy | Parent Project, Italy | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT01242306 Comparator | Mar → Nov 2009 | — | Azienda Ospedaliera San Camillo Forlanini | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT01516346 Comparator | Jan 2012 → Feb 2016 | congestive heart failure | Corporal Michael J. Crescenz VA Medical Center | Completed | No outcome recorded |
| Phase 33 trials | ||||||
| Phase 3 | NCT02789033 Comparator | Jun → Aug 2015 | ulcer of lower limbs | University of Guadalajara | Completed | No outcome recorded |
| Phase 3 | NCT01822808 Comparator | Jan 2013 → Jan 2016 | left ventricular failure | University of Cape Town | Unknown | No outcome recorded |
| Phase 3 | NCT00803634 Comparator | Dec 2008 → Feb 2012 | heart failure, hypertensive disorder | The Medicines Company | Completed | No outcome recorded |
| Phase 49 trials | ||||||
| Phase 4 | NCT05276219 Comparator | Sep 2023 → May 2027 expected | congestive heart failure, pulmonary edema | Rigshospitalet, Denmark | Recruiting | No outcome recorded |
| Phase 4 | NCT06400784 Comparator | Mar 2022 → Feb 2024 | — | University of Abuja | Completed | No outcome recorded |
| Phase 4 | NCT06218199 Comparator | Jul 2021 → Dec 2025 overdue | congestive heart failure | Heart Center Research, LLC | Recruiting | No outcome recorded |
| Phase 4 | NCT04206865 Comparator | Nov 2019 → Sep 2020 | cardiogenic shock | The Cleveland Clinic | Withdrawn | No outcome recorded |
| Phase 4 | NCT03514108 Comparator | Mar 2018 → Dec 2025 | diabetes mellitus, heart failure | Henrik Wiggers | Completed | No outcome recorded |
| Phase 4 | NCT03011775 Background | Nov 2012 → Jun 2014 | coronary atherosclerosis, metabolic syndrome X | Ukrainian Medical Stomatological Academy | Completed | No outcome recorded |
| Phase 4 | NCT01513070 Comparator | Apr → Jul 2012 | coronary stenosis | Guang'anmen Hospital of China Academy of Chinese Medical Sciences | Completed | No outcome recorded |
| Phase 4 | NCT00439075 Comparator | Oct 2006 → Apr 2008 | pulmonary edema | University Hospital, Toulouse | Completed | No outcome recorded |
| Phase 4 | NCT00827736 Comparator | Jun 2002 → Mar 2006 | ulcer of anus and rectum | Onze Lieve Vrouwe Gasthuis | Completed | No outcome recorded |
| Phase not applicable3 trials | ||||||
| — | NCT02649998 Comparator | Jan 2017 → Dec 2021 | heart failure | Chinese University of Hong Kong | Withdrawn | No outcome recorded |
| — | NCT02368795 Comparator | Feb 2015 → Jan 2017 | pancreatitis | Tehran University of Medical Sciences | Unknown | No outcome recorded |
| — | NCT00810381 Comparator | Jan → Jun 1999 | glaucoma | Medical University of Vienna | Completed | No outcome recorded |
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 36 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Isosorbidedinitrate | “Patients were randomized to receive either usual care, including conventional optimal treatment with furosemide, oxygen, and high-dose boluses of isosorbide dinitrate plus...” PMID 20825901 ↗ May 201031“Fixed-dose combination of isosorbide dinitrate and hydralazine (FDC-I/H) reduced mortality by 43% and death or first hospitalization for heart failure (HF) by 37% in the...” PMID 24970468 ↗ Jun 2014 “Intravenous boluses of isosorbide dinitrate in a hospital setting provides immediate, accurate (bioavailability ) and is an easily controlled modality for providing nitrates.” NCT00337116 ↗ “12 subjects will receive 5mg isosorbide dinitrate (an exogenous NO donor; Major Pharmaceuticals Inc, Livonia MI).” NCT00685945 ↗ “BiDil XR isosorbide dinitrate 40 mg and hydralazine hydrochloride 75 mg 2 capsules 9 hours apart for one day” NCT02522208 ↗ “2mg of isosorbide dinitrate or bolus 250microg of nitroglycerine will be infused by intracoronary bolus” NCT01242306 ↗ “Alternate vasodilators will include ARBs, hydralazine and isosorbide dinitrate, and ACEi” NCT04206865 ↗ “Hydralazine and Isosorbidedinitrate combination (oral agents)” NCT02343393 ↗ “Erythropoietin/Isosorbide dinitrate loaded cryogel scaffold” NCT05671250 ↗ “isosorbide dinitrate” NCT00803634 ↗ |
| Known as | ISDN | “We randomized 44 patients with heart failure with preserved ejection fraction in a double-blinded fashion to isosorbide dinitrate (ISDN; n=13), ISDN+hydralazine (ISDN+hydral;...” PMID 28219917 ↗ Feb 20177“This pilot study evaluated the safety and effect of isosorbide dinitrate (ISDN), a venodilator, on exercise capacity, peripheral venous pressure (PVP), and liver stiffness in...” PMID 37084132 ↗ Apr 2023 “Isosorbide dinitrate (ISDN), is an organic nitrate, is a vasodilator with effects on both arteries and veins.” NCT02789033 ↗ “Tablet BiDil (Hydralazine 37.5 mg/ Isosorbide Dinitrate (ISDN) 20 mg) 2 tablets x 3 daily” NCT03514108 ↗ “after isosorbide dinitrate (ISDN; 5 mg) or sildenafil (50 mg).” PMID 19841473 ↗ Oct 2009 “Isosorbide dinitrate (ISDN) increases NO bioavailability.” NCT02343393 ↗ |
| Known as | Isoket 0,1 % | “Isosorbide-Dinitrate: (Isoket 0,1 %, Gebro Broschek, Fieberbrunn, Austria):” NCT00810381 ↗ |
| Modality | Small molecule | “two different organic nitrates (PETN, ISDN)” NCT01030367 ↗ |
| Route | Oral | “Isosorbide dinitrate 5-20 mg PO x 1 dose” NCT00262470 ↗ |