Isosorbide Mononitrate
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | ISMO | — | 1991-12-30 | fda.gov ↗ |
Trials 28
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 16 trials · 1 missed | ||||||
| Phase 1 | NCT04729088 | Dec 2020 | — | Biolab Sanus Farmaceutica | Withdrawn | No outcome recorded |
| Phase 1 | NCT03255512 | Aug 2017 → Feb 2018 | coronary artery disorder | Bayer | Completed | No outcome recorded |
| Phase 1 | NCT02667535 | Jul → Oct 2017 | — | Biolab Sanus Farmaceutica | Withdrawn | No outcome recorded |
| Phase 1 | NCT02101710 | Jun → Jul 2011 | — | UCB Pharma | Completed | No outcome recorded |
| Phase 1 | NCT01130168 | May → Nov 2010 | hypertensive disorder | Merck Sharp & Dohme LLC | Completed | Mixed |
| Phase 1 | NCT00871871 | Mar 2009 → Feb 2010 | hypertensive disorder | Merck Sharp & Dohme LLC | Completed | Missed primary |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT07456852 | Apr 2026 → Apr 2028 expected | digestive system cancer | Mayo Clinic | Recruiting | No outcome recorded |
| Phase 1/2 | NCT03523754 | Jan → Oct 2018 | — | Dina Yahia Mansour | Unknown | No outcome recorded |
| Phase 23 trials | ||||||
| Phase 2 | NCT04051957 | Sep 2019 → Feb 2021 | acute kidney injury, hypertensive disorder, proteinuria | The University of Texas Health Science Center, Houston | Terminated | No outcome recorded |
| Phase 2 | NCT02791906 | May 2016 → Mar 2019 | chronic kidney disease | University of Pennsylvania | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT02481323 | Mar 2016 → Aug 2017 | cognitive disorder, stroke disorder | University of Edinburgh | Completed | No outcome recorded |
| Phase 37 trials · 1 met primary · 1 missed | ||||||
| Phase 3 | NCT07252544 | Dec 2025 → Aug 2027 expected | ischemic stroke | Beijing Tiantan Hospital | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT04312048 | Apr → Oct 2020 | — | Cairo University | Completed | No outcome recorded |
| Phase 3 | NCT04311658 | Mar → Jun 2020 | — | Cairo University | Unknown | No outcome recorded |
| Phase 3 | NCT03665779 | Aug 2018 → Apr 2019 | preterm premature rupture of the membranes | ahmed nagy shaker ramadan | Completed | Met primary |
| Phase 3 | NCT02152579 | Jul → Sep 2014 | — | Laboratórios Baldacci S.A | Unknown | No outcome recorded |
| Phase 3 | NCT01506388 | Feb 2012 → Dec 2013 | — | Cairo University | Completed | No outcome recorded |
| Phase 3 | NCT00930618 | Jun 2009 → Dec 2013 | — | Assistance Publique - Hôpitaux de Paris | Completed | Missed primary |
| Phase 46 trials · 1 missed | ||||||
| Phase 4 | NCT06730945 | Jun 2025 → Dec 2028 | — | Ruijin Hospital | Withdrawn | No outcome recorded |
| Phase 4 | NCT03544606 | Dec 2023 → Jun 2024 | — | ahmed nagy shaker ramadan | Completed | No outcome recorded |
| Phase 4 | NCT04310995 | Jun 2020 → Feb 2023 | coronary artery disorder | Ruijin Hospital | Completed | No outcome recorded |
| Phase 4 | NCT03171480 | Oct 2017 → Jul 2020 | preeclampsia | Ohio State University | Completed | Missed primary |
| Phase 4 | NCT00143195 | Apr 2001 → Jan 2005 | myocardial ischemia | Viatris Inc. | Completed | No outcome recorded |
| Phase 4 | NCT00450164 | Nov 2000 → Jun 2004 | cirrhosis of liver, portal hypertension | Sant Pau Research Institute | Completed | No outcome recorded |
