Wednesday, July 8, 2026

Drug profile · INN

isosorbide dinitrate

isosorbide dinitrate (ISORDIL SUBLINGUAL) is a soluble guanylate cyclase activator. Associated with Lacuna Pharma Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

FDA: approved TGA: approved
US status approved
Patents linked 2
Pipeline programs 10
News articles 0
Drug details — isosorbide dinitrate
US status
approved
Class
Route
ORAL
Patents
2
Programs
10
Data quality
0.89

Quick answer

isosorbide dinitrate (ISORDIL SUBLINGUAL) is a soluble guanylate cyclase activator. Associated with Lacuna Pharma Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN isosorbide dinitrate
Brand ISORDIL SUBLINGUAL
Mechanism Soluble guanylate cyclase activator
Target Soluble guanylate cyclase
Route ORAL
Formulation TABLET, EXTENDED RELEASE

Mechanism of action

Soluble guanylate cyclase activator

Primary target: Soluble guanylate cyclase

Approval history

Authority Status Date
FDA approved
TGA approved

Pipeline programs

  1. Sublingual film containing Dexmedetomidine (BXCL501) Phase 3 · BioXcel Therapeutics · Agitation Associated With Bipolar Disorder
  2. Sublingual film containing dexmedetomidine (BXCL501) Phase 3 · BioXcel Therapeutics · Agitation
  3. Sublingual film containing Dexmedetomidine Phase 2 · BioXcel Therapeutics · Agitation,Psychomotor
  4. sublingual nitroglycerine Phase 2 · United Therapeutics Europe · COLIC
  5. sublingual tizanidine 12 mg Phase 2 · Teva Pharma · Spasticity
  6. Sublingual Tizanidine HCl Phase 1 · Teva Pharma · Traumatic Brain Injury
  7. Sublingual film containing BXCL501 (Dexmedetomidine) Phase 1 · BioXcel Therapeutics · Agitation
  8. Sublingual film containing Igalmi Approved · BioXcel Therapeutics · Bipolar Disorder

Related & competitor drugs

  1. isosorbide mononitrate Soluble guanylate cyclase activator
  2. nitroglycerin Soluble guanylate cyclase activator
  3. riociguat Cardiovascular system (C02)
  4. sodium nitroprusside Soluble guanylate cyclase activator
  5. nitric oxide Respiratory system (R07)
  6. vericiguat Cardiovascular system (C01)
  1. US 10213389

    Controlled release compositions comprising a combination of isosorbide dinitrate and hydralazine hydrochloride

    Expires Mon Feb 21 2039 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  2. US 9463166

    Controlled release compositions comprising a combination of isosorbide dinitrate and hydralazine hydrochloride

    Expires Mon Oct 06 2036 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

Frequently asked questions

What is isosorbide dinitrate?

isosorbide dinitrate (ISORDIL SUBLINGUAL) is a soluble guanylate cyclase activator. Associated with Lacuna Pharma Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for isosorbide dinitrate?

ISORDIL SUBLINGUAL is a marketed brand name for isosorbide dinitrate. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of isosorbide dinitrate?

isosorbide dinitrate has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.