Imdur
(Isosorbide mononitrate)ApprovedSmall molecule
Isosorbide mononitrate is used to prevent and treat chest pain (angina) caused by heart disease. It works by relaxing blood vessels to improve blood flow to the heart.[2] Imdur is currently approved and in use across 14 indications[4].[1]
Imdur is one of 338 small molecule programs targeting Angina Pectoris. It is currently in Approved.
14
Indications
26
Total Trials
3
Active Trials
337
Competitors
4
FDA Applications
NDA/BLA/ANDA regulatory filings
Pipeline
Status by Indication[4][1]
Indication
Showing 10 of 13 indications
Competition
Competitive Landscape
157 competitors in Hypertension
#DrugCompanyPhaseTrials
1Imdur
OOmnivium
Approved
Baxfendy
AstraZenecaPhase 3
Foundayo
Eli LillyPhase 3
Nitrostat
VViatris Specialty LLC
Phase 3
Minocycline /d
UUniversity of Florida
Phase 3
HCP1803-3
Hanmi Pharmaceutical Company LimitedPhase 3
Avastin
RochePreclinical
Winrevair
Merck & Co.Preclinical
Alphagan
AbbViePreclinical
Deltavit
HHyundai Pharmaceutical Co., LTD.
Preclinical
Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.
Timeline
Expected Milestones
Clinical
Trials by Indication[1]
Induction of Labor3 trials
Headache2 trials
Prophylaxis1 trial
Secondary Prophylaxis After Variceal Bleeding in Non-Responders
Completed·FFundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau·Phase 4·NCT00450164·50 enrolled
17 more indications
Cesarean Section1 trial
Pain Relief During IUD Insertion in Women Delivered Only by Elective Cesarean Section
Unknown status·—·N/A·NCT03587077·113 enrolled
Anal fissure1 trial
Pain1 trial
the Effect of Isosorbide Mononitrate in Reducing Pain During Cooper Intrauterine Device Insertion
Completed·—·Phase 3·NCT04312048·110 enrolled
Abortion1 trial
Misoprosotol and Isosorbide Mononitrate for Induction of Second Trimester Abortion
Completed·—·Phase 4·NCT03407521·60 enrolled
Kidney Injury1 trial
Intestinal Cancer1 trial
Pregnancy1 trial
Termination Of Anembryonic Pregnancy
Withdrawn·—·Phase 2·NCT02573051
ART1 trial
Uterine Artery Doppler Changes After Vaginal Administration of Isosorbide Mononitrate In Patients With URPL
Unknown status·—·Phase 1·NCT05341856·60 enrolled
Oligohydramnios1 trial
Nitric Oxide Donors for Treatment of Isolated Oligohydramnios
Completed·—·Phase 2/3·NCT02712125·100 enrolled
Heart Failure1 trial
Left Ventricular Hypertrophy1 trial
Effect of Isosorbide Mononitrate on Hypertension to Improve Left Ventricular Hypertrophy, Fibrosis and Myocardial Function
Withdrawn·—·Phase 2·NCT01961453
Coronary Artery Disease1 trial
Safety and Efficacy1 trial
Safety and Efficacy of the Effect of Isosorbide Mononitrate in Reducing Pain During Levonorgestrel-releasing Intrauterine Device Insertion
Unknown status·—·Phase 3·NCT04311658·88 enrolled
Homeostasis1 trial
Induction of Labour1 trial
Isosorbide Mononitrate in Induction of Labour
Unknown status·—·Phase 1·NCT04482881·130 enrolled
Stroke1 trial
Isosorbide Mononitrate and Butylphthalide to Reduce the Risk of Disability in Patients With Acute Lacunar Stroke (IMPACT)
Not yet recruiting·—·Phase 3·NCT07252544·3,156 enrolled
Regulatory
FDA Approval Timeline[5]
Jan 1, 1982
ISMOTIC
NDA NDA017063
Dec 30, 1991
ISMO
NDA NDA019091
Jun 30, 1993
MONOKET
NDA NDA020215
Aug 12, 1993
IMDUR
NDA NDA020225
Sources
References
- [1]
- [2]MedlinePlus Drug Information — Imdur drug information. U.S. National Library of Medicine, National Institutes of Health.
- [3]
- [4]Open Targets Platform — Drug–disease associations for Isosorbide mononitrate. EMBL-EBI & Wellcome Sanger Institute.
- [5]
- [6]