| Phase not applicable4 trials | ||||||
| — | NCT07121634 | Jan 2024 → Aug 2025 overdue | cervix disorder | Raid M. Al-Ani | Active not recruiting | No outcome recorded |
| — | NCT04217668 | Dec 2019 → Mar 2020 | headache disorder | Danish Headache Center | Completed | No outcome recorded |
| — | NCT04218760 | Oct 2019 → Mar 2020 | headache disorder | Danish Headache Center | Completed | No outcome recorded |
| — | NCT03587077 | Sep 2018 → Apr 2019 | — | Assiut University | Unknown | No outcome recorded |
| Comparator or background therapy20 trials | ||||||
| Phase 0 | NCT05341856 Comparator | May → Aug 2022 | habitual spontaneous abortion | Al-Azhar University | Unknown | No outcome recorded |
| Phase 0 | NCT04482881 Comparator | Jul → Sep 2020 | — | Aljazeera Hospital | Unknown | No outcome recorded |
| Phase 1 | NCT04981457 Comparator | Mar → Sep 2021 | pregnancy disorder with abortive outcome | Cairo University | Unknown | No outcome recorded |
| Phase 1 | NCT00943852 Comparator | Aug → Dec 2006 | hypertensive disorder | Organon and Co | Completed | No outcome recorded |
| Phase 2 | NCT03854383 Comparator | Mar → May 2019 | — | Abdelrahman Ali Fadel Youssef Mohamed | Unknown | No outcome recorded |
| Phase 2 | NCT02738177 Comparator | Nov 2015 → Jun 2016 | cervix disorder | Cairo University | Unknown | No outcome recorded |
| Phase 2 | NCT02573051 Comparator | Jun → Oct 2015 | pregnancy disorder with abortive outcome | Assiut University | Withdrawn | No outcome recorded |
| Phase 2 | NCT02053493 Comparator | Apr 2014 → Feb 2015 | heart failure | Adrian Hernandez | Completed | No outcome recorded |
| Phase 2 | NCT01961453 Comparator | Aug 2013 → Jan 2016 | hypertensive disorder | Corporal Michael J. Crescenz VA Medical Center | Withdrawn | No outcome recorded Stop: Business |
| Phase 2/3 | NCT03451591 Comparator | Jan 2018 → May 2022 | stroke disorder | University of Edinburgh | Completed | No outcome recorded |
| Phase 2/3 | NCT02712125 Comparator | Aug 2013 → Jun 2015 | oligohydramnios | Benha University | Completed | No outcome recorded |
| Phase 3 | NCT01387672 Comparator | Sep 2011 → Dec 2014 | osteoporosis | University of Toronto | Completed | No outcome recorded |
| Phase 4 | NCT05800938 Comparator | Jun → Dec 2022 | fetal growth restriction | Ain Shams University | Completed | No outcome recorded |
| Phase 4 | NCT04661709 Background | Mar 2021 → Mar 2023 | intermediate coronary syndrome | Guang'anmen Hospital of China Academy of Chinese Medical Sciences | Unknown | No outcome recorded |
| Phase 4 | NCT03072082 Background | Jun 2017 → Dec 2018 | coronary artery disorder | Jun Li | Unknown | No outcome recorded |
| Phase 4 | NCT03407521 Comparator | Apr → Oct 2017 | — | Ain Shams University | Completed | No outcome recorded |
| Phase 4 | NCT01103154 Comparator | Mar 2005 → Jan 2010 | esophageal varices with bleeding | E-DA Hospital | Completed | No outcome recorded |
| — | NCT00374621 Comparator | Sep 2006 → Dec 2007 | cervix disorder | Stanford University | Completed | No outcome recorded |
| — | NCT00766805 Comparator | Oct 2002 → Dec 2006 | portal hypertension | Govind Ballabh Pant Hospital | Completed | No outcome recorded |
