Last reviewed · How we verify
Hydralazine/Isorsorbide Dinitrate
Hydralazine/Isorsorbide Dinitrate is a Vasodilator combination Small molecule drug developed by Brigham and Women's Hospital. It is currently FDA-approved for Heart failure in self-identified Black patients, Heart failure with reduced ejection fraction. Also known as: Apresoline, Isordil.
Hydralazine relaxes blood vessel smooth muscle while isosorbide dinitrate provides nitric oxide to dilate vessels, together reducing cardiac afterload and preload to improve heart function.
Hydralazine relaxes blood vessel smooth muscle while isosorbide dinitrate provides nitric oxide to dilate vessels, together reducing cardiac afterload and preload to improve heart function. Used for Heart failure in self-identified Black patients, Heart failure with reduced ejection fraction.
At a glance
| Generic name | Hydralazine/Isorsorbide Dinitrate |
|---|---|
| Also known as | Apresoline, Isordil |
| Sponsor | Brigham and Women's Hospital |
| Drug class | Vasodilator combination |
| Target | Vascular smooth muscle (hydralazine); soluble guanylate cyclase (isosorbide dinitrate) |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | FDA-approved |
Mechanism of action
Hydralazine is a direct-acting vasodilator that preferentially dilates arterioles, reducing systemic vascular resistance and afterload. Isosorbide dinitrate is an organic nitrate that donates nitric oxide, causing venous and arterial dilation to reduce preload and afterload. The combination synergistically improves cardiac output and reduces workload on the failing heart.
Approved indications
- Heart failure in self-identified Black patients
- Heart failure with reduced ejection fraction
Common side effects
- Headache
- Dizziness
- Palpitations
- Lupus-like syndrome (hydralazine)
- Hypotension
- Tachycardia
Key clinical trials
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Hydralazine/Isorsorbide Dinitrate CI brief — competitive landscape report
- Hydralazine/Isorsorbide Dinitrate updates RSS · CI watch RSS
- Brigham and Women's Hospital portfolio CI
Frequently asked questions about Hydralazine/Isorsorbide Dinitrate
What is Hydralazine/Isorsorbide Dinitrate?
How does Hydralazine/Isorsorbide Dinitrate work?
What is Hydralazine/Isorsorbide Dinitrate used for?
Who makes Hydralazine/Isorsorbide Dinitrate?
Is Hydralazine/Isorsorbide Dinitrate also known as anything else?
What drug class is Hydralazine/Isorsorbide Dinitrate in?
What development phase is Hydralazine/Isorsorbide Dinitrate in?
What are the side effects of Hydralazine/Isorsorbide Dinitrate?
What does Hydralazine/Isorsorbide Dinitrate target?
Related
- Drug class: All Vasodilator combination drugs
- Target: All drugs targeting Vascular smooth muscle (hydralazine); soluble guanylate cyclase (isosorbide dinitrate)
- Manufacturer: Brigham and Women's Hospital — full pipeline
- Therapeutic area: All drugs in Cardiovascular
- Indication: Drugs for Heart failure in self-identified Black patients
- Indication: Drugs for Heart failure with reduced ejection fraction
- Also known as: Apresoline, Isordil
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing