Data updated: Jun 17, 2026
ISOSORBIDE MONONITRATE
Cardiovascular
Approved 1998-09-22
Isosorbide Mononitrate Tablets USP are indicated for the prevention and treatment of angina pectoris due to coronary artery disease. The onset of action of oral isosorbide mononitrate is not sufficiently rapid for this product to be useful in aborting an acute anginal episode.
Source: FDA Label • Hikma
18
Indications
--
Phase 3 Trials
27
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1998-09-22
- Routes
- ORAL
- Dosage Forms
- TABLET, EXTENDED RELEASE, TABLET
ISOSORBIDE MONONITRATE Approval History
1999
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
218 FDA actions from 1998 to 2025
Jul 2025 SUPPL
Label · Labeling
Feb 2024 ORIGINAL
Update
Nov 2022 ORIGINAL
Update
Apr 2022 ORIGINAL
Update
Jan 2022 SUPPL
Label
Nov 2018 ORIGINAL
Update
Aug 2018 ORIGINAL
Update
Oct 2017 ORIGINAL
Update
Nov 2015 SUPPL
Label
Mar 2015 SUPPL
Label
Oct 2014 SUPPL
Mfg
Jun 2011 ORIGINAL
Update
Apr 2011 SUPPL
Label
Aug 2010 ORIGINAL
Update
Oct 2007 SUPPL
Label
Jun 2007 SUPPL
Mfg
Jan 2007 SUPPL
Mfg
Mar 2006 SUPPL
Mfg
Jan 2005 ORIGINAL
Update
Nov 2004 SUPPL
Label
Mar 2004 SUPPL
Label
Sep 2002 SUPPL
Mfg
Aug 2002 SUPPL
Mfg
Mar 2002 SUPPL
Mfg
Feb 2002 SUPPL
Mfg
Nov 2001 SUPPL
Mfg
Sep 2001 SUPPL
Mfg
Aug 2001 SUPPL
Mfg
Apr 2001 SUPPL
Label
Mar 2001 SUPPL
Mfg
Mar 2001 SUPPL
Mfg
Jan 2001 SUPPL
Mfg
Jan 2001 SUPPL
Mfg
Dec 2000 SUPPL
Label
Dec 2000 SUPPL
Mfg
Aug 2000 SUPPL
Mfg
Aug 2000 SUPPL
Mfg
Jun 2000 SUPPL
Mfg
Jun 2000 SUPPL
Label
May 2000 SUPPL
Mfg
Apr 2000 SUPPL
Label
Mar 2000 SUPPL
Mfg
Mar 2000 SUPPL
Label
Jan 2000 SUPPL
Mfg
Dec 1999 SUPPL
Mfg
Nov 1999 SUPPL
Label
Sep 1999 SUPPL
Mfg
Sep 1999 SUPPL
Label
Aug 1999 SUPPL
Mfg
Jul 1999 SUPPL
Mfg
Jun 1999 SUPPL
Label
May 1999 SUPPL
Mfg
Dec 1998 ORIGINAL
Update
What ISOSORBIDE MONONITRATE Treats
18 FDA approvalsOriginally approved for its first indication in 1998 . Covers 18 distinct patient populations.
- Other (18)
Other
(18 approvals)- • Approved indication (Sep 1998)Label Letter
- • Approved indication (Oct 1998)Letter
- • Approved indication (Nov 1998)Label Letter
- • Approved indication (Dec 1998)
- • Approved indication (Oct 1999)Letter
- • Approved indication (Mar 2000)Letter
- • Approved indication (Apr 2000)Letter
- • Approved indication (Jun 2000)Letter
- • Approved indication (Oct 2000)Letter
- • Approved indication (Jan 2005)
- • Approved indication (Aug 2010)
- • Approved indication (Jun 2011)
- • Approved indication (Oct 2017)
- • Approved indication (Aug 2018)
- • Approved indication (Nov 2018)
- • Approved indication (Apr 2022)
- • Approved indication (Nov 2022)
- • Approved indication (Feb 2024)
📋
Clinical Trial Registry
13 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07456852 | MC250411 NCI-2026-01065, MC250411 | Ph 1, Ph 2 | recruiting | Vasodilator Therapy With Isosorbide Mononitrate or Diltiazem to Reduce Vasotoxicity in Patients With Gastrointestinal Cancer Receiving Fluoropyrimidine Therapy |
| NCT07252544 | 2023ZD0504802 | Ph 3 | not yet recruiting | Isosorbide Mononitrate and Butylphthalide to Reduce the Risk of Disability in Patients With Acute Lacunar Stroke (IMPACT) |
| NCT03544606 | ISMN and labor induction | Ph 4 | completed | Nitric Oxide Donor Isosorbide Mono Nitrate for Cervical Ripening in Induction of Labor |
| NCT02573051 | ANP | Ph 2 | withdrawn | Termination Of Anembryonic Pregnancy |
| NCT04051957 results posted | HSC-MS-19-0429 | Ph 2 | terminated | Isosorbide Mononitrate For Anti-Vascular Endothelial Growth Factor (VEGF) Induced Kidney Injury |
| NCT04729088 | CAEP 56.003.19PC | Ph 1 | withdrawn | Pharmacokinetics Trial of Isosorbide Mononitrate 0.5% Gel for Intra Anal Application in Healthy Subjects |
| NCT04312048 | 00249 | Ph 3 | completed | the Effect of Isosorbide Mononitrate in Reducing Pain During Cooper Intrauterine Device Insertion |
| NCT03665779 | AN1988 | Ph 3 | completed | Nitric Oxide Donor Isosorbide Mono Nitrate for Induction of Labor With Pre-labor Rupture of Membranes |
| NCT03407521 | R02 MH12345 | Ph 4 | completed | Misoprosotol and Isosorbide Mononitrate for Induction of Second Trimester Abortion |
| NCT02481323 Prevent-SVD | PrevSVD-2015 2015-001953-33, 252 (AS-PG-14-033) | Ph 2 | completed | Lacunar Intervention Trial 1 (LACI-1) |
| NCT02667535 | GDN 001/16 | Ph 1 | withdrawn | PK, PD and Safety Comparative Trial of Isosorbide Mononitrate Gel in Healthy Participants and With Anal Fissure |
| NCT02053493 NEAT-HFpeF results posted | Pro00050042 4U10HL084904-10 | Ph 2 | completed | Nitrate's Effect on Activity Tolerance in Heart Failure With Preserved Ejection Fraction |
| NCT02712125 | Benha-023 | Ph 2, Ph 3 | completed | Nitric Oxide Donors for Treatment of Isolated Oligohydramnios |
🔬
Pro Active Pipeline
Ongoing clinical trials by development phase
Loading...
⭐
Pro Key Completed Trials
Completed studies with published results, ranked by significance
Loading...
📊
Trial Timeline
Full development history with FDA approval milestones
|
Loading...
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
ISOSORBIDE MONONITRATE FDA Label Details
Indications & Usage
FDA Label (PDF)Isosorbide Mononitrate Tablets USP are indicated for the prevention and treatment of angina pectoris due to coronary artery disease. The onset of action of oral isosorbide mononitrate is not sufficiently rapid for this product to be useful in aborting an acute anginal episode.
Looking for the branded version?
MONOKET
Full clinical data, patents, trials, and competitive landscape for isosorbide mononitrate.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.