| — | NCT00168519 Comparator | Oct 2002 → Apr 2009 | type 2 diabetes mellitus | Baker Heart Research Institute | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2024-02-16 | Zydus Lifesciences Limited | Regulatory Zydus receives Final Approval from the USFDA for Isosorbide Mononitrate Extended-Release, Tablets USP, 30 mg, 60 mg, and 120 mg zyduslife.com ↗
Zydus Lifesciences Limited (including its subsidiaries/affiliates, hereafter referred to as “Zydus”) has received final approval from the United States Food and Drug Administration (USFDA) to manufacture and market Isosorbide Mononitrate Extended-Release, Tablets USP, 30 mg, 60 mg, and 120 mg (USRLD: Imdur® Extended-Release Tablets). |
All press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2024-02-16 | Zydus Lifesciences Limited | Zydus receives Final Approval from the USFDA for Isosorbide Mononitrate Extended-Release, Tablets USP, 30 mg, 60 mg, and 120 mg zyduslife.com ↗ |
Evidence & citations 15 cited values
Every value below carries the sentence it was read from. 51 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Isosorbide mononitrate | “Those who tolerate all formulations will enter the 12-week treatment phase and be randomly assigned to one of five groups: 0.3 mg sublingual nitroglycerin tablet, 0.6 mg of the...” PMID 24010992 ↗ Sep 201343“This study will test the relationship between CBP (central blood pressure) and PBP (peripheral blood pressure) effects after single and multiple doses of Isosorbide mononitrate...” NCT01130168 ↗ “Endoscopic Variceal Ligation Plus Propranolol And Isosorbide Mononitrate Versus Endoscopic Variceal Ligation Alone For Secondary Prophylaxis Of Variceal Bleeding: A Randomized...” NCT00766805 ↗ “OBJECTIVE: To evaluate the efficacy of isosorbide mononitrate (IMN) for stimulating cervical ripening among pregnant women with premature rupture of membranes (PROM) at or post term.” PMID 33458819 ↗ Feb 2021 “Randomized Controlled Trial of Nitric-oxide Donor (NOD) Isosorbide Mononitrate (IMN) Versus Placebo for Induction of Labor in Pregnancies Complicated by Preeclampsia” NCT03171480 ↗ “The purpose of this trial is to determine whether cervical ripening with isosorbide mononitrate reduce caesarean section in women with post term pregnancies.” NCT00930618 ↗ “The Isosorbide Mononitrate group: will receive (IMDUR®, 30 mg, tablet, AstraZeneca, Egypt) (Isosorbide-5-mononitrate Biphasic) twice daily for 4-6 weeks” NCT05800938 ↗ “intra-cervical Foley catheter combined with intra-vaginal isosorbide mononitrate (IMN) versus intra-vaginal misoprostol” PMID 25694257 ↗ Feb 2015 “three different daily doses of sustained release isosorbide mononitrate (SR-ISMN) will be administered” NCT02791906 ↗ “isosorbide mononitrate 60mg daily, Imdur” NCT00168519 ↗ “Effox (Isosorbide mononitrate) 20 mg” NCT02738177 ↗ |
| Known as | Effox | “Women will receive vaginally one tablet misoprostol 200 mcg(Misotac; Sigma Pharma, SAE, EGYPT) plus one tablet isosorbide mononitrate 40 mg(Effox 40 mg; Minapharm).” NCT03587077 ↗2“with Isosorbide-5-mononitrate (20 mg). Effox 20 mg )once at the beginning” NCT04981457 ↗ “40 mg isosorbide mononitrate (Effox 40 mg Minipharma Company)” NCT02573051 ↗ |
| Known as | Elantan | “Elantan SR 60 mg and Imdur 60 mg are two formulations of Isosorbide 5-mononitrate.” NCT02101710 ↗ |
| Known as | Imdur | “It is sold in the USA by Kremers Urban under the trade name Monoket, also sold in the USA under the name Imdur,” NCT03171480 ↗4“Elantan SR 60 mg and Imdur 60 mg are two formulations of Isosorbide 5-mononitrate.” NCT02101710 ↗ “Isosorbide Mononitrate 60 MG Extended Release Oral Tablet [Imdur]” NCT04218760 ↗ “Isosorbide Mononitrate (Imdur, ISMO, Monoket)” NCT02053493 ↗ “isosorbide mononitrate 60mg daily, Imdur” NCT00168519 ↗ |
| Known as | IMN | “OBJECTIVE: To evaluate the efficacy of isosorbide mononitrate (IMN) for stimulating cervical ripening among pregnant women with premature rupture of membranes (PROM) at or post term.” PMID 33458819 ↗ Feb 20213“intra-cervical Foley catheter combined with intra-vaginal isosorbide mononitrate (IMN) versus intra-vaginal misoprostol” PMID 25694257 ↗ Feb 2015 “Isosorbide mononitrate (IMN) is a drug used principally in the treatment of angina pectoris” NCT02573051 ↗ “20 mg isosorbide mononitrate (IMN) tablet applied vaginally once daily until delivery .” NCT02712125 ↗ |
| Known as | ISMN | “Thirteen patients with prehypertensive/Stage 1 hypertension were randomized to five single-dose treatments separated by ≤4 days using a double-blind, crossover study design:...” PMID 21130977 ↗ Nov 20106“We investigated whether short-term isosorbide mononitrate (ISMN) and cilostazol, alone or in combination, improved magnetic resonance imaging-measured cerebrovascular function...” PMID 34847709 ↗ Dec 2021 “extended release ISMN mononitrate (120mg ) administered once on the morning of Visit 2, 3 or 4” NCT00168519 ↗ “Drug: Isosorbide mononitrate (ISMN)” NCT03255512 ↗ “Isosorbide Mononitrate XL (ISMN)” NCT03451591 ↗ “Isosorbide mononitrate (ISMN)” NCT00871871 ↗ |
| Known as | ISMN ER | “Isosorbide mononitrate extended release (ISMN ER)” NCT01130168 ↗ |
| Known as | ISMO | “Isosorbide Mononitrate (Imdur, ISMO, Monoket)” NCT02053493 ↗ |
| Known as | Isosorbide mononitrate extended release | “Isosorbide mononitrate extended release (ISMN ER)” NCT01130168 ↗ |
| Known as | Isosorbide mononitrate non-XL (ISMN) | “Isosorbide mononitrate non-XL (ISMN)” NCT03451591 ↗ |
| Known as | isosorbide-5-mononitrate | “The objective of study is to compare the anti-ischemic efficacy and safety profiles of once daily amlodipine or isosorbide-5-mononitrate in the treatment of stable asymptomatic...” NCT00143195 ↗5“Elantan SR 60 mg and Imdur 60 mg are two formulations of Isosorbide 5-mononitrate.” NCT02101710 ↗ “with Isosorbide-5-mononitrate (20 mg). Effox 20 mg )once at the beginning” NCT04981457 ↗ “isosorbide-5-mononitrate (ISMN)” NCT01103154 ↗ |
| Known as | MNI | “Isosorbide Mononitrate (MNI)” NCT00450164 ↗ |
| Known as | Monoket | “It is sold in the USA by Kremers Urban under the trade name Monoket, also sold in the USA under the name Imdur,” NCT03171480 ↗1“Isosorbide Mononitrate (Imdur, ISMO, Monoket)” NCT02053493 ↗ |
| Modality | Other / unclassified | “the nitric oxide donor isosorbide mononitrate” PMID 25415159 ↗ Dec 2014 |
| Route | Other | “40 mg of isosorbide mononitrate given intravaginally” NCT00930618 ↗ |